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Last Updated: November 19, 2019

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BINIMETINIB - Generic Drug Details

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What are the generic sources for binimetinib and what is the scope of freedom to operate?

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 two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for BINIMETINIB
International Patents:202
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 67
Clinical Trials: 39
Patent Applications: 162
DailyMed Link:BINIMETINIB at DailyMed
Recent Clinical Trials for BINIMETINIB

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

SponsorPhase
InxMed (Shanghai) Co., Ltd.Phase 1
M.D. Anderson Cancer CenterPhase 1
Hospices Civils de LyonN/A

See all BINIMETINIB clinical trials

Synonyms for BINIMETINIB
181R97MR71
5-((4-bromo-2-fluorophenyl)amino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzo[d]imidazole-6-carboxamide
5-(4-Bromo-2-fluoroanilino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide
5-[(4-Bromo-2-Fluorophenyl)Amino]-4-Fluoro-N-(2-Hydroxyethoxy)-1-Methyl-1H-Benzimidazole-6-Carboxami
5-[(4-Bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide
6-(4-bromo-2-fluoroanilino)-7-fluoro-N-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamide
6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide
6-(4-bromo-2-fluorophenylamino)-7-fluoro-N-(2-hydroxyethoxy)-3-methyl-3H-benzo[d]imidazole-5-carboxamide
6-[(4-bromo-2-fluorophenyl)amino]-7-fluoro-N-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamide
606143-89-9
A11493
AB0095018
AC-29023
ACWZRVQXLIRSDF-UHFFFAOYSA-N
AK175886
AKOS026750517
AOB2072
ARRY 162
ARRY 438162
ARRY-162
ARRY-162,MEK-162
ARRY-162; ARRY-438162; MEK 162; ARRY 162; ARRY 438162
ARRY-438162
AS-16706
BC600594
BCP06780
Binimetinib (JAN/USAN)
Binimetinib (MEK162, ARRY-162, ARRY-438162)
Binimetinib [USAN:INN]
Binimetinib;MEK-162; ARRY-162;ARRY-438162
C17H15BrF2N4O3
cas:606143-89-9;MEK162
CHEMBL3187723
CS-0627
D10604
DB11967
DTXSID70209422
EX-A1024
FT-0697088
GTPL7921
HMS3652J14
HY-15202
J-516581
KS-0000062X
MEK-162
MEK162
MEK162 (ARRY-162, ARRY-438162)
MEK162 (Arry-162)
MEK162(Binimetinib)
Mektovi
MFCD22124525
MLS006011180
NCGC00345804-01
NCGC00345804-10
NVP-MEK162
QCR-138
RL04283
s7007
SB16501
SCHEMBL570088
SMR004702949
SW219910-1
UNII-181R97MR71
W-5894
Y1468
ZINC38460704

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 Y Y   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
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
2727918 2019C/509 Belgium   Start Trial PRODUCT NAME: COMBINAISON DE BINIMETINIB ET D'ENCORAFENIB, CHACUN SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 ET EU/1/18/1314 20180924
2470526 300973 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1482932 2019C/510 Belgium   Start Trial PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
2727918 PA2019006 Lithuania   Start Trial PRODUCT NAME: BINIMETINIBO IR ENKORAFENIBO, KIEKVIENO BET KURIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA, DERINYS; REGISTRATION NO/DATE: EU/1/18/1314, EU/1/18/1835 20190920
2470526 LUC00101 Luxembourg   Start Trial PRODUCT NAME: BRAFTOVI - ENCORAFENIB; AUTHORISATION NUMBER AND 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:

McKinsey
Baxter
Dow
Johnson and Johnson
Colorcon
Moodys

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