Details for New Drug Application (NDA): 202806

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.

Summary for 202806

Tradename:	TAFINLAR
Applicant:	Novartis
Ingredient:	dabrafenib mesylate
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202806

Constraining patent/regulatory exclusivity:

8,703,781*PED

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.

Pharmacology for NDA: 202806

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Protein Kinase Inhibitors

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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