DAYTRANA (nda021514)- (10MG/9HR (1.1MG/HR),15MG/9HR (1.6MG/HR),20MG/9HR (2.2MG/HR),30MG/9HR (3.3MG/HR))

Generic Name	METHYLPHENIDATE	Innovator	NOVEN PHARMS INC
Dosage	10MG/9HR (1.1MG/HR),15MG/9HR (1.6MG/HR),20MG/9HR (2.2MG/HR),30MG/9HR (3.3MG/HR)
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2025-Oct-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DAYTRANA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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
10MG/9HR (1.1MG/HR)	**	**	Up	-	1
15MG/9HR (1.6MG/HR)	**	**	Up	-	1
20MG/9HR (2.2MG/HR)	**	**	Up	-	1
30MG/9HR (3.3MG/HR)	**	**	Up	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of DAYTRANA