Details for New Drug Application (NDA): 210496
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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: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
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 | ||||||||
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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