REVEX (nda020459)- (EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML),EQ 2MG BASE/2ML (EQ 1MG BASE/ML))

Generic Name	NALMEFENE HYDROCHLORIDE	Innovator	HIKMA
Dosage	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML),EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	REVEX is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. REVEX is indicated in the management of known or suspected opioid overdose.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	**	**	-	-	-
EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of REVEX