~ Buy the COTELLIC (cobimetinib fumarate) Drug Profile, 2024 PDF Report in the Report Store ~

COTELLIC Drug Patent Profile

✉ Email this page to a colleague

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 seven patents protecting this drug.

This drug has one hundred and eighty 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

< Available with Subscription >

Sign Up

Summary for COTELLIC

International Patents:	180
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

Drug patent expirations by year for COTELLIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COTELLIC

Generic Entry Date for COTELLIC^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COTELLIC is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Immediate-release tablets containing combimetinib and methods of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Combination therapies
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: AS A SINGLE AGENT FOR THE TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting COTELLIC

TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷ Sign Up

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

Patent: 5483
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 16288209
Estimated Expiration: ⤷ Sign Up

Patent: 21200202
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2017028516
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 90222
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 17003475
Estimated Expiration: ⤷ Sign Up

China

Patent: 7810183
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 18000086
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 180056
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 17264
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 52433
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 6423
Estimated Expiration: ⤷ Sign Up

Patent: 5052
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 38950
Estimated Expiration: ⤷ Sign Up

Patent: 18519318
Estimated Expiration: ⤷ Sign Up

Patent: 21035967
Estimated Expiration: ⤷ Sign Up

Patent: 23025000
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 2545
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 17017037
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 301
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 180692
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 017502414
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 62181
Estimated Expiration: ⤷ Sign Up

Patent: 18103172
Estimated Expiration: ⤷ Sign Up

Patent: 21132394
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 202105196Y
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1708760
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 180021775
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 10556
Estimated Expiration: ⤷ Sign Up

Patent: 75187
Estimated Expiration: ⤷ Sign Up

Patent: 1718535
Estimated Expiration: ⤷ Sign Up

Patent: 2108568
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 4728
Estimated Expiration: ⤷ Sign Up

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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	025871	ИНГИБИТОРЫ MEK И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (MEK INHIBITORS AND METHODS OF USING THE SAME)	⤷ Sign Up
Australia	2022201067	Immediate-release tablets containing a drug and processes for forming the tablets	⤷ Sign Up
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	⤷ Sign Up
South Korea	20130058072	AZETIDINES AS MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES	⤷ Sign Up
Japan	7232284		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for COTELLIC

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	CR 2016 00021	Denmark	⤷ Sign Up	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	⤷ Sign Up	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	364 5005-2016	Slovakia	⤷ Sign Up	PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
1934174	PA2016016	Lithuania	⤷ Sign Up	PRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174	650	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description