Ibsrela is a drug owned by Ardelyx Inc. It is protected by 5 US drug patents filed from 2019 to 2024 out of which none have expired yet. Ibsrela's patents have been open to challenges since 13 September, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 01, 2033. Details of Ibsrela's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8541448 | Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders |
Aug, 2033
(8 years from now) | Active |
| US8969377 | Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders |
Dec, 2029
(4 years from now) | Active |
| US12016856 | Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders |
Dec, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9006281 | Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders |
May, 2030
(4 years from now) | Active |
| US9408840 | Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder |
Dec, 2029
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ibsrela's patents.
Latest Legal Activities on Ibsrela's Patents
Given below is the list of recent legal activities going on the following patents of Ibsrela.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 09 Feb, 2024 | US9408840 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 14 Oct, 2022 | US9006281 |
| Patent Term Extension Certificate Critical | 06 Oct, 2022 | US8541448 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 Sep, 2022 | US8969377 |
| Notice of Final Determination -Eligible | 20 Jul, 2022 | US8541448 |
| Notice of Final Determination -Eligible | 14 Jul, 2022 | US8541448 |
| FDA Final Eligibility Letter Critical | 17 Feb, 2022 | US8541448 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 24 Mar, 2021 | US8541448 |
| transaction for FDA Determination of Regulatory Review Period | 08 Feb, 2021 | US8541448 |
| Second letter to regulating agency to determine regulatory review period | 15 Jul, 2020 | US8541448 |
FDA has granted several exclusivities to Ibsrela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ibsrela, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ibsrela.
Exclusivity Information
Ibsrela holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Ibsrela's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 12, 2024 |
US patents provide insights into the exclusivity only within the United States, but Ibsrela is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ibsrela's family patents as well as insights into ongoing legal events on those patents.
Ibsrela's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ibsrela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 01, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ibsrela Generics:
There are no approved generic versions for Ibsrela as of now.
Alternative Brands for Ibsrela
Ibsrela which is used for treating irritable bowel syndrome with constipation., has several other brand drugs using the same active ingredient (Tenapanor Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Ardelyx Inc |
|
About Ibsrela
Ibsrela is a drug owned by Ardelyx Inc. It is used for treating irritable bowel syndrome with constipation. Ibsrela uses Tenapanor Hydrochloride as an active ingredient. Ibsrela was launched by Ardelyx Inc in 2019.
Approval Date:
Ibsrela was approved by FDA for market use on 12 September, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ibsrela is 12 September, 2019, its NCE-1 date is estimated to be 13 September, 2023.
Active Ingredient:
Ibsrela uses Tenapanor Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tenapanor Hydrochloride ingredient
Treatment:
Ibsrela is used for treating irritable bowel syndrome with constipation.
Dosage:
Ibsrela is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET | Prescription | ORAL |