Cobimetinib fumarate - Generic Drug Details

What are the generic drug 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
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
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
Peru	20180692	SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODOFENILAMINO)FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL)AZETIDIN-1-IL]-METANONA
South Korea	101341792
China	107810183	(S)‑[3,4‑二氟‑2‑(2‑氟‑4‑碘苯基氨基)苯基][3‑羟基‑3‑(哌啶‑2‑基)氮杂环丁烷‑1‑基]‑甲酮的结晶反丁烯二酸盐 (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
China	101365676	Azetidines as mek inhibitors for the treatment of proliferative diseases
Singapore	10202105196Y	CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE

Supplementary Protection Certificates for cobimetinib fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	300809	Netherlands		PRODUCT NAME: COBIMETINIBI, DESGEWENST FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1048 20151124
1934174	C01934174/01	Switzerland		PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015
1934174	1691019-2	Sweden		PRODUCT NAME: COBIMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE, IN PARTICULAR COBIMETINIB HEMIFUMARATE; EU/1/15/1048 2015-11-24
1934174	132016000050893	Italy		PRODUCT NAME: COBIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE, INCLUSI SALI E SOLVATI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE COBIMETINIB EMIFUMARATO(COTELLIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1048, 20151124
1934174	364 5005-2016	Slovakia		PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124