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Last Updated: December 11, 2025

Iron sucrose - Generic Drug Details


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What are the generic sources for iron sucrose and what is the scope of patent protection?

Iron sucrose is the generic ingredient in two branded drugs marketed by Intl Medication Sys, Mylan Labs Ltd, Sandoz, and Am Regent, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for iron sucrose. Six suppliers are listed for this compound.

Summary for iron sucrose
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 13
Finished Product Suppliers / Packagers: 6
Clinical Trials: 179
Patent Applications: 1,751
What excipients (inactive ingredients) are in iron sucrose?iron sucrose excipients list
DailyMed Link:iron sucrose at DailyMed
Recent Clinical Trials for iron sucrose

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San DiegoPHASE2
Regeneron PharmaceuticalsPHASE2
Regeneron PharmaceuticalsPHASE4

See all iron sucrose clinical trials

Pharmacology for iron sucrose

US Patents and Regulatory Information for iron sucrose

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intl Medication Sys IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977-001 Aug 8, 2025 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-002 Mar 20, 2005 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-001 Nov 6, 2000 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212340-001 Aug 8, 2025 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-003 Mar 29, 2005 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mylan Labs Ltd IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212559-002 Aug 8, 2025 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Iron Sucrose: A Comprehensive Analysis

Last updated: October 6, 2025


Introduction

Iron sucrose, an injectable iron preparation, plays a pivotal role in managing iron deficiency anemia, particularly among patients with chronic kidney disease (CKD). As the global burden of anemia rises alongside advancements in healthcare, understanding the market dynamics and financial trajectory of iron sucrose becomes essential for pharmaceutical companies, investors, and healthcare policymakers. This analysis explores the key drivers, market restraints, emerging trends, and financial forecasts shaping the future of iron sucrose.


Market Overview

Iron sucrose is a complex iron carbohydrate used intravenously to replenish iron stores in various clinical scenarios. Its convenience and efficacy in patients intolerant to oral iron derivatives have cemented its position in nephrology and hematology markets. The global market for iron sucrose was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.5% from 2023 to 2030[1].

The primary revenue streams for iron sucrose are concentrated in North America, Europe, and Asia-Pacific, with emerging markets showing accelerated growth due to increasing prevalence of CKD and expanded access to intravenous therapies.


Market Dynamics

Key Drivers

1. Rising Prevalence of Chronic Kidney Disease and Anemia

The escalating incidence of CKD globally is a principal market driver. According to the Global Burden of Disease study, CKD affects over 840 million individuals worldwide, with many developing anemia as a complication[2]. Iron sucrose remains a preferred management therapy, especially in dialysis-dependent patients requiring rapid iron replenishment.

2. Advancements in Dialysis and Hemodialysis Services

Expansion and modernization of dialysis centers, especially in emerging economies, facilitate increased administration of intravenous iron therapies. The increased frequency of dialysis treatments correlates with higher iron sucrose prescriptions.

3. Patient Preference for Parenteral Iron Therapy

Enhanced formulations of iron sucrose with improved safety and tolerability profiles favor patient compliance. Parenteral iron therapies bypass absorption hurdles and reduce side effects associated with oral iron, increasing demand among diverse patient populations.

4. Regulatory Approvals and Reimbursement Policies

Regulatory granting of generic versions and biosimilars of iron sucrose, coupled with supportive reimbursement policies in developed markets, bolster market penetration. These factors lower costs and expand access, fueling growth.

5. Expansion into New Clinical Indications

Recent studies have explored iron sucrose's benefits beyond CKD, including anemia of chronic disease, postpartum anemia, and chemotherapy-induced anemia. Market expansion into these indications offers revenue diversification.

Market Restraints

1. Competition From Alternative Iron Therapies

The market faces competition from other intravenous iron formulations such as ferric carboxymaltose, ferric derisomaltose, and iron dextran, which offer differing dosing regimens and safety profiles. The emergence of newer agents challenges iron sucrose's market share.

2. Safety Concerns and Adverse Events

Though generally well-tolerated, iron sucrose administration carries risks like hypersensitivity reactions, iron overload, and cardiovascular events. Concerns over safety influence clinician prescribing habits.

3. Cost and Accessibility in Emerging Markets

Price sensitivity and limited healthcare infrastructure pose barriers to widespread adoption in developing regions, restraining growth.

4. Stringent Regulatory Environment

Evolving regulations and the need for continuous post-marketing surveillance can delay product approvals and prompt discontinuations, impacting revenue flow.


Emerging Trends Impacting Financial Trajectory

1. Biosimilar and Generic Entrants

The expiration of patents has spurred development of biosimilars, intensifying price competition. For example, companies like Fresenius Kabi and Dr. Reddy's Laboratories have launched biosimilar iron sucrose products, leading to decreased average selling prices (ASPs) and margins.

2. Innovation in Formulation and Delivery

Next-generation formulations offering higher doses per infusion, shorter administration times, and improved safety profiles could redefine market dynamics. These innovations attract a broader patient base and bolster revenue streams.

3. Integration of Digital Health

Adoption of electronic health records and telemedicine facilitates more targeted and timely iron therapy administration, expanding patient reach.

4. Strategic Partnerships and Market Entries

Pharmaceutical firms are engaging in collaborations with healthcare providers and expanding distribution networks, particularly in emerging economies, to maximize market penetration.


Financial Trajectory and Market Forecast

Analyzing historical data, the iron sucrose market demonstrated steady growth driven by CKD prevalence, with revenues expanding approximately 8% annually between 2017 and 2022. Projecting forward, market expansion will be influenced by factors such as demographic shifts, technological advancements, and competitive pressures.

Forecasts estimate that revenues will reach USD 2.3 billion by 2030, reflecting a CAGR of 7.5%. The Asian-Pacific region is expected to demonstrate the fastest growth rate, driven by increasing CKD burden and expanding healthcare infrastructure.

Profit margins are also anticipated to fluctuate due to biosimilar competition and pricing pressures. Gross margins may compress by 2-4% over the next five years, necessitating strategic differentiation through formulation innovations.

Investment in R&D will be pivotal in maintaining competitive advantage, focusing on developing higher-dose formulations and safer administration protocols.


Regulatory and Reimbursement Outlook

Regulatory agencies globally are standardizing pathways for biosimilars, which could streamline approvals and facilitate market entry. Conversely, reimbursement landscape shifts—particularly in Medicare and Medicaid—may influence prescribing patterns, necessitating adaptive commercialization strategies.


Conclusion

The market for iron sucrose exhibits resilient growth prospects anchored by high disease prevalence and clinical utility. However, intensified competition, safety considerations, and pricing dynamics present ongoing challenges. Companies that innovate with safer, more efficient formulations and capitalize on emerging markets will likely realize favorable financial trajectories.


Key Takeaways

  • Demand drivers: The expanding burden of CKD and anemia globally sustains steady growth for iron sucrose.
  • Competitive pressure: Biosimilars and alternative therapies are exerting downward price and margin pressures.
  • Innovation focus: Developing high-dose, safer formulations can strengthen market position.
  • Market expansion: Emerging economies and new indications offer significant revenue opportunities.
  • Regulatory landscape: Evolving regulations can both facilitate and challenge market access, requiring agile strategies.

FAQs

1. What factors contribute most to the growth of the iron sucrose market?
The primary growth drivers include the escalating prevalence of CKD and anemia, advances in dialysis infrastructure, and patient preferences for intravenous therapy over oral iron options.

2. How do biosimilars impact iron sucrose’s profitability?
Biosimilars increase market competition, often leading to reduced prices and margins. While they expand access, they pressure innovator companies to optimize formulations and operational efficiencies.

3. Are there significant safety concerns associated with iron sucrose?
While generally safe, adverse reactions like hypersensitivity and iron overload are possible. Proper patient screening and monitoring are essential to mitigate risks.

4. What emerging markets present the greatest opportunities for iron sucrose?
Asia-Pacific and Latin America are poised for rapid growth, propelled by rising CKD prevalence and expanding healthcare infrastructure.

5. What strategic approaches can companies adopt to maximize revenue from iron sucrose?
Innovating with high-dose, safe formulations, expanding indications, establishing strategic partnerships, and tailoring offerings to emerging markets are vital.


Sources

[1] MarketWatch. Iron Sucrose Market Size, Share & Trends Analysis Report. 2022.
[2] Global Burden of Disease Study 2019. CKD and Anemia statistics.

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