FDA Orange Book · active-ingredient family
Montelukast sodium
Montelukast sodium: 3 brands, 49 generics; first approved Feb 20, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 49 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
49
Listed patents
0
Presentations
73
Brand (NDA) products
Originator applications
- SINGULAIRRLDORGANONNDA 0214092002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Discontinued — - SINGULAIRRLDORGANONNDA 02083020002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — - ORGANONNDA 0208291998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (49)
Abbreviated applications
- MONTELUKAST SODIUMBRECKENRIDGEANDA 2053192020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMAMNEAL PHARMSANDA 20510720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMAUROBINDO PHARMA LTDANDA 2134712020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Rx AB - MONTELUKAST SODIUMCHARTWELL MOLECULARANDA 20746420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMTORRENTANDA 2104312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Rx AB - MONTELUKAST SODIUMUNICHEMANDA 20862120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUML PERRIGO COANDA 2061122017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMRISINGANDA 2090122017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMRISINGANDA 20901120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMCIPLAANDA 2074632016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMANBISON LABANDA 2056832016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMANBISON LABANDA 20569520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMUNICHEMANDA 2042902015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMAMNEAL PHARMSANDA 2046042015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMRSAJANTA PHARMA LTDANDA 2034382015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Rx AB - MONTELUKAST SODIUMAJANTA PHARMA LTDANDA 20332820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMAJANTA PHARMA LTDANDA 2034322015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMHETERO LABS LTD VANDA 20409320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMMACLEODS PHARMSANDA 20358220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMJUBILANT GENERICSANDA 20379520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMPHARMOBEDIENTANDA 20303720142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMPHARMOBEDIENTANDA 2028592014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMMACLEODS PHARMSANDA 2033662014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMHETERO LABS LTD VANDA 2028432014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMPHARMOBEDIENTANDA 2027762012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Discontinued — - MONTELUKAST SODIUMACCORD HLTHCAREANDA 2027172012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMDR REDDYS LABS LTDANDA 2029062012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Rx AB - MONTELUKAST SODIUMSENORES PHARMSANDA 20158120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMDR REDDYS LABS LTDANDA 2015822012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMTEVA PHARMSANDA 0909552012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/PACKET GRANULE ORAL Discontinued — - MONTELUKAST SODIUMAIPING PHARM INCANDA 09141420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMAPOTEX INCANDA 20150820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMAUROBINDO PHARMA LTDANDA 20209620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMHIKMAANDA 09112820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMLANNETT CO INCANDA 20040520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMNATCO PHARMAANDA 07914220122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMPHARMACOANDA 09158820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 5MG BASE TABLET, CHEWABLE ORAL Discontinued — - MONTELUKAST SODIUMTEVA PHARMSANDA 07872320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMTORRENT PHARMS LTDANDA 09098420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 5MG BASE TABLET, CHEWABLE ORAL Rx AB - MONTELUKAST SODIUMAPOTEX CORPANDA 2012942012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMAUROBINDO PHARMA LTDANDA 2024682012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMCHARTWELL MOLECULARANDA 2015222012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMGLENMARK PHARMS LTDANDA 0909262012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMHIKMAANDA 0906552012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMPHARMOBEDIENTANDA 0791032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMSANDOZ INCANDA 2008892012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMSTRIDES PHARMA INTLANDA 0915762012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - MONTELUKAST SODIUMTEVA PHARMSANDA 0786052012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - MONTELUKAST SODIUMTORRENT PHARMS LTDANDA 2015152012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
29 yr 1 mo ago
Most recent approval
6 yr 1 mo ago
Approvals span 1998–2020 across 52 FDA applications.
Brand (NDA) 36%
Generic (ANDA) 4994%
Montelukast sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Go beyond the database.
Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.