Details for New Drug Application (NDA): 217514
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NDA 217514 describes TAFINLAR, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the TAFINLAR profile page.
The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.
The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.
Summary for 217514
| Tradename: | TAFINLAR |
| Applicant: | Novartis |
| Ingredient: | dabrafenib mesylate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217514
Generic Entry Date for 217514*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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.
Pharmacology for NDA: 217514
Suppliers and Packaging for NDA: 217514
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAFINLAR | dabrafenib mesylate | TABLET, FOR SUSPENSION;ORAL | 217514 | NDA | Novartis Pharmaceuticals Corporation | 0078-1154 | 0078-1154-21 | 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Mar 16, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2030 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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