Ferric maltol - Generic Drug Details

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

Ferric maltol is the generic ingredient in one branded drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric maltol has fifty-one patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for ferric maltol

International Patents:	51
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	12
What excipients (inactive ingredients) are in ferric maltol?	ferric maltol excipients list
DailyMed Link:	ferric maltol at DailyMed

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

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 ferric maltol

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

Sponsor	Phase
Norgine	Phase 4
University Medical Center Groningen	Phase 4
Radboud University Medical Center	Phase 4

See all ferric maltol clinical trials

Pharmacology for ferric maltol

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

Anatomical Therapeutic Chemical (ATC) Classes for ferric maltol

B03AB	Iron trivalent, oral preparations
B03A	IRON PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for ferric maltol

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 ferric maltol

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 ferric maltol

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201418708
South Korea	102351422
South Korea	20160105499	철 트리말톨의 복용량 양생법 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
Japan	6404358
Israel	246613	משטר מינון של ברזל טרימלטול (Dosage regimen of ferric trimaltol)

Market Dynamics and Financial Trajectory for Ferric Maltol

Last updated: July 28, 2025

Introduction

Ferric maltol has become a noteworthy entity in the pharmaceutical landscape, primarily indicated for iron deficiency anemia (IDA). Its unique formulation positions it as a potent alternative to traditional oral iron therapies, with potential to reshape treatment paradigms. Understanding market dynamics and financial trajectory requires a detailed review of its development stage, competitive environment, regulatory landscape, and adoption trends, driven by therapeutic efficacy and safety profiles.

Therapeutic Profile and Clinical Landscape

Ferric maltol is an oral iron complex designed to address iron deficiency anemia, especially for patients intolerant to conventional ferrous salts. The drug's molecular structure facilitates targeted iron delivery with reduced gastrointestinal adverse effects, a significant market differentiator [1]. Clinical trials demonstrate high bioavailability and a tolerability profile that encourages long-term compliance, positioning ferric maltol as a preferred option within specialist and primary care settings.

Market Size and Growth Drivers

The global iron deficiency anemia market is forecasted to reach approximately USD 13 billion by 2026, with a compound annual growth rate (CAGR) of around 8%, driven primarily by an aging population, increased prevalence of gastrointestinal disorders, and rising awareness of IDA management [2]. Ferric maltol taps into unmet needs—patients with intolerance to traditional therapies and those requiring long-term management—creating a niche segment with considerable expansion potential.

Regulatory and Commercial Milestones

Ferric maltol, marketed under brand names like Feraccru and Accrufer, has received regulatory approvals across multiple jurisdictions, including the European Union and the United States. Its initial approval was based on Phase III clinical trial success, confirming efficacy comparable or superior to ferrous sulfate, with fewer gastrointestinal side effects [3].

Commercial deployment has been incremental, as the drug gains acceptance among prescribers and formulary inclusion. Strategic partnerships, such as licensing and distribution agreements, have facilitated entry into diverse markets. The speed of adoption hinges on clinical advocacy and healthcare provider education emphasizing its safety profile.

Market Dynamics: Competitive Environment

The competitive landscape includes ferrous sulfate, ferrous fumarate, and ferrous gluconate—standard oral iron therapies with established efficacy but notable gastrointestinal tolerance issues. Injectable iron formulations, like iron sucrose and ferric carboxymaltose, present alternatives for refractory cases but are associated with higher costs and administration complexities.

Ferric maltol's commercial advantage lies in its oral route with improved tolerability. This positions it favorably for outpatient management and long-term therapy, especially in chronic conditions such as inflammatory bowel disease (IBD), where iron deficiency is prevalent [4]. However, its market penetration is challenged by the entrenched use of generics and the need for continued evidence generation to demonstrate cost-effectiveness.

Financial Trajectory and Revenue Potential

Initial revenue streams for ferric maltol reflect limited market penetration but show promising growth trajectories. The drug's premium positioning, driven by its tolerability, warrants higher pricing compared to generic ferrous salts, contributing to robust margins once market share stabilizes.

Forecast models project sales in the range of USD 200–300 million globally within five years post-approval, contingent on regulatory expansion, formulary inclusion, and physician uptake. Key factors influencing revenues include:

• Pricing strategies: Premium pricing models due to differentiation.
• Market penetration: Expansion across chronic IDA indications.
• Regulatory approvals: Accelerated pathways or additional indications.
• Competitive pressures: Emergence of new formulations or generics.

Major pharmaceutical companies engaged in ongoing marketing and education efforts are poised to capitalize on this growth, especially those with overlapping gastrointestinal or hematological portfolios. International markets, including emerging economies, possess significant growth potential but necessitate tailored strategies considering healthcare infrastructure and reimbursement policies.

Risks and Challenges

Despite promising prospects, several risks could temper financial trajectory:

• Regulatory delays in approving new indications or markets.
• Generic competition once patent exclusivity lapses.
• Market acceptance influenced by prescriber inertia and existing treatment guidelines.
• Pricing pressures amid healthcare cost containment policies.

Additionally, the long-term safety profile and real-world efficacy data will be critical to sustain growth.

Strategic Opportunities

• Broadening indications: Use in other anemia forms, such as chemotherapy-induced anemia or perioperative anemia.
• Combination therapies: Potential co-administration with other hematologic agents.
• Digital engagement: Enhancing prescriber and patient awareness through digital channels.

Conclusion

Ferric maltol’s market dynamics are defined by its positioning as a tolerable, effective oral therapy for iron deficiency anemia. Its financial trajectory depends on regulatory progress, clinical adoption, and market expansion. While facing challenges like generic competition and healthcare cost pressures, its differentiated profile offers a compelling growth avenue, with a projected revenue potential reaching hundreds of millions globally over the next few years.

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Key Takeaways

• Ferric maltol addresses unmet needs in iron deficiency anemia, offering superior tolerability over traditional oral iron therapies.
• The global IDA market, projected to reach USD 13 billion by 2026, provides a substantial growth platform for ferric maltol.
• Market acceptance hinges on regulatory approvals, clinical evidence, and formulary placements, with revenue forecasts indicating promising growth.
• The competitive landscape favors ferric maltol’s oral route and safety profile but faces threats from generics and new formulations.
• Strategic expansion and indication broadening will be key to maximizing its financial impact in diverse healthcare settings.

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FAQs

Q1: What differentiates ferric maltol from traditional oral iron therapies?
A1: Ferric maltol provides targeted iron delivery with fewer gastrointestinal side effects, improving patient adherence relative to ferrous salts.

Q2: What is the current regulatory status of ferric maltol?
A2: It has received approval in key markets like Europe and the US for treating iron deficiency anemia, with ongoing efforts for broader indication expansion.

Q3: How does ferric maltol fit into the treatment landscape for IDA?
A3: It serves as an alternative for patients intolerant to traditional oral iron or requiring long-term therapy, competing with injectables and existing oral formulations.

Q4: What are the primary growth drivers for ferric maltol’s market expansion?
A4: Increasing IDA prevalence, clinical preference for tolerable therapies, formulary inclusion, and strategic partnerships.

Q5: When can investors expect significant revenue growth for ferric maltol?
A5: Likely within five years, contingent on regulatory milestones, market adoption, and global expansion, with revenues potentially reaching hundreds of millions USD.