Last Updated: October 1, 2026

Details for New Drug Application (NDA): 211801


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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 six patents protecting this drug. Additional details are available on the IBSRELA profile page.

The generic ingredient in IBSRELA is tenapanor hydrochloride. There is one drug master file entry for this compound. 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:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211801
Generic Entry Date for 211801*:

⤷  Start Trial

Constraining patent/regulatory exclusivity:

⤷  Start Trial

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.

Pharmacology for NDA: 211801
Mechanism of ActionOrganic Anion Transporting Polypeptide 2B1 Inhibitors
Sodium-Hydrogen Exchanger 3 Inhibitors
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:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Sep 12, 2019TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Dec 30, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Start TrialPatent Expiration:Nov 26, 2042Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Start TrialPatent Expiration:Aug 1, 2033Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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