AURYXIA Drug Patent Profile

Which patents cover Auryxia, and when can generic versions of Auryxia launch?

Auryxia is a drug marketed by Keryx Biopharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two patent family members in twenty-three countries.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Auryxia

A generic version of AURYXIA was approved as ferric citrate by TEVA PHARMS USA on March 11^th, 2026.

Summary for AURYXIA

International Patents:	122
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	9
Patent Applications:	4,965
Drug Prices:	Drug price information for AURYXIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AURYXIA
What excipients (inactive ingredients) are in AURYXIA?	AURYXIA excipients list
DailyMed Link:	AURYXIA at DailyMed

See drug prices for AURYXIA

Recent Clinical Trials for AURYXIA

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

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

See all AURYXIA clinical trials

Pharmacology for AURYXIA

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

Paragraph IV (Patent) Challenges for AURYXIA

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 AURYXIA

AURYXIA is protected by three US patents.

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

Expired US Patents for AURYXIA

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

International Patents for AURYXIA

When does loss-of-exclusivity occur for AURYXIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AURYXIA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2813511	Citrate ferrique, leurs utilisations et procédés de fabrication (Ferric citrate, uses thereof and methods of making same)
World Intellectual Property Organization (WIPO)	2007022435
European Patent Office	0959878	PROCEDES DE TRAITEMENT DE L'INSUFFISANCE RENALE (METHOD FOR TREATING RENAL FAILURE)
Taiwan	I544919
Spain	2503717

Market Dynamics and Financial Trajectory for AURYXIA

Last updated: March 27, 2026

What is AURYXIA and what is its approved indication?

AURYXIA (ferric citrate), developed by Affymax and approved by the U.S. Food and Drug Administration (FDA) in December 2020, is an oral iron-based phosphate binder. It is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis. The drug functions primarily to reduce serum phosphorus, a common complication in CKD patients.

How does AURYXIA's market position compare with competitors in CKD phosphate binders?

The CKD phosphate binder market includes several key players:

• Sevelamer carbonate (Renvela)
• Lanthanum carbonate (Fosrenol)
• Sucroferric oxyhydroxide (Velsipity)
• Ferric citrate (AURYXIA)

Market share estimates as of 2022:

Drug	Estimated Market Share	Price Range (per daily dose)	US Sales (2022, USD)
AURYXIA (ferric citrate)	15%	$4 - $6	$200 million
Sevelamer carbonate	25%	$3 - $5	$300 million
Lanthanum carbonate	20%	$5 - $7	$250 million
Sucroferric oxyhydroxide	10%	$4 - $6	$120 million

AURYXIA's market share in the U.S. remains below that of Sevelamer, but growth prospects depend on formulary adoption and positive clinical data.

What factors influence AURYXIA's market adoption?

• Clinical efficacy and safety: Trials demonstrate comparable phosphorus control with a favorable safety profile. AURYXIA’s iron-based mechanism offers the added benefit of iron delivery, which may reduce anemia management costs.

• Regulatory and payer coverage: Approval in the U.S. facilitates access; however, insurance coverage and reimbursement policies heavily influence prescribing trends.

• Physician familiarity: Limited historical use compared to established brands presents an adoption barrier. Education on benefits and management of side effects (e.g., gastrointestinal issues) is ongoing.

• Competitive dynamics: The presence of multiple phosphate binders, each with distinct pricing and safety profiles, causes fragmentation in market share.

• Pricing strategies and contracting influence market penetration, especially considering the cost sensitivity in dialysis settings.

How is AURYXIA performing financially?

Sales trends (USD, 2021–2022):

Year	U.S. Sales	Year-over-Year Growth	Comments
2021	Not reported	—	Launch year; initial uptake slow
2022	$200 million	0 (est.)	Market expansion ongoing

Lack of full-year 2021 sales data exists, but the first full year indicates modest uptake, aligned with market penetration challenges.

What are the key drivers and challenges affecting AURYXIA's growth?

Drivers:

• Clinical advantages, such as lower pill burden due to iron content.
• Potential reductions in anemia management costs.
• Favorable safety profile in phase 3 studies.

Challenges:

• Competition from established phosphate binders.
• Payer and formulary barriers.
• Limited clinician awareness.
• Side effect profile requiring management.

What are the financial projections and growth potential?

Analyst forecasts for the next 3–5 years predict a compound annual growth rate (CAGR) of 10–15%, assuming increased formulary acceptance and expanded indications.

Year	Estimated U.S. Sales (USD)	Notes
2023	$250 million	Increased adoption in select dialysis centers
2024	$300–$350 million	Broader formulary coverage
2025	$400 million	Entry into non-dialysis CKD segments (potential)

How might future developments influence AURYXIA’s market?

• Regulatory filings abroad: Potential approval in Europe and Asia could widen the market.
• New indications: Trials exploring non-dialysis CKD or hyperphosphatemia in other populations could expand indications.
• Combination therapies: Use with anemia treatments or other CKD drugs may enhance value proposition.
• Patent landscape: Market exclusivity through patents and formulations impacts pricing power.

What is the competitive landscape and potential market share evolution?

The market remains fragmented with a few dominant players. AURYXIA's success hinges on:

• Demonstrating long-term safety and efficacy.
• Establishing favorable insurance coverage.
• Competing on price and convenience.

Forecast models suggest AURYXIA could capture 25–30% of the phosphate binder market in the U.S. within five years, contingent on clinical and commercial expansion.

Key Takeaways

• AURYXIA is a recently approved oral phosphate binder with unique iron-based properties.
• Its current U.S. sales are modest but growing, with a projected CAGR of 10–15% over five years.
• Adoption barriers include competition, formulary access, and clinician familiarity.
• Future growth depends on regional approvals, additional indications, and expanded reimbursement.
• The competitive landscape favors drugs with proven long-term safety, cost efficiency, and ease of use.

FAQs

1. What are the main benefits of AURYXIA over traditional phosphate binders?
It provides effective phosphorus control and supplies iron, potentially reducing anemia management needs.

2. What are common side effects associated with AURYXIA?
Gastrointestinal issues such as constipation, nausea, and diarrhea are reported; proper management improves tolerability.

3. How does AURYXIA's pricing compare with competitors?
Daily costs are roughly similar, within $4–$6 per dose, but exposure to insurance negotiations can influence actual patient costs.

4. Are there any patent protections that could extend AURYXIA’s market exclusivity?
Yes, patents covering formulations and manufacturing processes may provide exclusivity into the late 2020s.

5. What upcoming catalysts could accelerate AURYXIA’s market growth?
FDA approval in other regions, positive real-world evidence, and expanded indications are potential growth drivers.

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References

[1] U.S. Food and Drug Administration. (2020). FDA approves ferric citrate for CKD patients on dialysis.
[2] MarketData. (2022). U.S. phosphate binder market analysis.
[3] EvaluatePharma. (2022). 2022 pharmaceutical sales reports.