VEMURAFENIB - Generic Drug Details

What are the generic drug 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:	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

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

Sponsor	Phase
University of Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3

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
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y	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
Poland	2414356
Malaysia	160737	PROPANE-I-SULFONIC ACID {3- [5-(4-CHLORO-PHENYL) -1H -PYRROLO [2, 3-B] PYRIDINE-3-CARBONYL] -2,4 DIFLUORO-PHENYL} - AMIDE COMPOSITIONS AND USES THEREOF
Spain	2371397
World Intellectual Property Organization (WIPO)	2007002433
Ecuador	SP11011282	COMPOSICIONES DEL ÁCIDO PROPANO-1-SULFÓNICO {3-[5-(4-CLORO-FENIL)-1H-PIRROLO [2,3-b]-PIRIDINA-3-CARBONIL]-2,4-DIFLUORO-FENIL}-AMIDA Y EL USO DE LAS MISMAS

Supplementary Protection Certificates for VEMURAFENIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	C01893612/01	Switzerland		VERTRETERLOESCHUNG
1893612	92035	Luxembourg		92035, EXPIRES: 20270217
1893612	SPC/GB12/021	United Kingdom		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK 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
1893612	28/2012	Austria		PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221