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Last Updated: July 6, 2020

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MEKTOVI Drug Profile


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Which patents cover Mektovi, and what generic alternatives are available?

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 nineteen patent family members in fifty-three 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:219
US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 67
Clinical Trials: 11
Patent Applications: 124
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
Jonsson Comprehensive Cancer CenterPhase 2
PfizerPhase 1/Phase 2
Massachusetts General HospitalPhase 1/Phase 2

See all MEKTOVI clinical trials

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 LUC00100 Luxembourg   Start Trial PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
2470526 300973 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2470526 122019000021 Germany   Start Trial PRODUCT NAME: ENCORAFENIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/18/1314 20180920
1482932 300974 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2727918 LUC00102 Luxembourg   Start Trial PRODUCT NAME: BRAFTOVI - ENCORAFENIB; MEKTOVI - BINIMETINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
2727918 122019000023 Germany   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Johnson and Johnson
Moodys
Dow
Colorcon

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.