PRECEDEX (nda021038)- (EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML),EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML),EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML),EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML),EQ 1MG BASE/250ML (EQ 4MCG BASE/ML))

Generic Name	DEXMEDETOMIDINE HYDROCHLORIDE	Innovator	HOSPIRA
Dosage	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML),EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML),EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML),EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML),EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Oct-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
27	1	24

Other Developers

Total Other Developers	15

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	**	**	-	-	-
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	**	**	-	-	-
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	**	**	-	-	-
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	**	**	-	-	-
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	20

Manufacturing Details of PRECEDEX