BELBUCA (nda207932)- (EQ 0.075MG BASE,EQ 0.15MG BASE,EQ 0.3MG BASE,EQ 0.45MG BASE,EQ 0.6MG BASE,EQ 0.75MG BASE,EQ 0.9MG BASE)

Generic Name	BUPRENORPHINE HYDROCHLORIDE	Innovator	BDSI
Dosage	EQ 0.075MG BASE,EQ 0.15MG BASE,EQ 0.3MG BASE,EQ 0.45MG BASE,EQ 0.6MG BASE,EQ 0.75MG BASE,EQ 0.9MG BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2032-Dec-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2018-Oct-23
GAIN Expiry	None	Drug Complexity	No
Indication	BELBUCA buccal film contains buprenorphine, a partial opioid agonist. BELBUCA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	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 0.075MG BASE	**	**	Up	-	-
EQ 0.15MG BASE	**	**	Up	-	-
EQ 0.3MG BASE	**	**	Up	-	-
EQ 0.45MG BASE	**	**	Up	-	-
EQ 0.6MG BASE	**	**	Up	-	-
EQ 0.75MG BASE	**	**	Up	-	-
EQ 0.9MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BELBUCA