Binimetinib - Generic Drug Details
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What are the generic drug 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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Binimetinib has two hundred and twenty-five patent family members in fifty-five countries.
One supplier is listed for this compound.
Summary for binimetinib
| International Patents: | 225 |
| US Patents: | 10 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 84 |
| Patent Applications: | 3,325 |
| What excipients (inactive ingredients) are in binimetinib? | binimetinib excipients list |
| DailyMed Link: | binimetinib at DailyMed |
Recent Clinical Trials for binimetinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Ronnie Shapira | Phase 2 |
| Children's Hospital Colorado | Phase 2 |
| Nationwide Children's Hospital | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for binimetinib
US Patents and Regulatory Information for binimetinib
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 |
|---|---|---|---|
| Tunisia | 2012000081 | COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS | See Plans and Pricing |
| Japan | 2019194272 | ＭＥＫ阻害剤の調製およびＭＥＫ阻害剤を含む製剤 (PREPARATION OF MEK INHIBITOR AND FORMULATION COMPRISING MEK INHIBITOR) | See Plans and Pricing |
| Guatemala | 201200053 | COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA | See Plans and Pricing |
| Dominican Republic | P2012000051 | COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEINA | See Plans and Pricing |
| Australia | 2009222613 | N3 alkylated benzimidazole derivatives as MEK inhibitors | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for binimetinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | C 2019 008 | Romania | See Plans and Pricing | PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920 |
| 2470526 | 19C1013 | France | See Plans and Pricing | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 1482932 | 19C1014 | France | See Plans and Pricing | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| 1482932 | C01482932/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019 |
| 2470526 | C20190011 00282 | Estonia | See Plans and Pricing | PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
