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 thirty-one patent family members in fifty-five countries.
One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for BINIMETINIB
International Patents: | 231 |
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
Generic Entry Date for BINIMETINIB*:
Constraining patent/regulatory exclusivity:
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 BINIMETINIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharpe & Dohme LLC | Phase 2 |
National Cancer Center, Japan | Phase 2 |
Accord Healthcare, Inc. | Phase 3 |
Generic filers with tentative approvals for BINIMETINIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 15MG | TABLET |
⤷ Subscribe | ⤷ Subscribe | 15MG | TABLET;ORAL |
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Subscribe | ⤷ Subscribe |
Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Subscribe | ⤷ Subscribe |
>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 |
---|---|---|---|
Japan | 2016503391 | MEK阻害剤の調製およびMEK阻害剤を含む製剤 | ⤷ Subscribe |
San Marino | T201400133 | Composti e composizioni come inibitori di protein chinasi | ⤷ Subscribe |
Argentina | 090143 | COMPOSICION FARMACEUTICA PARA INHIBIR EL CRECIMIENTO DE CELULAS ANORMALES | ⤷ Subscribe |
Iceland | 2990 | ⤷ Subscribe | |
Portugal | 2909182 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BINIMETINIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2470526 | LUC00101 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924 |
2727918 | CA 2019 00013 | Denmark | ⤷ Subscribe | PRODUCT NAME: KOMBINATION AF BINIMETINIB OG ENCORAFENIB, I ALLE FORMER HVERT ISAER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 ELLER EU/1/18/1314 20180924 |
2470526 | C20190011 00282 | Estonia | ⤷ Subscribe | PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018 |
2470526 | 2019/012 | Ireland | ⤷ Subscribe | PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
1482932 | LUC00100 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
BINIMETINIB Market Analysis and Financial Projection Experimental
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