FERTINEX (nda019415)- (75 IU/AMP,150 IU/AMP)

Generic Name	UROFOLLITROPIN	Innovator	SERONO
Dosage	75 IU/AMP,150 IU/AMP
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2015-Jun-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication

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
75 IU/AMP	**	**	-	-	-
150 IU/AMP	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of FERTINEX