VELTASSA (nda205739)- (EQ 8.4GM BASE/PACKET,EQ 16.8GM BASE/PACKET,EQ 25.2GM BASE/PACKET,EQ 1GM BASE/PACKET)

Generic Name	PATIROMER SORBITEX CALCIUM	Innovator	VIFOR PHARMA
Dosage	EQ 8.4GM BASE/PACKET,EQ 16.8GM BASE/PACKET,EQ 25.2GM BASE/PACKET,EQ 1GM BASE/PACKET
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-Oct-08	NCE Excl Expiry	2020-Oct-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Veltassa is a potassium binder indicated for the treatment of hyperkalemia.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 8.4GM BASE/PACKET	**	**	Up	-	-
EQ 16.8GM BASE/PACKET	**	**	Up	-	-
EQ 25.2GM BASE/PACKET	**	**	-	-	-
EQ 1GM BASE/PACKET	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VELTASSA