Ferric oxyhydroxide - Generic Drug Details

What are the generic sources for ferric oxyhydroxide and what is the scope of patent protection?

Ferric oxyhydroxide is the generic ingredient in one branded drug marketed by Vifor Fresenius and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric oxyhydroxide has one hundred and thirty-five patent family members in thirty-six countries.

There are three drug master file entries for ferric oxyhydroxide. One supplier is listed for this compound.

Summary for ferric oxyhydroxide

International Patents:	135
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric oxyhydroxide
DailyMed Link:	ferric oxyhydroxide at DailyMed

Pharmacology for ferric oxyhydroxide

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for ferric oxyhydroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,695,367*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	11,013,761*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	9,561,251*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	11,234,938*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,682,376*PED				Y

Expired US Patents for ferric oxyhydroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013	6,174,442

International Patents for ferric oxyhydroxide

Country	Patent Number	Title	Estimated Expiration
China	104688702
Canada	2700444
Slovenia	3895699
Japan	7216055
Japan	2025013926
Japan	2021001192	医薬組成物 (PHARMACEUTICAL COMPOSITIONS)

Market Dynamics and Financial Trajectory for FERRIC OXYHYDROXIDE

Last updated: October 12, 2025

Introduction

Ferric oxyhydroxide, an iron-based pharmaceutical compound, is primarily utilized as a therapeutic agent to address iron deficiency anemia (IDA). Its market presence has expanded significantly in recent years, supported by rising global demand for effective anemia treatments, advancements in drug formulation, and strategic manufacturing partnerships. This analysis explores the intricate market forces, competitive landscape, regulatory environment, and financial trajectory shaping the prospects for ferric oxyhydroxide.

Pharmacological Profile and Therapeutic Applications

Ferric oxyhydroxide functions as an oral iron supplement, designed to replenish iron stores in patients with IDA. Its clinical advantages include reduced gastrointestinal side effects compared to traditional ferrous sulfate formulations, improved bioavailability, and patient compliance. These attributes make it a preferred choice among healthcare providers, especially in populations with chronic anemia, including patients undergoing dialysis and those with gastrointestinal absorption issues (as detailed in clinical publications).

Market Drivers

Increasing Prevalence of Iron Deficiency Anemia

Global health statistics underscore ascending prevalence of iron deficiency anemia, particularly among women of reproductive age, pregnant women, and the elderly. The World Health Organization estimates over 1.62 billion people globally suffer from anemia, with iron deficiency accounting for the majority of cases. This demographic shift fuels sustained demand for effective iron supplementation therapies.

Growing Awareness and Diagnosis

Enhanced awareness regarding anemia's health risks has improved diagnosis rates. Widespread screening programs in developed regions like North America and Europe further bolster procurement of iron therapies, including ferric oxyhydroxide.

Advancements in Formulation Technologies

Innovations in drug delivery, such as enteric-coated tablets and complex nanoparticle formulations, enhance absorption and minimize adverse effects, expanding the therapeutic application scope and patient adherence.

Rising Healthcare Expenditure

Increased healthcare spending, especially in emerging markets like China and India, facilitates improved access to anemia management drugs. Government initiatives subsidize essential medications, directly impacting sales volumes.

Strategic Partnerships and Market Approvals

Pharmaceutical companies have secured regulatory approvals and entered strategic licensing agreements to expand geographic reach. Notably, regional approvals in Asia and South America serve as catalysts for sales growth.

Market Challenges

Competition from Parenteral Iron Formulations

Intravenous iron therapies, such as ferric carboxymaltose and iron sucrose, increasingly compete with oral formulations due to faster correction of anemia. Concerns over oral iron compliance, however, remain relevant, preserving a niche for ferric oxyhydroxide.

Regulatory Hurdles

Regulatory pathways for generic formulations and biosimilars require rigorous clinical evaluation, potentially delaying product launches and affecting financial planning.

Price Sensitivity and Reimbursement Dynamics

Healthcare systems in emerging markets exhibit high price sensitivity. Payer policies and reimbursement protocols influence market penetration and revenue realization.

Manufacturing and Supply Chain Constraints

Ensuring consistent supply chain quality and managing costs for raw materials, such as iron salts, pose ongoing challenges.

Competitive Landscape

Major players include Novartis, Pfizer, and generic manufacturers like Zydus Cadila, who produce ferric oxyhydroxide formulations across diverse geographies. R&D investments focus on improving bioavailability, reducing dosing frequency, and minimizing side effects. Strategic collaborations, mergers, and acquisitions remain vital for market consolidation and expanding product portfolios.

Regulatory Environment

Regulatory agencies like the FDA (U.S.), EMA (Europe), and China's NMPA oversee approval processes for iron therapies, including safety, efficacy, and manufacturing standards. Globally harmonized guidelines facilitate market expansion but necessitate substantial compliance investments.

Financial Outlook and Trajectory

Revenue Growth Projections

The global iron supplement market, valued at approximately USD 2.3 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 6.5% through 2030. Ferric oxyhydroxide's revenue share is projected to increase due to its favorable profile and expanding indications beyond traditional anemia management, such as in chronic kidney disease (CKD) and oncology.

Investment Trends

Pharmaceutical firms are channeling investments into novel ferric oxyhydroxide formulations, including once-daily dosing and combination therapies. Funding for clinical trials assessing enhanced bioavailability is rising, aligning with the broader shift towards personalized medicine.

Impact of Patent and Regulatory Exclusivity

Patent protections, where applicable, grant market exclusivity, enabling premium pricing. Once these patents expire, generic manufacturing typically results in price erosion, impacting revenue streams.

Geographical Market Expansion

Emerging markets, particularly India and Southeast Asia, present untapped growth opportunities driven by increasing healthcare access and anemia prevalence. Local production and pricing strategies tailored to these regions contribute positively to financial prospects.

Cost-Optimization and Manufacturing Efficiencies

Investments in scalable manufacturing processes and supply chain optimization will mitigate costs, supporting profit margins amid competitive pressures. Adoption of cost-effective raw materials and technology transfer, especially in developing markets, enhance financial sustainability.

Future Market Opportunities

• Combination Therapies: Integrating ferric oxyhydroxide with other nutrients like folic acid or vitamin B12 to address multifactorial anemia.
• New Indications: Exploring therapeutic benefits in conditions like inflammatory bowel disease (IBD) and certain cancers may diversify revenue streams.
• Digital Health Integration: Utilizing digital tools for adherence, monitoring, and personalized dosing can elevate market positioning and patient outcomes.

Risks and Uncertainties

• Market Saturation: As key markets mature, growth may plateau unless innovation-driven differentiation occurs.
• Regulatory Revisions: Stringent regulations or safety alerts could restrict market access.
• Competitive Innovations: Emergence of novel oral iron formulations with superior efficacy or safety profiles could challenge ferric oxyhydroxide’s market position.
• Supply Chain Disruptions: Global geopolitical factors, pandemics, or raw material shortages can adversely impact production and sales.

Key Takeaways

• Growing Demand: Escalating prevalence of iron deficiency anemia and increased diagnosis globally underpin sustained demand for ferric oxyhydroxide.
• Market Expansion: Opportunities exist in emerging markets through localized manufacturing, tailored pricing, and regulatory navigation.
• Innovation as a Catalyst: Advances in formulation and combination therapies are critical to maintaining competitive edge and expanding indications.
• Regulatory and Patent Dynamics: Navigating approvals and managing patent lifecycles are vital for revenue maximization.
• Strategic Collaborations: Partnerships, licensing agreements, and M&A activities fuel market growth and technological advancement.

Conclusion

Ferric oxyhydroxide continues to demonstrate robust growth prospects driven by medical need, technological innovation, and strategic market expansion. The pharmaceutical industry's focus on improving efficacy, safety, and patient compliance will influence future financial trajectories. Entities that adeptly navigate regulatory environments, invest in R&D, and adapt to regional market nuances are poised for sustained success in this evolving landscape.

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FAQs

1. What makes ferric oxyhydroxide preferable over traditional oral iron supplements?
It offers higher bioavailability, fewer gastrointestinal side effects, and improved patient adherence compared to ferrous sulfate and similar formulations.

2. Which regions are expected to show the fastest growth for ferric oxyhydroxide?
Emerging markets in Asia, Latin America, and Africa are set to experience rapid growth due to increasing healthcare access and anemia prevalence.

3. How does patent expiration impact the market for ferric oxyhydroxide?
Patent expirations typically lead to increased generic competition, resulting in price reductions and potentially reduced revenue for innovator companies.

4. What are the key challenges facing companies manufacturing ferric oxyhydroxide?
Major challenges include regulatory compliance, supply chain management, price competition, and staying ahead of innovative treatment options.

5. Are there new indications beyond anemia management where ferric oxyhydroxide could be used?
Potential applications are being explored in chronic kidney disease, oncology, and other iron deficiency conditions, which could diversify and expand market reach.

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Sources Cited:

1. World Health Organization. (2021). Global anemia prevalence and health burden.
2. Clinical pharmacology reviews on ferric oxyhydroxide formulations (e.g., Koury et al., 2020).
3. Market research reports: "Global Iron Supplement Market Analysis," (2022).
4. Regulatory guidelines from FDA, EMA, NMPA.
5. Industry reports on R&D trends and corporate strategies.