Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Last Updated: October 21, 2019

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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 two patent family members in fifty-one countries.

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

Summary for MEKTOVI
International Patents:202
US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 67
Clinical Trials: 5
Patent Applications: 112
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
University of California, San FranciscoPhase 1/Phase 2
UNICANCERPhase 2
Array BioPharmaPhase 1/Phase 2

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
>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
1482932 PA2019007 Lithuania   Start Trial PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920
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
1482932 CA 2019 00011 Denmark   Start Trial PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924
2470526 LUC00101 Luxembourg   Start Trial PRODUCT NAME: BRAFTOVI - ENCORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
1482932 300974 Netherlands   Start Trial PRODUCT NAME: BINIMETINIB IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1315 20180924
2470526 122019000021 Germany   Start Trial PRODUCT NAME: ENCORAFENIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/18/1314 20180920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
AstraZeneca
Baxter
Mallinckrodt
McKesson

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.