COBIMETINIB FUMARATE - Generic Drug Details

What are the generic sources for cobimetinib fumarate and what is the scope of patent protection?

Cobimetinib fumarate is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobimetinib fumarate has one hundred and seventy-seven patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for COBIMETINIB FUMARATE

International Patents:	177
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Patent Applications:	1
DailyMed Link:	COBIMETINIB FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBIMETINIB FUMARATE

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.

Pharmacology for COBIMETINIB FUMARATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

US Patents and Regulatory Information for COBIMETINIB FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes					Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes					Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes

International Patents for COBIMETINIB FUMARATE

Country	Patent Number	Title	Estimated Expiration
South Africa	200802075	MEK inhibitors and methods of their use
Brazil	112017028516	sal de fumarato cristalino de (s)-[3,4-difluoro-2-(2-fluoro-4-iodofenilamino)fenil][3-hidroxi-3-(piperidin-2-il) azetidin-1-il]-metanona
Norway	344876

Supplementary Protection Certificates for COBIMETINIB FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	C201630028	Spain		PRODUCT NAME: COBIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1048; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1048; DATE OF FIRST AUTHORISATION IN EEA: 20151120
1934174	CR 2016 00021	Denmark		PRODUCT NAME: COBIMETINIB OG FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER DERAF, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124
1934174	CA 2016 00021	Denmark		PRODUCT NAME: COBIMETINIB, EVENTUELT I EN HVILKEN SOM HELST FORM BESKYTTET AF GRUNDPATENTET, DER INDBEFATTER FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124