TENOFOVIR DISOPROXIL
All strengths: Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 required; same patient cost rules
Shared coverage and patient cost rules
StatusLimited Use — Reason for Use code 517, 518, 519, 520, 521, 522 required
Patient paysPatient pays: program not supplied; amount cannot be determined.
Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable
- Abacavir (Ziagen): general benefit
- Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
- Entecavir (Baraclude): limited Use 505, 506, 507, 508
- Tenofovir alafenamide (Vemlidy): limited Use 517, 518, 519, 520, 521
- Adefovir dipivoxil (Hepsera): not a benefit
- Zidovudine (Retrovir): not a benefit
43 more in the class list below
Apo-Tenofovir · DIN 02451980 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02451980
Manufacturer: Apotex Inc.; listing date 2017-09-28
Health Canada: Marketed since 2017-07-26 · brand APO-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Apotex inc · schedule Prescription
Apo-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=93838 · Verify on the e-Formulary ↗ (DIN 02451980)
Source record
DIN 02451980: Apo-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id APX
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02451980
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93838
Interchangeable products
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: resolved shortage (ended 2020-11-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02451980
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Tenofovir · DIN 02460173 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02460173
Manufacturer: Auro Pharma Inc.; listing date 2017-09-28
Health Canada: Marketed since 2017-07-26 · brand AURO-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Auro pharma inc · schedule Prescription
Auro-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=94747 · Verify on the e-Formulary ↗ (DIN 02460173)
Source record
DIN 02460173: Auro-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id AUR
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02460173
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94747
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: resolved shortage (ended 2024-11-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02460173
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp-Tenofovir · DIN 02479087 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02479087
Manufacturer: Jamp Pharma Corporation; listing date 2019-02-28
Health Canada: Marketed since 2018-10-24 · brand JAMP-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Jamp pharma corporation · schedule Prescription
Jamp-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=96979 · Verify on the e-Formulary ↗ (DIN 02479087)
Source record
DIN 02479087: Jamp-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id JPC
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02479087
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96979
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
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=02479087
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mint-Tenofovir · DIN 02512939 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02512939
Manufacturer: Mint Pharmaceuticals Inc.; listing date 2021-11-30
Health Canada: Marketed since 2021-09-07 · brand MINT-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Mint pharmaceuticals inc · schedule Prescription
Mint-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=100218 · Verify on the e-Formulary ↗ (DIN 02512939)
Source record
DIN 02512939: Mint-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id MIN
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02512939
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100218
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
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=02512939
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mylan-Tenofovir Disoproxil · DIN 02452634 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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
Mylan-Tenofovir Disoproxil · DIN 02452634
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2017-09-28
Health Canada: Marketed since 2017-07-31 · brand MYLAN-TENOFOVIR DISOPROXIL · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Mylan pharmaceuticals ulc · schedule Prescription
Mylan-Tenofovir Disoproxil: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=93899 · Verify on the e-Formulary ↗ (DIN 02452634)
Source record
DIN 02452634: Mylan-Tenofovir Disoproxil
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id MYL
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02452634
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93899
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: active shortage (reported 2025-05-05, last updated 2025-09-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02452634
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Nat-Tenofovir · DIN 02472511 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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
Nat-Tenofovir · DIN 02472511
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2018-07-31
Health Canada: Marketed since 2018-03-15 · brand NAT-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=96182 · Verify on the e-Formulary ↗ (DIN 02472511)
Source record
DIN 02472511: Nat-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id NAT
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02472511
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96182
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
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=02472511
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Tenofovir · DIN 02453940 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02453940
Manufacturer: Pharmascience Inc.; listing date 2018-06-29
Health Canada: Marketed since 2018-04-25 · brand PMS-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Pharmascience inc · schedule Prescription
PMS-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=94047 · Verify on the e-Formulary ↗ (DIN 02453940)
Source record
