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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210496


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NDA 210496 describes BRAFTOVI, which is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the BRAFTOVI profile page.

The generic ingredient in BRAFTOVI is encorafenib. One supplier is listed for this compound. Additional details are available on the encorafenib profile page.
Summary for 210496
Tradename:BRAFTOVI
Applicant:Array Biopharma Inc
Ingredient:encorafenib
Patents:13
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210496
Generic Entry Date for 210496*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 210496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRAFTOVI encorafenib CAPSULE;ORAL 210496 NDA Array BioPharma Inc. 70255-025 70255-025-01 2 BOTTLE in 1 CARTON (70255-025-01) / 90 CAPSULE in 1 BOTTLE (70255-025-02)
BRAFTOVI encorafenib CAPSULE;ORAL 210496 NDA Array BioPharma Inc. 70255-025 70255-025-03 2 BOTTLE in 1 CARTON (70255-025-03) / 60 CAPSULE in 1 BOTTLE (70255-025-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 27, 2018TE: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
Regulatory Exclusivity Expiration:Oct 11, 2030
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

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