RELYVRIO (NDA216660)- (3GM/PACKET; 1GM/PACKET)

Generic Name	SODIUM PHENYLBUTYRATE; TAURURSODIOL	Innovator	AMYLYX
Dosage	3GM/PACKET; 1GM/PACKET
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2040-Jul-27	NCE Excl Expiry	2027-Sep-29
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

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
3GM/PACKET; 1GM/PACKET	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of RELYVRIO