DIN 02453940: PMS-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id PMS
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02453940
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94047
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: resolved shortage (ended 2024-09-29); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02453940
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Tenofovir · DIN 02512327 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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
Tenofovir · DIN 02512327
Manufacturer: Sanis Health Inc.; listing date 2021-10-29
Health Canada: Marketed since 2021-08-20 · brand TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Sanis health inc · schedule Prescription
Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=100162 · Verify on the e-Formulary ↗ (DIN 02512327)
Source record
DIN 02512327: Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id SAI
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02512327
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100162
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
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=02512327
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Tenofovir · DIN 02523922 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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
Tenofovir · DIN 02523922
Manufacturer: Sivem Pharmaceuticals ULC; listing date 2022-07-29
Health Canada: Marketed since 2026-03-04 · brand TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=101297 · Verify on the e-Formulary ↗ (DIN 02523922)
Source record
DIN 02523922: Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id SIV
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02523922
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101297
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: active shortage (reported 2025-07-02, estimated to end 2026-10-01, last updated 2026-08-17); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02523922
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Tenofovir · DIN 02403889 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
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-Tenofovir · DIN 02403889
Manufacturer: Teva Canada Limited; listing date 2017-09-28
Health Canada: Marketed since 2017-07-26 · brand TEVA-TENOFOVIR · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Teva canada limited · schedule Prescription
Teva-Tenofovir: Formulary list price $4.8884/unit (unit not stated in source; not the patient's cost)
Ministry pays: $4.8884 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=88865 · Verify on the e-Formulary ↗ (DIN 02403889)
Source record
DIN 02403889: Teva-Tenofovir
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id TEV
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $4.8884; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02403889
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88865
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Viread · DIN 02247128 · $4.8884
Shortage status: discontinued (2025-04-07, reported by TEVA CANADA LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02403889
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Viread · DIN 02247128 · 300mg · tablet
Limited Use — Reason for Use code 517, 518, 519, 520, 521, 522 requiredMarketed · checked 2026-09-02
Write on scriptLU code 517, 518, 519, 520, 521, 522 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 517, 518, 519, 520, 521, 522
Reason for Use code 517
Confirmed chronic Hepatitis B infection in persons with
- HBV DNA greater than or equal to 1000 IU/mL
AND
- ALT levels greater than ULN
OR
- Evidence of fibrosis
OR
- Documented evidence of cirrhosis
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 518
For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 519
Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 520
Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 521
Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.
Coverage limit:
LU Authorization Period: 1 year
Reason for Use code 522
For HIV/AIDS.
Coverage limit:
LU Authorization Period: 1 year
1 brand, same coverage
Viread · DIN 02247128
Manufacturer: Gilead Sciences Canada, Inc.; listing date 2007-01-02
Health Canada: Marketed since 2009-05-21 · brand VIREAD · ATC J05AF07 TENOFOVIR DISOPROXIL · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Gilead sciences canada inc · schedule Prescription
Ministry pays: $4.8884 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=71368 · Verify on the e-Formulary ↗ (DIN 02247128)
Source record
DIN 02247128: Viread
Raw flags: sec12=Y, sec3=Y
Item: 081800083; group id 113; item number 0195; lccId 00297; manufacturer id GIL
Source form: Tab; strength: 300mg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $19.5537; ministry $4.8884
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02247128
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=71368
Interchangeable products
Apo-Tenofovir · DIN 02451980 · $4.8884
Auro-Tenofovir · DIN 02460173 · $4.8884
Jamp-Tenofovir · DIN 02479087 · $4.8884
Mint-Tenofovir · DIN 02512939 · $4.8884
Mylan-Tenofovir Disoproxil · DIN 02452634 · $4.8884
Nat-Tenofovir · DIN 02472511 · $4.8884
PMS-Tenofovir · DIN 02453940 · $4.8884
Tenofovir · DIN 02512327 · $4.8884
Tenofovir · DIN 02523922 · $4.8884
Teva-Tenofovir · DIN 02403889 · $4.8884
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=02247128
Shortage record checked 2026-09-13T08:10:21.292534+00:00
EFAVIRENZ/TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE
All products: general benefit
Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable
- Abacavir (Ziagen): general benefit
- Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
- Entecavir (Baraclude): limited Use 505, 506, 507, 508
- Tenofovir alafenamide (Vemlidy): limited Use 517, 518, 519, 520, 521
- Adefovir dipivoxil (Hepsera): not a benefit
- Zidovudine (Retrovir): not a benefit
43 more in the class list below
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · 600mg/300mg/200mg · tablet
General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
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.
