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Last Updated: June 22, 2021

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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 twenty-two 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.

DrugPatentWatch® 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:222
US Patents:11
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 75
Clinical Trials: 18
Patent Applications: 1,203
What excipients (inactive ingredients) are in MEKTOVI?MEKTOVI excipients list
DailyMed Link:MEKTOVI at DailyMed
Drug patent expirations by year for MEKTOVI
DrugPatentWatch® Estimated 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
Roswell Park Cancer InstituteEarly Phase 1
Merck Sharp & Dohme Corp.Phase 3
PfizerPhase 3

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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 1990010-9 Sweden   Try Before You Buy PRODUCT NAME: BINIMETINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES THEROF; REG. NO/DATE: EU/1/18/1315 20180924
2727918 LUC00102 Luxembourg   Try Before You Buy PRODUCT NAME: BRAFTOVI - ENCORAFENIB; MEKTOVI - BINIMETINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
1482932 2019C/510 Belgium   Try Before You Buy PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
2470526 2019C/508 Belgium   Try Before You Buy 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:

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.