NEOPROFEN (nda021903)- (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))

Generic Name	IBUPROFEN LYSINE	Innovator	RECORDATI RARE
Dosage	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2032-Mar-02	NCE Excl Expiry	Expired
ODE Expiry	2013-Apr-13	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NeoProfen is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.s

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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 20MG BASE/2ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of NEOPROFEN