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Last Updated: February 23, 2020

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MEKTOVI Drug Profile


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When do Mektovi patents expire, and when can generic versions of Mektovi launch?

Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and eight patent family members in fifty-two countries.

The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.

US ANDA Litigation and Generic Entry Outlook for Mektovi

Mektovi will be eligible for patent challenges on June 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MEKTOVI
International Patents:208
US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 68
Clinical Trials: 8
Patent Applications: 118
DailyMed Link:MEKTOVI at DailyMed
Drug patent expirations by year for MEKTOVI
Generic Entry Opportunity Date for MEKTOVI
Generic Entry Date for MEKTOVI*:
Constraining patent/regulatory exclusivity:
NDA:
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 MEKTOVI

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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
InxMed (Shanghai) Co., Ltd.Phase 1
National Cancer Institute (NCI)Phase 1

See all MEKTOVI clinical trials

Synonyms for MEKTOVI
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
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)
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 MEKTOVI

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   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
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 MEKTOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1482932 14/2019 Austria   Start Trial PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924
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
2470526 C20190011 00282 Estonia   Start Trial PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018
1482932 CA 2019 00011 Denmark   Start Trial PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924
1482932 PA2019007 Lithuania   Start Trial PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920
2470526 2019C/508 Belgium   Start Trial PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; 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:

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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 verifification 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.