NUCYNTA ER (nda200533)- (EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE,EQ 200MG BASE,EQ 250MG BASE)

Generic Name	TAPENTADOL HYDROCHLORIDE	Innovator	COLLEGIUM PHARM INC
Dosage	EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE,EQ 200MG BASE,EQ 250MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Mar-22	NCE Excl Expiry	2013-Nov-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NUCYNTA ER is an opioid agonist 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 • neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults 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
0	3	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG BASE	**	**	Up	-	-
EQ 100MG BASE	**	**	Up	-	-
EQ 150MG BASE	**	**	Up	-	-
EQ 200MG BASE	**	**	Up	-	-
EQ 250MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of NUCYNTA ER