GABITRIL (nda020646)- (2MG,4MG,6MG,8MG,10MG,12MG,16MG,20MG)

Generic Name	TIAGABINE HYDROCHLORIDE	Innovator	CEPHALON
Dosage	2MG,4MG,6MG,8MG,10MG,12MG,16MG,20MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Jun-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

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
2MG	**	**	-	-	2
4MG	**	**	-	-	2
6MG	**	**	-	-	-
8MG	**	**	-	-	-
10MG	**	**	-	-	-
12MG	**	**	-	-	1
16MG	**	**	-	-	-
20MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of GABITRIL