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Binimetinib - Generic Drug Details

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What are the generic drug sources for binimetinib and what is the scope of patent protection?

Binimetinib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Binimetinib has two hundred and twenty-two patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for binimetinib

International Patents:	222
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	62
Patent Applications:	2,510
What excipients (inactive ingredients) are in binimetinib?	binimetinib excipients list
DailyMed Link:	binimetinib at DailyMed

Recent Clinical Trials for binimetinib

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

Sponsor	Phase
Roswell Park Cancer Institute	Early Phase 1
Peter MacCallum Cancer Centre, Australia	N/A
AbbVie	Phase 1/Phase 2

See all binimetinib clinical trials

ATC Classes for binimetinib

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 binimetinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes			Y	Y
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes

International Patents for binimetinib

Country	Patent Number	Estimated Expiration
Peru	20120861
Luxembourg	C00101
Croatia	P20170005
San Marino	T201400133
Poland	401636

Supplementary Protection Certificates for binimetinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	C 2019 008	Romania		PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
1482932	CR 2019 00011	Denmark		PRODUCT NAME: BINIMETINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1315 20180924
1482932	334 8-2019	Slovakia		PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1482932	C201930018	Spain		PRODUCT NAME: BINIMETINIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526	C02470526/01	Switzerland		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019