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Last Updated: November 24, 2020

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COTELLIC Drug Profile

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Which patents cover Cotellic, and what generic alternatives are available?

Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-two patent family members in forty 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.

US ANDA Litigation and Generic Entry Outlook for Cotellic

Cotellic was eligible for patent challenges on November 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COTELLIC
Drug patent expirations by year for COTELLIC
Drug Prices for COTELLIC

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Generic Entry Opportunity Date for COTELLIC
Generic Entry Date for COTELLIC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for COTELLIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Uppsala University HospitalPhase 2
Texas Children's HospitalPhase 2
Carl AllenPhase 2

See all COTELLIC clinical trials

Pharmacology for COTELLIC
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for COTELLIC

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   Start Trial
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 Y Y   Start Trial
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
>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 COTELLIC

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 C01934174/01 Switzerland   Start Trial PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015
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
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 PA2016016,C1934174 Lithuania   Start Trial PRODUCT NAME: KOBIMETINIBAS, PASIRINKTINAI KAIP JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR SOLVATAI, YPAC KOBIMETINIBO HEMIFUMARATAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
>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.