APTIOM (nda022416)- (200MG,400MG,600MG,800MG)

Generic Name	ESLICARBAZEPINE ACETATE	Innovator	SUMITOMO PHARMA AM
Dosage	200MG,400MG,600MG,800MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2032-Aug-24	NCE Excl Expiry	2018-Nov-08
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	APTIOM is indicated as adjunctive treatment of partial-onset seizures.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	2	1

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
200MG	**	**	Up	-	-
400MG	**	**	Up	-	-
600MG	**	**	Up	-	-
800MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of APTIOM