Active substance
Montelukast
- SFDA 74
- US FDA 53
- Health Canada 42
- US price lines 6
- NHS prices 4
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| AIRFAST 10MG FILM COATED TABLET | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 100.10 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| AIRFAST 4MG CHEWABLE TABLETS | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 100.10 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| AIRFAST 4MG GRANULES | 4 mg | Granules · Oral use | 28 Sachet | SAR 95.15 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| AIRFAST 5MG CHEWABLE TABLETS | 5 mg | Chewable tablet · Oral use | 30 Blister | SAR 100.10 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| ALLAIR 10 mg Film Coated Tablet | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 71.45 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| ALLAIR 4 mg chewable tablet | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 64.30 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| ALLAIR 5 mg chewable tablet | 5 mg | Chewable tablet · Oral use | 30 Blister | SAR 64.30 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| ANTIKAST 10 mg film-coated tablet | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 40.05 | Generic · Prescription | Pharma International Co. | Valid |
| ANTIKAST 4 mg chewable tablet | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 40.05 | Generic · Prescription | Pharma International Co. | Valid |
| ANTIKAST 5 mg chewable tablet | 5 mg | Chewable tablet · Oral use | 30 Blister | SAR 40.05 | Generic · Prescription | Pharma International Co. | Valid |
| BRONCAST 10 mg film-coated tablet | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 71.45 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
| BRONCAST 5 mg chewable tablet | 5 mg | Chewable tablet · Oral use | 28 Blister | SAR 79.40 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
| BRONCHOFAST 10 mg film-coated tablet | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 71.45 | Generic · Prescription | RIYADH PHARMA | Valid |
| Broncast | 10 mg | Film-coated tablet · Oral use | 504 Blister | SAR 1285.20 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
| Broncast Pediatric | 5 mg | Chewable tablet · Oral use | 504 Blister | SAR 1429.20 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
| Broncast Pediatric Chewable Tablet | 4 mg | Chewable tablet · Oral use | 28 Blister | SAR 60.00 | Generic · Prescription | Middle East Pharmaceutical Industries Co Ltd Avalon Pharma | Valid |
| EMCAST 10 MG | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 71.45 | Generic · Prescription | Med City Pharma | Valid |
| EMCAST 4 MG CHEWABLE TABLET | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 64.30 | Generic · Prescription | Med City Pharma | Valid |
| EMCAST 5 MG CHEWABLE TABLET | 5 mg | Chewable tablet · Oral use | 30 Blister | SAR 64.30 | Generic · Prescription | Med City Pharma | Valid |
| LEUKAIR | 5 mg | Chewable tablet · Oral use | 30 Blister | SAR 35.70 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| LEUKAIR | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 29.75 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| LEUKAIR 10MG F.C.TABLET | 10 mg | Film-coated tablet · Oral use | 28 Blister | SAR 71.45 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| LEUKAST 10MG FILM COATED TABLETS | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 94.55 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| LEUKAST 4 mg Granules | 4 mg | Granules · Oral use | 28 Sachet | SAR 77.10 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| LEUKAST 4 mg chewable tablet | 4 mg | Chewable tablet · Oral use | 30 Blister | SAR 64.30 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
49 more — full table
Indications — CHI Daman Drug Formulary
ALLERGIC RHINITIS; ASTHMA; SINUSITIS; URTICARIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SINGULAIR | EQ 10MG BASE | tablet · oral | ORGANON | Prescription | 20 Feb 1998 |
| SINGULAIR | EQ 5MG BASE | tablet, chewable · oral | ORGANON | Prescription | 20 Feb 1998 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | TEVA PHARMS | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | TEVA PHARMS | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | GLENMARK PHARMS LTD | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | TORRENT PHARMS LTD | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | LANNETT CO INC | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | AIPING PHARM INC | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | TORRENT PHARMS LTD | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | CHARTWELL MOLECULAR | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | AUROBINDO PHARMA LTD | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 3 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | SENORES PHARMS | Prescription | 6 Aug 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | DR REDDYS LABS LTD | Prescription | 6 Aug 2012 |
| MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | granule · oral | DR REDDYS LABS LTD | Prescription | 17 Sep 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | ACCORD HLTHCARE | Prescription | 21 Sep 2012 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | HETERO LABS LTD V | Prescription | 10 Sep 2014 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | MACLEODS PHARMS | Prescription | 11 Sep 2014 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | PHARMOBEDIENT | Prescription | 30 Oct 2014 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | PHARMOBEDIENT | Prescription | 30 Oct 2014 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | MACLEODS PHARMS | Prescription | 12 Mar 2015 |
| MONTELUKAST SODIUM | EQ 4MG BASE; EQ 5MG BASE | tablet, chewable · oral | HETERO LABS LTD V | Prescription | 22 May 2015 |
| MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | granule · oral | AJANTA PHARMA LTD | Prescription | 31 Jul 2015 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | AMNEAL PHARMS | Prescription | 4 Sep 2015 |
| MONTELUKAST SODIUM | EQ 10MG BASE | tablet · oral | UNICHEM | Prescription | 8 Oct 2015 |
28 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ACH-MONTELUKAST | 02379236 | 10 MG | TABLET · ORAL | ACCORD HEALTHCARE INC |
| AG-MONTELUKAST | 02482835 | 10 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| APO-MONTELUKAST | 02374609 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-MONTELUKAST | 02377608 | 4 MG | TABLET (CHEWABLE) · ORAL | APOTEX INC |
| APO-MONTELUKAST | 02377616 | 5 MG | TABLET (CHEWABLE) · ORAL | APOTEX INC |
| AURO-MONTELUKAST | 02401274 | 10 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-MONTELUKAST CHEWABLE TABLET | 02422867 | 4 MG | TABLET (CHEWABLE) · ORAL | AURO PHARMA INC |
| AURO-MONTELUKAST CHEWABLE TABLET | 02422875 | 5 MG | TABLET (CHEWABLE) · ORAL | AURO PHARMA INC |
| BIO-MONTELUKAST | 02445735 | 10 MG | TABLET · ORAL | BIOMED PHARMA |
| JAMP MONTELUKAST CHEWABLE TABLETS | 02514877 | 4 MG | TABLET (CHEWABLE) · ORAL | JAMP PHARMA CORPORATION |
| JAMP MONTELUKAST CHEWABLE TABLETS | 02514885 | 5 MG | TABLET (CHEWABLE) · ORAL | JAMP PHARMA CORPORATION |
| JAMP-MONTELUKAST | 02391422 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| M-MONTELUKAST | 02488183 | 10 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-MONTELUKAST | 02399997 | 10 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-MONTELUKAST | 02408627 | 4 MG | TABLET (CHEWABLE) · ORAL | MINT PHARMACEUTICALS INC |
| MINT-MONTELUKAST | 02408635 | 5 MG | TABLET (CHEWABLE) · ORAL | MINT PHARMACEUTICALS INC |
| MINT-MONTELUKAST | 02408643 | 10 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MONTELUKAST | 02379325 | 5 MG | TABLET (CHEWABLE) · ORAL | SANIS HEALTH INC |
| MONTELUKAST | 02379333 | 10 MG | TABLET · ORAL | SANIS HEALTH INC |
| MONTELUKAST | 02379821 | 4 MG | TABLET (CHEWABLE) · ORAL | PRO DOC LIMITEE |
| MONTELUKAST | 02379848 | 5 MG | TABLET (CHEWABLE) · ORAL | PRO DOC LIMITEE |
| MONTELUKAST | 02379856 | 10 MG | TABLET · ORAL | PRO DOC LIMITEE |
| MONTELUKAST | 02382458 | 4 MG | TABLET (CHEWABLE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| MONTELUKAST | 02382466 | 5 MG | TABLET (CHEWABLE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| MONTELUKAST | 02382474 | 10 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
17 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MONTELUKAST SOD 10 MG TABLET | $0.04191 | per EA | 23 Sep 2026 |
| US NADAC | MONTELUKAST SOD 4 MG GRANULES | $0.81256 | per EA | 23 Sep 2026 |
| US NADAC | MONTELUKAST SOD 4 MG TAB CHEW | $0.07528 | per EA | 23 Sep 2026 |
| US NADAC | MONTELUKAST SOD 5 MG TAB CHEW | $0.07045 | per EA | 23 Sep 2026 |
| US NADAC | SINGULAIR 10 MG TABLET | $9.21312 | per EA | 23 Sep 2026 |
| US NADAC | SINGULAIR 5 MG TABLET CHEW | $9.2741 | per EA | 1 Jan 2026 |
| NHS Drug Tariff | Montelukast 10mg tablets | £0.94 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Montelukast 4mg chewable tablets sugar free | £1.01 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Montelukast 4mg granules sachets sugar free | £7.96 | 28 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Montelukast 5mg chewable tablets sugar free | £1.04 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 11 Jul 2024 PRAC signal: Persistent neuropsychiatric events
Action for MAH: update of the product information: No - MHRA 29 Apr 2024 Montelukast: reminder of the risk of neuropsychiatric reactions
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals should advise patients and their caregivers to be alert to these risks and seek medical advice as soon as possible if neuropsychiatric reactions occur. - US FDA 22 Feb 2021 SINGULAIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Feb 2021 SINGULAIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Feb 2021 SINGULAIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 19 Sep 2019 Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur. - EMA PRAC 12 Jul 2018 PRAC signal: Dysphemia (speech disorders)
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.