BUPRENEX (nda018401)- (EQ 0.3MG BASE/ML)

Generic Name	BUPRENORPHINE HYDROCHLORIDE	Innovator	INDIVIOR
Dosage	EQ 0.3MG 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	BUPRENEX is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

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 0.3MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of BUPRENEX