Auryxia Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Auryxia.

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Auryxia has patent protection in a total of 23 countries. It's US patent count contributes only to 35.8% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Auryxia.

Family Patents

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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