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Serving leading biopharmaceutical companies globally:

US Army
Novartis
Deloitte
Farmers Insurance
Federal Trade Commission
Citi
Cerilliant
Argus Health
Chinese Patent Office
Medtronic

Generated: December 17, 2017

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Vemurafenib - Generic Drug Details

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What are the generic sources for vemurafenib and what is the scope of vemurafenib freedom to operate?

Vemurafenib
is the generic ingredient in one branded drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vemurafenib has one hundred and eighty patent family members in forty-four countries and fifteen supplementary protection certificates in thirteen countries.

One supplier is listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Hoffmann La RocheZELBORAFvemurafenibTABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: vemurafenib

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
8,329,724Process for the manufacture of pharmaceutically active compounds► Subscribe
8,415,469Compounds and methods for kinase modulation, and indications therefor► Subscribe
9,663,517Compositions and uses thereof► Subscribe
7,846,941Compounds modulating c-kit and c-fms activity and uses therefor► Subscribe
8,067,434Compounds and methods for development of Ret modulators► Subscribe
8,530,661Process for the manufacture of pharmaceutically active 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: vemurafenib

Country Document Number Estimated Expiration
China105237530► Subscribe
World Intellectual Property Organization (WIPO)2007013896► Subscribe
Japan2008545652► Subscribe
Luxembourg92035► Subscribe
Mexico2012005224► Subscribe
China101243084► Subscribe
Australia2006261993► Subscribe
Canada2613015► Subscribe
Costa Rica20170089► Subscribe
Taiwan201345906► 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: VEMURAFENIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/025Ireland► SubscribePRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612/01Switzerland► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011
0120016 00059Estonia► SubscribePRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012
2, 5012-2012Slovakia► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
035Luxembourg► Subscribe92035, EXPIRES: 20270217
2012010Lithuania► SubscribePRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
2012 00028Denmark► Subscribe
C/GB12/021United Kingdom► SubscribePRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
90026-2Sweden► SubscribePRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
2012000043Germany► SubscribePRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
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Serving leading biopharmaceutical companies globally:

Dow
Deloitte
Cantor Fitzgerald
Chubb
Chinese Patent Office
Novartis
Healthtrust
UBS
Merck
Federal Trade Commission

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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