Other products in the same Health Canada class (R03D) — coverage varies; not interchangeable
Omalizumab (Omlyclo): limited Use 726, 727, 728
Apo-Montelukast · DIN 02377608 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Apo-Montelukast · DIN 02377608
Manufacturer: Apotex Inc.; listing date 2012-02-29
Health Canada: Marketed since 2020-04-01 · brand APO-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Apotex inc · schedule Prescription
Apo-Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86341 · Verify on the e-Formulary ↗ (DIN 02377608)
Source record
DIN 02377608: Apo-Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id APX
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02377608
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86341Interchangeable products
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: resolved shortage (ended 2023-10-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02377608
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Auro-Montelukast Chewable Tablet · DIN 02422867
Manufacturer: Auro Pharma Inc.; listing date 2014-05-29
Health Canada: Marketed since 2022-05-10 · brand AURO-MONTELUKAST CHEWABLE TABLET · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Auro pharma inc · schedule Prescription
Auro-Montelukast Chewable Tablet: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90752 · Verify on the e-Formulary ↗ (DIN 02422867)
Source record
DIN 02422867: Auro-Montelukast Chewable Tablet
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id AUR
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02422867
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90752Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: discontinued (2023-12-29, reported by AURO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02422867
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Jamp Montelukast Chewable Tablets · DIN 02514877
Manufacturer: Jamp Pharma Corporation; listing date 2022-10-31
Health Canada: Marketed since 2022-08-26 · brand JAMP MONTELUKAST CHEWABLE TABLETS · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Jamp pharma corporation · schedule Prescription
Jamp Montelukast Chewable Tablets: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100428 · Verify on the e-Formulary ↗ (DIN 02514877)
Source record
DIN 02514877: Jamp Montelukast Chewable Tablets
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id JPC
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02514877
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100428Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: resolved shortage (ended 2024-03-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02514877
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mint-Montelukast · DIN 02408627 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Mint-Montelukast · DIN 02408627
Manufacturer: Mint Pharmaceuticals Inc.; listing date 2014-01-03
Health Canada: Marketed since 2013-10-17 · brand MINT-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Mint pharmaceuticals inc · schedule Prescription
Mint-Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89336 · Verify on the e-Formulary ↗ (DIN 02408627)
Source record
DIN 02408627: Mint-Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id MIN
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02408627
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89336Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02408627
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Montelukast · DIN 02382458 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Montelukast · DIN 02382458
Manufacturer: Sivem Pharmaceuticals ULC; listing date 2020-06-30
Health Canada: Marketed since 2018-03-26 · brand MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86829 · Verify on the e-Formulary ↗ (DIN 02382458)
Source record
DIN 02382458: Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id SIV
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02382458
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86829Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: discontinued (2018-04-06, reported by SIVEM PHARMACEUTICALS ULC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02382458
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Montelukast · DIN 02354977 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
PMS-Montelukast · DIN 02354977
Manufacturer: Pharmascience Inc.; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand PMS-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Pharmascience inc · schedule Prescription
PMS-Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84016 · Verify on the e-Formulary ↗ (DIN 02354977)
Source record
DIN 02354977: PMS-Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id PMS
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02354977
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84016Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: resolved shortage (ended 2023-12-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02354977
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Montelukast · DIN 02330385 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Sandoz Montelukast · DIN 02330385
Manufacturer: Sandoz Canada Inc.; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand SANDOZ MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81612 · Verify on the e-Formulary ↗ (DIN 02330385)
Source record
DIN 02330385: Sandoz Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id SDZ
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02330385
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81612Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Singulair · DIN 02243602 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02330385
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Singulair · DIN 02243602 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Savings card: RxHelp ONE lists Singulair (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim. (rxhelp.ca ↗)
1 brand, same coverage
Singulair · DIN 02243602
Manufacturer: Organon Canada Inc.; listing date 2004-04-06
Health Canada: Marketed since 2022-03-28 · brand SINGULAIR · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Organon canada inc. · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67521 · Verify on the e-Formulary ↗ (DIN 02243602)
Source record
DIN 02243602: Singulair
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id OCI
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $1.8503; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02243602
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67521Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Teva-Montelukast · DIN 02355507 · $0.2758
Shortage status: resolved shortage (ended 2023-10-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02243602
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Montelukast · DIN 02355507 · 4mg · chewable tablet
Limited Use — Reason for Use code 382 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 382 required
Write on scriptLU code 382 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Ontario Limited Use criteria — code 382
Reason for Use code 382
For the treatment of asthma in patients aged 2-5 years old.