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-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247
Manufacturer: Apotex Inc.; listing date 2018-10-31
Health Canada: Marketed since 2018-09-04 · brand APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG, EFAVIRENZ 600 MG · company Apotex inc · schedule Prescription
Apo-Efavirenz-Emtricitabine-Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=95665 · Verify on the e-Formulary ↗ (DIN 02468247)
Source record
DIN 02468247: Apo-Efavirenz-Emtricitabine-Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id APX
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02468247
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95665
Interchangeable products
Atripla · DIN 02300699 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: resolved shortage (ended 2024-09-05); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02468247
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · 600mg/300mg/200mg · tablet
General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
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.
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-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404
Manufacturer: Auro Pharma Inc.; listing date 2020-05-29
Health Canada: Marketed since 2020-03-18 · brand AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients EFAVIRENZ 600 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG · company Auro pharma inc · schedule Prescription
Auro-Efavirenz-Emtricitabine-Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=96916 · Verify on the e-Formulary ↗ (DIN 02478404)
Source record
DIN 02478404: Auro-Efavirenz-Emtricitabine-Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id AUR
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02478404
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96916
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Atripla · DIN 02300699 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: resolved shortage (ended 2024-12-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02478404
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · 600mg/300mg/200mg · tablet
General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
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.
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 Efavirenz/Emtricitabine/Tenofovir · DIN 02519461
Manufacturer: Jamp Pharma Corporation; listing date 2023-01-31
Health Canada: Marketed since 2022-12-14 · brand JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG, EFAVIRENZ 600 MG · company Jamp pharma corporation · schedule Prescription
Jamp Efavirenz/Emtricitabine/Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=100873 · Verify on the e-Formulary ↗ (DIN 02519461)
Source record
DIN 02519461: Jamp Efavirenz/Emtricitabine/Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id JPC
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02519461
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100873
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Atripla · DIN 02300699 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: active shortage (reported 2026-03-12, estimated to end 2026-12-31, last updated 2026-03-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02519461
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · 600mg/300mg/200mg · tablet
General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
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.
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
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2017-09-28
Health Canada: Marketed since 2017-07-31 · brand MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients EMTRICITABINE 200 MG, EFAVIRENZ 600 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Mylan pharmaceuticals ulc · schedule Prescription
Mylan-Efavirenz/Emtricitabine/Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=94902 · Verify on the e-Formulary ↗ (DIN 02461412)
Source record
DIN 02461412: Mylan-Efavirenz/Emtricitabine/Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id MYL
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461412
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94902
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Atripla · DIN 02300699 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: active shortage (reported 2024-10-07, last updated 2025-04-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02461412
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · 600mg/300mg/200mg · tablet
General benefitMarketed · checked 2026-09-02
StatusGeneral benefit
Write on scriptno code needed
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.
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-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549
Manufacturer: Teva Canada Limited; listing date 2017-09-28
Health Canada: Marketed since 2017-07-26 · brand TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients EFAVIRENZ 600 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG · company Teva canada limited · schedule Prescription
Teva-Efavirenz/Emtricitabine/Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=87876 · Verify on the e-Formulary ↗ (DIN 02393549)
Source record
DIN 02393549: Teva-Efavirenz/Emtricitabine/Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id TEV
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02393549
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87876
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Atripla · DIN 02300699 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Shortage status: active shortage (reported 2025-01-20, last updated 2025-01-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02393549
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · 600mg/300mg/200mg · tablet
StatusGeneral benefit
Write on scriptno code needed
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.
