GEODON (nda020825)- (EQ 20MG BASE,EQ 40MG BASE,EQ 60MG BASE,EQ 80MG BASE)

Generic Name	ZIPRASIDONE HYDROCHLORIDE	Innovator	VIATRIS
Dosage	EQ 20MG BASE,EQ 40MG BASE,EQ 60MG BASE,EQ 80MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-May-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GEODON is indicated as an oral formulation for the: Treatment of schizophrenia, Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder, Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate,

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 20MG BASE	**	**	-	6	1
EQ 40MG BASE	**	**	-	-	7
EQ 60MG BASE	**	**	-	6	1
EQ 80MG BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of GEODON