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
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 |
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.
Anatomical Therapeutic Chemical (ATC) Classes for IBSRELA
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
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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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.
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