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Last Updated: June 14, 2021

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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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for binimetinib
International Patents:222
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 75
Clinical Trials: 62
Patent Applications: 2,510
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
Roswell Park Cancer InstituteEarly Phase 1
Peter MacCallum Cancer Centre, AustraliaN/A
AbbViePhase 1/Phase 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   Get Started Free   Get Started Free Y Y   Get Started Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for binimetinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 C 2019 008 Romania   Get Started Free 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
1482932 CR 2019 00011 Denmark   Get Started Free PRODUCT NAME: BINIMETINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1315 20180924
1482932 334 8-2019 Slovakia   Get Started Free PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1482932 C201930018 Spain   Get Started Free PRODUCT NAME: BINIMETINIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526 C02470526/01 Switzerland   Get Started Free 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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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.