Hetlioz LQ - (4 mg/mL ; Suspension)

Generic Name	Tasimelteon	Innovator	Vanda pharma
Dosage	4 mg/mL ; Suspension	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	None
Final Approvals	None	Generic Launches	None
Indication	HETLIOZ is a melatonin receptor agonist. HETLIOZ LQ oral suspension is indicated for the treatment of: • Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age.
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