Details for New Drug Application (NDA): 204790

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NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TIVICAY profile page.

The generic ingredient in TIVICAY 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 204790

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204790

Generic Entry Date for 204790^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for NDA: 204790

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

Suppliers and Packaging for NDA: 204790

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-226	49702-226-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)
TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-227	49702-227-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Aug 12, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 5, 2028	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jun 8, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 9, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 5, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

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