Auryxia is a drug owned by Keryx Biopharmaceuticals Inc. It is protected by 15 US drug patents filed from 2014 to 2019. Out of these, 3 drug patents are active and 12 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 21, 2030. Details of Auryxia'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. | |||
US8338642 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US7767851 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US9328133 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US9757416 | Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
US9387191 | Ferric citrate dosage forms |
Jul, 2030
(5 years from now) | Active |
US10300039 | Ferric citrate dosage forms |
Jul, 2030
(5 years from now) | Active |
US8093423 | Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same |
Apr, 2026
(1 year, 3 months from now) | Active |
US8846976 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US8901349 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US8609896 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US8299298 | Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same |
Feb, 2024
(10 months ago) |
Expired
|
US8754258 | Ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US8754257 | Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US9050316 | Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same |
Feb, 2024
(10 months ago) |
Expired
|
US5753706 | Methods for treating renal failure |
Feb, 2022
(2 years ago) |
Expired
|
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 Auryxia's patents.
Latest Legal Activities on Auryxia's Patents
Given below is the list of recent legal activities going on the following patents of Auryxia.
Activity | Date | Patent Number |
---|---|---|
Payment of Maintenance Fee, 12th Year, Large Entity | 17 Apr, 2024 | US8299298 |
Payment of Maintenance Fee, 8th Year, Large Entity | 27 Dec, 2023 | US9387191 |
Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jun, 2023 | US8093423 |
Payment of Maintenance Fee, 4th Year, Large Entity | 11 Nov, 2022 | US10300039 |
Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2022 | US9050316 |
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 09 Nov, 2022 | US10300039 |
Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8846976 |
Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jan, 2022 | US7767851 |
Payment of Maintenance Fee, 8th Year, Large Entity | 11 Nov, 2021 | US8754258 |
Payment of Maintenance Fee, 8th Year, Large Entity | 11 Nov, 2021 | US8754257 |
FDA has granted several exclusivities to Auryxia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Auryxia, 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 Auryxia.
Exclusivity Information
Auryxia holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Auryxia's exclusivity codes and their expiration dates are given below.
Drug Exclusivity | Drug Exclusivity Expiration |
---|---|
New Indication(I-790) | Nov 06, 2020 |
Several oppositions have been filed on Auryxia's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Auryxia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Auryxia patents.
Auryxia's Oppositions Filed in EPO
Auryxia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 25, 2015, by Hexal Ag. This opposition was filed on patent number EP06813544A. Click below to reveal the latest opposition data.
Application | Filing Date | Opposition Party | Legal Status |
---|---|---|---|
EP07717051A | Dec, 2016 | Hexal AG | Opposition rejected |
EP06813544A | Nov, 2015 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Auryxia 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 Auryxia's family patents as well as insights into ongoing legal events on those patents.
Auryxia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Auryxia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 21, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Auryxia Generics:
There are no approved generic versions for Auryxia as of now.
About Auryxia
Auryxia is a drug owned by Keryx Biopharmaceuticals Inc. It is used for lowering and managing serum phosphorus levels. Auryxia uses Ferric Citrate as an active ingredient. Auryxia was launched by Keryx Biopharms in 2014.
Approval Date:
Auryxia was approved by FDA for market use on 05 September, 2014.
Active Ingredient:
Auryxia uses Ferric Citrate as the active ingredient. Check out other Drugs and Companies using Ferric Citrate ingredient
Treatment:
Auryxia is used for lowering and managing serum phosphorus levels.
Dosage:
Auryxia is available in tablet form for oral use. Given below is detailed information on Dosage -
Strength | Dosage Form | Availability | Application Pathway |
---|---|---|---|
EQ 210MG IRON | TABLET | Prescription | ORAL |