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Last Updated: November 22, 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-six patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for encorafenib
Generic Entry Date for encorafenib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
National Cancer Institute (NCI)Phase 1
University of UtahPhase 1/Phase 2
Verastem, Inc.Phase 1/Phase 2

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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-001 Jun 27, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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

Country Patent Number Title Estimated Expiration
Slovenia 2470526 ⤷  Sign Up
Tunisia 2012000081 COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS ⤷  Sign Up
Poland 2727918 ⤷  Sign Up
China 105708819 医药制剂 (PHARMACEUTICAL FORMULATIONS) ⤷  Sign Up
Croatia P20190537 ⤷  Sign Up
Denmark 2882440 ⤷  Sign Up
China 102725283 Compounds and compositions as protein kinase inhibitors ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for encorafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2727918 2019C/509 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2470526 CR 2019 00012 Denmark ⤷  Sign Up PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
2470526 PA2019005,C2470526 Lithuania ⤷  Sign Up PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
2727918 300975 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 C201930019 Spain ⤷  Sign Up 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 C20190011 00282 Estonia ⤷  Sign Up PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018
2727918 LUC00102 Luxembourg ⤷  Sign Up PRODUCT NAME: COMBINAISON DE BINIMETINIB ET D'ENCORAFENIB, CHACUN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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