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COTELLIC Drug Profile

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Which patents cover Cotellic, and what generic alternatives are available?

Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.

Summary for COTELLIC

US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	7
Drug Prices:	Drug price information for COTELLIC
DailyMed Link:	COTELLIC at DailyMed

Generic Entry Opportunity Date for COTELLIC

NDA:

206192

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 COTELLIC

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Synonyms for COTELLIC

1369665-02-0

6EXI96H8SV

bis[(2S)-2-{1-[3,4-difluoro-2-(2-fluoro-4-iodoanilino)benzoyl]-3-hydroxyazetidin-3-yl}piperidin-1-ium] (2E)-but-2-enedioate

CHEBI:90853

CHEMBL2364607

Cobimetinib Fumarate

Cobimetinib fumarate (USAN)

Cobimetinib fumarate [USAN]

Cobimetinib hemifumarate

Cotellic (TN)

D10615

GDC-0973 hemifumarate

Methanone, (3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)phenyl)(3-hydroxy-3-(2S)-2-piperidinyl-1-azetidinyl)-, (2E)-2-butenedioate (2:1)

UNII-6EXI96H8SV

Xl-518 hemifumarate

US Patents and Regulatory Information for COTELLIC

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
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes			Y	Y

International Patents for COTELLIC

Country	Document Number	Estimated Expiration
Japan	5856211
Luxembourg	93078
Slovenia	1934174

Supplementary Protection Certificates for COTELLIC

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0021	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
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
0809	Netherlands		PRODUCT NAME: COBIMETINIBI, DESGEWENST FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1048 20151124