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Last Updated: June 4, 2023

CHANTIX Drug Patent Profile


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When do Chantix patents expire, and what generic alternatives are available?

Chantix is a drug marketed by Pf Prism Cv and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty-eight countries.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Chantix

A generic version of CHANTIX was approved as varenicline tartrate by PAR PHARM INC on August 11th, 2021.

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Paragraph IV (Patent) Challenges for CHANTIX
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 CHANTIX

CHANTIX is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting CHANTIX

Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7- ,9-pentaene and pharmaceutical compositions thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting CHANTIX

INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  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
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 CHANTIX

See the table below for patents covering CHANTIX around the world.

Country Patent Number Title Estimated Expiration
Germany 122008000038 ⤷  Try a Trial
Poland 366551 ⤷  Try a Trial
European Patent Office 1259489 COMPOSES AZAPOLYCYCLIQUES A FUSION ARYLE (ARYL FUSED AZAPOLYCYCLIC COMPOUNDS) ⤷  Try a Trial
Slovenia 1044189 ⤷  Try a Trial
Spain 2246396 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CHANTIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 SPC021/2008 Ireland ⤷  Try a Trial SPC021/2008: 20081105, EXPIRES: 20210925
1044189 CA 2008 00031 Denmark ⤷  Try a Trial
1044189 122008000038 Germany ⤷  Try a 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 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 91442 Luxembourg ⤷  Try a Trial 91442, EXPIRES: 20210926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Baxter
Medtronic
Merck
McKinsey

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