Details for New Drug Application (NDA): 210795

NDA 210795 describes KRINTAFEL, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the KRINTAFEL profile page.

The generic ingredient in KRINTAFEL is tafenoquine succinate. Two suppliers are listed for this compound. Additional details are available on the tafenoquine succinate profile page.

Summary for 210795

Tradename:	KRINTAFEL
Applicant:	Glaxosmithkline
Ingredient:	tafenoquine succinate
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210795

Constraining patent/regulatory exclusivity:

INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION

Dosage:

TABLET;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: 210795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KRINTAFEL	tafenoquine succinate	TABLET;ORAL	210795	NDA	GlaxoSmithKline LLC	0173-0889	0173-0889-39	2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jul 20, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 20, 2025
Regulatory Exclusivity Use:	INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION

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