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Last Updated: November 4, 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 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 ⤷  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 cobimetinib fumarate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 201990219 ИНГИБИТОРЫ MEK И СПОСОБЫ ИХ ПРИМЕНЕНИЯ ⤷  Sign Up
South Korea 20150038068 코비메티닙 및 베무라피닙을 투여함을 포함하는 흑색종의 조합 치료법 (COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB) ⤷  Sign Up
Poland 3881833 ⤷  Sign Up
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 ⤷  Sign Up
Costa Rica 20180056 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 ⤷  Sign Up
Taiwan 202108568 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
Japan 2019089841 MEKインヒビターおよびその使用方法 (MEK INHIBITOR AND APPLICATION METHOD THEREOF) ⤷  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 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 132016000050893 Italy ⤷  Sign Up 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 PA2016016,C1934174 Lithuania ⤷  Sign Up PRODUCT NAME: KOBIMETINIBAS, PASIRINKTINAI KAIP JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR SOLVATAI, YPAC KOBIMETINIBO HEMIFUMARATAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
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 300809 Netherlands ⤷  Sign Up PRODUCT NAME: COBIMETINIBI, DESGEWENST FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1048 20151124
1934174 C 2016 018 Romania ⤷  Sign Up 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 364 5005-2016 Slovakia ⤷  Sign Up PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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