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Last Updated: August 8, 2020

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IBSRELA Drug Profile

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When do Ibsrela patents expire, and what generic alternatives are available?

Ibsrela is a drug marketed by Ardelyx Inc and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-four patent family members in twenty-one countries.

The generic ingredient in IBSRELA is tenapanor hydrochloride. Additional details are available on the tenapanor hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Ibsrela

Ibsrela will be eligible for patent challenges on September 12, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for IBSRELA
International Patents:34
US Patents:4
Applicants:1
NDAs:1
Bulk Api Vendors: 18
Patent Applications: 6
DailyMed Link:IBSRELA at DailyMed
Drug patent expirations by year for IBSRELA
Generic Entry Opportunity Date for IBSRELA
Generic Entry Date for IBSRELA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for IBSRELA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Ardelyx Inc IBSRELA tenapanor hydrochloride TABLET;ORAL 211801-001 Sep 12, 2019 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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. 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.