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

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)