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COTELLIC Drug Patent Profile

When do Cotellic patents expire, and what generic alternatives are available?

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

This drug has one hundred and seventy-seven patent family members in forty-three 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.

DrugPatentWatch^® Generic Entry Outlook for Cotellic

Cotellic was eligible for patent challenges on November 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COTELLIC

International Patents:	177
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	35
Patent Applications:	1
Drug Prices:	Drug price information for COTELLIC
What excipients (inactive ingredients) are in COTELLIC?	COTELLIC excipients list
DailyMed Link:	COTELLIC at DailyMed

See drug prices for COTELLIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for COTELLIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	Phase 2/Phase 3
University of Birmingham	Phase 2/Phase 3

See all COTELLIC clinical trials

Pharmacology for COTELLIC

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COTELLIC

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 COTELLIC

COTELLIC is protected by seven US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COTELLIC

FDA Regulatory Exclusivity protecting 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					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					Y

International Patents for COTELLIC

When does loss-of-exclusivity occur for COTELLIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COTELLIC around the world.

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
France	16C0021
Hong Kong	1254389	含有藥物的立即釋放片劑和用於形成片劑的方法 (IMMEDIATE-RELEASE TABLETS CONTAINING A DRUG AND PROCESSES FOR FORMING THE TABLETS)

Supplementary Protection Certificates for COTELLIC

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
1934174	93078	Luxembourg		PRODUCT NAME: COBIMETINIB, EVENTUELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE, Y COMPRIS LES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER HEMIFUMARATE DE COBIMETINIB; FIRST REGISTRATION DATE: 20151124
1934174	2016/022	Ireland		PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120