ELEPSIA XR (nda204417)- (1GM,1.5GM)

Generic Name	LEVETIRACETAM	Innovator	TRIPOINT
Dosage	1GM,1.5GM
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2027-Oct-31	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.

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
1GM	**	**	-	-	-
1.5GM	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ELEPSIA XR