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. One supplier is listed for this compound. Additional details are available on the tenapanor hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Ibsrela
Ibsrela was eligible for patent challenges on September 12, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 1, 2033. 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 1 |
| Patent Applications: | 63 |
| Drug Prices: | Drug price information for IBSRELA |
| What excipients (inactive ingredients) are in IBSRELA? | IBSRELA excipients list |
| DailyMed Link: | IBSRELA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for IBSRELA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ardelyx | Phase 3 |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR
FDA Regulatory Exclusivity protecting IBSRELA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ardelyx Inc | IBSRELA | tenapanor hydrochloride | TABLET;ORAL | 211801-001 | Sep 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Brazil
Patent: 0923861
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 48607
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2333759
Estimated Expiration: ⤷ Try a Trial
Patent: 3819403
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180289
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20451
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
Patent: 51248
Estimated Expiration: ⤷ Try a Trial
Patent: 39964
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 98162
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 36405
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3852
Estimated Expiration: ⤷ Try a Trial
Patent: 0641
Estimated Expiration: ⤷ Try a Trial
Patent: 9851
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 02106
Estimated Expiration: ⤷ Try a Trial
Patent: 05802
Estimated Expiration: ⤷ Try a Trial
Patent: 12514009
Estimated Expiration: ⤷ Try a Trial
Patent: 14114300
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 5283
Estimated Expiration: ⤷ Try a Trial
Patent: 11007024
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 84318
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1683318
Estimated Expiration: ⤷ Try a Trial
Patent: 1766619
Estimated Expiration: ⤷ Try a Trial
Patent: 110110287
Estimated Expiration: ⤷ Try a Trial
Patent: 160140994
Estimated Expiration: ⤷ Try a Trial
Patent: 170091783
Estimated Expiration: ⤷ Try a Trial
Patent: 200111230
Estimated Expiration: ⤷ Try a Trial
Patent: 220042487
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 57938
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| South Korea | 101766619 | ⤷ Try a Trial | |
| European Patent Office | 3939964 | COMBINAISONS D'INHIBITION D'UN ANTIPORT A MEDIATION PAR NHE DANS LE TRAITEMENT DE TROUBLES ASSOCIES A UNE RETENTION DE FLUIDE OU A UNE SURCHARGE DE SEL ET DE TROUBLES DU TRACTUS GASTRO-INTESTINAL (COMBINATIONS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS) | ⤷ Try a Trial |
| South Korea | 20110110287 | COMPOUNDS AND METHODS FOR INHIBITING NHE-MEDIATED ANTIPORT IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS | ⤷ Try a Trial |
| Hong Kong | 1198162 | 用於治療與體液瀦留或鹽超負荷有關的病症和胃腸道病症的化合物和方法 (COMPOUNDS AND METHODS IN THE TREATMENT OF DISORDERS ASSOCIATED WITH FLUID RETENTION OR SALT OVERLOAD AND GASTROINTESTINAL TRACT DISORDERS) | ⤷ Try a Trial |
| Japan | 2012514009 | ⤷ Try a Trial | |
| Portugal | 2384318 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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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