IMCIVREE (nda213793)- (EQ 10MG BASE/ML (EQ 10MG BASE/ML))

Generic Name	SETMELANOTIDE ACETATE	Innovator	RHYTHM
Dosage	EQ 10MG BASE/ML (EQ 10MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2034-Jul-04	NCE Excl Expiry	2025-Nov-25
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to: • Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). • Bardet-Biedl syndrome (BBS).

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 10MG BASE/ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of IMCIVREE