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Last Updated: March 28, 2024

Varenicline - Generic Drug Details


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Recent Clinical Trials for varenicline

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

SponsorPhase
Pradeesh SivapalanPhase 4
Truth InitiativeN/A
Montefiore Medical CenterN/A

See all varenicline clinical trials

Generic filers with tentative approvals for VARENICLINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 1MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 0.5MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Mankind Pharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214255-001 Aug 1, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 201785-002 Aug 11, 2021 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mankind Pharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214255-002 Aug 1, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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