Details for New Drug Application (NDA): 213983

NDA 213983 describes TIVICAY PD, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TIVICAY PD profile page.

The generic ingredient in TIVICAY PD is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

Summary for 213983

Tradename:	TIVICAY PD
Applicant:	Viiv Hlthcare
Ingredient:	dolutegravir sodium
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213983

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: 213983

Mechanism of Action

HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 213983

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983	NDA	ViiV Healthcare Company	49702-255	49702-255-37	1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 12, 2020	TE:		RLD:	Yes
Patent:		Patent Expiration:	Apr 5, 2028	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:		Patent Expiration:	Jun 8, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

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