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Generated: September 23, 2018

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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.

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

Drug patent expirations by year for CHANTIX
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.

Pharmacology for CHANTIX
Medical Subject Heading (MeSH) Categories for CHANTIX

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX 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

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Paragraph IV (Patent) Challenges for CHANTIX
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.5 mg and 1 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for CHANTIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
442 Luxembourg ➤ Sign Up 91442, EXPIRES: 20210926
C021/2008 Ireland ➤ Sign Up SPC021/2008: 20081105, EXPIRES: 20210925
2008010,C1044189 Lithuania ➤ Sign Up PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Chinese Patent Office
Johnson and Johnson
Citi
Cerilliant
Medtronic
Boehringer Ingelheim
Baxter
Cantor Fitzgerald

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