Coverage limit:
LU Authorization Period: 1 year
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Teva-Montelukast · DIN 02355507
Manufacturer: Teva Canada Limited; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand TEVA-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG · company Teva canada limited · schedule Prescription
Teva-Montelukast: Formulary list price $0.2758/unit (unit not stated in source; not the patient's cost)
Ministry pays: $0.2758 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84073 · Verify on the e-Formulary ↗ (DIN 02355507)
Source record
DIN 02355507: Teva-Montelukast
Raw flags: sec12=Y, sec3=Y
Item: 920000406; group id 935; item number 2229; lccId 00154; manufacturer id TEV
Source form: Chew Tab; strength: 4mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $0.2758; ministry $0.2758
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02355507
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84073Interchangeable products
Apo-Montelukast · DIN 02377608 · $0.2758
Auro-Montelukast Chewable Tablet · DIN 02422867 · $0.2758
Jamp Montelukast Chewable Tablets · DIN 02514877 · $0.2758
Jamp-Montelukast · DIN 02442353 · $0.2758
Mar-Montelukast · DIN 02399865 · $0.2758
Mint-Montelukast · DIN 02408627 · $0.2758
Montelukast · DIN 02382458 · $0.2758
Nat-Montelukast · DIN 02522101 · $0.2758
PMS-Montelukast · DIN 02354977 · $0.2758
Sandoz Montelukast · DIN 02330385 · $0.2758
Singulair · DIN 02243602 · $0.2758
Shortage status: resolved shortage (ended 2020-05-08); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02355507
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Montelukast · DIN 02358611 · 4mg · Gran Pk
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Montelukast · DIN 02358611
Manufacturer: Sandoz Canada Inc.; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand SANDOZ MONTELUKAST · ATC R03DC03 MONTELUKAST · form Granules · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG/SACHET · company Sandoz canada incorporated · schedule Prescription
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84365 · Verify on the e-Formulary ↗ (DIN 02358611)
Source record
DIN 02358611: Sandoz Montelukast
Raw flags: notABenefit=Y, sec3=Y, sec3b=Y
Item: 920000645; group id 936; item number 2231; lccId None; manufacturer id SDZ
Source form: Gran Pk; strength: 4mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit
Source prices (unrounded): $1.3440; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02358611
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84365Interchangeable products
Singulair · DIN 02247997 · not recorded
Shortage status: discontinued (2025-11-07, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02358611
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Montelukast · DIN 02377616 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Apo-Montelukast · DIN 02377616
Manufacturer: Apotex Inc.; listing date 2012-02-29
Health Canada: Marketed since 2020-04-01 · brand APO-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Apotex inc · schedule Prescription
Apo-Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86342 · Verify on the e-Formulary ↗ (DIN 02377616)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02377616).
DIN 02377616: Apo-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id APX
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02377616
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86342Interchangeable products
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2026-02-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02377616
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Auro-Montelukast Chewable Tablet · DIN 02422875
Manufacturer: Auro Pharma Inc.; listing date 2016-02-25
Health Canada: Marketed since 2022-05-10 · brand AURO-MONTELUKAST CHEWABLE TABLET · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Auro pharma inc · schedule Prescription
Auro-Montelukast Chewable Tablet: Formulary list price $1.2077/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2077 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90753 · Verify on the e-Formulary ↗ (DIN 02422875)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02422875).
DIN 02422875: Auro-Montelukast Chewable Tablet
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id AUR
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2077; ministry $1.2077
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02422875
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90753Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: discontinued (2023-12-29, reported by AURO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02422875
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Jamp Montelukast Chewable Tablets · DIN 02514885
Manufacturer: Jamp Pharma Corporation; listing date 2022-03-31
Health Canada: Marketed since 2022-08-26 · brand JAMP MONTELUKAST CHEWABLE TABLETS · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Jamp pharma corporation · schedule Prescription
Jamp Montelukast Chewable Tablets: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100429 · Verify on the e-Formulary ↗ (DIN 02514885)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02514885).
