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Last Updated: March 9, 2021

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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 one branded drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has one hundred and eighty-three patent family members in fifty-seven countries.

There are twelve drug master file entries for varenicline tartrate. Five 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
CTC Bio, Inc.Phase 1
University of Kansas Medical CenterPhase 3
University of ChicagoPhase 4

See all varenicline tartrate clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 1MG BASETABLET;ORAL
  Start Trial  Start 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.

Pharmacology for varenicline tartrate
Medical Subject Heading (MeSH) Categories for varenicline tartrate
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
CHANTIX TABLET;ORAL varenicline tartrate 021928 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 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 325 Finland   Start Trial
1044189 122008000038 Germany   Start Trial PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926
1044189 PA2008010,C1044189 Lithuania   Start Trial PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
>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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