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Last Updated: December 5, 2022

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, and Par Pharm Inc, and is included in three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has eighty-seven patent family members in fifty countries.

There are eleven drug master file entries for varenicline tartrate. Six 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
National Institute on Drug Abuse (NIDA)Phase 3

See all varenicline tartrate clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 1MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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.

Pharmacology for varenicline tartrate
Medical Subject Heading (MeSH) Categories for varenicline tartrate
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for varenicline tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 SPC/GB08/034 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Dow
Merck
McKesson
Mallinckrodt

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