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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

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 ↗)

M-Montelukast · DIN 02488183 Manufacturer: Mantra Pharma Inc.; listing date 2021-10-29 Health Canada: Marketed since 2024-12-23 · brand M-MONTELUKAST · ATC R03DC03 MONTELUKAST · form Tablet · route Oral · ingredients MONTELUKAST (MONTELUKAST SODIUM) 10 MG · company Mantra pharma inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02488183). DIN 02488183: M-Montelukast Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000316; group id 936; item number 2232; lccId None; manufacturer id MAT Source form: Tab; strength: 10mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.7735; ministry $1.7735 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02488183 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97829

Interchangeable products

Ach-Montelukast · DIN 02379236 · $1.7735 Apo-Montelukast · DIN 02374609 · $1.7735 Auro-Montelukast · DIN 02401274 · $1.7735 Jamp-Montelukast · DIN 02391422 · $1.7735 Mar-Montelukast · DIN 02399997 · $1.7735 Mint-Montelukast · DIN 02408643 · $1.7735 Montelukast · DIN 02379333 · $1.7735 Montelukast · DIN 02382474 · $1.7735 NRA-Montelukast · DIN 02489821 · $1.7735 Nat-Montelukast · DIN 02522136 · $1.7737 PMS-Montelukast FC · DIN 02373947 · $1.7735 Ran-Montelukast · DIN 02389517 · $1.7735 Sandoz Montelukast · DIN 02328593 · $1.7735 Singulair · DIN 02238217 · not recorded Teva-Montelukast · DIN 02355523 · $1.7737

Shortage status: avoided shortage; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02488183

Shortage record checked 2026-09-13T08:10:21.292534+00:00