Details for New Drug Application (NDA): 210498
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NDA 210498 describes MEKTOVI, which is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the MEKTOVI profile page.
The generic ingredient in MEKTOVI is binimetinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.
The generic ingredient in MEKTOVI is binimetinib. There is one drug master file entry for this compound. 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 27, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 27, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
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 | ⤷ Start Trial | ⤷ Start Trial |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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