EDEX (nda020649)- (0.005MG/VIAL,0.01MG/VIAL,0.01MG/VIAL,0.02MG/VIAL,0.02MG/VIAL,0.04MG/VIAL,0.04MG/VIAL)

Generic Name	ALPROSTADIL	Innovator	ENDO OPERATIONS
Dosage	0.005MG/VIAL,0.01MG/VIAL,0.01MG/VIAL,0.02MG/VIAL,0.02MG/VIAL,0.04MG/VIAL,0.04MG/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Edex® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	18

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.005MG/VIAL	**	**	-	-	-
0.01MG/VIAL	**	**	-	-	-
0.02MG/VIAL	**	**	-	-	-
0.04MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of EDEX