BIXLENVO (NDA221104)- (EQ 75MG BASE;EQ 50MG BASE)

Generic Name	BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM	Innovator	GILEAD SCIENCES INC
Dosage	EQ 75MG BASE;EQ 50MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2038-Aug-16	NCE Excl Expiry	2027-Dec-22
ODE Expiry	None	NP Expiry	2029-Aug-27
GAIN Expiry	None	Drug Complexity	No
Indication	BIXLENVO, a two-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and lenacapavir (LEN), an HIV-1 capsid inhibitor, is indicated as a complete regimen for the treatment of HIV-1 in adults 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 known or suspected resistance to the individual components of BIXLENVO.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 75MG BASE;EQ 50MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of BIXLENVO