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Last Updated: November 22, 2024

Cobimetinib fumarate - Generic Drug Details


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What are the generic sources for cobimetinib fumarate and what is the scope of patent protection?

Cobimetinib fumarate is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobimetinib fumarate has one hundred and eighty-four patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for cobimetinib fumarate
International Patents:184
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 10
Patent Applications: 1
DailyMed Link:cobimetinib fumarate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cobimetinib fumarate
Generic Entry Date for cobimetinib fumarate*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for cobimetinib fumarate
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for cobimetinib fumarate

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 ⤷  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
>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 cobimetinib fumarate

Country Patent Number Title Estimated Expiration
Ukraine 124728 КРИСТАЛІЧНА ФУМАРАТНА СІЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНІЛАМІНО)ФЕНІЛ][3-ГІДРОКСИ-3-(ПІПЕРИДИН-2-ІЛ)АЗЕТИДИН-1-ІЛ]МЕТАНОНУ (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
Malaysia 162174 AZETIDINES MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES ⤷  Sign Up
Russian Federation 2021132394 КРИСТАЛЛИЧЕСКАЯ ФУМАРАТНАЯ СОЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНИЛАМИНО)ФЕНИЛ][3-ГИДРОКСИ-3-(ПИПЕРИДИН-2-ИЛ)АЗЕТИДИН-1-ИЛ]МЕТАНОНА ⤷  Sign Up
Croatia P20191533 ⤷  Sign Up
Eurasian Patent Organization 019983 ИНГИБИТОРЫ MEK И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (MEK INHIBITORS AND METHODS OF USING SAME) ⤷  Sign Up
European Patent Office 1934174 AZETIDINES EN TANT QU'INHIBITEURS DE MEK ET LEUR UTILISATION POUR LE TRAITEMENT DES MALADIES PROLIFERATIVES (AZETIDINES AS MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cobimetinib fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1934174 22/2016 Austria ⤷  Sign Up 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 SPC/GB16/023 United Kingdom ⤷  Sign Up 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 C201630028 Spain ⤷  Sign Up PRODUCT NAME: COBIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1048; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1048; DATE OF FIRST AUTHORISATION IN EEA: 20151120
1934174 93078 Luxembourg ⤷  Sign Up 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 650 Finland ⤷  Sign Up
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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