Xofluza - (40, 80mg ; Tablet)

Generic Name	Baloxavir Marboxil	Innovator	Genentech, Inc.
Dosage	40, 80mg ; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	XOFLUZATM is a polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Xofluza - (2MG/1ML, 30MG, 40MG)

Generic Name	Baloxavir Marboxil	Innovator	None
Dosage	2MG/1ML, 30MG, 40MG	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
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.
Complexities	Yes

Executive Summary

Patent Status

Chronology Of Events