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Last Updated: August 19, 2022

IBSRELA Drug Patent 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-seven 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.

DrugPatentWatch® 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:37
US Patents:4
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 30
Patent Applications: 84
Drug Prices: Drug price information for IBSRELA
What excipients (inactive ingredients) are in IBSRELA?IBSRELA excipients list
DailyMed Link:IBSRELA at DailyMed
Drug patent expirations by year for IBSRELA
Drug Prices for IBSRELA

See drug prices for IBSRELA

DrugPatentWatch® Estimated 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

IBSRELA is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IBSRELA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting IBSRELA

Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR

Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR

FDA Regulatory Exclusivity protecting IBSRELA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

International Patents for IBSRELA

When does loss-of-exclusivity occur for IBSRELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09334511
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0923861
Estimated Expiration: See Plans and Pricing

Canada

Patent: 48607
Estimated Expiration: See Plans and Pricing

China

Patent: 2333759
Estimated Expiration: See Plans and Pricing

Patent: 3819403
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180289
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20451
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 84318
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 84318
Estimated Expiration: See Plans and Pricing

Patent: 51248
Estimated Expiration: See Plans and Pricing

Patent: 39964
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 98162
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 36405
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3852
Estimated Expiration: See Plans and Pricing

Patent: 0641
Estimated Expiration: See Plans and Pricing

Patent: 9851
Estimated Expiration: See Plans and Pricing

Japan

Patent: 02106
Estimated Expiration: See Plans and Pricing

Patent: 05802
Estimated Expiration: See Plans and Pricing

Patent: 12514009
Estimated Expiration: See Plans and Pricing

Patent: 14114300
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 84318
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5283
Estimated Expiration: See Plans and Pricing

Patent: 11007024
Estimated Expiration: See Plans and Pricing

Norway

Patent: 84318
Estimated Expiration: See Plans and Pricing

Poland

Patent: 84318
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 84318
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 84318
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1683318
Estimated Expiration: See Plans and Pricing

Patent: 1766619
Estimated Expiration: See Plans and Pricing

Patent: 110110287
Estimated Expiration: See Plans and Pricing

Patent: 160140994
Estimated Expiration: See Plans and Pricing

Patent: 170091783
Estimated Expiration: See Plans and Pricing

Patent: 200111230
Estimated Expiration: See Plans and Pricing

Patent: 220042487
Estimated Expiration: See Plans and Pricing

Spain

Patent: 57938
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IBSRELA around the world.

Country Patent Number Title Estimated Expiration
Poland 2384318 See Plans and Pricing
Japan 2012514009 See Plans and Pricing
Israel 213852 תרכובות ושיטות לעיכוב אנטיפורט מתווך nhe בטיפול בהפרעות הקשורות לאצירת נוזלים או עומס יתר של מלחים ואי-סדרים במערכת העיכול (Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders) See Plans and Pricing
Cyprus 1120451 See Plans and Pricing
European Patent Office 2384318 COMPOSÉS ET PROCÉDÉS D'INHIBITION D'UN ANTIPORT À MÉDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIÉS À UNE RÉTENTION DE FLUIDE OU À UNE SURCHARGE DE SEL ET DE TROUBLES DU TRACTUS GASTRO-INTESTINAL (COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS) See Plans and Pricing
South Korea 101683318 See Plans and Pricing
Hungary E036405 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.