FOSRENOL (nda021468)- (EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE,EQ 1GM BASE)

Generic Name	LANTHANUM CARBONATE	Innovator	TAKEDA PHARMS USA
Dosage	EQ 250MG BASE,EQ 500MG BASE,EQ 750MG BASE,EQ 1GM BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Aug-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

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 250MG BASE	**	**	-	-	-
EQ 500MG BASE	**	**	-	-	3
EQ 750MG BASE	**	**	-	-	3
EQ 1GM BASE	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of FOSRENOL