You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

VARENICLINE TARTRATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Sign Up

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

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

SponsorPhase
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

Make Better Decisions: Try a trial or see plans & pricing

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. 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.