Details for New Drug Application (NDA): 211801

NDA 211801 describes IBSRELA, which is a drug marketed by Ardelyx Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the IBSRELA profile page.

The generic ingredient in IBSRELA is tenapanor hydrochloride. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.

Summary for 211801

Tradename:	IBSRELA
Applicant:	Ardelyx Inc
Ingredient:	tenapanor hydrochloride
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211801

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 211801

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801	NDA	Ardelyx, Inc.	73154-050	73154-050-06	6 TABLET in 1 BOTTLE (73154-050-06)
IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801	NDA	Ardelyx, Inc.	73154-050	73154-050-60	60 TABLET in 1 BOTTLE (73154-050-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Sep 12, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 12, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:		Patent Expiration:	Dec 30, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Aug 1, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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