DOVATO (nda211994)- (EQ 50MG BASE;300MG)

Generic Name	DOLUTEGRAVIR SODIUM; LAMIVUDINE	Innovator	VIIV HLTHCARE
Dosage	EQ 50MG BASE;300MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Jan-24	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	2	0

Other Developers

Total Other Developers	17

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG BASE;300MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of DOVATO