DEXMEDETOMIDINE HYDROCHLORIDE (nda206628)- (EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML),EQ 1MG BASE/10ML (EQ 100MCG BASE/ML),EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML),EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML))

Generic Name	DEXMEDETOMIDINE HYDROCHLORIDE	Innovator	HQ SPCLT PHARMA
Dosage	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML),EQ 1MG BASE/10ML (EQ 100MCG BASE/ML),EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML),EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Dexmedetomidine Hydrochloride Injection is a central alpha-2 adrenergic agonist indicated for: • Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Dexmedetomidine Hydrochloride Injection by continuous infusion not to exceed 24 hours. • Sedation of non-intubated patients prior to and/or during surgical and other procedures.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	0

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	**	**	-	-	-
EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	**	**	-	-	-
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	**	**	-	-	-
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DEXMEDETOMIDINE HYDROCHLORIDE