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Last Updated: December 15, 2025

Montelukast - Generic Drug Details


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US Patents and Regulatory Information for montelukast

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 090655-001 Aug 3, 2012 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dr Reddys Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 201582-001 Aug 6, 2012 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal Pharms MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 205107-002 Sep 4, 2020 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Breckenridge MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 205319-001 Oct 30, 2020 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Anbison Lab MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 205695-002 Nov 5, 2015 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Pharms MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 078605-001 Aug 3, 2012 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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