Wakix - (4.45 and 17.8 mg; Tablet)

Generic Name	Pitolisant Hydrochloride	Innovator	Harmony Biosciences LLC
Dosage	4.45 and 17.8 mg; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	More Than 5	Known Para IV Filers	More Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Wakix is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.
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
*****	*** \ *********	*** **, ****	*******	****	******* *** **** *** *** ****
******* ******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
*** ************	*** \ *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events