XOFLUZA (nda210854)- (20MG,40MG,80MG)

Generic Name	BALOXAVIR MARBOXIL	Innovator	GENENTECH INC
Dosage	20MG,40MG,80MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2039-Oct-09	NCE Excl Expiry	2023-Oct-24
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: • Treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are: -otherwise healthy adults and pediatric patients 5 years of age and older, OR -adults and pediatric patients 12 years of age and older who are at high- risk of developing influenza-related complications. • Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG	**	**	-	-	-
40MG	**	**	Up	-	-
80MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of XOFLUZA