ZYCUBO (NDA211241)- (2.9MG/VIAL)

Generic Name	COPPER HISTIDINATE	Innovator	SENTYNL THERAPS INC
Dosage	2.9MG/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	2031-Jan-12
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients.

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
2.9MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZYCUBO