FENTANYL (nda020195)- (EQ 0.2MG BASE,EQ 0.3MG BASE,EQ 0.4MG BASE,EQ 0.1MG BASE)

Generic Name	FENTANYL CITRATE	Innovator	CEPHALON
Dosage	EQ 0.2MG BASE,EQ 0.3MG BASE,EQ 0.4MG BASE,EQ 0.1MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2005-May-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Fentanyl buccal tablet 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
0	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 0.2MG BASE	**	**	-	-	-
EQ 0.3MG BASE	**	**	-	-	-
EQ 0.4MG BASE	**	**	-	-	-
EQ 0.1MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of FENTANYL