Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Colorcon
McKesson
Mallinckrodt
Merck

Last Updated: June 29, 2022

MEKTOVI Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 ten patents protecting this drug.

This drug has two hundred and twenty-five 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.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

Summary for MEKTOVI
International Patents:225
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 28
Patent Applications: 1,569
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
Nationwide Children's HospitalPhase 2
Children's Hospital ColoradoPhase 2
Roswell Park Cancer InstituteEarly Phase 1

See all MEKTOVI clinical trials

US Patents and Regulatory Information for MEKTOVI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MEKTOVI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MELANOMA

Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

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

Preparation of and formulation comprising a MEK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Preparation of and formulation comprising a MEK inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MELANOMA

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA WITH A BRAF MUTATION

FDA Regulatory Exclusivity protecting MEKTOVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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

Brazil

Patent: 2015008623
Estimated Expiration: See Plans and Pricing

Canada

Patent: 88474
Estimated Expiration: See Plans and Pricing

Patent: 79071
Estimated Expiration: See Plans and Pricing

China

Patent: 4870427
Estimated Expiration: See Plans and Pricing

Patent: 9336824
Estimated Expiration: See Plans and Pricing

Patent: 9456272
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 09182
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 09182
Estimated Expiration: See Plans and Pricing

Patent: 02351
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 14254
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 47708
Estimated Expiration: See Plans and Pricing

Japan

Patent: 85939
Estimated Expiration: See Plans and Pricing

Patent: 37838
Estimated Expiration: See Plans and Pricing

Patent: 16503391
Estimated Expiration: See Plans and Pricing

Patent: 18135399
Estimated Expiration: See Plans and Pricing

Patent: 19194272
Estimated Expiration: See Plans and Pricing

Poland

Patent: 09182
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 09182
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 69391
Estimated Expiration: See Plans and Pricing

Patent: 15118572
Estimated Expiration: See Plans and Pricing

Patent: 18127873
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 09182
Estimated Expiration: See Plans and Pricing

Spain

Patent: 72498
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 50316
Estimated Expiration: See Plans and Pricing

Patent: 1427956
Estimated Expiration: See Plans and Pricing

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
Serbia 53489 JEDINJENJA I PREPARATI PROTEIN KINAZNIH INHIBITORA (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Japan 2008019277 N3 ALKYLATED BENZIMIDAZOLE AS MEK INHIBITOR See Plans and Pricing
Chile 2012002380 Compuestos derivados de bezoimidazol, inhibidores de mek; utiles en el tratamiento del cancer.(divisional solicitud cl 521-03) See Plans and Pricing
Cyprus 1113454 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MEKTOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 1990012-5 Sweden See Plans and Pricing PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2470526 7-2019 Slovakia See Plans and Pricing PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 CR 2019 00012 Denmark See Plans and Pricing PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
1482932 14/2019 Austria See Plans and Pricing PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924
>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:

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.