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Last Updated: July 12, 2020

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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-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vemurafenib
International Patents:192
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 111
Clinical Trials: 130
Patent Applications: 242
Formulation / Manufacturing:see details
DailyMed Link:vemurafenib at DailyMed
Recent Clinical Trials for vemurafenib

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

SponsorPhase
Acrotech BiopharmaPhase 1
NovartisPhase 1
OHSU Knight Cancer InstitutePhase 1

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

Supplementary Protection Certificates for vemurafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 PA2012010 Lithuania   Start Trial PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 92035 Luxembourg   Start Trial 92035, EXPIRES: 20270217
1893612 132012902073472 Italy   Start Trial PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): 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

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