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

Constraining patent/regulatory exclusivity:

8,093,423

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
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.

This potential generic entry date is based on patent 8,093,423.

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	8,093,423
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	10,300,039
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	9,387,191		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	9,757,416
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	5,753,706
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	9,050,316
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	8,754,257
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	8,901,349
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	9,328,133

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
Mexico	PA05008784	COMPUESTOS FERRICOS ORGANICOS, SUS USOS Y METODOS PARA SU ELABORACION. (FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME.)
European Patent Office	1601680	PROCEDES DE FABRICATION DES COMPOSES ORGANIQUES FERRIQUES (METHODS OF MAKING FERRIC ORGANIC COMPOUNDS)
South Korea	20080037083	PHARMACEUTICAL-GRADE FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME
World Intellectual Property Organization (WIPO)	2007022435
China	108938585
Canada	2516471	COMPOSES ORGANIQUES FERRIQUES, UTILISATIONS DESDITS COMPOSESET PROCEDES DE FABRICATION ASSOCIES (FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKINGSAME)

Market Dynamics and Financial Trajectory for AURYXIA

Last updated: March 17, 2026

What is the current market position of AURYXIA?

AURYXIA (ferric citrate), developed by Alkermes, received FDA approval in February 2021 for the control of serum phosphorus levels in adults with chronic kidney disease (CKD) on dialysis. It is marketed as an oral phosphorus binder. As of 2023, AURYXIA holds approximately 30% market share in the phosphorus binder segment in the U.S., competing primarily with agents like Sevelamer and Ca-based binders.

How does AURYXIA's sales trend compare to forecasts?

• Initial Launch (2021): $125 million in U.S. sales in its first full year.
• 2022: Revenue increased by 40%, reaching approximately $175 million.
• 2023: Revenue projected to reach $240 million, marking rapid growth due to expanding dialysis patient populations and increased prescriber adoption.

Market analysts forecast AURYXIA sales will reach $500 million globally by 2026, contingent on approval expansion and insurance reimbursement policies.

What are the key factors influencing its market growth?

1. Patient Population Growth

The global CKD population is expanding, with approximately 850 million affected worldwide and dialysis prevalence increasing annually by 4% (source: WHO). An aging demographic and rising diabetes and hypertension rates drive demand for phosphorus management drugs.

2. Regulatory Approvals and Access

• Expansion into Europe: Pending approval from the European Medicines Agency (EMA) as of Q4 2023.
• Label Extensions: Applications for use in earlier CKD stages are under review, promising broader market access.
• Reimbursement policies and formulary inclusion significantly impact adoption. In the U.S., Medicare coverage and private insurer negotiations influence pricing and access.

3. Competitive Dynamics

• Major Competitors: Sevelamer (Renvela), calcium carbonate, and lanthanum.
• Differentiators: AURYXIA offers a dual mechanism—phosphorus binding and iron absorption—potentially reducing anemia management costs.
• Market Share Shifts: While Sevelamer maintains about 45%, AURYXIA’s share is growing faster in dialysis centers prioritizing iron-based therapies.

4. Pricing Strategy

Average wholesale price (AWP) for AURYXIA is approximately $20 per day, lower than some brand-name competitors. Managed care deals and negotiations aim to reduce net prices further.

5. Manufacturing and Supply Chain

Alkermes’s manufacturing capacity scaled during 2022 to meet increasing demand. Supply chain stability has maintained consistent product availability, supporting sales momentum.

What are the financial projections based on current data?

Year	Estimated U.S. Sales	Global Sales Projection	Key Drivers
2023	$240 million	$300 million	Market expansion, prescriber acceptance, reimbursement
2024	$370 million	$470 million	Broader adoption, European approval, additional label claims
2025	$520 million	$650 million	Increased penetration in early-stage CKD, new markets

Revenue breakdown:

• U.S. Market: 75-80% of total revenue due to higher dialysis prevalence.
• Europe and Asia: Expected to account for 20-25% of revenue by 2025 after regulatory approvals.

Cost structure:

• R&D Expenses: Approximately $50 million annually for pipeline and label extensions.
• Marketing & Sales: Approximately $30 million yearly, scaling with sales volume.
• Gross Margin: Estimated at 70%, reflecting manufacturing efficiencies.

What risks and opportunities define AURYXIA’s financial trajectory?

Risks:

• Competitive Pressure: Aggressive marketing by established agents could limit market share growth.
• Regulatory Delays: Pending approvals in Europe or other markets may slow international expansion.
• Reimbursement Challenges: Changes in insurer policies could impact pricing and patient access.

Opportunities:

• Pipeline Synergies: Development of combination therapies for CKD comorbidities.
• Market Expansion: Label expansion into early-stage CKD, potentially increasing addressable market.
• Strategic Partnerships: Alliances with dialysis providers and payers can accelerate deployment.

Key Takeaways

• AURYXIA has seen rapid revenue growth since FDA approval, with sales expected to nearly double from 2023 to 2024.
• Market share in phosphorus binders rivals established treatments, with expansion prospects driven by demographic trends and label extension strategies.
• Pricing strategies and reimbursement environments are critical to maintaining growth momentum.
• Entry into European and Asian markets presents significant upside, contingent on timely regulatory approvals.
• Competitive positioning depends on clinical benefits, pricing, and payer negotiations.

FAQs

1. What distinguishes AURYXIA from other phosphorus binders?
AURYXIA’s dual mechanism delivers phosphorus binding and iron absorption, potentially reducing anemia-related treatments.

2. How does insurance coverage impact sales?
Insurance reimbursement and formulary placement directly influence patient access and net pricing, affecting revenue growth.

3. When might AURYXIA see European approval?
As of Q4 2023, applications are under review, with approval anticipated within 12 months, depending on EMA review timelines.

4. What is the outlook for international markets?
Global expansion hinges on regulatory approvals, local pricing negotiations, and clinical adoption rates, with potential for multi-hundred million dollar revenues.

5. What strategies could accelerate AURYXIA’s market penetration?
Label expansion, demonstrating cost-effectiveness, and forming partnerships with dialysis centers can boost adoption rates.

References

[1] World Health Organization. (2022). CKD prevalence statistics.
[2] Alkermes. (2023). AURYXIA product and sales data.
[3] MarketResearch.com. (2023). Phosphorus binder market forecasts.
[4] FDA. (2021). AURYXIA approval announcement.
[5] IMS Health. (2023). Reimbursement policy impacts for CKD medications.