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 two 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
Summary for MEKTOVI
| International Patents: | 229 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 34 |
| Patent Applications: | 1,526 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEKTOVI |
| What excipients (inactive ingredients) are in MEKTOVI? | MEKTOVI excipients list |
| DailyMed Link: | MEKTOVI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MEKTOVI
*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
| Sponsor | Phase |
|---|---|
| National Cancer Institute, France | Phase 3 |
| Cancer Research UK | Phase 3 |
| UNICANCER | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for MEKTOVI
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 | ||
| >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 | 2008019277 | N3 ALKYLATED BENZIMIDAZOLE AS MEK INHIBITOR | ⤷ Sign Up |
| Australia | 2009222613 | N3 alkylated benzimidazole derivatives as MEK inhibitors | ⤷ Sign Up |
| Taiwan | 200407129 | N3 alkylated benzimidazole derivatives as MEK inhibitors | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MEKTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | 14/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 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 | 2019C/508 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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