ULTIVA (nda020630)- (EQ 1MG BASE/VIAL,EQ 2MG BASE/VIAL,EQ 5MG BASE/VIAL)

Generic Name	REMIFENTANIL HYDROCHLORIDE	Innovator	MYLAN INSTITUTIONAL
Dosage	EQ 1MG BASE/VIAL,EQ 2MG BASE/VIAL,EQ 5MG BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2018-Mar-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ULTIVA is an opioid agonist indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. • As an analgesic component of monitored anesthesia care in adult patients.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE/VIAL	**	**	-	-	-
EQ 2MG BASE/VIAL	**	**	-	-	-
EQ 5MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of ULTIVA