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Last Updated: November 4, 2024

BINIMETINIB - Generic Drug Details


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

Binimetinib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Binimetinib has two hundred and thirty-one patent family members in fifty-five countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

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

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

SponsorPhase
Merck Sharpe & Dohme LLCPhase 2
National Cancer Center, JapanPhase 2
Taiho Oncology, Inc.Phase 3

See all BINIMETINIB clinical trials

Generic filers with tentative approvals for BINIMETINIB
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up15MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for BINIMETINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MEKTOVI Tablets binimetinib 15 mg 210498 3 2022-06-27

US Patents and Regulatory Information for BINIMETINIB

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 MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  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

Expired US Patents for BINIMETINIB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for BINIMETINIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pierre Fabre Medicament Mektovi binimetinib EMEA/H/C/004579
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Authorised no no no 2018-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BINIMETINIB

Country Patent Number Title Estimated Expiration
Poland 233493 ⤷  Sign Up
European Patent Office 2275102 Dérivés de benzimidazole d'alkylat N3 en tant qu'inhibiteurs de Mek (N3 alkylated benzimidazole derivatives as MEK inhibitors) ⤷  Sign Up
Spain 2492499 ⤷  Sign Up
Russian Federation 2015118572 ПОЛУЧЕНИЕ И СОСТАВЛЕНИЕ КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ИНГИБИТОР МЕК ⤷  Sign Up
Netherlands 300973 ⤷  Sign Up
Norway 20061432 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BINIMETINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 132019000000047 Italy ⤷  Sign Up 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 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
1482932 SPC/GB19/007 United Kingdom ⤷  Sign Up PRODUCT NAME: BINIMETINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1315/001-002 20180920
2727918 CA 2019 00013 Denmark ⤷  Sign Up 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
1482932 LUC00100 Luxembourg ⤷  Sign Up PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
2470526 122019000021 Germany ⤷  Sign Up PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
>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.