KEPPRA (nda021035)- (1GM,250MG,500MG,750MG)

Generic Name	LEVETIRACETAM	Innovator	UCB INC
Dosage	1GM,250MG,500MG,750MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Dec-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
29	1	21

Other Developers

Total Other Developers	16

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM	**	**	Up	-	10
250MG	**	**	Up	-	9
500MG	**	**	Up	-	11
750MG	**	**	Up	-	10

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	16

Manufacturing Details of KEPPRA