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Last Updated: March 28, 2024

ENCORAFENIB - Generic Drug Details


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What are the generic sources for encorafenib and what is the scope of patent protection?

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-two patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for ENCORAFENIB
International Patents:192
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
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*:
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
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncPhase 1/Phase 2
National Cancer Institute (NCI)Phase 2/Phase 3
Alliance for Clinical Trials in OncologyPhase 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

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 ⤷  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
>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
Hong Kong 1204976 種包含 抑制劑, 抑制劑,及視需要 抑制劑的醫藥組合 (PHARMACEUTICAL COMBINATIONS COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR B-RAF EGFR PI3K-ALPHA) ⤷  Try a Trial
Canada 2856406 FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS) ⤷  Try a Trial
Taiwan I607754 ⤷  Try a Trial
Tunisia 2012000081 COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ENCORAFENIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 7-2019 Slovakia ⤷  Try a Trial PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: 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
2470526 122019000021 Germany ⤷  Try a Trial PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
2470526 C02470526/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.