MOTEGRITY (nda210166)- (EQ 1MG BASE,EQ 2MG BASE)

Generic Name	PRUCALOPRIDE SUCCINATE	Innovator	TAKEDA PHARMS USA
Dosage	EQ 1MG BASE,EQ 2MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	2023-Dec-14
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MOTEGRITY ® is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	20

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE	**	**	Up	-	-
EQ 2MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of MOTEGRITY