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Last Updated: February 28, 2021

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CHANTIX Drug 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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-three patent family members in fifty-seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Chantix

Chantix was eligible for patent challenges on May 10, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2023. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $474mm indicating the motivation for generic entry.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (varenicline tartrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for CHANTIX
Drug Prices for CHANTIX

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Drug Sales Revenue Trends for CHANTIX

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Generic Entry Opportunity Date for CHANTIX
Generic Entry Date for CHANTIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHANTIX

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

SponsorPhase
Joseph Valentino, MDPhase 2
Vanderbilt-Ingram Cancer CenterPhase 3
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 NDA Submissiondate
CHANTIX TABLET;ORAL varenicline tartrate 021928 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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   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   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
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial Y   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 CHANTIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1044189 PA2008010,C1044189 Lithuania   Start Trial PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
1044189 91442 Luxembourg   Start Trial 91442, EXPIRES: 20210926
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 08C0039 France   Start 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 C01044189/01 Switzerland   Start Trial PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
1044189 SPC021/2008 Ireland   Start Trial SPC021/2008: 20081105, EXPIRES: 20210925
>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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