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Generated: November 15, 2018

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Details for New Drug Application (NDA): 202806

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NDA 202806 describes TAFINLAR, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are six 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.
Summary for 202806
Tradename:TAFINLAR
Applicant:Novartis Pharms Corp
Ingredient:dabrafenib mesylate
Patents:6
Generic Entry Opportunity Date for 202806
Generic Entry Date for 202806*:
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: 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:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 30, 2021
Regulatory Exclusivity Use:DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Regulatory Exclusivity Expiration:May 4, 2021
Regulatory Exclusivity Use:DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
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

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Boehringer Ingelheim
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Harvard Business School
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