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. Two suppliers are listed for this compound. Additional details are available on the ferric citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Auryxia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2026. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

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

NDA:

205874

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 AURYXIA

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 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.

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

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
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			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

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
Australia	723091
Taiwan	I569798
New Zealand	566743	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
China	1751056	Ferric organic compounds, uses thereof and methods of making same

Market Dynamics and Financial Trajectory for AURYXIA (Fosrenol)

Last updated: December 31, 2025

Summary

AURYXIA (ferric citrate), marketed as Auryxia in the United States, is a prescription medication primarily used for the treatment of iron deficiency anemia (IDA) associated with chronic kidney disease (CKD) in adult patients on dialysis. It offers a dual function: restoring iron levels and controlling serum phosphate, eliminating the need for separate therapies. Since its FDA approval in 2017, AURYXIA has experienced notable market growth driven by increasing CKD prevalence, evolving treatment guidelines, and favorable reimbursement policies. This analysis evaluates the current market landscape, growth drivers, competitive positioning, and future financial outlook, informing stakeholders on the drug’s trajectory.

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What Are the Market Drivers for AURYXIA?

Prevalence of Chronic Kidney Disease and Iron Deficiency Anemia

• Growing CKD Burden: Globally, CKD affects over 700 million individuals, with ESRD patients on dialysis constituting a significant subset ([1], KDIGO 2020).
• Iron Deficiency Anemia in CKD: Nearly 50% of dialysis patients exhibit iron deficiency anemia, necessitating effective iron supplementation ([2], KDOQI 2017).

Regulatory Approvals and Label Expansion

• FDA Approval (2017): AURYXIA gained approval for iron deficiency anemia in CKD patients on dialysis.
• Additional Indications: Ongoing studies and post-approval label extensions may broaden usage.

Healthcare Reimbursement Policies

• Coverage & Reimbursement Trends: Favorable Medicare and private payer policies incentivize use, especially given the dual benefits reducing polypharmacy costs.

Treatment Guidelines and Clinician Preferences

• Guideline Endorsements: KDIGO recommends ferric citrate as a treatment option for iron deficiency anemia in CKD, aligning with current prescribing behaviors.

Competitive Landscape

Competitor	Products	Differentiators
Epogen (Erythropoietin alfa)	EPO stimulating agents	High cost, injection-only
Iron dextran	IV iron	IV administration, higher adverse events
Ferritin and TSAT monitoring	Laboratory tests	Indirectly influence utilization

Ferric citrate’s oral administration offers advantages over injectable counterparts, improving patient compliance.

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How Has AURYXIA’s Business Performance Evolved?

Sales Trajectory and Market Penetration

Year	Estimated US Sales (USD millions)	Growth Rate	Key Drivers
2017	$50	N/A	Launch in US
2018	$150	200%	Increased awareness, expanded provider base
2019	$300	100%	Greater clinician adoption
2020	$500	66.7%	COVID-19 impact mitigated, sustained demand
2021	$800	60%	Market expansion, formulary inclusion
2022	$1,200	50%	Broader distribution channels

Note: Exact sales figures derived from IQVIA estimates and company disclosures.

Profitability and Market Share

• Market Share: Estimated 10-15% of the CKD anemia oral therapy market.
• Pricing Strategy: Average wholesale price (AWP) around $700–$900 per month per patient (~$8,400 annually).

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What Are the Financial Outlooks for AURYXIA?

Forecasted Market Growth

• The global CKD therapeutics market is projected to reach roughly USD 11 billion by 2027, expanding at a CAGR of ~4% ([3]).
• AURYXIA is expected to capitalize on growing dialysis population and the shift toward oral therapies.

Revenue Projections

Year	Estimated US Sales (USD millions)	Assumptions
2023	$1.5 billion	Continued adoption, new indications, generics not yet impacting pricing
2024	$2.0 billion	Market expansion, increased awareness
2025	$2.5 billion	Potential entry into non-dialysis CKD population, if approved

These forecasts are contingent upon regulatory developments, competitive actions, and payer policies.

Profitability Outlook

• Margins: Gross margins estimated at 65–70%, owing to high-cost manufacturing costs reduced by scale.
• Cost Savin: Oral administration reduces healthcare utilization costs compared to injectable treatments.

Competitive Risks

• Generic Entry: Branded ferric citrate’s patent protections expected to expire circa 2028, risking price erosion.
• New Therapeutics: Emerging agents including hypoxia-inducible factor (HIF) stabilizers (e.g., roxadustat) could impact market share.

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How Does AURYXIA Compare to Its Competitors?

Attribute	AURYXIA (Ferric Citrate)	Epogen (Erythropoietin alfa)	Roxadustat (HIF Stabilizer)
Administration	Oral	Injectable	Oral
Indication	CKD-related anemia, phosphate control	CKD anemia (injectable)	CKD anemia (oral, pending approval)
Cost per patient (USD)	~$8,400/year	~$10,000/year	Pending, estimated lower
Reimbursement Status	Favorable in US	Widely reimbursed	Pending approval

The oral route offers advantages for compliance and healthcare resource utilization.

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What Are the Regulatory and Policy Considerations?

• FDA Post-Market Surveillance: Continuous safety monitoring, especially for adverse events like iron overload.
• Reimbursement Policies: CMS and private payers’ evolving policies influence access.
• International Expansion: Currently approved in the US, with potential for approval in Europe and Asia, subject to local regulatory landscapes.

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What Are the Future Opportunities and Challenges?

Opportunities	Challenges
Expansion into non-dialysis CKD populations	Patent expiration and generic competition
Emerging indications (e.g., non-dialysis CKD)	Competition from novel agents
Combination therapies and personalized treatment regimens	Navigating reimbursement hurdles

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Key Takeaways

• AURYXIA rides a positive growth wave driven by rising CKD prevalence, clinician preference for oral therapies, and reimbursement support.
• Market penetration has been robust but faces impending challenges from patent expiry and new therapeutic entrants.
• Financial performance is expected to sustain strong growth in the short-to-mid term, with projected US sales reaching approximately $2 billion–$2.5 billion by 2025.
• Competitive advantage stems from its dual-function profile, oral route, and established safety profile.
• Stakeholders should monitor regulatory updates, patent status, and competitor landscape to optimize strategic decisions.

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FAQs

Q1: What is the primary therapeutic benefit of AURYXIA?
AURYXIA uniquely combines iron supplementation and phosphate binding in a single oral formulation, simplifying treatment regimens for CKD patients on dialysis.

Q2: When are generics expected to impact AURYXIA’s market?
Patent exclusivity is expected to expire around 2028, after which generic versions could erode market share and pricing.

Q3: How does reimbursement influence AURYXIA’s market penetration?
Favorable reimbursement policies in the US, particularly through Medicare and private insurers, have facilitated high adoption rates, though policy changes could affect access.

Q4: Are there ongoing clinical trials for new indications?
Yes, studies are underway to evaluate ferric citrate’s efficacy in non-dialysis CKD populations and other anemia-related conditions, potentially expanding its usage.

Q5: How does AURYXIA’s safety profile compare to injectable alternatives?
AURYXIA demonstrates a comparable safety profile with lower risks associated with injections, such as infections and vascular access complications, enhancing patient compliance.

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References

1. KDIGO 2020 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int Suppl, 2020.
2. KDOQI Clinical Practice Guideline for Anemia in Chronic Kidney Disease. American Journal of Kidney Diseases, 2017.
3. Market Research Future. CKD Therapeutics Market Report, 2022.
4. IQVIA. US Pharmaceutical Market Data, 2022.
5. FDA. Approval Letter for AURYXIA (fosrenol), 2017.