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Serving leading biopharmaceutical companies globally:

Novartis
Colorcon
Cipla
Julphar
Queensland Health
Federal Trade Commission
Citi
Cantor Fitzgerald
Farmers Insurance
Johnson and Johnson

Generated: December 11, 2017

DrugPatentWatch Database Preview

ZELBORAF Drug Profile

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Which patents cover Zelboraf, and when can generic versions of Zelboraf launch?

Zelboraf is a drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.

US Patents and Regulatory Information

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

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

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005062795► Subscribe
Taiwan201040179► Subscribe
South Africa200709919► Subscribe
Mexico340572► Subscribe
Israel219108► Subscribe
Portugal1893612► Subscribe
Japan2013501024► Subscribe
South Korea101461291► Subscribe
South Korea101440257► Subscribe
Spain2552386► 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: ZELBORAF

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00534Netherlands► SubscribePRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
90026-2Sweden► SubscribePRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
2Finland► Subscribe
2 5012-2012Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
2, 5012-2012Slovakia► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
C/GB12/021United Kingdom► SubscribePRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
035Luxembourg► Subscribe92035, EXPIRES: 20270217
2012000043Germany► SubscribePRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612/01Switzerland► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011
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:

AstraZeneca
Colorcon
Fish and Richardson
Chinese Patent Office
Cipla
Cerilliant
Teva
Express Scripts
Medtronic
QuintilesIMS

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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