Cobimetinib fumarate - Generic Drug Details
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What are the generic drug 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 seventy-six patent family members in forty-three countries.
One supplier is listed for this compound.
Summary for cobimetinib fumarate
International Patents: | 176 |
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 Class | Kinase Inhibitor |
Mechanism of Action | Kinase 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 | ⤷ 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 | ⤷ 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 | ||||
>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 |
---|---|---|---|
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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cobimetinib fumarate
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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