MACRILEN (nda205598)- (EQ 60MG BASE/POUCH)

Generic Name	MACIMORELIN ACETATE	Innovator	NOVO
Dosage	EQ 60MG BASE/POUCH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2027-Oct-12	NCE Excl Expiry	2022-Dec-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

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 60MG BASE/POUCH	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of MACRILEN