GIVLAARI (nda212194)- (EQ 189MG BASE/ML (EQ 189MG BASE/ML))

Generic Name	GIVOSIRAN SODIUM	Innovator	ALNYLAM PHARMS INC
Dosage	EQ 189MG BASE/ML (EQ 189MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2034-Oct-03	NCE Excl Expiry	2024-Nov-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GIVLAARI is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP).

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 189MG BASE/ML (EQ 189MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of GIVLAARI