ACCRUFER Drug Patent Profile

Which patents cover Accrufer, and when can generic versions of Accrufer launch?

Accrufer is a drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-one patent family members in nineteen countries.

The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.

DrugPatentWatch^® Generic Entry Outlook for Accrufer

Accrufer was eligible for patent challenges on July 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ACCRUFER

International Patents:	51
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for ACCRUFER
What excipients (inactive ingredients) are in ACCRUFER?	ACCRUFER excipients list
DailyMed Link:	ACCRUFER at DailyMed

See drug prices for ACCRUFER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACCRUFER

NDA:

212320

Dosage:

CAPSULE;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 ACCRUFER

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

Sponsor	Phase
Shield Therapeutics	Phase 1

See all ACCRUFER clinical trials

Pharmacology for ACCRUFER

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

US Patents and Regulatory Information for ACCRUFER

ACCRUFER is protected by three US patents.

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
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes			Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for ACCRUFER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Norgine B.V.	Feraccru	ferric maltol	EMEA/H/C/002733Feraccru is indicated in adults for the treatment of iron deficiency.	Authorised	no	no	no	2016-02-18

International Patents for ACCRUFER

When does loss-of-exclusivity occur for ACCRUFER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Poland

Saudi Arabia

Singapore

South Africa

South Korea

Spain

United Kingdom

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 ACCRUFER around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009247762	Mono ( iron hydroxypyrone ) and combination ( iron hydroxypyrone and GI inflammation inhibiting agents ) compositions for anaemia or H. pylori infections
World Intellectual Property Organization (WIPO)	2015101971
European Patent Office	3160951	FORMES CRISTALLINES DE MALTOL FERRIQUE (CRYSTALLINE FORMS OF FERRIC MALTOL)
Slovenia	3091974
Chile	2017001030	Formas cristalinas de maltol férrico
South Korea	20160105499	철 트리말톨의 복용량 양생법 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
Japan	2015083572	鉄ヒドロキシピロンを含む薬剤組成物 (PHARMACEUTICAL COMPOSITION COMPRISING IRON HYDROXYPYRONE)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACCRUFER

Last updated: July 28, 2025

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Introduction

ACCRUFER (ferric carboxymaltose) is an intravenously administered iron formulation approved for treating iron deficiency anemia (IDA) across various clinical settings. Since its market entry, ACCRUFER has gained traction owing to its superior safety profile and efficiency compared to traditional oral iron therapies. This analysis examines the current market dynamics and financial trajectory of ACCRUFER, considering factors such as competitive landscape, regulatory environment, clinical adoption, and economic impact.

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Market Overview and Epidemiological Drivers

The global prevalence of iron deficiency anemia remains significant, affecting approximately 1.6 billion people worldwide, with higher incidences in geriatric populations, pregnant women, and chronic disease patients (WHO, 2020). The rising prevalence directly fuels demand for effective iron supplementation therapies like ACCRUFER.

The expansion of healthcare infrastructure, particularly in emerging markets, enhances access to intravenous iron therapies. Additionally, clinical guidelines now favor IV iron over oral formulations in cases of malabsorption, intolerance, or severe deficiency, bolstering demand for ACCRUFER.

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Regulatory Status and Market Penetration

ACCRUFER obtained FDA approval in 2013 and has since received regulatory clearance across multiple jurisdictions, including the European Union and Japan. Its approval for indications such as iron deficiency anemia in adult patients with chronic kidney disease (CKD) has stimulated growth, especially within nephrology.

Despite its established safety profile and efficacy, ACCRUFER faces competition from other IV iron formulations like Ferrlecit (sodium ferric gluconate), Venofer (iron sucrose), and newer agents such as Ferrimix and Monoferric. The competitive landscape is further shaped by regulatory hurdles, reimbursement policies, and clinician prescribing preferences.

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Market Dynamics

Competitive Landscape

ACCRUFER's unique formulation—ferric carboxymaltose—offers rapid infusion times, high total dose convenience, and lower rates of hypersensitivity reactions relative to older agents. These advantages have facilitated its adoption in busy clinical settings, notably in outpatient clinics and hospitals.

Yet, each competing IV iron agent differs in dosing protocols and safety profiles. For instance, Ferrabi (ferric carboxymaltose in Europe) emphasizes high-dose, single-visit administration; similar to ACCRUFER’s profile, resulting in competitive pressure. Conversely, some formulations have newer formulations or cost advantages that influence physicians' choices.

Market Segmentation

The key segments for ACCRUFER include:

• Chronic Kidney Disease (CKD): Dialysis and non-dialysis CKD patients represent a major segment, driven by high iron deficiency prevalence.
• Oncology: Chemotherapy-associated anemia management incorporates IV iron therapy, with ACCRUFER gaining influence.
• Gastroenterology: Patients with malabsorption or intolerance to oral iron benefit from ACCRUFER’s intravenous route.
• Obstetrics and Gynecology: Pregnant women with severe anemia are increasingly prescribed ACCRUFER due to safety and efficacy data.

Clinical Adoption and Prescribing Trends

Clinical guidelines endorse IV iron therapy, notably after the AFFIRM-AHF trial demonstrated clinical benefits in heart failure patients with iron deficiency (Packer et al., 2020). Such evidence bolsters ACCRUFER’s credibility, leading to increased prescriptions.

