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Serving leading biopharmaceutical companies globally:

Queensland Health
Cipla
Harvard Business School
UBS
Fuji
Chubb
Citi
QuintilesIMS
Julphar
Boehringer Ingelheim

Generated: October 20, 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 seventy-eight patent family members in forty-four countries and fifteen supplementary protection certificates in thirteen countries.

One supplier is listed for this compound.

Summary for Generic Name: vemurafenib

US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list81
Clinical Trials: see list115
Patent Applications: see list172
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:vemurafenib at DailyMed

Pharmacology for Ingredient: vemurafenib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► SubscribeYY ► 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
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
8,329,724Process 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
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
CroatiaP20141228► Subscribe
World Intellectual Property Organization (WIPO)2007013896► Subscribe
San MarinoT201500302► Subscribe
Japan2014205682► Subscribe
Uruguay32540► Subscribe
New Zealand594398► Subscribe
European Patent Office1885723► Subscribe
Taiwan201345906► Subscribe
TaiwanI432193► Subscribe
Russian Federation2008100933► 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
2 5012-2012Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
C/GB12/021United Kingdom► SubscribePRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
2, 5012-2012Slovakia► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
90026-2Sweden► SubscribePRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
00534Netherlands► SubscribePRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
2012 00028Denmark► Subscribe
12/025Ireland► SubscribePRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION 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
035Luxembourg► Subscribe92035, EXPIRES: 20270217
C0040France► SubscribePRODUCT NAME: VEMURAFENIB, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Deloitte
Cipla
US Army
Covington
Citi
Federal Trade Commission
Accenture
Boehringer Ingelheim

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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