Look up one drug

Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

Patient plan: look up a medication list

MONTELUKAST SODIUM

All products: not a benefit

Other products in the same Health Canada class (R03D) — coverage varies; not interchangeable

  • Omalizumab (Omlyclo): limited Use 726, 727, 728

Sandoz Montelukast · DIN 02358611 · 4mg · Gran Pk

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Singulair; DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Montelukast Brand(s): Singulair DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Updated criteria: October 28, 2010 For the treatment of asthma patients who cannot manage the use of an inhalation device despite assistance with a spacer (e.g. physically or mentally disabled patients or pediatric patients). Duration of Approval: 5 years OR For the treatment of asthma in children and adolescents whose asthma cannot be controlled on ICS alone and where the condition remains uncontrolled despite using full doses of ICS with addition of LABA, and with assurance of good adherence and inhaler technique Duration of Approval: 5 years (up until age of 18) Renewal of requests that meet the above criteria will be provided where the following apply: • Current medications and dosages must be clearly specified; AND Objective evidence of positive response from treatment (spirometry OR decrease in health care utilization) must be provided Duration of Approval: 5 years (up until age of 18) 65 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 65, record 42, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Montelukast · DIN 02358611 Manufacturer: Sandoz Canada Inc.; listing date 2012-01-19 Health Canada: Marketed since 2011-10-11 · brand SANDOZ MONTELUKAST · ATC R03DC03 MONTELUKAST · form Granules · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 4 MG/SACHET · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84365 · Verify on the e-Formulary ↗ (DIN 02358611)

Source record
DIN 02358611: Sandoz Montelukast Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 920000645; group id 936; item number 2231; lccId None; manufacturer id SDZ Source form: Gran Pk; strength: 4mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.3440; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02358611 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84365
Interchangeable products
Singulair · DIN 02247997 · not recorded
Shortage status: discontinued (2025-11-07, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02358611
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

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: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

OMALIZUMAB

· 4 products · Limited Use, codes 726, 727, 728 · strengths: 75mg/0.5mL, 150mg/mL · Inj Sol-0.5mL Pref Pen Pk, Inj Sol-0.5mL Pref Syr Pk, Inj Sol-1mL Pref Pen Pk, Inj Sol-1mL Pref Syr Pk

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Asthma SINGULAIR® (montelukast sodium) is indicated in adult and pediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including prevention of day- and night-time symptoms, and the treatment of acetylsalicylic acid (ASA)-sensitive asthmatic patients. SINGULAIR® is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. SINGULAIR® and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. SINGULAIR® (montelukast sodium) Page 3 of 33 In patients who continue to experience asthma symptoms, SINGULAIR® can be an additional treatment option following initial management with an “as needed” short-acting beta-agonist (SABA), an inhaled corticosteroid, or inhaled corticosteroid together with a long-acting beta agonist. In adults, SINGULAIR® can be a treatment option after “as needed” SABAs if patients remain symptomatic and cannot or will not use an inhaler device or would prefer not to be treat… https://pdf.hres.ca/dpd_pm/00060895.PDF PM date: May 5, 2021 Source product: SINGULAIR; DIN 02238216; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Sandoz Montelukast · DIN 02358611 Shortage status: discontinued (2025-11-07, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02358611

Check this DIN again

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Montelukast (Singulair)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of asthma patients who cannot manage the use of an inhalation device despite assistance with a spacer (e.g. physically or mentally disabled patients or pediatric patients).

Ministry criteria corpus 2025-01-01; page 65

Montelukast Brand(s): Singulair DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Updated criteria: October 28, 2010
For the treatment of asthma patients who cannot manage the use of an inhalation device despite assistance with a spacer (e.g. physically or mentally disabled patients or pediatric patients).
Duration of Approval: 5 years
OR
For the treatment of asthma in children and adolescents whose asthma cannot be controlled on ICS alone and where the condition remains uncontrolled despite using full doses of ICS with addition of LABA, and with assurance of good adherence and inhaler technique
Duration of Approval: 5 years (up until age of 18)
Renewal of requests that meet the above criteria will be provided where the following apply:
• Current medications and dosages must be clearly specified; AND
Objective evidence of positive response from treatment (spirometry OR decrease in health care utilization) must be provided
Duration of Approval: 5 years (up until age of 18)
65

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Other review policies

For Sandoz Montelukast: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026