INJECTAFER (nda203565)- (1GM IRON/20ML (50MG IRON/ML),100MG IRON/2ML (50MG IRON/ML),500MG IRON/10ML (50MG IRON/ML),750MG IRON/15ML (50MG IRON/ML))

Generic Name	FERRIC CARBOXYMALTOSE	Innovator	AM REGENT
Dosage	1GM IRON/20ML (50MG IRON/ML),100MG IRON/2ML (50MG IRON/ML),500MG IRON/10ML (50MG IRON/ML),750MG IRON/15ML (50MG IRON/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Feb-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2016-Jul-25
GAIN Expiry	None	Drug Complexity	No
Indication	Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in: • Adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron. • Adult patients who have non-dialysis dependent chronic kidney disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	32

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM IRON/20ML (50MG IRON/ML)	**	**	-	-	-
100MG IRON/2ML (50MG IRON/ML)	**	**	-	-	-
500MG IRON/10ML (50MG IRON/ML)	**	**	-	-	-
750MG IRON/15ML (50MG IRON/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INJECTAFER