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-eight patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	188
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	52
Patent Applications:	1,641
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
Dr. Ronnie Shapira	Phase 2
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3
Eli Lilly and Company	Phase 2

See all encorafenib clinical trials

Anatomical Therapeutic Chemical (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

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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
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for encorafenib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Braftovi	encorafenib	EMEA/H/C/004580 Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy	Authorised	no	no	no	2018-09-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for encorafenib

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010010154		See Plans and Pricing
Serbia	53489	JEDINJENJA I PREPARATI PROTEIN KINAZNIH INHIBITORA (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)	See Plans and Pricing
Spain	2695099		See Plans and Pricing
South Korea	20140095500	PHARMACEUTICAL FORMULATIONS	See Plans and Pricing
Mexico	2014006278	FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.)	See Plans and Pricing
Jordan	3493	صيغ صيدلانية (PHARMACEUTICAL FORMULATIONS)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for encorafenib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	7-2019	Slovakia	See Plans and Pricing	PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	C02470526/01	Switzerland	See Plans and Pricing	PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
2470526	2019012	Norway	See Plans and Pricing	PRODUCT NAME: ENKORAFENIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT DERAV; REG. NO/DATE: EU/1/18/1314 20180925
2470526	132019000000047	Italy	See Plans and Pricing	PRODUCT NAME: ENCORAFENIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(BRAFTOVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1314, 20180924
2470526	2019/012	Ireland	See Plans and Pricing	PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	C20190011 00282	Estonia	See Plans and Pricing	PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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