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Last Updated: May 9, 2024

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 ninety-four patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	194
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	62
Patent Applications:	1,637
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for encorafenib
What excipients (inactive ingredients) are in encorafenib?	encorafenib excipients list
DailyMed Link:	encorafenib at DailyMed

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

Generic Entry Date for encorafenib^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;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 encorafenib

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

Sponsor	Phase
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc	Phase 1/Phase 2
Alliance for Clinical Trials in Oncology	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3

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

Paragraph IV (Patent) Challenges for ENCORAFENIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRAFTOVI	Capsules	encorafenib	75 mg	210496	3	2022-06-27

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	210496-001	Jun 27, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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
Hong Kong	1211831	包含抑制劑、抑制劑和任選 α抑制劑的藥物組合 (PHARMACEUTICAL COMBINATIONS COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR B-RAF EGFR PI3K)	⤷ Try a Trial
Croatia	P20170005		⤷ Try a Trial
Turkey	201904980		⤷ Try a Trial
Canada	2731146	3,4-DIARYLPYRAZOLES UTILISES COMME INHIBITEURS DE PROTEINE KINASE (3,4-DIARYLPYRAZOLES AS PROTEIN KINASE INHIBITORS)	⤷ Try a Trial
Lithuania	2882440		⤷ Try a Trial
>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
2727918	CA 2019 00013	Denmark	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AF BINIMETINIB OG ENCORAFENIB, I ALLE FORMER HVERT ISAER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 ELLER EU/1/18/1314 20180924
2470526	132019000000047	Italy	⤷ Try a Trial	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	SPC/GB19/009	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ENCORAFENIB OR PHARMACEUTICALLY ACCEPTABLE SALTS OR SOLVATES THEREOF; REGISTERED: UK EU/1/18/1314/001-002 20180924; UK PLGB 00603/0240-0001 20180924; UK PLGB 00603/0241-0001 20180924
2727918	16/2019	Austria	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AUS BINIMETINIB UND ENCORAFENIB, JEWEILS IN ALLEN FORMEN EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/18/1314 EU/1/18/1315 (MITTEILUNG) 20180924
2470526	2019012	Norway	⤷ Try a Trial	PRODUCT NAME: ENKORAFENIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT DERAV; REG. NO/DATE: EU/1/18/1314 20180925
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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