Xphozah is a drug owned by Ardelyx Inc. It is protected by 5 US drug patents filed from 2023 to 2024 out of which none have expired yet. Xphozah'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 Apr 10, 2034. Details of Xphozah'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 |
| 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
(5 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
(5 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). | |||
| US10940146 | NHE3-binding compounds and methods for inhibiting phosphate transport |
Apr, 2034
(9 years from now) | Active |
| US10272079 | NHE3-binding compounds and methods for inhibiting phosphate transport |
Apr, 2034
(9 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 Xphozah's patents.
Latest Legal Activities on Xphozah's Patents
Given below is the list of recent legal activities going on the following patents of Xphozah.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 31 Oct, 2022 | US10272079 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Mar, 2021 | US10940146 |
| Recordation of Patent Grant Mailed Critical | 09 Mar, 2021 | US10940146 |
| Email Notification Critical | 18 Feb, 2021 | US10940146 |
| Issue Notification Mailed Critical | 17 Feb, 2021 | US10940146 |
| Dispatch to FDC | 10 Feb, 2021 | US10940146 |
| Email Notification Critical | 07 Jan, 2021 | US10940146 |
| Mail Response to 312 Amendment (PTO-271) Critical | 07 Jan, 2021 | US10940146 |
| Response to Amendment under Rule 312 Critical | 04 Jan, 2021 | US10940146 |
| Application Is Considered Ready for Issue Critical | 31 Dec, 2020 | US10940146 |
FDA has granted several exclusivities to Xphozah. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xphozah, 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 Xphozah.
Exclusivity Information
Xphozah holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Xphozah's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 12, 2024 |
| New Product(NP) | Oct 17, 2026 |
US patents provide insights into the exclusivity only within the United States, but Xphozah 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 Xphozah's family patents as well as insights into ongoing legal events on those patents.
Xphozah's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xphozah's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 10, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xphozah Generics:
There are no approved generic versions for Xphozah as of now.
Alternative Brands for Xphozah
Xphozah which is used for reducing serum phosphorus levels and treating hyperphosphatemia in adults., 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 Xphozah
Xphozah is a drug owned by Ardelyx Inc. It is used for reducing serum phosphorus levels and treating hyperphosphatemia in adults. Xphozah uses Tenapanor Hydrochloride as an active ingredient. Xphozah was launched by Ardelyx Inc in 2023.
Approval Date:
Xphozah was approved by FDA for market use on 17 October, 2023.
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 Xphozah is 17 October, 2023, its NCE-1 date is estimated to be 13 September, 2023.
Active Ingredient:
Xphozah uses Tenapanor Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tenapanor Hydrochloride ingredient
Treatment:
Xphozah is used for reducing serum phosphorus levels and treating hyperphosphatemia in adults.
Dosage:
Xphozah is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 30MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Discontinued | ORAL |