Generic Auryxia Availability
Last updated on Apr 10, 2025.
Auryxia is a brand name of ferric citrate, approved by the FDA in the following formulation(s):
AURYXIA (ferric citrate - tablet;oral)
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Manufacturer: KERYX BIOPHARMS
Approval date: September 5, 2014
Strength(s): EQ 210MG IRON [RLD]
Is there a generic version of Auryxia available?
An Authorized Generic version of Auryxia has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Ferric Citrate ORAL TABLET, FILM COATED 210 mg
Mylan Pharmaceuticals Inc.
NDC Code: 003782895
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Auryxia. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Ferric citrate dosage forms
Patent 10,300,039
Issued: May 28, 2019
Inventor(s): Le Henry Trong
Assignee(s): KERYX BIOPHARMACEUTICALS, INC.Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).
Patent expiration dates:
- July 21, 2030✓
- July 21, 2030
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Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent 8,093,423
Issued: January 10, 2012
Inventor(s): Chan Keith & Town Winston
Assignee(s): GloboAsia, LLCThe present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
Patent expiration dates:
- April 21, 2026✓
- April 21, 2026
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Ferric citrate dosage forms
Patent 9,387,191
Issued: July 12, 2016
Inventor(s): Le Henry Trong
Assignee(s): Keryx Biopharmaceuticals, Inc.Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).
Patent expiration dates:
- July 21, 2030✓
- July 21, 2030
More about Auryxia (ferric citrate)
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- Drug class: phosphate binders
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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