IBSRELA (nda211801)- (EQ 50MG BASE)

Generic Name	TENAPANOR HYDROCHLORIDE	Innovator	ARDELYX INC
Dosage	EQ 50MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2033-Aug-01	NCE Excl Expiry	2024-Sep-12
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	IBSRELA is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) 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
EQ 50MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of IBSRELA