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Last Updated: March 4, 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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has ninety-four patent family members in fifty 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
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
Lupin Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 211862-002 Dec 4, 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 ⤷  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

International Patents for varenicline tartrate

Country Patent Number Title Estimated Expiration
Norway 20035036 ⤷  Try a Trial
Australia 2002253482 ⤷  Try a Trial
Montenegro 00466 TARTARATNE SOLI 5,8,14-TRIAZATETRACIKLO( 10.3.1.02,11.04,9)-HEKSADEKA-2 (11),3,5,7,9-PENTAENA (TARTRATE SALTS OF 5,8,14-TRIAZATETRACYCLO {10.3.1.02,11.04,9}-HEXADECA-2(11),3,5,7,9-PENTAENE AND PHARMACEUTICAL COMPOSITIONS THEREOF) ⤷  Try a Trial
Israel 293188 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
Ecuador SP034849 SALES TARTRATO DE 5, 8, 14-TRIAZATETRACICLO [10.3.1.02,11.04,9] HEXADECA-2 (11),3,5,7,9-PENTAENO Y COMPOSICIONES FARMACEUTICAS DE LA MISMA ⤷  Try a Trial
Singapore 10202011669P 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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