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
Sponsor | Phase |
---|---|
Oregon Health and Science University | Phase 2 |
OHSU Knight Cancer Institute | Phase 2 |
Shanghai Kechow Pharma, Inc. | Phase 2 |
Pharmacology for vemurafenib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors |
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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