DIN 02514885: Jamp Montelukast Chewable Tablets
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id JPC
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02514885
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100429Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02514885
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mint-Montelukast · DIN 02408635 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Mint-Montelukast · DIN 02408635
Manufacturer: Mint Pharmaceuticals Inc.; listing date 2014-01-03
Health Canada: Marketed since 2013-10-17 · brand MINT-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Mint pharmaceuticals inc · schedule Prescription
Mint-Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89337 · Verify on the e-Formulary ↗ (DIN 02408635)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02408635).
DIN 02408635: Mint-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id MIN
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02408635
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89337Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2018-05-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02408635
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Montelukast · DIN 02379325 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Montelukast · DIN 02379325
Manufacturer: Sanis Health Inc.; listing date 2022-08-31
Health Canada: Marketed since 2022-09-28 · brand MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Sanis health inc · schedule Prescription
Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86520 · Verify on the e-Formulary ↗ (DIN 02379325)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02379325).
DIN 02379325: Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id SAI
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02379325
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86520Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2024-12-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02379325
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Montelukast · DIN 02382466 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Montelukast · DIN 02382466
Manufacturer: Sivem Pharmaceuticals ULC; listing date 2020-06-30
Health Canada: Marketed since 2018-03-26 · brand MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86830 · Verify on the e-Formulary ↗ (DIN 02382466)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02382466).
DIN 02382466: Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id SIV
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02382466
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86830Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2018-08-06); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02382466
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Montelukast · DIN 02354985 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
PMS-Montelukast · DIN 02354985
Manufacturer: Pharmascience Inc.; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand PMS-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Pharmascience inc · schedule Prescription
PMS-Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84017 · Verify on the e-Formulary ↗ (DIN 02354985)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02354985).
DIN 02354985: PMS-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id PMS
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02354985
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84017Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2022-09-29); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02354985
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sandoz Montelukast · DIN 02330393 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Sandoz Montelukast · DIN 02330393
Manufacturer: Sandoz Canada Inc.; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand SANDOZ MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Sandoz canada incorporated · schedule Prescription
Sandoz Montelukast: Formulary list price $1.2075/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2075 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81613 · Verify on the e-Formulary ↗ (DIN 02330393)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02330393).
DIN 02330393: Sandoz Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id SDZ
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2075; ministry $1.2075
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02330393
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81613Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Singulair · DIN 02238216 · not recorded
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2023-06-05); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02330393
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Singulair · DIN 02238216 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
How long EAP takes
Turnaround times
The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used.
Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE.
EAP Weekly Progress Report
Date: September 15, 2026
Processing categories and examples | Target | Current |
Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day |
Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days |
Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days |
Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗)
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)
Savings card: RxHelp ONE lists Singulair (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim. (rxhelp.ca ↗)
1 brand, same coverage
Singulair · DIN 02238216
Manufacturer: Organon Canada Inc.; listing date 2012-01-19
Health Canada: Marketed since 2022-06-23 · brand SINGULAIR · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Organon canada inc. · schedule Prescription
Singulair: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=61609 · Verify on the e-Formulary ↗ (DIN 02238216)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02238216).
DIN 02238216: Singulair
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id OCI
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02238216
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=61609Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Teva-Montelukast · DIN 02355515 · $1.2077
Shortage status: resolved shortage (ended 2026-07-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02238216
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Montelukast · DIN 02355515 · 5mg · chewable tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Teva-Montelukast · DIN 02355515
Manufacturer: Teva Canada Limited; listing date 2012-01-19
Health Canada: Marketed since 2011-10-11 · brand TEVA-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet (chewable) · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 5 MG · company Teva canada limited · schedule Prescription
Teva-Montelukast: Formulary list price $1.2077/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.2077 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84074 · Verify on the e-Formulary ↗ (DIN 02355515)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02355515).
