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Last Updated: February 3, 2023

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-eight patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vemurafenib
International Patents:198
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 133
Clinical Trials: 147
Patent Applications: 7,335
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
Oregon Health and Science UniversityPhase 2
OHSU Knight Cancer InstitutePhase 2
Shanghai Kechow Pharma, Inc.Phase 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for vemurafenib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH Zelboraf vemurafenib EMEA/H/C/002409
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
Authorised no no no 2012-02-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for vemurafenib

Country Patent Number Title Estimated Expiration
China 103601725 Process for the manufacture of pharmaceutically active compounds See Plans and Pricing
Japan 5138938 See Plans and Pricing
Israel 251336 תכשירי פרופאן-1-חומצה סולפונית {3-[5-(4-כלורו-פניל)-h1-פירולו[b-3,2] פירידין-3-קרבוניל]-4,2-דיפלואורו-פניל}-אמיד ושימושים בהם (Propane-1-sulfonic acid {3- [5- (4 -chloro-phenyl) -1h-pyrrolo [2, 3-b] pyridine-3-carbonyl] -2, 4-difluoro-phenyl } -amide compositions and uses thereof) See Plans and Pricing
Taiwan 200804370 Compounds and methods for kinase modulation, and indications therefor See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for vemurafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 28/2012 Austria See Plans and Pricing PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221
1893612 2012C/028 Belgium See Plans and Pricing 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 12C0040 France See Plans and Pricing PRODUCT NAME: VEMURAFENIB, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/751/001 20120221
1893612 C300534 Netherlands See Plans and Pricing PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.