BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) (NDA221443)- (EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE)

Generic Name	BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM	Innovator	GILEAD SCIENCES INC
Dosage	EQ 75MG BASE, EQ 50MG BASE; EQ 300MG 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 SUNLENCA STARTER PACK, is a co-packaged product that contains 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; and SUNLENCA (lenacapavir) tablets, which are indicated for the initiation of BIXLENVO, a complete regimen for the treatment of HIV-1 infection, 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; EQ 300MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)