OSMOLEX ER (nda209410)- (EQ 129MG BASE,EQ 193MG BASE,EQ 258MG BASE,EQ 161MG BASE)

Generic Name	AMANTADINE HYDROCHLORIDE	Innovator	SUPERNUS PHARMS
Dosage	EQ 129MG BASE,EQ 193MG BASE,EQ 258MG BASE,EQ 161MG BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2038-Feb-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OSMOLEX ER is indicated for the treatment of: • Parkinson's disease • Drug-induced extrapyramidal reactions in adult patients.

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 129MG BASE	**	**	-	-	-
EQ 193MG BASE	**	**	-	-	-
EQ 258MG BASE	**	**	-	-	-
EQ 161MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OSMOLEX ER