Vemurafenib - Generic Drug Details

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

See all vemurafenib clinical trials

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			Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y

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

International Patents for vemurafenib

Country	Patent Number	Title	Estimated Expiration
China	103601725	Process for the manufacture of pharmaceutically active compounds
Japan	5138938
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)
Taiwan	200804370	Compounds and methods for kinase modulation, and indications therefor

Supplementary Protection Certificates for vemurafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	28/2012	Austria		PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221
1893612	2012C/028	Belgium		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		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		PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217