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 patent family members in forty-three countries.
One supplier is listed for this compound.
Summary for cobimetinib fumarate
| International Patents: | 180 |
| 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
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for cobimetinib fumarate
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 | 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 | 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 |
|---|---|---|---|
| Philippines | 12015500186 | COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB | ⤷ Sign Up |
| China | 107810183 | (S)‑[3,4‑二氟‑2‑(2‑氟‑4‑碘苯基氨基)苯基][3‑羟基‑3‑(哌啶‑2‑基)氮杂环丁烷‑1‑基]‑甲酮的结晶反丁烯二酸盐 (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 |
| Argentina | 121624 | COMPRIMIDOS DE LIBERACIÓN INMEDIATA QUE CONTIENEN UN FÁRMACO Y PROCESOS PARA FORMAR LOS COMPRIMIDOS | ⤷ Sign Up |
| China | 101365676 | Azetidines as mek inhibitors for the treatment of proliferative diseases | ⤷ Sign Up |
| Mexico | 2022015606 | COMPRIMIDOS DE LIBERACION INMEDIATA QUE CONTIENEN UN FARMACO Y PROCESOS PARA FORMAR LOS COMPRIMIDOS. (IMMEDIATE-RELEASE TABLETS CONTAINING A DRUG AND PROCESSES FOR FORMING THE TABLETS.) | ⤷ 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 | C20160012 00193 | Estonia | ⤷ Sign Up | PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015 |
| 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 | 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 | 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 | CA 2016 00021 | Denmark | ⤷ Sign Up | PRODUCT NAME: COBIMETINIB, EVENTUELT I EN HVILKEN SOM HELST FORM BESKYTTET AF GRUNDPATENTET, DER INDBEFATTER FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER, 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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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.
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