VELPHORO (nda205109)- (EQ 500MG IRON)

Generic Name	FERRIC OXYHYDROXIDE	Innovator	VIFOR FRESENIUS
Dosage	EQ 500MG IRON
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2035-May-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2016-Nov-27
GAIN Expiry	None	Drug Complexity	No
Indication	Velphoro is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

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
EQ 500MG IRON	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VELPHORO