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Serving leading biopharmaceutical companies globally:

Moodys
Cerilliant
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Cipla
Chubb
McKinsey
Colorcon
Accenture

Generated: January 21, 2018

DrugPatentWatch Database Preview

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 three 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 eighty-two patent family members in fifty-six countries.

There are eight drug master file entries for varenicline tartrate. Nine suppliers are listed for this compound.
Summary for varenicline tartrate
Pharmacology for varenicline tartrate
Medical Subject Heading (MeSH) Categories for varenicline tartrate

US Patents and Regulatory Information for 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;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pfizer Inc CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Non-Orange Book US Patents for 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
7,144,882 Aryl fused azapolycyclic compounds ➤ Subscribe
6,605,610 Aryl fused azapolycyclic compounds ➤ Subscribe
6,887,884 Aryl fused azapolycyclic compounds ➤ Subscribe
7,205,300 Aryl fused azapolycyclic compounds ➤ Subscribe
6,951,938 Aryl fused azapolycyclic compounds ➤ Subscribe
6,897,310 Aryl fused azapolycyclic compounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for varenicline tartrate

Supplementary Protection Certificates for varenicline tartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/034 United Kingdom ➤ Subscribe 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
2008010 Lithuania ➤ Subscribe PRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926
1044189/01 Switzerland ➤ Subscribe PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
0355 Netherlands ➤ Subscribe 300355, 20181113, EXPIRES: 20220425
5 Finland ➤ Subscribe
442 Luxembourg ➤ Subscribe 91442, EXPIRES: 20210926
2008010,C1044189 Lithuania ➤ Subscribe PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926
2008 00031 Denmark ➤ Subscribe
2008000038 Germany ➤ Subscribe PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926
C021/2008 Ireland ➤ Subscribe SPC021/2008: 20081105, EXPIRES: 20210925
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Daiichi Sankyo
Teva
Cantor Fitzgerald
Express Scripts
Accenture
Chinese Patent Office
Cipla

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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