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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 fourteen patents protecting this drug.

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. One supplier is listed for this compound. Additional details are available on the ferric citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Auryxia

There have been six 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:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	9
Patent Applications:	552
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
Akebia Therapeutics	Phase 3
USRC Kidney Research	Phase 3
Akebia Therapeutics Inc.	Phase 4

See all AURYXIA clinical trials

Pharmacology for AURYXIA

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

US Patents and Regulatory Information for AURYXIA

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

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I697340
European Patent Office	1601680	PROCEDES DE FABRICATION DES COMPOSES ORGANIQUES FERRIQUES (METHODS OF MAKING FERRIC ORGANIC COMPOUNDS)
Canada	2272711	PROCEDES DE TRAITEMENT DE L'INSUFFISANCE RENALE (METHOD FOR TREATING RENAL FAILURE)
Japan	6154226
South Korea	20120046753	FERRIC CITRATE DOSAGE FORMS
Germany	69738824
Mexico	2008002360	COMPUESTOS ORGANICOS FERRICOS GRADO FARMACEUTICO, USO DE LOS MISMOS Y METODOS PARA ELABORAR LOS MISMOS. (PHARMACEUTICAL-GRADE FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME.)

AURYXIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Auryxia

Introduction

Auryxia, a ferric citrate medication developed by Akebia Therapeutics, is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis and to treat iron deficiency anemia in patients with CKD not on dialysis. Here, we delve into the market dynamics and financial trajectory of Auryxia, highlighting key milestones, revenue trends, and future outlook.

Market Context

The phosphate binder market, where Auryxia operates, has been impacted by several factors, including COVID-19 and dialysis staffing issues. Despite these challenges, Auryxia has shown resilience and growth.

Revenue Performance

2022 Financial Highlights

In 2022, Auryxia achieved significant revenue growth, with net product revenues reaching $177.1 million, a 24.5% increase compared to 2021. This growth was driven by the drug's increasing adoption and market share in the phosphate binder segment[1].

2023 Financial Performance

For 2023, Akebia reported Auryxia net product revenues of $170.3 million, which was within the company's guidance range of $170-$175 million. This performance was slightly lower than the previous year but still robust given the market conditions[2].

2024 Financial Outlook

In the first quarter of 2024, Auryxia net product revenues were $31.0 million. Despite a slight decrease in the second quarter of 2024 to $41.2 million compared to the same period in 2023, Akebia expects Auryxia full-year 2024 net product revenues to be in line with 2023 levels. The company is optimistic about future growth, particularly with the anticipated inclusion of phosphate binders in the Centers for Medicare and Medicaid Services (CMS) dialysis bundle in January 2025[4][5].

Cost Management and Operational Efficiency

Akebia has implemented several initiatives to reduce costs and enhance operational efficiency. These include restructuring and simplifying the Auryxia supply chain, which is expected to save significant cash over a five-year period. The company has also been mindful of non-essential spending and has worked to reduce overall costs, contributing to a more stable financial position[1].

Regulatory and Market Expansion

European Market

Akebia signed a European license agreement with Averoa SAS for the development and commercialization of Auryxia in Europe. Additionally, the company regained the rights for vadadustat (another key drug) from Otsuka Pharmaceutical Co. Ltd. in several territories, including the U.S., Europe, and others. This move is expected to expand Akebia's global footprint and revenue potential[1].

FDA and Regulatory Updates

Akebia completed an End of Dispute Type A meeting with the FDA to discuss the resubmission of its New Drug Application (NDA) for vadadustat. The company plans to resubmit the NDA by the end of the quarter, with a potential PDUFA date projected in March 2024. This development could further bolster Akebia's revenue streams once vadadustat is approved[3].

Financial Guidance and Cash Position

Akebia has set a cautious yet optimistic financial guidance for Auryxia. For 2023, the company reaffirmed its revenue guidance of $175-$180 million, despite the contracting phosphate binder market. The cash position of the company is stable, with sufficient funds to support operations for at least the next two years, including investments in the Vafseo (vadadustat) launch expected in 2025[4].

Impact of Market Dynamics

Phosphate Binder Market

The phosphate binder market continues to face challenges, including a modest contraction due to COVID-19 and dialysis staffing issues. However, Akebia's commercial organization is actively engaged in contracting efforts with dialysis organizations to ensure broad access to Auryxia, especially with the upcoming inclusion in the CMS dialysis bundle[4][5].

Competitive Landscape

Auryxia operates in a competitive market, but its unique positioning and clinical benefits have helped it maintain market share. The drug's ability to address both hyperphosphatemia and iron deficiency anemia in CKD patients sets it apart from other phosphate binders.

Future Outlook

Akebia is poised for significant growth with several upcoming milestones:

• Vafseo Launch: The potential approval and launch of Vafseo in Europe and other territories could significantly boost revenue.
• CMS Dialysis Bundle: The inclusion of phosphate binders in the CMS dialysis bundle in January 2025 is expected to enhance Auryxia's market access and revenue.
• Cost Management: Continued cost reduction initiatives and operational efficiencies will help maintain a stable financial position.

Key Takeaways

• Revenue Growth: Auryxia has demonstrated consistent revenue growth, with a 24.5% increase in 2022 and stable performance in 2023.
• Cost Management: Akebia has implemented various cost-saving initiatives to enhance operational efficiency.
• Regulatory Milestones: The company is nearing key regulatory milestones, including the potential approval of Vafseo.
• Market Expansion: Auryxia's market reach is set to expand with European licensing agreements and the anticipated inclusion in the CMS dialysis bundle.
• Financial Stability: Akebia's cash position is stable, ensuring sufficient funds for operations and future investments.

FAQs

Q: What is Auryxia used for? Auryxia is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis and to treat iron deficiency anemia in patients with CKD not on dialysis.

Q: How has Auryxia's revenue performed in recent years? Auryxia's revenue has shown significant growth, with a 24.5% increase in 2022 to $177.1 million, followed by stable performance in 2023 with revenues of $170.3 million.

Q: What are the key regulatory milestones for Akebia? Akebia is nearing the resubmission of its NDA for vadadustat and anticipates potential Marketing Authorization for Vafseo in Europe. The company also expects the inclusion of phosphate binders in the CMS dialysis bundle in January 2025.

Q: How is Akebia managing costs and operational efficiency? Akebia has implemented several cost-saving initiatives, including restructuring and simplifying the Auryxia supply chain, and has been mindful of non-essential spending to reduce overall costs.

Q: What is the outlook for Auryxia's future revenue? Akebia expects Auryxia full-year 2024 net product revenues to be in line with 2023 levels, with potential growth driven by the inclusion in the CMS dialysis bundle and the launch of Vafseo.

Sources

1. Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights - PR Newswire
2. Akebia Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results - Akebia Therapeutics
3. Akebia Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights - PR Newswire
4. Akebia Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights - BioSpace
5. Akebia Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights - PR Newswire