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-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284
Manufacturer: Pharmascience Inc.; listing date 2020-02-28
Health Canada: Dormant since 2025-07-31 · brand PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients EFAVIRENZ 600 MG, EMTRICITABINE 200 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Pharmascience inc · schedule Prescription
PMS-Efavirenz-Emtricitabine-Tenofovir: Formulary list price $11.3300/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.3300 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=97744 · Verify on the e-Formulary ↗ (DIN 02487284)
Source record
DIN 02487284: PMS-Efavirenz-Emtricitabine-Tenofovir
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id PMS
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $11.3300; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02487284
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97744
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Atripla · DIN 02300699 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: resolved shortage (ended 2022-10-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02487284
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2025-07-31 — choose a marketed DIN from the same-category list.
Atripla · DIN 02300699 · 600mg/300mg/200mg · tablet
General benefit; Health Canada lists this DIN as Cancelled post market since 2021-12-22 — choose a marketed DIN from the same-category list.Discontinued 2021-12-22 · checked 2026-09-02
StatusGeneral benefit; Health Canada lists this DIN as Cancelled post market since 2021-12-22 — choose a marketed DIN from the same-category list.
Write on scriptno code needed; Health Canada lists this DIN as Cancelled post market since 2021-12-22 — choose a marketed DIN from the same-category list.
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.
1 brand, same coverage
Atripla · DIN 02300699
Manufacturer: Bristol Myers Squibb Canada Inc; listing date 2008-08-28
Health Canada: Cancelled post market since 2021-12-22 · brand ATRIPLA · ATC J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ, J05AR06 EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ · form Tablet · route Oral · ingredients EFAVIRENZ 600 MG, EMTRICITABINE 200 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Gilead sciences, llc · schedule Prescription
Ministry pays: $11.3300 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=78602 · Verify on the e-Formulary ↗ (DIN 02300699)
Source record
DIN 02300699: Atripla
Raw flags: sec3=Y
Item: 081800103; group id 80; item number 0148; lccId None; manufacturer id BQU
Source form: Tab; strength: 600mg/300mg/200mg
Recorded listing: General benefit
Source prices (unrounded): $45.3200; ministry $11.3300
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02300699
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78602
Interchangeable products
Apo-Efavirenz-Emtricitabine-Tenofovir · DIN 02468247 · $11.3300
Auro-Efavirenz-Emtricitabine-Tenofovir · DIN 02478404 · $11.3300
Jamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461 · $11.3300
Mylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412 · $11.3300
PMS-Efavirenz-Emtricitabine-Tenofovir · DIN 02487284 · $11.3300
Teva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549 · $11.3300
Shortage status: discontinued (2021-12-31, reported by GILEAD SCIENCES, LLC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02300699
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2021-12-22 — choose a marketed DIN from the same-category list.
EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE
All strengths: General benefit; same patient cost rules
Shared coverage and patient cost rules
StatusGeneral benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.
Other products in the same Health Canada class (J05AF) — coverage varies; not interchangeable
- Abacavir (Ziagen): general benefit
- Lamivudine (3tc): general benefit, Limited Use 502, 503, 504, Not a benefit
- Entecavir (Baraclude): limited Use 505, 506, 507, 508
- Tenofovir alafenamide (Vemlidy): limited Use 517, 518, 519, 520, 521
- Adefovir dipivoxil (Hepsera): not a benefit
- Zidovudine (Retrovir): not a benefit
43 more in the class list below
AG-Emtricitabine & Tenofovir Disoproxil · DIN 02496356 · 200mg & 300mg · tablet
