LATUDA (nda200603)- (20MG,40MG,60MG,80MG,120MG)

Generic Name	LURASIDONE HYDROCHLORIDE	Innovator	SUNOVION PHARMS INC
Dosage	20MG,40MG,60MG,80MG,120MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Nov-23	NCE Excl Expiry	2015-Oct-28
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LATUDA is an atypical antipsychotic indicated for the treatment of:  Schizophrenia in adults and adolescents (13 to 17 years)  Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy  Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
17	2	16

Other Developers

Total Other Developers	17

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG	**	**	Down	13	1
40MG	**	**	Down	13	1
60MG	**	**	Down	12	1
80MG	**	**	Down	13	1
120MG	**	**	Down	12	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	14

Manufacturing Details of LATUDA