VEMURAFENIB - Generic Drug Details

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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
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3
University of Manchester	Phase 2/Phase 3
University of Birmingham	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

Anatomical Therapeutic Chemical (ATC) Classes for VEMURAFENIB

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VEMURAFENIB

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Glossary

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

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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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	565255	Pyrrolo[2,3-b] pyridine derivatives as protein kinase inhibitors	⤷ Sign Up
Portugal	1893612		⤷ Sign Up
South Korea	101440257		⤷ Sign Up
Uruguay	32540	COMPOSICIONES QUE INCLUYEN COMPUESTOS QUE CONTIENEN LA {3-[5-(4-CLORO-FENIL)-1H-PIRROLO[2,3-B]PIRIDINA-3-CARBONIL]-2,4-DIFLUOR-FENIL}-AMIDA DEL ÁCIDO PROPANO-1-SULFÓNICO Y MÉTODOS PARA FABRICAR ESTAS COMPOSICIONES	⤷ Sign Up
Malaysia	153898	COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR	⤷ Sign Up
Poland	2462116		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VEMURAFENIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	C01893612/01	Switzerland	⤷ Sign Up	VERTRETERLOESCHUNG
1893612	28/2012	Austria	⤷ Sign Up	PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221
1893612	132012902073472	Italy	⤷ Sign Up	PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120221
1893612	CA 2012 00028	Denmark	⤷ Sign Up
1893612	2012C/028	Belgium	⤷ Sign Up	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	462	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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