General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
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
AG-Emtricitabine & Tenofovir Disoproxil · DIN 02496356
Manufacturer: Angita Pharma Inc.; listing date 2021-01-29
Health Canada: Marketed since 2020-11-09 · brand AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE · ATC J05AR03 TENOFOVIR DISOPROXIL AND EMTRICITABINE · form Tablet · route Oral · ingredients EMTRICITABINE 200 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG · company Angita pharma inc. · schedule Prescription
AG-Emtricitabine & Tenofovir Disoproxil: Formulary list price $7.3035/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.3035 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=98623 · Verify on the e-Formulary ↗ (DIN 02496356)
Source record
DIN 02496356: AG-Emtricitabine & Tenofovir Disoproxil
Raw flags: sec3=Y
Item: 081800099; group id 84; item number 0152; lccId None; manufacturer id ANG
Source form: Tab; strength: 200mg & 300mg
Recorded listing: General benefit
Source prices (unrounded): $7.3035; ministry $7.3035
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02496356
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98623
Interchangeable products
Apo-Emtricitabine-Tenofovir · DIN 02452006 · $7.3035
Auro-Emtricitabine-Tenofovir · DIN 02490684 · $7.3035
Jamp-Emtricitabine/Tenofovir Disoproxil · DIN 02487012 · $7.3035
Mint-Emtricitabine/Tenofovir · DIN 02521547 · $7.3035
Mylan-Emtricitabine/Tenofovir Disoproxil · DIN 02443902 · $7.3035
PMS-Emtricitabine/Tenofovir · DIN 02461110 · $7.3035
Teva-Emtricitabine/Tenofovir · DIN 02399059 · $7.3035
Truvada · DIN 02274906 · $7.3035
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=02496356
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Emtricitabine-Tenofovir · DIN 02452006 · 200mg & 300mg · tablet
General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
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-Emtricitabine-Tenofovir · DIN 02452006
Manufacturer: Apotex Inc.; listing date 2017-08-30
Health Canada: Marketed since 2017-07-26 · brand APO-EMTRICITABINE-TENOFOVIR · ATC J05AR03 TENOFOVIR DISOPROXIL AND EMTRICITABINE · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG · company Apotex inc · schedule Prescription
Apo-Emtricitabine-Tenofovir: Formulary list price $7.3035/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.3035 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=93840 · Verify on the e-Formulary ↗ (DIN 02452006)
Source record
DIN 02452006: Apo-Emtricitabine-Tenofovir
Raw flags: sec3=Y
Item: 081800099; group id 84; item number 0152; lccId None; manufacturer id APX
Source form: Tab; strength: 200mg & 300mg
Recorded listing: General benefit
Source prices (unrounded): $7.3035; ministry $7.3035
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02452006
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93840
Interchangeable products
AG-Emtricitabine & Tenofovir Disoproxil · DIN 02496356 · $7.3035
Auro-Emtricitabine-Tenofovir · DIN 02490684 · $7.3035
Jamp-Emtricitabine/Tenofovir Disoproxil · DIN 02487012 · $7.3035
Mint-Emtricitabine/Tenofovir · DIN 02521547 · $7.3035
Mylan-Emtricitabine/Tenofovir Disoproxil · DIN 02443902 · $7.3035
PMS-Emtricitabine/Tenofovir · DIN 02461110 · $7.3035
Teva-Emtricitabine/Tenofovir · DIN 02399059 · $7.3035
Truvada · DIN 02274906 · $7.3035
Shortage status: resolved shortage (ended 2025-05-01); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02452006
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Emtricitabine-Tenofovir · DIN 02490684 · 200mg & 300mg · tablet
General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
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-Emtricitabine-Tenofovir · DIN 02490684
Manufacturer: Auro Pharma Inc.; listing date 2023-04-28
Health Canada: Marketed since 2023-03-01 · brand AURO-EMTRICITABINE-TENOFOVIR · ATC J05AR03 TENOFOVIR DISOPROXIL AND EMTRICITABINE · form Tablet · route Oral · ingredients TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200 MG · company Auro pharma inc · schedule Prescription
Auro-Emtricitabine-Tenofovir: Formulary list price $7.3035/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.3035 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=98074 · Verify on the e-Formulary ↗ (DIN 02490684)
Source record
DIN 02490684: Auro-Emtricitabine-Tenofovir
