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Last Updated: June 28, 2022

Binimetinib - Generic Drug Details


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What are the generic drug 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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for binimetinib
International Patents:225
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 84
Patent Applications: 3,325
What excipients (inactive ingredients) are in binimetinib?binimetinib excipients list
DailyMed Link:binimetinib at DailyMed
Recent Clinical Trials for binimetinib

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

SponsorPhase
Dr. Ronnie ShapiraPhase 2
Children's Hospital ColoradoPhase 2
Nationwide Children's HospitalPhase 2

See all binimetinib clinical trials

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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
Tunisia 2012000081 COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS See Plans and Pricing
Japan 2019194272 MEK阻害剤の調製およびMEK阻害剤を含む製剤 (PREPARATION OF MEK INHIBITOR AND FORMULATION COMPRISING MEK INHIBITOR) See Plans and Pricing
Guatemala 201200053 COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA See Plans and Pricing
Dominican Republic P2012000051 COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEINA See Plans and Pricing
Australia 2009222613 N3 alkylated benzimidazole derivatives as MEK inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for binimetinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 C 2019 008 Romania See Plans and Pricing PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526 19C1013 France See Plans and Pricing PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
1482932 19C1014 France See Plans and Pricing PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1482932 C01482932/01 Switzerland See Plans and Pricing PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
2470526 C20190011 00282 Estonia See Plans and Pricing PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Baxter
Merck
Johnson and Johnson
Medtronic

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.