QUILLIVANT XR (nda202100)- (5MG/ML)

Generic Name	METHYLPHENIDATE HYDROCHLORIDE	Innovator	NEXTWAVE
Dosage	5MG/ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2031-Feb-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	QUILLIVANT XR 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	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5MG/ML	**	**	Down	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of QUILLIVANT XR