FENTORA (nda021947)- (EQ 0.1MG BASE,EQ 0.2MG BASE,EQ 0.4MG BASE,EQ 0.6MG BASE,EQ 0.8MG BASE,EQ 0.3MG BASE)

Generic Name	FENTANYL CITRATE	Innovator	CEPHALON
Dosage	EQ 0.1MG BASE,EQ 0.2MG BASE,EQ 0.4MG BASE,EQ 0.6MG BASE,EQ 0.8MG BASE,EQ 0.3MG BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2028-Jun-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FENTORA is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	1	0

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 0.1MG BASE	**	**	-	-	-
EQ 0.2MG BASE	**	**	-	-	-
EQ 0.4MG BASE	**	**	Up	-	-
EQ 0.6MG BASE	**	**	Up	-	-
EQ 0.8MG BASE	**	**	Up	-	-
EQ 0.3MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FENTORA