Last Updated: July 8, 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
Torrent Pharms Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	090984-001	Aug 3, 2012	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Anbison Lab	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	205695-001	Nov 5, 2015	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Aurobindo Pharma Ltd	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	202096-001	Aug 3, 2012	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hetero Labs Ltd V	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	204093-001	May 22, 2015	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	091128-001	Aug 3, 2012		DISCN	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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