DIN 02355515: Teva-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000315; group id 936; item number 2230; lccId None; manufacturer id TEV
Source form: Chew Tab; strength: 5mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.2077; ministry $1.2077
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02355515
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84074Interchangeable products
Apo-Montelukast · DIN 02377616 · $1.2075
Auro-Montelukast Chewable Tablet · DIN 02422875 · $1.2077
Jamp Montelukast Chewable Tablets · DIN 02514885 · $1.2075
Jamp-Montelukast · DIN 02442361 · $1.2075
Mar-Montelukast · DIN 02399873 · $1.2075
Mint-Montelukast · DIN 02408635 · $1.2075
Montelukast · DIN 02379325 · $1.2075
Montelukast · DIN 02382466 · $1.2075
Nat-Montelukast · DIN 02522128 · $1.2077
PMS-Montelukast · DIN 02354985 · $1.2075
Ran-Montelukast · DIN 02402807 · $1.2075
Sandoz Montelukast · DIN 02330393 · $1.2075
Singulair · DIN 02238216 · not recorded
Shortage status: resolved shortage (ended 2026-01-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02355515
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Ach-Montelukast · DIN 02379236 · 10mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Ach-Montelukast · DIN 02379236
Manufacturer: Accord Healthcare Inc.; listing date 2012-12-21
Health Canada: Marketed since 2023-01-25 · brand ACH-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 10 MG · company Accord healthcare inc · schedule Prescription
Ach-Montelukast: Formulary list price $1.7735/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.7735 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86511 · Verify on the e-Formulary ↗ (DIN 02379236)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02379236).
DIN 02379236: Ach-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000316; group id 936; item number 2232; lccId None; manufacturer id ACH
Source form: Tab; strength: 10mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.7735; ministry $1.7735
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02379236
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86511Interchangeable products
Apo-Montelukast · DIN 02374609 · $1.7735
Auro-Montelukast · DIN 02401274 · $1.7735
Jamp-Montelukast · DIN 02391422 · $1.7735
M-Montelukast · DIN 02488183 · $1.7735
Mar-Montelukast · DIN 02399997 · $1.7735
Mint-Montelukast · DIN 02408643 · $1.7735
Montelukast · DIN 02379333 · $1.7735
Montelukast · DIN 02382474 · $1.7735
NRA-Montelukast · DIN 02489821 · $1.7735
Nat-Montelukast · DIN 02522136 · $1.7737
PMS-Montelukast FC · DIN 02373947 · $1.7735
Ran-Montelukast · DIN 02389517 · $1.7735
Sandoz Montelukast · DIN 02328593 · $1.7735
Singulair · DIN 02238217 · not recorded
Teva-Montelukast · DIN 02355523 · $1.7737
Shortage status: resolved shortage (ended 2026-09-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02379236
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Montelukast · DIN 02374609 · 10mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Apo-Montelukast · DIN 02374609
Manufacturer: Apotex Inc.; listing date 2012-01-19
Health Canada: Marketed since 2020-02-26 · brand APO-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 10 MG · company Apotex inc · schedule Prescription
Apo-Montelukast: Formulary list price $1.7735/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.7735 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=85993 · Verify on the e-Formulary ↗ (DIN 02374609)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02374609).
DIN 02374609: Apo-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000316; group id 936; item number 2232; lccId None; manufacturer id APX
Source form: Tab; strength: 10mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.7735; ministry $1.7735
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02374609
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=85993Interchangeable products
Ach-Montelukast · DIN 02379236 · $1.7735
Auro-Montelukast · DIN 02401274 · $1.7735
Jamp-Montelukast · DIN 02391422 · $1.7735
M-Montelukast · DIN 02488183 · $1.7735
Mar-Montelukast · DIN 02399997 · $1.7735
Mint-Montelukast · DIN 02408643 · $1.7735
Montelukast · DIN 02379333 · $1.7735
Montelukast · DIN 02382474 · $1.7735
NRA-Montelukast · DIN 02489821 · $1.7735
Nat-Montelukast · DIN 02522136 · $1.7737
PMS-Montelukast FC · DIN 02373947 · $1.7735
Ran-Montelukast · DIN 02389517 · $1.7735
Sandoz Montelukast · DIN 02328593 · $1.7735
Singulair · DIN 02238217 · not recorded
Teva-Montelukast · DIN 02355523 · $1.7737
Shortage status: active shortage (reported 2026-09-01, last updated 2026-09-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02374609
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Montelukast · DIN 02401274 · 10mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Auro-Montelukast · DIN 02401274
Manufacturer: Auro Pharma Inc.; listing date 2013-04-30
Health Canada: Marketed since 2013-03-04 · brand AURO-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 10 MG · company Auro pharma inc · schedule Prescription
Auro-Montelukast: Formulary list price $1.7735/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.7735 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88618 · Verify on the e-Formulary ↗ (DIN 02401274)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02401274).
