COTELLIC Drug Patent Profile

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 six patents protecting this drug.

This drug has one hundred and fifty-six patent family members in forty-two 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 June 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COTELLIC

International Patents:	156
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	32
Patent Applications:	1,890
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 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.

Recent Clinical Trials for COTELLIC

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
Oregon Health and Science University	Phase 2
Servier Pharmaceuticals, LLC	Phase 1

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 six US patents and one FDA Regulatory Exclusivity.

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
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			Y	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

Mexico

Morocco

Peru

Philippines

Russian Federation

Singapore

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
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)
Japan	2020189882	ＭＥＫインヒビターおよびその使用方法 (MEK INHIBITORS AND METHOD FOR USING THE SAME)
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)
Poland	1934174

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	PA2016016,C1934174	Lithuania		PRODUCT NAME: KOBIMETINIBAS, PASIRINKTINAI KAIP JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR SOLVATAI, YPAC KOBIMETINIBO HEMIFUMARATAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
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	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	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