ZUBSOLV (nda204242)- (EQ 1.4MG BASE;EQ 0.36MG BASE,EQ 5.7MG BASE;EQ 1.4MG BASE,EQ 8.6MG BASE;EQ 2.1MG BASE,EQ 11.4MG BASE;EQ 2.9MG BASE,EQ 2.9MG BASE;EQ 0.71MG BASE,EQ 0.7MG BASE;EQ 0.18MG BASE)

Generic Name	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	Innovator	OREXO US INC
Dosage	EQ 1.4MG BASE;EQ 0.36MG BASE,EQ 5.7MG BASE;EQ 1.4MG BASE,EQ 8.6MG BASE;EQ 2.1MG BASE,EQ 11.4MG BASE;EQ 2.9MG BASE,EQ 2.9MG BASE;EQ 0.71MG BASE,EQ 0.7MG BASE;EQ 0.18MG BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2032-Sep-18	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZUBSOLV contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1.4MG BASE;EQ 0.36MG BASE	**	**	Up	-	-
EQ 5.7MG BASE;EQ 1.4MG BASE	**	**	Up	-	-
EQ 8.6MG BASE;EQ 2.1MG BASE	**	**	Up	-	-
EQ 11.4MG BASE;EQ 2.9MG BASE	**	**	Up	-	-
EQ 2.9MG BASE;EQ 0.71MG BASE	**	**	Up	-	-
EQ 0.7MG BASE;EQ 0.18MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZUBSOLV