OXTELLAR XR (nda202810)- (150MG,300MG,600MG)

Generic Name	OXCARBAZEPINE	Innovator	SUPERNUS PHARMS
Dosage	150MG,300MG,600MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2027-Apr-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Oxtellar XR® is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	2	2

Other Developers

Total Other Developers	18

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
150MG	**	**	Up	-	1
300MG	**	**	Up	-	1
600MG	**	**	Up	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OXTELLAR XR