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Last Updated: June 17, 2024

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MEKTOVI Drug Patent 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-nine patent family members in fifty-five 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 was eligible for patent challenges on June 27, 2022.

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.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for MEKTOVI
Drug patent expirations by year for MEKTOVI
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
ServierPhase 3
GlaxoSmithKline Research & Development LimitedPhase 3
Belgian Group of Digestive OncologyPhase 3

See all MEKTOVI clinical trials

Paragraph IV (Patent) Challenges for MEKTOVI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MEKTOVI Tablets binimetinib 15 mg 210498 3 2022-06-27

US Patents and Regulatory Information for MEKTOVI

MEKTOVI is protected by nine US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MEKTOVI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MEKTOVI

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEKTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH ENCORAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEKTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH ENCORAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING MELANOMA

Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION

Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MELANOMA WITH A BRAF MUTATION

FDA Regulatory Exclusivity protecting MEKTOVI

ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MEKTOVI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for MEKTOVI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pierre Fabre Medicament Mektovi binimetinib EMEA/H/C/004579
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Authorised no no no 2018-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for MEKTOVI

When does loss-of-exclusivity occur for MEKTOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9630
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015008623
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 88474
Estimated Expiration: ⤷  Sign Up

Patent: 79071
Estimated Expiration: ⤷  Sign Up

China

Patent: 4870427
Estimated Expiration: ⤷  Sign Up

Patent: 9336824
Estimated Expiration: ⤷  Sign Up

Patent: 9456272
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22670
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 09182
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 09182
Estimated Expiration: ⤷  Sign Up

Patent: 02351
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 14254
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 47708
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 85939
Estimated Expiration: ⤷  Sign Up

Patent: 37838
Estimated Expiration: ⤷  Sign Up

Patent: 16503391
Estimated Expiration: ⤷  Sign Up

Patent: 18135399
Estimated Expiration: ⤷  Sign Up

Patent: 19194272
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 0130304
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 09182
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 09182
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 69391
Estimated Expiration: ⤷  Sign Up

Patent: 15118572
Estimated Expiration: ⤷  Sign Up

Patent: 18127873
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 09182
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 72498
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 50316
Estimated Expiration: ⤷  Sign Up

Patent: 1427956
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MEKTOVI around the world.

Country Patent Number Title Estimated Expiration
Japan 4093966 ⤷  Sign Up
Norway 20061432 ⤷  Sign Up
Hungary S1900011 ⤷  Sign Up
Cyprus 1122670 ⤷  Sign Up
Israel 163995 N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS ⤷  Sign Up
Iceland 8959 N3 alkýleraðar bensimíðasól afleiður sem MEK hindrar ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MEKTOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 2019/012 Ireland ⤷  Sign Up PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 19C1013 France ⤷  Sign Up PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 122019000021 Germany ⤷  Sign Up PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
1482932 PA2019007 Lithuania ⤷  Sign Up PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932 C01482932/01 Switzerland ⤷  Sign Up PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
2470526 CR 2019 00012 Denmark ⤷  Sign Up PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.