DIN 02401274: Auro-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000316; group id 936; item number 2232; lccId None; manufacturer id AUR
Source form: Tab; strength: 10mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.7735; ministry $1.7735
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02401274
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88618Interchangeable products
Ach-Montelukast · DIN 02379236 · $1.7735
Apo-Montelukast · DIN 02374609 · $1.7735
Jamp-Montelukast · DIN 02391422 · $1.7735
M-Montelukast · DIN 02488183 · $1.7735
Mar-Montelukast · DIN 02399997 · $1.7735
Mint-Montelukast · DIN 02408643 · $1.7735
Montelukast · DIN 02379333 · $1.7735
Montelukast · DIN 02382474 · $1.7735
NRA-Montelukast · DIN 02489821 · $1.7735
Nat-Montelukast · DIN 02522136 · $1.7737
PMS-Montelukast FC · DIN 02373947 · $1.7735
Ran-Montelukast · DIN 02389517 · $1.7735
Sandoz Montelukast · DIN 02328593 · $1.7735
Singulair · DIN 02238217 · not recorded
Teva-Montelukast · DIN 02355523 · $1.7737
Shortage status: resolved shortage (ended 2024-04-29); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02401274
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp-Montelukast · DIN 02391422 · 10mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block.
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Montelukast
Brand(s): Singulair
DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet
Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims:
6.2 Medically Necessary "No Substitution" Claims
The Side Effect Reporting Form will not have to be renewed. However, the
pharmacy must maintain a copy of the prescription that contains a direction that
there be no substitution and the required Health Canada Side Effect Reporting Form
(completed and signed by the prescriber). The prescriber must write “No
Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and
indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will
be reimbursed the DBP plus a mark-up and the lesser of the posted usual and
customary fee or the ODB dispensing fee minus the applicable ODB co-payment
amount. Where a completed Side Effect Reporting Form is not available at the
pharmacy during an inspection, the difference between the cost of the higher-cost
product and the lowest DBP listed for the interchangeable category will be
recovered.
(ontario.ca, Revision #17; 2026-08-03 ↗)
6.2 Medically Necessary "No Substitution" Claims
The Ministry will provide reimbursement of a higher-cost interchangeable product in
medically necessary circumstances where a patient has experienced a significant
adverse reaction with two (2) lower-cost interchangeable drug products, where
available. When a prescriber identifies a patient for which it is medically necessary
that a higher cost interchangeable product be provided, the prescriber must:
• Complete, sign and forward to the pharmacist a copy of the Health Canada
side effect reporting form for each lower-cost interchangeable drug product
trialed (Side Effect Reporting Form[s]); and
• Write “No Substitution” or “No Sub” on a written prescription or indicate “No
Substitution” to the pharmacist in the case of a verbal prescription.
The prescriber should keep a copy of the completed form in the patient’s record for
future use and reference.
In the case of a written prescription, when the pharmacist or dispensing physician
receives a prescription with the written notation “No Substitution” or “No Sub”,
reimbursement will be provided for the higher-cost interchangeable product only if
the prescription is accompanied by a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed.
This form must be completely filled out noting the details of the adverse reaction
and signed by the prescriber.
In the case of a verbal prescription, the prescriber must satisfy the operator of the
pharmacy or dispensing physician that a completed Health Canada Side Effect
Reporting Form for each of the lower-cost interchangeable drug products trialed
has been completed and signed by the prescriber. A written record of this verbal
prescription and the completed Health Canada Side Effect Reporting Form must be
received by the pharmacy prior to claim submission.
Upon receipt, the pharmacist must:
• Fax, submit online or mail the completed and signed form to Health Canada’s
Canada Vigilance Program; and
• Retain his or her copy of the completed and signed Side Effect Reporting
Form.
(ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Jamp-Montelukast · DIN 02391422
Manufacturer: Jamp Pharma Corporation; listing date 2012-11-27
Health Canada: Marketed since 2020-03-25 · brand JAMP-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 10 MG · company Jamp pharma corporation · schedule Prescription
Jamp-Montelukast: Formulary list price $1.7735/unit (unit not stated in source; not the patient's cost)
Ministry pays: $1.7735 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87677 · Verify on the e-Formulary ↗ (DIN 02391422)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02391422).
DIN 02391422: Jamp-Montelukast
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000316; group id 936; item number 2232; lccId None; manufacturer id JPC
Source form: Tab; strength: 10mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $1.7735; ministry $1.7735
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02391422
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87677Interchangeable products
Ach-Montelukast · DIN 02379236 · $1.7735
Apo-Montelukast · DIN 02374609 · $1.7735
Auro-Montelukast · DIN 02401274 · $1.7735
M-Montelukast · DIN 02488183 · $1.7735
Mar-Montelukast · DIN 02399997 · $1.7735
Mint-Montelukast · DIN 02408643 · $1.7735
Montelukast · DIN 02379333 · $1.7735
Montelukast · DIN 02382474 · $1.7735
NRA-Montelukast · DIN 02489821 · $1.7735
Nat-Montelukast · DIN 02522136 · $1.7737
PMS-Montelukast FC · DIN 02373947 · $1.7735
Ran-Montelukast · DIN 02389517 · $1.7735
Sandoz Montelukast · DIN 02328593 · $1.7735
Singulair · DIN 02238217 · not recorded
Teva-Montelukast · DIN 02355523 · $1.7737
Shortage status: resolved shortage (ended 2022-06-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02391422
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered
· 16 products · General benefit · strengths: 10mg, 20mg · Tab
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00
and 75 more
Full class listing
Related classes:
Same formulary class, not same indication: class membership alone does not establish equivalent uses.What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE
Asthma
SINGULAIR® (montelukast sodium) is indicated in adult and pediatric patients 2 years of age
and older for the prophylaxis and chronic treatment of asthma, including prevention of day- and
night-time symptoms, and the treatment of acetylsalicylic acid (ASA)-sensitive asthmatic
patients.
SINGULAIR® is effective alone or in combination with other agents used in the maintenance
treatment of chronic asthma. SINGULAIR® and inhaled corticosteroids may be used
concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid
dose while maintaining clinical stability.
SINGULAIR® (montelukast sodium) Page 3 of 33
In patients who continue to experience asthma symptoms, SINGULAIR® can be an additional
treatment option following initial management with an “as needed” short-acting beta-agonist
(SABA), an inhaled corticosteroid, or inhaled corticosteroid together with a long-acting beta
agonist.
In adults, SINGULAIR® can be a treatment option after “as needed” SABAs if patients remain
symptomatic and cannot or will not use an inhaler device or would prefer not to be treat…
https://pdf.hres.ca/dpd_pm/00060895.PDF
PM date: May 5, 2021
Source product: SINGULAIR; DIN 02238216; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.
Availability
Auro-Montelukast Chewable Tablet · DIN 02422867
Shortage status: discontinued (2023-12-29, reported by AURO PHARMA INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02422867
Apo-Montelukast · DIN 02374609
Shortage status: active shortage (reported 2026-09-01, last updated 2026-09-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02374609
SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE
Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.
EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026
Posted turnaround and Telephone Request Service scope
Turnaround times
The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used.
Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE.
EAP Weekly Progress Report
Date: September 15, 2026
Processing categories and examples | Target | Current |
Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day |
Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days |
Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days |
Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Prepare answers: For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
For the treatment of asthma patients who cannot manage the use of an inhalation
device despite assistance with a spacer (e.g. physically or mentally disabled patients or
pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be
controlled on ICS alone and where the condition remains uncontrolled despite using full
doses of ICS with addition of LABA, and with assurance of good adherence and inhaler
technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following
apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health
care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65
Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.
Other review policies
For Sandoz Montelukast, Apo-Montelukast, Auro-Montelukast Chewable Tablet, Jamp Montelukast Chewable Tablets, Mint-Montelukast, Montelukast, PMS-Montelukast, Teva-Montelukast, Ach-Montelukast, Auro-Montelukast, Jamp-Montelukast: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.
For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy
Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.
For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)
Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.