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Last Updated: August 14, 2020

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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 nineteen patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for binimetinib
International Patents:219
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 69
Clinical Trials: 47
Patent Applications: 201
DailyMed Link:binimetinib at DailyMed
Recent Clinical Trials for binimetinib

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

SponsorPhase
Fundacion OncosurPhase 1/Phase 2
Apices Soluciones S.L.Phase 1/Phase 2
Pierre Fabre Ibérica, S.A.Phase 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   Start Trial   Start Trial   Start Trial
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 1990010-9 Sweden   Start Trial PRODUCT NAME: BINIMETINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES THEROF; REG. NO/DATE: EU/1/18/1315 20180924
1482932 334 8-2019 Slovakia   Start Trial PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1482932 300974 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2727918 300975 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924
>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

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