Last Updated: August 28, 2026

Montelukast - Generic Drug Details

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US Patents and Regulatory Information for montelukast

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ajanta Pharma Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203328-002	Jul 31, 2015		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Glenmark Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	090926-001	Aug 3, 2012	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Macleods Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203582-001	Mar 12, 2015	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Molecular	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	207464-001	Dec 6, 2018	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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