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CHANTIX Drug Profile

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Chantix is a drug marketed by Pfizer Inc and is included in one NDA. It is available from eight suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-nine patent family members in fifty-five countries.

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

Summary for Tradename: CHANTIX

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list8

Pharmacology for Tradename: CHANTIX

Clinical Trials for: CHANTIX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXNo6,410,550<disabled>YY <disabled>
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-002May 10, 2006RXYes6,890,927<disabled>YY <disabled>
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXNo<disabled><disabled>
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Paragraph IV activity for: CHANTIX

Drugname Dosage Strength RLD Submissiondate
varenicline tartrateTablets0.5 mg and 1 mgChantix5/10/2010

Non-Orange Book Patents for Tradename: CHANTIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,205,300Aryl fused azapolycyclic compounds<disabled in preview>
6,605,610 Aryl fused azapolycyclic compounds<disabled in preview>
6,897,310 Aryl fused azapolycyclic compounds<disabled in preview>
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International Patent Family for Tradename: CHANTIX

Country Document Number Estimated Expiration
Australia2002253482<disabled in preview>
Poland209404<disabled in preview>
Ukraine66825<disabled in preview>
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Supplementary Protection Certificates for Tradename: CHANTIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
5Finland<disabled>
C0039France<disabled>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
0355Netherlands<disabled>300355, 20181113, EXPIRES: 20220425
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