Last Updated: May 6, 2026

VARENICLINE Drug Patent Profile


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When do Varenicline patents expire, and what generic alternatives are available?

Varenicline is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd Iii, Kanchan Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Ne Rx Pharma, Ph Health, Pharmobedient, Piramal, Regcon Holdings, Rhodes Pharms, Shilpa, Umedica, Viwit Pharm, and Zydus. and is included in twenty-one NDAs.

The generic ingredient in VARENICLINE is varenicline tartrate. There are twelve drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Varenicline

A generic version of VARENICLINE was approved as varenicline tartrate by PH HEALTH on August 11th, 2021.

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Recent Clinical Trials for VARENICLINE

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SponsorPhase
VA Office of Research and DevelopmentPHASE4
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPHASE2
National Cancer Institute (NCI)PHASE2

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US Patents and Regulatory Information for VARENICLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 216723-001 Jun 12, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Regcon Holdings VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 219106-002 Oct 29, 2024 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 202019-002 Feb 28, 2024 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rhodes Pharms VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 213268-001 May 21, 2025 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Piramal VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 217115-001 Jul 23, 2024 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ajanta Pharma Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 213019-001 Mar 19, 2024 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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