QUILLICHEW ER (nda207960)- (20MG,30MG,40MG)

Generic Name	METHYLPHENIDATE HYDROCHLORIDE	Innovator	NEXTWAVE PHARMS
Dosage	20MG,30MG,40MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2033-Aug-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2018-Dec-04
GAIN Expiry	None	Drug Complexity	No
Indication	QuilliChew ER 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
0	1	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG	**	**	Down	-	-
30MG	**	**	Up	-	-
40MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of QUILLICHEW ER