BIKTARVY (nda210251)- (EQ 50MG BASE;200MG;EQ 25MG BASE,EQ 30MG BASE;120MG;EQ 15MG BASE)

Generic Name	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	Innovator	GILEAD SCIENCES INC
Dosage	EQ 50MG BASE;200MG;EQ 25MG BASE,EQ 30MG BASE;120MG;EQ 15MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2036-Nov-08	NCE Excl Expiry	2023-Feb-07
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have 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 BIKTARVY.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	14

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG BASE;200MG;EQ 25MG BASE	**	**	Up	-	-
EQ 30MG BASE;120MG;EQ 15MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BIKTARVY