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Last Updated: May 20, 2022

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 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

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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
Drug patent expirations by year for COTELLIC
Drug Prices for COTELLIC

See drug prices for COTELLIC

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
Servier Pharmaceuticals, LLCPhase 1

See all COTELLIC clinical trials

Pharmacology for COTELLIC
Drug ClassKinase Inhibitor
Mechanism of Action Kinase Inhibitors

US Patents and Regulatory Information for COTELLIC

COTELLIC is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COTELLIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

Combination therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Azetidines as MEK inhibitors for the treatment of proliferative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

FDA Regulatory Exclusivity protecting COTELLIC

FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATION, IN COMBINATION WITH VEMURAFENIB. COTELLIC IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH WILD-TYPE BRAF MELANOMA
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 16288209
Estimated Expiration: See Plans and Pricing

Patent: 21200202
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017028516
Estimated Expiration: See Plans and Pricing

Canada

Patent: 90222
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17003475
Estimated Expiration: See Plans and Pricing

China

Patent: 7810183
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 18000086
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 180056
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 17264
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 52433
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6423
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18519318
Estimated Expiration: See Plans and Pricing

Patent: 21035967
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17017037
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 301
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180692
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017502414
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 62181
Estimated Expiration: See Plans and Pricing

Patent: 18103172
Estimated Expiration: See Plans and Pricing

Patent: 21132394
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202105196Y
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180021775
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 10556
Estimated Expiration: See Plans and Pricing

Patent: 1718535
Estimated Expiration: See Plans and Pricing

Patent: 2108568
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4728
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
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) See Plans and Pricing
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) See Plans and Pricing
Poland 1934174 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COTELLIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1934174 PA2016016,C1934174 Lithuania See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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