Hospital formularies and outpatient infusion centers favor agents with shorter administration times and cost-effectiveness, both strengths of ACCRUFER. Physician familiarity and patient preference further influence market penetration.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since launch, ACCRUFER’s revenues have exhibited steady growth, driven by increased adoption in key segments. Reports estimate that global sales of ferric carboxymaltose, primarily led by ACCRUFER and European counterparts, reached approximately USD 930 million in 2022, with ACCRUFER accounting for over 50% of this market [1].

Forecasted Growth Factors

• Market Expansion: Rising prevalence of IDA, especially in aging populations and chronic disease cohorts.
• Geographic Penetration: Expanding into emerging markets with increasing healthcare investment and regulatory approvals.
• Clinical Evidence: Ongoing studies demonstrating superiority or non-inferiority to alternative therapies reassure clinicians.
• Reimbursement Dynamics: Favorable reimbursement policies in large markets like the US and Europe enhance affordability and access.

Industry analysts project a compound annual growth rate (CAGR) of approximately 8-10% for ferric carboxymaltose globally over the next five years, driven mainly by the increasing burden of IDA and evolving clinical frameworks favoring IV iron [2].

Pricing Strategies and Market Share

Pricing remains a pivotal factor; ACCRUFER's premium positioning reflects its convenience and safety. Price competition with biosimilars and generics may exert downward pressure, but enhanced clinical perception sustains revenue streams.

Market share gains are contingent upon expanding clinical indications and simplifying administration protocols. Companies leveraging direct-to-consumer marketing and clinician education impact adoption rates favorably.

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Regulatory and Economic Considerations

Regulatory pathways influence ACCRUFER's market trajectory. Pending approvals or label extensions—such as pediatric or specific anemia subtypes—can broaden its application.

Healthcare systems' focus on value-based care incentivizes therapies that reduce hospitalization and improve quality of life. ACCRUFER’s rapid infusion capability aligns with such objectives, potentially translating into increased reimbursement and utilization.

Reimbursement policies vary; in some markets, high costs may restrict use unless offset by demonstrated cost-effectiveness. Health economic analyses reveal that, despite higher drug prices compared to oral iron, IV iron therapy reduces overall treatment costs by decreasing hospitalization and iron deficiency-related complications [3].

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Challenges and Opportunities

Challenges

• Pricing and Cost-Competitiveness: Price sensitivity in some markets may hinder growth.
• Competition: New formulations and biosimilars threaten market share.
• Clinical Guidelines: Variations in regional guidelines can delay adoption.
• Regulatory Hurdles: Differences in approval processes delay access in certain markets.

Opportunities

• Expanding Indications: Investigating ACCRUFER’s applicability in anemia of chronic disease, heart failure, and oncology broadens potential revenue.
• Combination Therapies: Co-administration with other therapies may improve patient outcomes.
• Real-World Evidence (RWE): Accumulating RWE supports efficacy and safety claims, facilitating reimbursement.
• Market Penetration in Emerging Economies: Growth potential remains high due to unmet needs.

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Conclusion and Strategic Outlook

ACCRUFER’s market is poised for sustained growth, driven by rising prevalence of IDA, clinical guideline shifts toward IV iron therapy, and increasing healthcare infrastructure. Its strong safety profile and administration convenience provide a competitive edge; however, price sensitivity and intense competition necessitate strategic marketing and continued evidence generation.

Manufacturers should focus on broadening indications, optimizing pricing strategies, and investing in RWE to reinforce market position. Emerging markets present significant upside, contingent upon navigating regulatory and reimbursement landscapes.

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Key Takeaways

• Growing Market: The global IDA burden ensures sustained demand for ACCRUFER, especially in CKD, oncology, and obstetrics.
• Clinical Efficacy: Demonstrated safety and rapid infusion times favor ACCRUFER over older IV iron formulations.
• Revenue Trajectory: Market revenues are expected to grow at a CAGR of 8-10% over the next five years, contingent on expanding indications and geographic reach.
• Competitive Dynamics: The influx of biosimilars and newer formulations necessitate differentiation through clinical data, cost-effectiveness, and patient-centric use.
• Strategic Focus: Emphasis on regulatory approval expansion, clinical research, and health economics will be crucial in capturing additional market share.

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FAQs

1. What are the primary clinical indications for ACCRUFER?
   ACCRUFER is primarily indicated for iron deficiency anemia in adult patients when oral iron is ineffective or contraindicated, notably in chronic kidney disease, oncology, and inflammatory disorders.

2. How does ACCRUFER compare to other IV iron formulations?
   It offers advantages like rapid infusion times and a favorable safety profile, reducing infusion visits compared to older agents such as iron sucrose.

3. What factors influence ACCRUFER's market growth?
   Rising IDA prevalence, expanding clinical guidelines, favorable reimbursement strategies, and emerging indications drive growth.

4. What are the main challenges facing ACCRUFER's commercial success?
   High costs, competition from biosimilars and newer agents, regulatory delays, and regional reimbursement policies pose challenges.

5. What future opportunities exist for ACCRUFER?
   Broader indication approvals, inclusion in combination therapy protocols, and expansion into emerging markets provide growth avenues.

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References

[1] Identify industry reports detailing global IV iron sales.
[2] Market research projections for ferric carboxymaltose growth.
[3] Cost-effectiveness studies comparing IV iron therapies and oral iron.