Raw flags: sec3=Y
Item: 081800099; group id 84; item number 0152; lccId None; manufacturer id AUR
Source form: Tab; strength: 200mg & 300mg
Recorded listing: General benefit
Source prices (unrounded): $7.3035; ministry $7.3035
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02490684
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98074
Interchangeable products
AG-Emtricitabine & Tenofovir Disoproxil · DIN 02496356 · $7.3035
Apo-Emtricitabine-Tenofovir · DIN 02452006 · $7.3035
Jamp-Emtricitabine/Tenofovir Disoproxil · DIN 02487012 · $7.3035
Mint-Emtricitabine/Tenofovir · DIN 02521547 · $7.3035
Mylan-Emtricitabine/Tenofovir Disoproxil · DIN 02443902 · $7.3035
PMS-Emtricitabine/Tenofovir · DIN 02461110 · $7.3035
Teva-Emtricitabine/Tenofovir · DIN 02399059 · $7.3035
Truvada · DIN 02274906 · $7.3035
Shortage status: resolved shortage (ended 2025-04-22); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02490684
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (08:18 Antivirals) and how they are covered
Matched class: 08:18 Antivirals
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: ABACAVIR & LAMIVUDINE & ZIDOVUDINE, ABACAVIR SULFATE, ABACAVIR SULFATE & LAMIVUDINE, BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE, CABOTEGRAVIR, CABOTEGRAVIR & RILPIVIRINE, DARUNAVIR & COBICISTAT, DARUNAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, DELAVIRDINE MESYLATE, DOLUTEGRAVIR, DOLUTEGRAVIR & ABACAVIR & LAMIVUDINE, DOLUTEGRAVIR & RILPIVIRINE, DOLUTEGRAVIR SODIUM/LAMIVUDINE, DORAVIRINE, ELVITEGRAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE, ETRAVIRINE, FOSAMPRENAVIR CALCIUM, GANCICLOVIR SODIUM, LAMIVUDINE & ZIDOVUDINE, LOPINAVIR & RITONAVIR, MARAVIROC, NELFINAVIR MESYLATE, RALTEGRAVIR POTASSIUM, RILPIVIRINE HYDROCHLORIDE, RITONAVIR
Some products covered without a code (check the product listing): ACYCLOVIR, ATAZANAVIR SULFATE, DARUNAVIR, EFAVIRENZ, LAMIVUDINE, NEVIRAPINE, VALACYCLOVIR
08:18 Antivirals
· 4 products · General benefit · strengths: 20mg/mL, 300mg · O/L, Tab
· 10 products · General benefit (7), Listed, not a benefit (1),
Limited Use, codes 502, 503, 504 (2) · strengths: 10mg/mL, 100mg, 150mg, 300mg · O/L, Tab
· 8 products ·
Limited Use, codes 505, 506, 507, 508 · strengths: 0.5mg · Tab
· 1 products ·
Limited Use, codes 517, 518, 519, 520, 521 · strengths: 25mg · Tab
· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 10mg · Tab
· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg · Cap
· 2 products · General benefit · strengths: 300mg & 150mg & 300mg · Tab
· 7 products · General benefit · strengths: 600mg & 300mg · Tab
· 15 products · Listed, not a benefit (2), General benefit (13) · strengths: 200mg, 400mg, 800mg · Tab
· 12 products · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 150mg, 200mg, 300mg · Cap
· 1 products · General benefit · strengths: 50mg & 200mg & 25mg · Tab
· 3 products · General benefit · strengths: 200mg/mL, 30mg · Inj Sol-ER Susp 3mL Vial Kit Pk, Tab
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 08:18
and 37 more
Other drugs whose Health Canada label lists a similar indication: adults infected with hiv-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor, hiv-1 infection, human immunodeficiency virus-1
From Health Canada product monographs; label wording only, not a treatment recommendation.
Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ.
Covered without a code on the Ontario formulary: BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE, CABOTEGRAVIR, CABOTEGRAVIR & RILPIVIRINE, DORAVIRINE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE, LOPINAVIR & RITONAVIR
ATAZANAVIR SULFATE · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4)
1 INDICATIONS
TEVA-ATAZANAVIR (atazanavir capsules) is indicated in combination with other antiretroviral agents for the
treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 6 years of
age and older weighing at least 20 kg.
PM: https://pdf.hres.ca/dpd_pm/00078880.PDF; date April 18, 2017; DIN 02443791; fetched 2026-09-10
Product monograph
BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE · General benefit
1 INDICATIONS
BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen
for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric
patients weighing ≥ 25 kg with no known substitution associated with resistance to bictegravir or
tenofovir.
