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

Anatomical Therapeutic Chemical (ATC) Classes for cobimetinib fumarate

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
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					Y

International Patents for cobimetinib fumarate

Country	Patent Number	Title	Estimated Expiration
Japan	2019089841	ＭＥＫインヒビターおよびその使用方法 (MEK INHIBITOR AND APPLICATION METHOD THEREOF)
South Africa	201708760	CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE
Taiwan	I804919
Mexico	367970	TRATAMIENTOS DE COMBINACIÓN PARA MELANOMA QUE COMPRENDEN LA ADMINISTRACIÓN DE COBIMETINIB Y VEMURAFINIB. (COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB.)
China	108135854	含有药物的立即释放片剂和用于形成片剂的方法 (IMMEDIATE-RELEASE TABLETS CONTAINING A DRUG AND PROCESSES FOR FORMING THE TABLETS)
Australia	2022201067	Immediate-release tablets containing a drug and processes for forming the tablets
Hong Kong	1252433	(S)-[3，4-二氟-2-(2-氟-4-碘苯基氨基)苯基][3-羥基-3-(呱啶-2-基)氮雜環丁烷-1-基]-甲酮的結晶反丁烯二酸鹽 (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	122016000033	Germany		PRODUCT NAME: COBIMETINIB, OPTIONAL ALS PHARMAZEUTISCH ZULAESSIGES SALZ ODER SOLVAT DAVON, INSBESONDERE COBIMETINIB-HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 20151120
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
1934174	22/2016	Austria		PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEREOISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
1934174	364 5005-2016	Slovakia		PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
1934174	1690019-3	Sweden		PRODUCT NAME: COBIMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REG. NO/DATE: EU/1/15/1048 20151124
1934174	16C0021	France		PRODUCT NAME: COBIMETINIB,OPTIONNELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE,NOTAMMENT SES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'HEMIFUMARATE DE COBIMETINIB; REGISTRATION NO/DATE: EU/1/15/1048 20151124
1934174	C 2016 018	Romania		PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 015; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 2228064; DATE OF FIRST AUTHORISATION IN EEA: 20220530