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Varenicline tartrate - Generic Drug Details

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Varenicline tartrate is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are six drug master file entries for varenicline tartrate. Eight suppliers are listed for this compound.

Summary for Generic Name: varenicline tartrate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list8
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: varenicline tartrate

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;ORAL021928-002May 10, 2006RXYes6,890,927► subscribeYY ► subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXNo► subscribe► subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXNo6,890,927► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: varenicline tartrate

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► subscribe
6,897,310 Aryl fused azapolycyclic compounds► subscribe
6,605,610 Aryl fused azapolycyclic compounds► subscribe
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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 Ingredient: varenicline tartrate

Country Document Number Estimated Expiration
CroatiaP20030910► subscribe
Eurasian Patent Organization005316► subscribe
Yugoslavia59602► subscribe
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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: VARENICLINE TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0039France► subscribePRODUCT 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
2008010,C1044189Lithuania► subscribePRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
442Luxembourg► subscribe91442, EXPIRES: 20210926
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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