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COTELLIC Drug Profile

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Cotellic is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug.

This drug has thirty-eight patent family members in twenty-six countries.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.

Summary for Tradename: COTELLIC

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: COTELLIC

Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc
COTELLIC
cobimetinib fumarate
TABLET;ORAL206192-001Nov 10, 2015RXYes8,362,002► subscribe ► subscribe
Genentech Inc
COTELLIC
cobimetinib fumarate
TABLET;ORAL206192-001Nov 10, 2015RXYes► subscribe► subscribe
Genentech Inc
COTELLIC
cobimetinib fumarate
TABLET;ORAL206192-001Nov 10, 2015RXYes7,803,839► subscribeYY ► subscribe
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Non-Orange Book Patents for Tradename: COTELLIC

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,915,250Azetidines as MEK inhibitors for the treatment of proliferative diseases► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: COTELLIC

Country Document Number Estimated Expiration
China104892582► subscribe
Canada2927656► subscribe
China103524392► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: COTELLIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016016Lithuania► subscribePRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
2016 00021Denmark► subscribePRODUCT 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
078Luxembourg► subscribePRODUCT 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
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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 verifification 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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