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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 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-three patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for vemurafenib

International Patents:	193
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	140
Patent Applications:	7,917
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
West China Hospital	Phase 1
Maria Sklodowska-Curie Institute - Oncology Center	Phase 2
Peter MacCallum Cancer Centre, Australia	N/A

See all vemurafenib clinical trials

Pharmacology for vemurafenib

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 1A2 Inhibitors P-Glycoprotein 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
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

International Patents for vemurafenib

Country	Patent Number	Estimated Expiration
Croatia	P20141228
Taiwan	I473808
European Patent Office	2414356
South Africa	200711152
World Intellectual Property Organization (WIPO)	2011057974
Australia	2010280848
Hong Kong	1168590

Supplementary Protection Certificates for vemurafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	122 5012-2012	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
1893612	SPC/GB12/021	United Kingdom		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
1893612	122, 5012-2012	Slovakia		PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612	1290026-2	Sweden		PRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
1893612	C300534	Netherlands		PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612	CA 2012 00028	Denmark
1893612	2012/025	Ireland		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217