RIVFLOZA (NDA215842)- (EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML),EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML),EQ 160MG BASE/ML (EQ 160MG BASE/ML))

Generic Name	NEDOSIRAN SODIUM	Innovator	NOVO
Dosage	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML),EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML),EQ 160MG BASE/ML (EQ 160MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2038-Oct-12	NCE Excl Expiry	2028-Sep-29
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RIVFLOZA is an LDHA-directed small interfering RNA indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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 80MG BASE/0.5ML (EQ 160MG BASE/ML)	**	**	-	-	-
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	**	**	-	-	-
EQ 160MG BASE/ML (EQ 160MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of RIVFLOZA