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Last Updated: March 18, 2024

Varenicline tartrate - Generic Drug Details


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What are the generic drug 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, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Par Pharm Inc, and Zydus, and is included in ten NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has thirty-four patent family members in eighteen countries.

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

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
⤷  Try a Trial⤷  Try a TrialEQ 1MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 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
Leading Pharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 217151-002 Jul 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 201785-001 Aug 11, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214557-002 Aug 23, 2023 AB RX No No ⤷  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

International Patents for varenicline tartrate

Country Patent Number Title Estimated Expiration
Israel 251769 תרכובת ורניקלין לשימוש כתרופה לטיפול בעין יבשה , הגברת ייצור דמעות וטיפול באי נוחות בעין ותכשיר פרמבצטי המכיל ורניקלין (The compound varenicline for use as a medicament for treating dry eye, increasing tear production and treating ocular discomfort, and a pharmaceutical formulation comprising varenicline) ⤷  Try a Trial
China 111956650 治疗眼部病状的方法 (Methods of treating ocular conditions) ⤷  Try a Trial
Mexico 2017005064 METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for varenicline tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 08C0039 France ⤷  Try a Trial 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
1044189 SPC/GB08/034 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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