UZEDY (NDA213586)- (50MG/0.14ML (50MG/0.14ML),75MG/0.21ML (75MG/0.21ML),100MG/0.28ML (100MG/0.28ML),125MG/0.35ML (125MG/0.35ML),150MG/0.42ML (150MG/0.42ML),200MG/0.56ML (200MG/0.56ML),250MG/0.7ML (250MG/0.7ML))

Generic Name	RISPERIDONE	Innovator	TEVA
Dosage	50MG/0.14ML (50MG/0.14ML),75MG/0.21ML (75MG/0.21ML),100MG/0.28ML (100MG/0.28ML),125MG/0.35ML (125MG/0.35ML),150MG/0.42ML (150MG/0.42ML),200MG/0.56ML (200MG/0.56ML),250MG/0.7ML (250MG/0.7ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2040-Sep-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2026-Apr-28
GAIN Expiry	None	Drug Complexity	No
Indication	UZEDY is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
50MG/0.14ML (50MG/0.14ML)	**	**	-	-	-
75MG/0.21ML (75MG/0.21ML)	**	**	-	-	-
100MG/0.28ML (100MG/0.28ML)	**	**	-	-	-
125MG/0.35ML (125MG/0.35ML)	**	**	-	-	-
150MG/0.42ML (150MG/0.42ML)	**	**	-	-	-
200MG/0.56ML (200MG/0.56ML)	**	**	-	-	-
250MG/0.7ML (250MG/0.7ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of UZEDY