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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
Baxter
Queensland Health
Fuji
McKinsey
McKesson
US Army
Harvard Business School
Express Scripts

Generated: June 27, 2017

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Varenicline tartrate - Generic Drug Details

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What are the generic drug sources for varenicline tartrate and what is the scope of varenicline tartrate patent protection?

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

Varenicline tartrate has one hundred and seventy-five patent family members in fifty-six countries.

There are seven drug master file entries for varenicline tartrate. Nine suppliers are listed for this compound.

Summary for Generic Name: varenicline tartrate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list9
Bulk Api Vendors: see list62
Clinical Trials: see list334
Patent Applications: see list13
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:varenicline tartrate at DailyMed

Pharmacology for Ingredient: varenicline tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXYesNo6,890,927► SubscribeYY ► Subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-002May 10, 2006RXYesYes7,265,119► SubscribeYY ► Subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-002May 10, 2006RXYesYes► Subscribe► Subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXYesNo7,265,119► SubscribeYY ► Subscribe
Pfizer Inc
CHANTIX
varenicline tartrate
TABLET;ORAL021928-001May 10, 2006RXYesNo► Subscribe► 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
6,951,938 Aryl fused azapolycyclic compounds► Subscribe
7,205,300Aryl fused azapolycyclic compounds► Subscribe
6,605,610 Aryl fused azapolycyclic compounds► Subscribe
6,897,310 Aryl fused azapolycyclic compounds► Subscribe
7,144,882Aryl 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
Israel136727► Subscribe
World Intellectual Property Organization (WIPO)02092089► Subscribe
Japan3779682► Subscribe
Canada2401229► Subscribe
Canada2447405► 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
442Luxembourg► Subscribe91442, EXPIRES: 20210926
C021/2008Ireland► SubscribeSPC021/2008: 20081105, EXPIRES: 20210925
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
2008010Lithuania► SubscribePRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926
0355Netherlands► Subscribe300355, 20181113, EXPIRES: 20220425
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Cipla
Queensland Health
Harvard Business School
Deloitte
Citi
QuintilesIMS
Johnson and Johnson
Healthtrust
McKesson

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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