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Generated: November 19, 2018

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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 eleven patents protecting this drug. Additional details are available on the MEKTOVI profile page.

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:11
Generic Entry Opportunity 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 27, 2018TE:RLD:Yes
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
Regulatory Exclusivity Expiration:Jun 27, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Aug 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

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