Generic Auryxia Availability

Last updated on Jan 11, 2023.

Auryxia is a brand name of ferric citrate, approved by the FDA in the following formulation(s):

AURYXIA (ferric citrate - tablet;oral)

Manufacturer: KERYX BIOPHARMS
Approval date: September 5, 2014
Strength(s): EQ 210MG IRON ^[RLD]

Has a generic version of Auryxia been approved?

No. There is currently no therapeutically equivalent version of Auryxia available in the United States.

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.

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.

Ferric citrate dosage forms
Patent 10,300,039
Issued: May 28, 2019
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
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  Patent use: CONTROL OF SERUM PHOSPHORUS LEVELS
Methods for treating renal failure
Patent 5,753,706
Issued: May 19, 1998
Inventor(s): Hsu; Chen Hsing
Methods of controlling phosphate metabolism and metabolic acidosis in patients suffering from renal failure and associated hyperphosphatemia or patients predisposed to development of a hyperphosphatemic condition are provided. The method in accordance with this invention comprises administering to a patient a ferric-containing compound selected from the group consisting of ferric citrate, ferric acetate, and combinations thereof. Therapeutic benefit can be realized in accordance with such method by administering the compound orally to a patient to contact and bind with ingested phosphate in the patient's digestive tract, and thereby prevent its intestinal absorption.
Patent expiration dates:
- February 3, 2022
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  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
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  Drug product
Ferric organic compounds, uses thereof and methods of making same
Patent 7,767,851
Issued: August 3, 2010
Inventor(s): Kwok; David W. K. & Stoynov; Nikolay Mintchev
Assignee(s): Panion & BF Biotech, Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
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  Drug substance
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  Drug product
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, LLC
The 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
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  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent 8,299,298
Issued: October 30, 2012
Inventor(s): Chan; Keith & Town; Winston
Assignee(s): Globoasia, LLC
The present invention discloses 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:
- February 18, 2024
  ✓
  Drug product
Ferric organic compounds, uses thereof and methods of making same
Patent 8,338,642
Issued: December 25, 2012
Inventor(s): Kwok; David W. K. & Stoynov; Nikolay Mintchev
Assignee(s): Panion & BF Biotech, Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
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  Drug substance
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  Drug product
Ferric organic compounds, uses thereof and methods of making same
Patent 8,609,896
Issued: December 17, 2013
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Drug product
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent 8,754,257
Issued: June 17, 2014
Assignee(s): Panion & BF Biotech Inc.
The 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:
- February 18, 2024
  ✓
  Drug product
Ferric organic compounds, uses thereof and methods of making same
Patent 8,754,258
Issued: June 17, 2014
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Drug product
Ferric organic compounds, uses thereof and methods of making same
Patent 8,846,976
Issued: September 30, 2014
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent 8,901,349
Issued: December 2, 2014
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent 9,050,316
Issued: June 9, 2015
Assignee(s): Panion & BF Biotech Inc.
The 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:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
Ferric organic compounds, uses thereof and methods of making same
Patent 9,328,133
Issued: May 3, 2016
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses a novel form of ferric organic compounds, including a form of ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. The ferric organic compounds of the present invention can be delivered effectively by oral route with better delivery to treat patients suffering from hyperphosphatemia, metabolic acidosis and other disorders responsive to ferric organic compound therapy.
Patent expiration dates:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
  ✓
  Drug substance
  ✓
  Drug product
Ferric citrate dosage forms
Patent 9,387,191
Issued: July 12, 2016
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
  ✓
  Drug product
Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent 9,757,416
Issued: September 12, 2017
Assignee(s): Panion & BF Biotech Inc.
The present invention discloses 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:
- February 18, 2024
  ✓
  Patent use: CONTROL OF SERUM PHOSPHOROUS LEVELS
  ✓
  Drug substance
  ✓
  Drug product

More about Auryxia (ferric citrate)

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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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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

6 Reviews

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Pill KX52 is Auryxia 210 mg (ferric iron)

Auryxia 210 mg (ferric iron) (KX52)