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Last Updated: May 27, 2024

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.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-two 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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Mexico PA03010364 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 LAS MISMAS. (TARTRATE SALTS OF 5,8,14-TRIAZATETRACYCLO {10.3.1.02.) ⤷  Sign Up
South Korea 100537976 ⤷  Sign Up
Iceland 6957 ⤷  Sign Up
Portugal 1392307 ⤷  Sign Up
European Patent Office 1392307 SELS DE TARTRATE DE 5,8,14-TRIAZATETRACYCLO 10.3.1.02,11.04,9]-HEXADECA-2(11),3,5,7,9-PENTAENE (TARTRATE SALTS OF 5,8,14-TRIAZATETRACYCLO[10.3.1.02,11.04,9]-HEXADECA-2(11),3,5,7,9-PENTAENE) ⤷  Sign Up
Australia 784081 ⤷  Sign Up
Bulgaria 65058 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CHANTIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 PA2008010,C1044189 Lithuania ⤷  Sign Up PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
1044189 SPC/GB08/034 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up 91442, EXPIRES: 20210926
1044189 325 Finland ⤷  Sign Up
1044189 122008000038 Germany ⤷  Sign Up 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 C01044189/01 Switzerland ⤷  Sign Up PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.