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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
6,605,610 Aryl fused azapolycyclic compounds<disabled in preview>
7,144,882Aryl fused azapolycyclic compounds<disabled in preview>
6,897,310 Aryl fused azapolycyclic compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CHANTIX

Country Document Number Estimated Expiration
Norway2006016<disabled in preview>
South Korea100537976<disabled in preview>
Brazil9814592<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CHANTIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C021/2008Ireland<disabled>SPC021/2008: 20081105, EXPIRES: 20210925
C/GB08/034United Kingdom<disabled>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
5Finland<disabled>
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