Details for New Drug Application (NDA): 202806
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NDA 202806 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 202806
| Tradename: | TAFINLAR |
| Applicant: | Novartis |
| Ingredient: | dabrafenib mesylate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202806
*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: 202806
Suppliers and Packaging for NDA: 202806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806 | NDA | Novartis Pharmaceuticals Corporation | 0078-0681 | 0078-0681-66 | 120 CAPSULE in 1 BOTTLE (0078-0681-66) |
| TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806 | NDA | Novartis Pharmaceuticals Corporation | 0078-0682 | 0078-0682-66 | 120 CAPSULE in 1 BOTTLE (0078-0682-66) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | May 29, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS | ||||||||
| Regulatory Exclusivity Expiration: | Dec 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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