BINIMETINIB - Generic Drug Details
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What are the generic sources for binimetinib and what is the scope of patent protection?
Binimetinib
is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Binimetinib has two hundred and twenty-nine patent family members in fifty-five countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for BINIMETINIB
| International Patents: | 229 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 94 |
| Patent Applications: | 3,165 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BINIMETINIB |
| What excipients (inactive ingredients) are in BINIMETINIB? | BINIMETINIB excipients list |
| DailyMed Link: | BINIMETINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BINIMETINIB
*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 BINIMETINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharpe & Dohme LLC | Phase 2 |
| National Cancer Center, Japan | Phase 2 |
| National Cancer Institute, France | Phase 3 |
Generic filers with tentative approvals for BINIMETINIB
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for BINIMETINIB
Paragraph IV (Patent) Challenges for BINIMETINIB
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MEKTOVI | Tablets | binimetinib | 15 mg | 210498 | 3 | 2022-06-27 |
US Patents and Regulatory Information for BINIMETINIB
| 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 | ⤷ 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 BINIMETINIB
| 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 BINIMETINIB
| 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 BINIMETINIB
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1652776 | N3 alkylated benzimidazole derivatives as MEK inhibitors | ⤷ Sign Up |
| Japan | 2014098022 | COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS | ⤷ Sign Up |
| Australia | 2010286569 | Compounds and compositions as protein kinase inhibitors | ⤷ Sign Up |
| Spain | 2394347 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BINIMETINIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2727918 | PA2019006 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BINIMETINIBO IR ENKORAFENIBO, KIEKVIENO BET KURIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA, DERINYS; REGISTRATION NO/DATE: EU/1/18/1314, EU/1/18/1835 20190920 |
| 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 |
| 1482932 | 122019000022 | Germany | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 2727918 | 122019000023 | Germany | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
