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Last Updated: August 4, 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 patent protection?

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: 132
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
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2

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 Y   Start Trial
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
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   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 2012C/028 Belgium   Start Trial PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221
1893612 C20120016 00059 Estonia   Start Trial PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012
1893612 92035 Luxembourg   Start Trial 92035, EXPIRES: 20270217
1893612 C300534 Netherlands   Start Trial PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 122, 5012-2012 Slovakia   Start Trial PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612 CA 2012 00028 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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