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Last Updated: October 5, 2024

VARENICLINE TARTRATE - Generic Drug Details


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What are the generic sources for varenicline tartrate and what is the scope of freedom to operate?

Varenicline tartrate is the generic ingredient in three branded drugs marketed by Oyster Point Pharma, Pf Prism Cv, Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Avalanche Pharm, Endo Operations, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Slate Run Pharma, and Zydus, and is included in fourteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has thirty-eight patent family members in nineteen countries.

There are eleven drug master file entries for varenicline tartrate. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary 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
University of Kansas Medical CenterPhase 3

See all VARENICLINE TARTRATE clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 1MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 0.5MG BASETABLET;ORAL

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

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
Zydus VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 216723-001 Jun 12, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 201962-001 Jan 25, 2023 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
Apotex VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 201962-002 Jan 25, 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VARENICLINE TARTRATE

Country Patent Number Title Estimated Expiration
Japan 7257371 ⤷  Sign Up
Eurasian Patent Organization 035335 СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ С ПРИМЕНЕНИЕМ ВАРЕНИКЛИНА (METHODS OF TREATING OCULAR DISORDERS USING VARENICLINE) ⤷  Sign Up
Denmark 3848028 ⤷  Sign Up
Eurasian Patent Organization 201790893 СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ ⤷  Sign Up
European Patent Office 3209295 MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VARENICLINE TARTRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 SPC/GB08/034 United Kingdom ⤷  Sign Up PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
1044189 08C0039 France ⤷  Sign Up PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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