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Last Updated: March 19, 2024

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-seven patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vemurafenib
International Patents:197
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 139
Clinical Trials: 149
Patent Applications: 7,190
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in vemurafenib?vemurafenib excipients list
DailyMed Link:vemurafenib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vemurafenib
Generic Entry Date for vemurafenib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for vemurafenib

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

SponsorPhase
Cancer Research UKPhase 2/Phase 3
Royal Marsden NHS Foundation TrustPhase 2/Phase 3
University of ManchesterPhase 2/Phase 3

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Ukraine 108842 ТВЕРДА ДИСПЕРСІЯ, СПОСІБ ЇЇ ОДЕРЖАННЯ, А ТАКОЖ КОМПОЗИЦІЯ І ЛІКАРСЬКА ФОРМА, ЩО ЇЇ МІСТЯТЬ ⤷  Try a Trial
Hungary E027370 ⤷  Try a Trial
Russian Federation 2418800 ПИРРОЛО[2, 3-В]ПИРИДИНОВЫЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗ (PYRROLO[2,3-B]PYRIDINE DERIVATIVE AS PROTEIN KINASE INHIBITORS) ⤷  Try a Trial
Mexico 340572 PROCESO PARA LA FABRICACION DE COMPUESTOS FARMACEUTICAMENTE ACTIVOS. (PROCESS FOR THE MANUFACTURE OF PHARMACEUTICALLY ACTIVE COMPOUNDS.) ⤷  Try a Trial
South Africa 201202025 INTERMEDIATES USEFUL IN THE PREPARATION OF PYRROLO[2,3-b] PYRIDINE DERIVATIVES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for vemurafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 1290026-2 Sweden ⤷  Try a Trial PRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
1893612 2012/025 Ireland ⤷  Try a Trial PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 PA2012010,C1893612 Lithuania ⤷  Try a Trial PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 C01893612/01 Switzerland ⤷  Try a Trial VERTRETERLOESCHUNG
1893612 PA2012010 Lithuania ⤷  Try a Trial PRODUCT NAME: VEMURAFENIBUM; 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.