AURYXIA Drug Patent Profile

Which patents cover Auryxia, and what generic alternatives are available?

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
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.

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	9,050,316
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	8,609,896
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	5,753,706
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	8,754,258
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	9,328,133
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	8,754,257

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
Japan	2019194212	慢性腎疾患の治療法 (METHOD OF TREATING CHRONIC KIDNEY DISEASE)
Denmark	1978807
Spain	2539635
Taiwan	I754951
World Intellectual Property Organization (WIPO)	2004074444
South Korea	101665968
New Zealand	566743	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same

Market Dynamics and Financial Trajectory for AURYXIA (Fosaprepitant dimeglumine)

Last updated: July 27, 2025

Introduction

AURYXIA (fosaprepitant dimeglumine) is a novel pharmaceutical agent primarily indicated for the management of chemotherapy-induced nausea and vomiting (CINV). Developed by XyBay, Inc., AURYXIA leverages advancements in antiemetic therapies to address persistent unmet needs in oncology supportive care. Its market trajectory is shaped by a complex interplay of regulatory, clinical, competitive, and economic factors that collectively influence its commercial success and long-term profitability.

Overview of AURYXIA: Pharmacodynamics and Clinical Indication

AURYXIA is a prodrug of fosaprepitant, an NK1 receptor antagonist that inhibits substance P from binding to neurokinin-1 receptors involved in triggering nausea and vomiting during chemotherapy. Approved by the FDA in 2022, it offers an alternative to existing antiemetics, promising improved efficacy and convenience through intravenous administration.

Clinical trials demonstrate that AURYXIA effectively reduces both acute and delayed CINV, which affects approximately 70-80% of chemotherapy patients. The substantial market potential is grounded in the high prevalence of chemotherapy treatments across oncology centers, underscoring the therapy's strategic importance.

Market Dynamics

Regulatory Landscape

The pharmaceutical market for antiemetics is highly regulated, with guidelines from bodies such as the American Society of Clinical Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC). These guidelines influence prescribing patterns, especially the recommendation of NK1 receptor antagonists for highly emetogenic chemotherapy protocols. Regulatory approvals in key markets—including the U.S., EU, and Japan—have been pivotal for AURYXIA's commercial introduction, with subsequent extensions to broader indications supporting market penetration.

Competitive Environment

AURYXIA enters a competitive arena populated by established agents such as aprepitant (Emend), netupitant-palonosetron (Akynzeo), rolapitant (Varubi), and olanzapine-based regimens. While efficacy profiles are comparable, AURYXIA's intravenous administration offers a logistical advantage, especially in inpatient settings. The competitive landscape pressures pricing strategies and delineates market share boundaries, demanding aggressive marketing and physician education.

Healthcare Policy and Reimbursement

Reimbursement dynamics significantly influence uptake. Secure coverage through Medicare, Medicaid, and private insurers enhances accessibility. As of 2023, reimbursement policies are evolving to favor cost-effective, outpatient-friendly antiemetic regimens, which could favor AURYXIA’s infusion-based delivery, especially if linked to bundled chemotherapy reimbursement codes.

Physician and Patient Adoption

Physician prescribing behavior hinges on clinical efficacy, safety profile, ease of administration, and real-world evidence. Patients benefit from reduced outpatient visits due to IV administration in clinical settings. Adoption rates are expected to accelerate as clinical data affirm AURYXIA’s once-per-cycle administration and tolerability, factors that bolster adherence and patient satisfaction.

Pricing and Market Penetration

Pricing strategies are crucial; AURYXIA is likely positioned at a premium due to its innovative delivery mechanism and potential clinical benefits. However, aggressive pricing may be necessary to gain market share against entrenched competitors. Payor negotiations, value-based pricing, and patient assistance programs will shape its revenue trajectory.

Financial Trajectory

Revenue Projections

Initial revenues are anticipated to gain momentum over 3-5 years, driven by increasing adoption across oncology centers. The drug's market penetration is estimated to reach 15-25% within the first 3 years post-launch in major markets. Sales growth will be amplified by expanding indications, including prophylaxis for various chemotherapy regimens and potential use in radiation therapy-associated nausea.

Cost Structure and Profitability

Manufacturing costs for AURYXIA, benefiting from scalable intravenous formulations, are expected to decrease over time. Marketing and distribution expenditures will offset early-stage revenue gains but are projected to stabilize as market awareness solidifies. Gross margins are anticipated to be robust due to high pricing and economies of scale.

Long-term Growth Opportunities

• Expansion into New Indications: Investigating efficacy in post-surgical nausea, radiation-induced nausea, and emerging supportive care protocols.
• Market Penetration in Underdeveloped Regions: Growing access in Asia, Latin America, and Eastern Europe, where oncology markets are expanding.
• Strategic Partnerships and Licensing: Collaborations with global pharma entities could unlock rapid distribution channels and localized manufacturing, boosting revenues.
• Digital Health Integration: Incorporating patient monitoring and adherence tools may enhance outcomes and foster brand loyalty.

Market Risks and Challenges

• Competitive Intensity: Dominance of existing agents necessitates differentiation through clinical outcomes and logistical advantages.
• Pricing Pressures: Payers’ push for cost containment may limit pricing flexibility.
• Regulatory Hurdles: Additional approvals or label extensions could modulate market scope.
• Clinical Data Emergence: Ongoing studies might reveal safety or efficacy concerns, influencing prescribing habits.

Conclusion

AURYXIA’s market and financial prospects revolve around its clinical efficacy, delivery modality, and strategic positioning within supportive cancer care. While the competitive landscape presents challenges, its intravenous formulation addresses key unmet needs, promising steady revenue growth driven by expanding indications, market acceptance, and global expansion.

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Key Takeaways

• Strategic Differentiation: AURYXIA’s IV administration supports its role as a convenient, effective antiemetic, offering a competitive edge.
• Market Growth Drivers: Clinical validation, guideline endorsement, and reimbursement coding are core to expanding its market share.
• Revenue Potential: Projected to grow steadily with early adoption critical in oncology centers, reaching mature sales within 3-5 years.
• Risks to Watch: Competitive pressures, pricing negotiations, and regulatory developments could impact profitability.
• Expansion Opportunities: Broader indication approvals and global market penetration are essential for long-term financial success.

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FAQs

1. What distinguishes AURYXIA from other NK1 receptor antagonists?
   Its intravenous formulation allows for rapid, once-per-cycle dosing, enhancing convenience and compliance relative to oral alternatives.

2. In which markets is AURYXIA currently approved?
   Primarily in the U.S., with anticipated regulatory submissions underway in the EU and other regions during 2023–2024.

3. How does reimbursement influence AURYXIA’s market penetration?
   Favorable reimbursement policies enable broader access and adoption, especially when aligned with existing chemotherapy funding structures.

4. What are the main barriers to its widespread adoption?
   Established competitors, pricing negotiations, and physician familiarity with existing regimens may slow uptake.

5. What future developments could accelerate AURYXIA’s market growth?
   Expanded indications, evidence of superior efficacy, global market expansion, and strategic alliances will positively impact its financial trajectory.

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Sources:
[1] FDA Label for Fosaprepitant Dimeglumine, 2022.
[2] Market analysis reports by GlobalData and IQVIA, 2023.
[3] Oncology supportive care guidelines by ASCO, 2022.