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Last Updated: December 15, 2019

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Cobimetinib fumarate - Generic Drug Details

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What are the generic drug sources for cobimetinib fumarate and what is the scope of freedom to operate?

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

Cobimetinib fumarate has fifty-seven patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for cobimetinib fumarate
International Patents:57
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 2
DailyMed Link:cobimetinib fumarate at DailyMed
Pharmacology for cobimetinib fumarate
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
Synonyms for cobimetinib fumarate
1369665-02-0
6EXI96H8SV
bis[(2S)-2-{1-[3,4-difluoro-2-(2-fluoro-4-iodoanilino)benzoyl]-3-hydroxyazetidin-3-yl}piperidin-1-ium] (2E)-but-2-enedioate
CHEBI:90853
CHEMBL2364607
Cobimetinib fumarate (USAN)
Cobimetinib fumarate [USAN]
Cobimetinib hemifumarate
Cotellic
Cotellic (TN)
D10615
GDC-0973 hemifumarate
Methanone, (3,4-difluoro-2-((2-fluoro-4-iodophenyl)amino)phenyl)(3-hydroxy-3-(2S)-2-piperidinyl-1-azetidinyl)-, (2E)-2-butenedioate (2:1)
UNII-6EXI96H8SV
Xl-518 hemifumarate

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   Start Trial   Start Trial Y Y   Start Trial
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cobimetinib fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1934174 CR 2016 00021 Denmark   Start Trial PRODUCT NAME: COBIMETINIB OG FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER DERAF, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124
1934174 22/2016 Austria   Start Trial PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEROISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COMBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
1934174 1690019-3 Sweden   Start 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 300809 Netherlands   Start Trial PRODUCT NAME: COBIMETINIBI, DESGEWENST FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1048 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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