Encorafenib - Generic Drug Details

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What are the generic 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-nine patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	189
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	62
Patent Applications:	2,061
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

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	210496-002	Jun 27, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
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	210496-001	Jun 27, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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 mutation, in 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
Japan	6342396		⤷ Try a Trial
Canada	2731146	3,4-DIARYLPYRAZOLES UTILISES COMME INHIBITEURS DE PROTEINE KINASE (3,4-DIARYLPYRAZOLES AS PROTEIN KINASE INHIBITORS)	⤷ Try a Trial
Costa Rica	20120102	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEINA	⤷ Try a Trial
Brazil	PI0916356		⤷ Try a Trial
Serbia	58734	FARMACEUTSKE KOMBINACIJE KOJE OBUHVATAJU B-RAF INHIBITOR, EGFR INHIBITOR I OPCIONO PI3K-ALFA INHIBITOR (PHARMACEUTICAL COMBINATIONS COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR)	⤷ 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
2470526	C201930019	Spain	⤷ Try a Trial	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
2727918	122019000023	Germany	⤷ Try a Trial
2470526	300973	Netherlands	⤷ Try a Trial	PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 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
2470526	PA2019005	Lithuania	⤷ Try a Trial	PRODUCT NAME: ENKORAFENIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1314 20180920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for encorafenib

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

Recent Clinical Trials for encorafenib

Paragraph IV (Patent) Challenges for ENCORAFENIB

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

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