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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the encorafenib profile page.
The generic ingredient in BRAFTOVI is encorafenib. There is one drug master file entry for this compound. 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: | Dec 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E 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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