Details for New Drug Application (NDA): 210498
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The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.
Summary for 210498
Tradename: | MEKTOVI |
Applicant: | Array Biopharma Inc |
Ingredient: | binimetinib |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210498
Generic Entry Date for 210498*:
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.
Suppliers and Packaging for NDA: 210498
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEKTOVI | binimetinib | TABLET;ORAL | 210498 | NDA | Array BioPharma Inc. | 70255-010 | 70255-010-02 | 1 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE |
MEKTOVI | binimetinib | TABLET;ORAL | 210498 | NDA | Array BioPharma Inc. | 70255-010 | 70255-010-03 | 90 TABLET, FILM COATED in 1 BOTTLE (70255-010-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 27, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 11, 2026 | ||||||||
Regulatory Exclusivity Use: | 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 | ||||||||
Regulatory Exclusivity Expiration: | Jun 27, 2025 | ||||||||
Regulatory Exclusivity Use: | 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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 27, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA |
Expired US Patents for NDA 210498
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 |
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