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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobimetinib fumarate has one hundred and eighty-four patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for COBIMETINIB FUMARATE

International Patents:	184
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for COBIMETINIB FUMARATE

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for COBIMETINIB FUMARATE

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Glossary

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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				⤷ 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				⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Ukraine	124728	КРИСТАЛІЧНА ФУМАРАТНА СІЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНІЛАМІНО)ФЕНІЛ][3-ГІДРОКСИ-3-(ПІПЕРИДИН-2-ІЛ)АЗЕТИДИН-1-ІЛ]МЕТАНОНУ (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
Malaysia	162174	AZETIDINES MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES	⤷ Sign Up
Russian Federation	2021132394	КРИСТАЛЛИЧЕСКАЯ ФУМАРАТНАЯ СОЛЬ (S)-[3,4-ДИФТОР-2-(2-ФТОР-4-ЙОДФЕНИЛАМИНО)ФЕНИЛ][3-ГИДРОКСИ-3-(ПИПЕРИДИН-2-ИЛ)АЗЕТИДИН-1-ИЛ]МЕТАНОНА	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for COBIMETINIB FUMARATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB16/023	United Kingdom	⤷ Sign Up	PRODUCT NAME: COBIMETINIB, INCLUDING A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REGISTERED: UK EU/1/15/1048/001(NI) 20151124; UK PLGB 00031/0849 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
>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.

Summary for COBIMETINIB FUMARATE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBIMETINIB FUMARATE

Pharmacology for COBIMETINIB FUMARATE

Anatomical Therapeutic Chemical (ATC) Classes for COBIMETINIB FUMARATE

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COBIMETINIB FUMARATE