LOKELMA (nda207078)- (5GM/PACKET,10GM/PACKET)

Generic Name	SODIUM ZIRCONIUM CYCLOSILICATE	Innovator	ASTRAZENECA
Dosage	5GM/PACKET,10GM/PACKET
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2035-Oct-14	NCE Excl Expiry	2023-May-18
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	11

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5GM/PACKET	**	**	Up	-	-
10GM/PACKET	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LOKELMA