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Last Updated: June 23, 2024


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Which patents cover Varenicline Tartrate, and what generic alternatives are available?

Varenicline Tartrate is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Avalanche Pharm, Endo Operations, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, and Zydus. and is included in eleven NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Varenicline Tartrate

A generic version of VARENICLINE TARTRATE was approved as varenicline tartrate by ENDO OPERATIONS on August 11th, 2021.

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Drug patent expirations by year for VARENICLINE TARTRATE
Recent Clinical Trials for VARENICLINE TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Yale UniversityPhase 2
CTC Bio, Inc.Phase 1
National Institute on Drug Abuse (NIDA)Phase 3

See all VARENICLINE TARTRATE clinical trials

Medical Subject Heading (MeSH) Categories for VARENICLINE TARTRATE
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYRVAYA Nasal Spray varenicline tartrate 0.03 mg/spray 213978 1 2023-04-21
CHANTIX Tablets varenicline tartrate 0.5 mg and 1 mg 021928 5 2010-05-10

US Patents and Regulatory Information for VARENICLINE TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 213019-001 Mar 19, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mankind Pharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214255-002 Aug 1, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avalanche Pharm VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 217283-001 Mar 6, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214557-002 Aug 23, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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