SUBOXONE (nda020733)- (EQ 2MG BASE;EQ 0.5MG BASE,EQ 8MG BASE;EQ 2MG BASE)

Generic Name	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	Innovator	INDIVIOR
Dosage	EQ 2MG BASE;EQ 0.5MG BASE,EQ 8MG BASE;EQ 2MG BASE
ParaIV Filing	Yes	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	SUBOXONE sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. SUBOXONE sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	9

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 2MG BASE;EQ 0.5MG BASE	**	**	-	-	9
EQ 8MG BASE;EQ 2MG BASE	**	**	-	-	9

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	9

Manufacturing Details of SUBOXONE