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Vemurafenib - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for vemurafenib?

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.

This ingredient has one hundred and fifty-four patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for Generic Name: vemurafenib

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Bulk Api Vendors: see list81
Clinical Trials: see list59
Patent Applications: see list78
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 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
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes8,143,271► SubscribeYY ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes► Subscribe► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes8,470,818► Subscribe ► Subscribe
Hoffmann La Roche
ZELBORAF
vemurafenib
TABLET;ORAL202429-001Aug 17, 2011RXYesYes7,863,288► 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
8,530,661Process for the manufacture of pharmaceutically active compounds► 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
8,415,469Compounds and methods for kinase modulation, and indications therefor► Subscribe
8,329,724Process 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
Portugal1893612► Subscribe
South Korea20120055586► Subscribe
Japan5784602► Subscribe
Hong Kong1164866► Subscribe
CroatiaP20151156► 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► SubscribePRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
2012010Lithuania► SubscribePRODUCT NAME: VEMURAFENIBUM; 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
2012010,C1893612Lithuania► SubscribePRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
2Finland► Subscribe
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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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