Ferric citrate - Generic Drug Details

What are the generic drug sources for ferric citrate and what is the scope of patent protection?

Ferric citrate is the generic ingredient in one branded drug marketed by Keryx Biopharms and is included in one NDA. 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.

There are six drug master file entries for ferric citrate. Two suppliers are listed for this compound.

Summary for ferric citrate

International Patents:	122
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	34
Drug Prices:	Drug price trends for ferric citrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric citrate
What excipients (inactive ingredients) are in ferric citrate?	ferric citrate excipients list
DailyMed Link:	ferric citrate at DailyMed

See drug prices for ferric citrate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ferric citrate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ferric citrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Akebia Therapeutics	Phase 3
USRC Kidney Research	Phase 3
USRC Kidney Research	Phase 4

See all ferric citrate clinical trials

Pharmacology for ferric citrate

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for ferric citrate

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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		RX	Yes	Yes			Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes

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
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014

International Patents for ferric citrate

Country	Patent Number	Title	Estimated Expiration
Spain	2539635
Australia	2006279333	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
European Patent Office	2813511	Citrate ferrique, leurs utilisations et procédés de fabrication (Ferric citrate, uses thereof and methods of making same)
Japan	2019194212	慢性腎疾患の治療法 (METHOD OF TREATING CHRONIC KIDNEY DISEASE)

Market Dynamics and Financial Trajectory for Ferric Citrate

Last updated: March 4, 2026

What is the current global market for ferric citrate?

The global market for ferric citrate was valued at approximately $350 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6% from 2023 to 2030, reaching around $560 million by 2030. The growth is driven by increasing demand for phosphate binders, especially in dialysis patients with chronic kidney disease (CKD).

What are the primary drivers influencing market growth?

The key drivers include:

• Rising CKD prevalence: The global CKD population is estimated to be over 850 million, with ESRD (End-Stage Renal Disease) cases increasing annually [1].

• Expanding dialysis treatments: An aging population and increased access to dialysis influence demand. In 2022, roughly 2.2 million patients worldwide received dialysis, a number expected to grow with demographic shifts.

• Regulatory approvals: Ferric citrate's approval as a phosphate binder in multiple regions, including the US (2017), EU (2019), and Japan (2020), broadens market access.

• Cost advantages: Ferric citrate offers an oral, less invasive alternative to traditional phosphate binders, reducing treatment costs and improving patient compliance.

How does competitive positioning influence the financial trajectory?

Major players include Keryx Biopharmaceuticals (now part of AstraZeneca), Vifor Pharma, and Kissei Pharmaceutical, with key products like Auryxia and Fosrenol.

• Market penetration: Ferric citrate's advantage as a therapy that manages both iron deficiency anemia and phosphate levels enhances its attractiveness.

• Pricing strategies: Average wholesale prices (AWP) range from $250 to $350 per month per patient in the US, with variations based on regional healthcare policies.

• Reimbursement landscape: Coverage by Medicare, Medicaid, and private insurers supports steady revenue streams.

What are the potential challenges affecting financial growth?

• Generic competition: Patent expirations for marketed products could lead to price erosion and market share loss.

• Regulatory hurdles: Approvals in emerging markets remain inconsistent; some regions impose restrictions due to safety concerns.

• Safety profile: Gastrointestinal side effects and iron overload risks can limit patient pool and prescriber acceptance.

• Market saturation: Increasing adoption lowers the exclusive growth rate in mature markets. New formulations or combination therapies could impact pricing.

How are regional markets performing?

Region	Market Size (2022)	CAGR (2023–2030)	Key Factors
North America	$200 million	5.8%	High CKD prevalence, established reimbursement
Europe	$80 million	6.2%	Growing dialysis rates, regulatory approval
Asia-Pacific	$40 million	7.5%	Rising CKD in China and India, expanding healthcare access
Latin America	$20 million	6.4%	Emerging markets, improving healthcare systems

What financial projections exist?

Market research estimates suggest:

• 2023 revenue: $370 million globally.

• 2025 forecast: Approximately $455 million, assuming steady market share growth and expatriate adoption.

• Key revenue contributors: North America accounts for roughly 60% of sales; efficacy and safety improvements could increase penetration.

What are the implications for investors and R&D?

• Investment opportunities: Companies developing next-generation phosphate binders or combination therapies could impact ferric citrate's market share.

• R&D focus: Enhancing safety profiles, reducing side effects, and improving bioavailability are primary R&D priorities.

• M&A activity: Consolidation trends could influence patent landscapes and market access strategies.

What is the regulatory outlook?

• US: Already approved (Auryxia) for CKD-associated anemia and phosphate control.

• EU: Approved under different brand names; ongoing studies could expand indications.

• Emerging markets: Regulatory approvals vary, creating potential for market entry but with caution.

Key Takeaways

• The ferric citrate market is in a growth phase, driven by increasing CKD rates and dialysis procedures.

• Price and reimbursement strategies, coupled with safety considerations, influence financial performance.

• Competition from generics and new therapies could pressure revenues in mature markets.

• Regional growth varies, with the highest CAGR expected in Asia-Pacific.

• Continued R&D aims to improve safety, efficacy, and patient outcomes.

FAQs

1. What is ferric citrate mainly used for?
   It is primarily used as a phosphate binder for patients with CKD on dialysis and for treating iron deficiency anemia.

2. How does ferric citrate compare to other phosphate binders?
   It is an oral therapy with dual benefits of phosphate binding and iron supplementation, which can reduce the need for additional iron therapy.

3. What are safety concerns associated with ferric citrate?
   Gastrointestinal side effects, including constipation and nausea, along with risks of iron overload if overused.

4. Are there any upcoming approvals for ferric citrate?
   Expansion into additional indications and regions is under review, with potential approval in emerging markets.

5. What strategies can companies employ to sustain growth in this market?
   Focus on expanding indications, optimizing pricing and reimbursement, and developing formulations with improved safety profiles.

References

[1] Global Burden of Disease Study. (2020). CKD prevalence estimates. Lancet, 396(10260), 71–80.