Is there a generic for Montelukast sodium?

Yes. The FDA Orange Book lists 49 approved generic (ANDA) applications for Montelukast sodium, referencing the brand SINGULAIR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Montelukast sodium?

SINGULAIR (NDA 021409, ORGANON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Montelukast sodium are approved?

Montelukast sodium is approved in the following dosage forms: granule, tablet, tablet, chewable.

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)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

SINGULAIRRLD

ORGANONNDA 0214092002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Discontinued	—

SINGULAIRRLD

ORGANONNDA 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	Rx	AB

SINGULAIRRLDRS

ORGANONNDA 0208291998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (49)

MONTELUKAST SODIUM

BRECKENRIDGEANDA 2053192020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

AMNEAL 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 SODIUM

AUROBINDO PHARMA LTDANDA 2134712020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Rx	AB

MONTELUKAST SODIUM

CHARTWELL 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 SODIUM

TORRENTANDA 2104312018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Rx	AB

MONTELUKAST SODIUM

UNICHEMANDA 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 SODIUM

L PERRIGO COANDA 2061122017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

RISINGANDA 2090122017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

RISINGANDA 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 SODIUM

CIPLAANDA 2074632016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

ANBISON LABANDA 2056832016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

ANBISON 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 SODIUM

UNICHEMANDA 2042902015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

AMNEAL PHARMSANDA 2046042015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUMRS

AJANTA PHARMA LTDANDA 2034382015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Rx	AB

MONTELUKAST SODIUM

AJANTA 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 SODIUM

AJANTA PHARMA LTDANDA 2034322015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

HETERO 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 SODIUM

MACLEODS PHARMS LTDANDA 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 SODIUM

JUBILANT 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 SODIUM

PHARMOBEDIENTANDA 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 SODIUM

PHARMOBEDIENTANDA 2028592014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

MACLEODS PHARMS LTDANDA 2033662014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

HETERO LABS LTD VANDA 2028432014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

PHARMOBEDIENTANDA 2027762012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Discontinued	—

MONTELUKAST SODIUM

ACCORD HLTHCAREANDA 2027172012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

DR 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 SODIUM

SENORES 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 SODIUM

DR REDDYS LABS LTDANDA 2015822012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

TEVA PHARMSANDA 0909552012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 4MG BASE/PACKET	GRANULE	ORAL	Discontinued	—

MONTELUKAST SODIUM

AIPING 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 SODIUM

APOTEX 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 SODIUM

AUROBINDO 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 SODIUM

HIKMAANDA 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 SODIUM

LANNETT 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 SODIUM

NATCO 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 SODIUM

PHARMACOANDA 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 SODIUM

TEVA 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 SODIUM

TORRENT 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 SODIUM

APOTEX CORPANDA 2012942012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

AUROBINDO PHARMA LTDANDA 2024682012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

CHARTWELL MOLECULARANDA 2015222012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

GLENMARK PHARMS LTDANDA 0909262012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

HIKMAANDA 0906552012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

PHARMOBEDIENTANDA 0791032012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

SANDOZ INCANDA 2008892012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

STRIDES PHARMA INTLANDA 0915762012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

MONTELUKAST SODIUM

TEVA PHARMSANDA 0786052012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

MONTELUKAST SODIUM

TORRENT PHARMS LTDANDA 2015152012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Feb 20, 1998

28 yr 10 mo ago

Most recent approval

Oct 30, 2020

5 yr 9 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.

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