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COTELLIC Drug Profile

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Which patents cover Cotellic, and when can generic versions of Cotellic launch?

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

This drug has forty-eight patent family members in thirty countries.

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

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	7
DailyMed Link:	COTELLIC at DailyMed

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

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Non-Orange Book US Patents for COTELLIC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
2,017,166,523
7,915,250	Azetidines as MEK inhibitors for the treatment of proliferative diseases

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International Patents for COTELLIC

Country	Document Number	Estimated Expiration
China	103524392
Japan	5856211
Eurasian Patent Organization	025871
Japan	2015232045

Supplementary Protection Certificates for COTELLIC

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90019-3	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
2016016	Lithuania		PRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
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
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