INGREZZA (nda209241)- (EQ 40MG BASE,EQ 80MG BASE,EQ 60MG BASE)

Generic Name	VALBENAZINE TOSYLATE	Innovator	NEUROCRINE
Dosage	EQ 40MG BASE,EQ 80MG BASE,EQ 60MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2040-Aug-10	NCE Excl Expiry	2022-Apr-11
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	2	0

Other Developers

Total Other Developers	12

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 40MG BASE	**	**	-	-	-
EQ 80MG BASE	**	**	-	-	-
EQ 60MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INGREZZA