COTELLIC Drug Patent 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 seven patents protecting this drug.
This drug has one hundred and seventy-two 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: | 172 |
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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COTELLIC
Generic Entry Date for COTELLIC*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Pharmacology for COTELLIC
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for COTELLIC
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Combination therapies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting COTELLIC
TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷ Try a Trial
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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: ⤷ Try a Trial
Australia
Patent: 16288209
Estimated Expiration: ⤷ Try a Trial
Patent: 21200202
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017028516
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 90222
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17003475
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7810183
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 18000086
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 180056
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 17264
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 52433
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6423
Estimated Expiration: ⤷ Try a Trial
Patent: 5052
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 18519318
Estimated Expiration: ⤷ Try a Trial
Patent: 21035967
Estimated Expiration: ⤷ Try a Trial
Patent: 23025000
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 2545
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17017037
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 301
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 180692
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017502414
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 62181
Estimated Expiration: ⤷ Try a Trial
Patent: 18103172
Estimated Expiration: ⤷ Try a Trial
Patent: 21132394
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202105196Y
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1708760
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 180021775
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 10556
Estimated Expiration: ⤷ Try a Trial
Patent: 75187
Estimated Expiration: ⤷ Try a Trial
Patent: 1718535
Estimated Expiration: ⤷ Try a Trial
Patent: 2108568
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 4728
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Japan | 2018058907 | MEKインヒビターおよびその使用方法 (MEK INHIBITOR AND APPLICATION METHOD THEREOF) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2014027056 | ⤷ Try a Trial | |
Australia | 2013304021 | Combination therapies for melanoma comprising administering cobimetinib and vemurafinib | ⤷ Try a Trial |
Peru | 20180692 | SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODOFENILAMINO)FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL)AZETIDIN-1-IL]-METANONA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COTELLIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1934174 | SPC/GB16/023 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COBIMETINIB, INCLUDING A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REGISTERED: UK EU/1/15/1048/001(NI) 20151124; UK PLGB 00031/0849 20151124 |
1934174 | 2016C/029 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COBIMETINIB IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI, INCLUSIEF FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1048 20111120 |
1934174 | 93078 | Luxembourg | ⤷ Try a Trial | 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 | CA 2016 00021 | Denmark | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |