FERRIC CITRATE - Generic Drug Details

What are the generic sources for ferric citrate and what is the scope of freedom to operate?

Ferric citrate is the generic ingredient in one branded drug marketed by Keryx Biopharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and twenty-two patent family members in twenty-three countries.

There are six drug master file entries for ferric citrate. One supplier is listed for this compound.

Summary for FERRIC CITRATE

International Patents:	122
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	34
Patent Applications:	2,751
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERRIC CITRATE
What excipients (inactive ingredients) are in FERRIC CITRATE?	FERRIC CITRATE excipients list
DailyMed Link:	FERRIC CITRATE at DailyMed

Recent Clinical Trials for FERRIC CITRATE

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 FERRIC CITRATE clinical trials

Pharmacology for FERRIC CITRATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FERRIC CITRATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for FERRIC CITRATE

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	8,338,642		Y	Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	8,754,258		Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	8,754,257		Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	9,328,133		Y	Y
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	7,767,851		Y	Y

Expired US Patents for FERRIC CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	5,753,706
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	9,050,316
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	8,754,257

International Patents for FERRIC CITRATE

Country	Patent Number	Title	Estimated Expiration
Spain	2539635
China	102573807	Ferric citrate dosage forms
Portugal	1601680
Japan	2006518391
South Korea	20140016438	FERRIC CITRATE DOSAGE FORMS
Spain	2699447

FERRIC CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ferric Citrate

Market Size and Growth Projections

The ferric citrate market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 1.82 billion and is projected to reach USD 2.08 billion in 2024. By 2032, the market is expected to expand to USD 6.15 billion, representing a Compound Annual Growth Rate (CAGR) of 14.5% during the forecast period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the ferric citrate market:

Increasing Prevalence of Chronic Kidney Disease (CKD)

The rising prevalence of CKD worldwide, particularly among aging populations, is a primary driver. CKD patients often require effective phosphate binders like ferric citrate to manage hyperphosphatemia, a common complication of the disease[1].

Advancements in Healthcare Infrastructure

The expansion of advanced healthcare systems in emerging economies is bolstering market growth. Countries such as India, China, and Brazil are seeing increased healthcare spending and improved access to medical treatments, which is driving the demand for ferric citrate[1].

Regulatory Approvals and New Formulations

Regulatory approvals for new ferric citrate formulations and the development of more targeted treatment options are also significant drivers. For instance, the FDA approval of Auryxia (ferric citrate) for treating iron deficiency anemia in CKD patients not on dialysis has expanded the market reach[2].

Market Trends

The ferric citrate market is witnessing several notable trends:

Shift Towards Personalized Medicine

There is an increasing shift towards personalized medicine, with healthcare providers moving towards more individualized treatment regimens. This trend is particularly evident in developed countries, where tailored care is becoming more common[1].

Preference for Patient-Friendly Treatments

There is a growing preference for treatments with fewer side effects. Ferric citrate, with its lower incidence of gastrointestinal side effects compared to traditional phosphate binders, is becoming a more attractive option for CKD patients[1].

Regional Outlook

The regional dynamics of the ferric citrate market vary significantly:

North America and Europe

These regions dominate the market due to their well-established healthcare infrastructure and high demand for effective phosphate binders. The FDA approval of Auryxia in the U.S. has been a significant factor in this region's market growth[1].

Emerging Markets

Asia-Pacific and the Middle East & Africa are expected to experience rapid growth. Increasing healthcare spending, the rising prevalence of chronic diseases, and improving access to advanced medical treatments are driving this growth. Companies are focusing on expanding their market presence in these regions[1].

Financial Performance and Revenue Projections

The financial performance of ferric citrate is robust and growing:

Revenue from Auryxia

Akebia Therapeutics reported net product revenues of $31.0 million from Auryxia (ferric citrate) in the first quarter of 2024. The company expects continued revenue growth from Auryxia in 2024 compared to 2023[3].

Market Expansion and Investments

Companies are investing heavily in the development of new formulations and expanding their distribution networks. These investments are expected to drive innovation and fuel market expansion. For example, Akebia is accelerating contracting discussions with dialysis organizations to ensure broad access to Auryxia[3].

Market Opportunities

The ferric citrate market presents several opportunities for growth:

Development of New Formulations

There is a significant opportunity in developing new formulations or combination therapies that could enhance the effectiveness of ferric citrate in managing CKD. Improving the bioavailability of ferric citrate is a key focus area for pharmaceutical companies[1].

Emerging Markets

The growing healthcare standards and increased healthcare expenditure in emerging markets such as India, China, and Brazil offer new avenues for ferric citrate adoption[1].

Applications Beyond CKD Treatment

Ferric citrate has applications beyond CKD treatment, such as in the food industry as a food additive and in iron supplementation. These additional uses provide further growth opportunities[1].

Challenges and Risks

While the market outlook is positive, there are challenges and risks to consider:

Regulatory Scrutiny

Regulatory bodies are scrutinizing new indications and formulations closely. For instance, there have been requests for additional clinical studies to ensure the long-term safety of ferric citrate for new indications[5].

Market Competition

The market for phosphate binders is competitive, with other products like Velphoro® (sucroferric oxyhydroxide) also vying for market share. Companies must navigate this competitive landscape to maintain and expand their market presence[5].

Key Takeaways

• The ferric citrate market is projected to grow significantly, driven by the increasing prevalence of CKD and advancements in healthcare infrastructure.
• Regulatory approvals and the development of new formulations are key drivers of market growth.
• The market is shifting towards personalized medicine and patient-friendly treatments with fewer side effects.
• Emerging markets in Asia-Pacific and the Middle East & Africa offer significant growth opportunities.
• Companies are investing in new formulations and expanding their distribution networks to drive innovation and market expansion.

FAQs

What is the current market size of the ferric citrate market?

The ferric citrate market was valued at USD 1.82 billion in 2023 and is projected to reach USD 2.08 billion in 2024[1].

What is the expected CAGR of the ferric citrate market from 2024 to 2032?

The ferric citrate market is expected to grow at a CAGR of 14.5% from 2024 to 2032[1].

What are the primary drivers of the ferric citrate market growth?

The primary drivers include the increasing prevalence of CKD, advancements in healthcare infrastructure, and regulatory approvals for new formulations[1].

Which regions are expected to experience rapid growth in the ferric citrate market?

Asia-Pacific and the Middle East & Africa are expected to experience rapid growth due to increasing healthcare spending and improving access to advanced medical treatments[1].

What are some of the new opportunities for ferric citrate beyond CKD treatment?

Ferric citrate has applications in the food industry as a food additive and in iron supplementation, providing additional growth opportunities[1].

Cited Sources:

1. Global Growth Insights: Ferric Citrate Market Latest Size, Forecast to 2032.
2. BioSpace: U.S. FDA Approves Keryx Biopharma's Auryxia (ferric citrate) Tablets.
3. BioSpace: Akebia Therapeutics Reports First Quarter 2024 Financial Results.
4. News Channel Nebraska: Ammonium Ferric Citrate Market 2024 Share Global Comprehensive Research Study.
5. Regulations.gov: Citizen Petition re: Supplemental NDA for Auryxia (ferric citrate).