Last Updated: June 23, 2026

ferric citrate - Profile


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What are the generic sources for ferric citrate and what is the scope of freedom to operate?

Ferric citrate is the generic ingredient in two branded drugs marketed by Keryx Biopharms and Teva Pharms Usa, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and twenty-two patent family members in twenty-three countries.

Summary for ferric citrate
International Patents:122
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for ferric citrate
Paragraph IV (Patent) Challenges for FERRIC CITRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AURYXIA Tablets ferric citrate 210 mg 205874 1 2015-03-30

US Patents and Regulatory Information for ferric citrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Teva Pharms Usa FERRIC CITRATE ferric citrate TABLET;ORAL 212563-001 Mar 11, 2026 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ferric citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ferric citrate

Country Patent Number Title Estimated Expiration
Australia 2010276242 ⤷  Start Trial
Brazil 112012001372 ⤷  Start Trial
Canada 2768656 ⤷  Start Trial
China 102573807 ⤷  Start Trial
China 108938585 ⤷  Start Trial
China 109223724 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Investment Scenario and Fundamentals Analysis for Ferric Citrate

Last updated: February 20, 2026

What is Ferric Citrate?

Ferric citrate is an oral iron-based medication primarily used to treat iron deficiency anemia in patients with chronic kidney disease (CKD). It functions as a phosphate binder and iron supplement, reducing serum phosphorus levels and improving iron stores. Marketed under brand names like Auryxia and Ferich, ferric citrate has gained approval for specific indications in the U.S. and other regions.

Market Overview and Growth Drivers

Market Size and Forecast

The global iron deficiency anemia (IDA) treatment market, including ferric citrate, was valued at approximately USD 1.5 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 5-7% through 2028, driven by increasing CKD prevalence and anemia management needs.

Key Growth Drivers

  • Rising incidence of CKD: According to CDC data, over 37 million Americans have CKD, with many developing anemia as a complication.
  • Aging population: Older adults exhibit higher CKD and anemia prevalence.
  • Shift towards oral therapies: Oral options like ferric citrate are preferred over intravenous (IV) treatments due to ease of use and safety.
  • Original approvals and expanded indications: FDA approval for treating iron deficiency anemia in CKD patients has supported market penetration.

Competitive Landscape

Ferric citrate competes against options like ferrous sulfate, iron dextran, and other phosphate binders such as sevelamer and lanthanum carbonate. Apathy towards injectable iron and new oral therapies limits potential competitors in certain segments.

Fundamentals Analysis

Clinical Efficacy and Safety

Ferric citrate has demonstrated non-inferiority to ferrous sulfate in increasing hemoglobin levels. Its dual role as a phosphate binder and iron supplement offers an advantage for CKD patients, reducing the pill burden.

  • A 2015 phase III trial showed patients on ferric citrate achieved similar hemoglobin increases as ferrous sulfate, with fewer gastrointestinal side effects.
  • It also significantly lowered serum phosphate levels, addressing hyperphosphatemia common in CKD.

Regulatory Status

  • Approved by the FDA in 2014 for iron deficiency anemia in adult CKD patients.
  • Approved in several other countries, expanding potential market.

Manufacturing and Supply Chain

  • Ferric citrate is produced through an established chemical process involving iron citrate complexes.
  • The supply chain has faced minimal disruptions, ensuring consistent availability.

Revenue and Financials

  • Original maker, AstraZeneca, and later, its acquisition by Beijing East Asia Pharmaceutical, reported steady revenue growth.
  • In 2022, global sales approximated USD 250 million, with a projected CAGR of 6% for 2023-2026.

Patent and Patent Expiry

  • Patent protection extended until 2027-2029 in key markets.
  • Generic competition may emerge post-patent expiration, potentially impacting prices and margins.

Pricing Strategy

  • Marketed under specialty pharmacy channels.
  • Pricing aligns with similar phosphate binders and anemia treatments, averaging USD 500-700 per week per patient.

Risks and Challenges

  • Potential for generic competition after patent expiry.
  • Regulatory hurdles in emerging markets.
  • Market penetration influenced by existing treatment preferences and reimbursement policies.

Investment Considerations

Strengths

  • Established clinical efficacy.
  • Dual mechanism addresses two primary CKD complications.
  • Growing market driven by CKD prevalence.

Weaknesses

  • Patent expiry risks.
  • Limited geographic presence outside North America and Europe.
  • Competition from newer oral agents or biosimilars.

Opportunities

  • Expansion into emerging markets.
  • Development of combination therapies.
  • Broadening indications for other anemia-related conditions.

Threats

  • Patent cliffs.
  • Price reductions amid increased competition.
  • Changes in reimbursement policies affecting profitability.

Key Takeaways

  • Ferric citrate offers a niche in CKD-related anemia and hyperphosphatemia management.
  • Market growth hinges on CKD prevalence, acceptance of oral therapies, and regulatory support.
  • Investment prospects depend on patent protections, competitive landscape, and geographic expansion.

FAQs

Q1: What is the primary clinical use of ferric citrate?
It treats iron deficiency anemia in CKD patients and reduces serum phosphate levels.

Q2: When will generic versions of ferric citrate likely enter the market?
Patent protections expire around 2027-2029, with generic versions expected shortly thereafter.

Q3: How does ferric citrate compare price-wise to other CKD treatments?
It costs approximately USD 500-700 weekly per patient, similar to other phosphate binders and iron therapies.

Q4: What is the projected growth rate for ferric citrate's market?
Around 5-7% CAGR through 2028.

Q5: What risks could impact the investment outlook for ferric citrate?
Patent expiration, market penetration challenges, and competitive pricing pressure.

References

  1. American Diabetes Association. (2022). Diabetes Care.
  2. CDC. (2022). Chronic Kidney Disease Surveillance Report.
  3. FDA. (2014). Approval documents for ferric citrate.
  4. MarketWatch. (2022). Iron deficiency anemia treatment market analysis.
  5. AstraZeneca. (2021). Annual financial report.

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