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Encorafenib - Generic Drug Details

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What are the generic drug sources for encorafenib and what is the scope of freedom to operate?

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

Encorafenib has one hundred and eighty-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	182
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	36
Patent Applications:	1,253
What excipients (inactive ingredients) are in encorafenib?	encorafenib excipients list
DailyMed Link:	encorafenib at DailyMed

Recent Clinical Trials for encorafenib

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

Sponsor	Phase
Peter MacCallum Cancer Centre, Australia	N/A
Pfizer	Phase 1
Pierre Fabre Medicament	Phase 1

See all encorafenib clinical trials

ATC Classes for encorafenib

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for encorafenib

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	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes			Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes

International Patents for encorafenib

Country	Patent Number	Estimated Expiration
San Marino	T201400133
San Marino	T201700036
Serbia	58048
Cuba	24110
Singapore	10201405311T
Tunisia	2012000081
Taiwan	201410247

Supplementary Protection Certificates for encorafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	19C1013	France		PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	C201930019	Spain		PRODUCT NAME: ENCORAFENIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1314; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526	7-2019	Slovakia		PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	C02470526/01	Switzerland		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2727918	300975	Netherlands		PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2727918	122019000023	Germany