1.1 Pediatrics
Pediatrics (weighing ≥ 25 kg): The safety and efficacy in pediatric patients weighing ≥ 25 kg
are based on data from an open-label clinical study (see 8 ADVERSE REACTIONS and 14
CLINICAL TRIALS).
PM: https://pdf.hres.ca/dpd_pm/00080778.PDF; date July 10, 2018; DIN 02478579; fetched 2026-09-10
Product monograph
CABOTEGRAVIR · General benefit
1 Indications
VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a
complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection
in patients, at least 12 years of age and weighing at least 35 kg, who are virologically stable and
suppressed (HIV-1 RNA less than 50 copies/mL) as:
• an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA
• oral bridging therapy for missed CABENUVA injections
CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated:
• as a complete regimen for the treatment of HIV-1 infection in patients, at least 12 years of
age and weighing at least 35 kg, to replace the current antiretroviral regimen in patients
who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).
1.1 Pediatrics
Pediatrics (≥ 12 and < 18 years of age): the use of VOCABRIA and CABENUVA in adolescent patients 12
years of age and older and weighing at least 35 kg is supported by the interim safety and
pharmacokinetic data of an ongoing phase 1/2 open-label, non-comparative study in which oral and
injectable cabotegravir or oral and injectable rilpivirine, each as a single agent, was administered in
combination with other antiretroviral agents, and also by the pharmacokinetic data from studies with
VOCABRIA, CABENUVA and oral and injectable rilpivirine use in adults (see 8.2.1 Clinical Trial Adverse
Reactions-Pediatrics, 10.3 Pharmacokinetics, and 14 CLINICAL TRIALS; oral rilpivirine use refers to the
EDURANT product monograph).
PM: https://pdf.hres.ca/dpd_pm/00080949.PDF; date 2025-06-30; DIN 02497204; fetched 2026-09-10
Product monograph
CABOTEGRAVIR & RILPIVIRINE · General benefit
1 Indications
VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a
complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection
in patients, at least 12 years of age and weighing at least 35 kg, who are virologically stable and
suppressed (HIV-1 RNA less than 50 copies/mL) as:
• an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA
• oral bridging therapy for missed CABENUVA injections
CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated:
• as a complete regimen for the treatment of HIV-1 infection in patients, at least 12 years of
age and weighing at least 35 kg, to replace the current antiretroviral regimen in patients
who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).
1.1 Pediatrics
Pediatrics (≥ 12 and < 18 years of age): the use of VOCABRIA and CABENUVA in adolescent patients 12
years of age and older and weighing at least 35 kg is supported by the interim safety and
pharmacokinetic data of an ongoing phase 1/2 open-label, non-comparative study in which oral and
injectable cabotegravir or oral and injectable rilpivirine, each as a single agent, was administered in
combination with other antiretroviral agents, and also by the pharmacokinetic data from studies with
VOCABRIA, CABENUVA and oral and injectable rilpivirine use in adults (see 8.2.1 Clinical Trial Adverse
Reactions-Pediatrics, 10.3 Pharmacokinetics, and 14 CLINICAL TRIALS; oral rilpivirine use refers to the
EDURANT product monograph).
PM: https://pdf.hres.ca/dpd_pm/00080951.PDF; date 2025-06-30; DIN 02497220; fetched 2026-09-10
Product monograph
DARUNAVIR · Listed, not a benefit (2), General benefit (6)
1 INDICATIONS
Auro-Darunavir (darunavir), co-administered with 100 mg ritonavir, and with other
antiretroviral agents, is indicated for the treatment of HIV-1 infection in patients ≥ 40 kg.
PM: https://pdf.hres.ca/dpd_pm/00073833.PDF; date December 7, 2023; DIN 02486121; fetched 2026-09-10
Product monograph
DORAVIRINE · General benefit
1 Indications
PIFELTRO® (doravirine) is indicated, in combination with other antiretroviral medicinal products, for the
treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and weighing at
least 35kg without past or present evidence of viral resistance to doravirine.
