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Last Updated: October 20, 2021

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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 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 ninety-three patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vemurafenib
International Patents:193
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 140
Patent Applications: 7,917
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in vemurafenib?vemurafenib excipients list
DailyMed Link:vemurafenib at DailyMed
Recent Clinical Trials for vemurafenib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
West China HospitalPhase 1
Maria Sklodowska-Curie Institute - Oncology CenterPhase 2
Peter MacCallum Cancer Centre, AustraliaN/A

See all vemurafenib clinical trials

US Patents and Regulatory Information for 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;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for vemurafenib

Country Patent Number Estimated Expiration
Croatia P20141228 ⤷  Free Forever Trial
Taiwan I473808 ⤷  Free Forever Trial
European Patent Office 2414356 ⤷  Free Forever Trial
South Africa 200711152 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2011057974 ⤷  Free Forever Trial
Australia 2010280848 ⤷  Free Forever Trial
Hong Kong 1168590 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for vemurafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 122 5012-2012 Slovakia ⤷  Free Forever Trial FIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
1893612 SPC/GB12/021 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
1893612 122, 5012-2012 Slovakia ⤷  Free Forever Trial PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612 1290026-2 Sweden ⤷  Free Forever Trial PRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
1893612 C300534 Netherlands ⤷  Free Forever Trial PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 CA 2012 00028 Denmark ⤷  Free Forever Trial
1893612 2012/025 Ireland ⤷  Free Forever Trial PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Dow
McKesson
Johnson and Johnson
Mallinckrodt

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 verification 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.