FOCALIN (nda021278)- (2.5MG,5MG,10MG)

Generic Name	DEXMETHYLPHENIDATE HYDROCHLORIDE	Innovator	SANDOZ
Dosage	2.5MG,5MG,10MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2015-Dec-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Focalin 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
7	0	7

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
2.5MG	**	**	Up	4	-
5MG	**	**	Up	5	1
10MG	**	**	Up	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of FOCALIN