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Last Updated: March 19, 2024

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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-six 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

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Summary for COTELLIC
International Patents:176
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
Drug Prices for COTELLIC

See drug prices for COTELLIC

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

SponsorPhase
Cancer Research UKPhase 2/Phase 3
Royal Marsden NHS Foundation TrustPhase 2/Phase 3
University of ManchesterPhase 2/Phase 3

See all COTELLIC clinical trials

Pharmacology for COTELLIC
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

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
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
>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: 38950
Estimated Expiration: ⤷  Try a Trial

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
Morocco 42301 SEL CRISTALLIN DE FUMARATE DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHÉNYLAMINO)PHÉNYL][3-HYDROXY-3-(PIPÉRIDIN-2-YL)AZÉTIDIN-1-YL]-MÉTHANONE ⤷  Try a Trial
Hong Kong 1119698 AZETIDINES AS MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES ⤷  Try a Trial
New Zealand 735626 Combination therapies for melanoma comprising administering cobimetinib and vemurafenib ⤷  Try a Trial
Hungary E044789 ⤷  Try a Trial
Japan 2017101071 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
Singapore 11201500582U COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB ⤷  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 2016/022 Ireland ⤷  Try a Trial PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120
1934174 122016000033 Germany ⤷  Try a Trial PRODUCT NAME: COBIMETINIB, OPTIONAL ALS PHARMAZEUTISCH ZULAESSIGES SALZ ODER SOLVAT DAVON, INSBESONDERE COBIMETINIB-HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174 C 2016 018 Romania ⤷  Try a Trial PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 015; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 2228064; DATE OF FIRST AUTHORISATION IN EEA: 20220530
1934174 1690019-3 Sweden ⤷  Try a Trial PRODUCT NAME: COBIMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REG. NO/DATE: EU/1/15/1048 20151124
1934174 22/2016 Austria ⤷  Try a Trial PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEREOISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
1934174 C20160012 00193 Estonia ⤷  Try a Trial PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.