NEURONTIN (nda020235)- (100MG,300MG,400MG)

Generic Name	GABAPENTIN	Innovator	VIATRIS
Dosage	100MG,300MG,400MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Oct-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NEURONTIN is indicated for: • Postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
18	0	16

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
100MG	**	**	-	-	15
300MG	**	**	Up	-	15
400MG	**	**	-	-	15

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	15

Manufacturing Details of NEURONTIN