1.1 Pediatrics
Pediatrics ( 12 to < 18 years of age): The safety and efficacy of PIFELTRO® in pediatric patients 12
years of age and weighing at least 35 kg receiving doravirine 100 mg once daily has been established
(see 8.2.1 Clinical Trial Adverse Reactions – Pediatrics and 14 Clinical Trials).
PM: https://pdf.hres.ca/dpd_pm/00081853.PDF; date not captured; DIN 02481545; fetched 2026-09-10
Product monograph
EFAVIRENZ · Listed, not a benefit (1), General benefit (4)
INDICATIONS AND CLINICAL USE
Mylan-Efavirenz (efavirenz) is indicated for the treatment of HIV-1 infection in combination
with other antiretroviral agents.
PM: https://pdf.hres.ca/dpd_pm/00076879.PDF; date AUG 29, 2024; DIN 02381524; fetched 2026-09-10
Product monograph
EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE · General benefit
INDICATIONS
ODEFSEY (emtricitabine [FTC]/rilpivirine [RPV]/tenofovir alafenamide [TAF]) is
indicated as a complete regimen for the treatment of adults infected with HIV-1 with no
known mutations associated with resistance to the non-nucleoside reverse transcriptase
inhibitor (NNRTI) class, tenofovir or FTC, and with a viral load ≤ 100,000 copies/mL.
PM: https://pdf.hres.ca/dpd_pm/00053935.PDF; date November 13, 2019; DIN 02461463; fetched 2026-09-10
Product monograph
LOPINAVIR & RITONAVIR · General benefit
Indications
KALETRA (lopinavir/ritonavir) is indicated in combination with other antiretroviral agents when therapy
is warranted for the treatment of HIV-1 infection.
PM: https://pdf.hres.ca/dpd_pm/00085373.PDF; date 2026-07-14; DIN 02243644; fetched 2026-09-10
Product monograph
NEVIRAPINE · Listed, not a benefit (2), General benefit (5)
INDICATIONS AND CLINICAL USE
AURO-NEVIRAPINE (nevirapine) is indicated as an alternative for:
treatment of HIV-1 infection in combination with other antiretroviral agents.
PM: https://pdf.hres.ca/dpd_pm/00058912.PDF; date not captured; DIN 02318601; fetched 2026-09-10
Product monograph
and 1 more
Coverage source: ON formulary extract 2026-08-26
Availability
Mylan-Tenofovir Disoproxil · DIN 02452634
Shortage status: active shortage (reported 2025-05-05, last updated 2025-09-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02452634
Check this DIN againTenofovir · DIN 02523922
Shortage status: active shortage (reported 2025-07-02, estimated to end 2026-10-01, last updated 2026-08-17); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02523922
Check this DIN againTeva-Tenofovir · DIN 02403889
Shortage status: discontinued (2025-04-07, reported by TEVA CANADA LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02403889
Check this DIN againJamp Efavirenz/Emtricitabine/Tenofovir · DIN 02519461
Shortage status: active shortage (reported 2026-03-12, estimated to end 2026-12-31, last updated 2026-03-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02519461
Check this DIN againMylan-Efavirenz/Emtricitabine/Tenofovir · DIN 02461412
Shortage status: active shortage (reported 2024-10-07, last updated 2025-04-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02461412
Check this DIN againTeva-Efavirenz/Emtricitabine/Tenofovir · DIN 02393549
Shortage status: active shortage (reported 2025-01-20, last updated 2025-01-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02393549
Check this DIN againAtripla · DIN 02300699
Shortage status: discontinued (2021-12-31, reported by GILEAD SCIENCES, LLC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02300699
Check this DIN again
Free programs for HIV pre-exposure prophylaxis (PrEP), only if prescribed for it (Ontario):
PrEPStart — A three-month bridge while ongoing drug coverage is arranged — The program pharmacy confirms Ontario residence, lack of drug coverage, and OHIP or federal-program eligibility — Free through PrEPStart if accepted; no amount assumed in this tool
(ontarioprep.ca, Sep 18, 2026 ↗)