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Last Updated: May 28, 2022

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.

Drug patent expirations by year for CHANTIX
Drug Prices for CHANTIX

See drug prices for CHANTIX

Drug Sales Revenue Trends for CHANTIX

See drug sales revenues for CHANTIX

Recent Clinical Trials for CHANTIX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mayo ClinicEarly Phase 1
Duke UniversityPhase 4
Medical University of South CarolinaPhase 1/Phase 2

See all CHANTIX clinical trials

Pharmacology for CHANTIX
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: 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
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 AB RX 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 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 AB RX 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 AB RX Yes No 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

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.) See Plans and Pricing
South Korea 100537976 See Plans and Pricing
Iceland 6957 See Plans and Pricing
Portugal 1392307 See Plans and Pricing
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) See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
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
1044189 91442 Luxembourg See Plans and Pricing 91442, EXPIRES: 20210926
1044189 325 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Baxter
Medtronic
Merck
McKinsey

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