FERRIC MALTOL - Generic Drug Details

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

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:	13
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
Pharmanutra S.p.a.	PHASE4
Norgine	Phase 4
Leiden 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
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
Australia	2009247762	Mono ( iron hydroxypyrone ) and combination ( iron hydroxypyrone and GI inflammation inhibiting agents ) compositions for anaemia or H. pylori infections
Poland	3160951
United Kingdom	2531742	Crystalline forms
South Korea	102351422
China	107001310	麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol)

Market Dynamics and Financial Trajectory for Ferric Maltol

Last updated: February 13, 2026

Ferric maltol is an oral iron therapy indicated primarily for iron deficiency anemia, especially in cases where traditional oral iron treatments are poorly tolerated or ineffective. Its niche positioning influences market potential, competitive landscape, and financial outlook.

Market Size and Demand Drivers

The global iron deficiency anemia market was valued at approximately $9.8 billion in 2022, with a projected compound annual growth rate (CAGR) of 4.2% from 2023 to 2030 [1]. Ferric maltol targets a subset of this market—patients who require oral iron therapy but are intolerant to traditional ferrous salts.

Key demand drivers comprise:

• Rising prevalence of iron deficiency anemia, affecting over 1.6 billion people worldwide [2].

• Increasing awareness and diagnosis rates, especially in developed countries.

• Preference for oral over intravenous (IV) iron, driven by ease of administration and safety profile.

• Limitations of existing oral iron therapies, which are associated with gastrointestinal side effects leading to poor compliance.

Product Positioning and Commercial Highlights

Ferric maltol is marketed under the brand name Feraccru in Europe and Accrufer in the United States. It is marketed by Shield Therapeutics, which launched the product in the UK in 2016, followed by the US in 2019.

The drug exhibits higher tolerability and fewer gastrointestinal adverse events compared to traditional ferrous salts like ferrous sulfate. This distinction enhances its appeal in specific patient populations.

In 2022, Shield Therapeutics reported international sales of approximately $21 million, with the US contributing around $3.4 million, indicating early-stage commercial penetration. The company estimates growing adoption in both outpatient and hospital settings.

Competitive Landscape

Ferric maltol competes with both oral and IV iron therapies:

• Oral ferrous salts (ferrous sulfate, ferrous fumarate): low cost, widely used but limited by tolerability issues.

• IV iron formulations (iron sucrose, ferric carboxymaltose, ferric derisomaltose): effective for refractory cases but involve higher costs, infusion planning, and risks of adverse reactions.

Major competitors in the oral segment include:

• Feraheme (ferumoxytol): mainly used IV but marketed for oral formulations in some regions.

• Dexferrum (iron dextran): primarily IV.

Market entry for ferric maltol aimed to capitalize on its tolerability advantage. Its limited patent life and the presence of generic competitors in the ferrous salts market pose challenges.

Regulatory and Reimbursement Environment

European regulatory approval was granted in 2016 (EMA), and the US FDA approved the drug in August 2019. Reimbursement coverage varies:

• In the US, insurance coverage depends on formulary inclusion, with limited prior authorization requirements.

• In Europe, reimbursement policies are country-specific. Early sales suggest positive reception where formulary access is established.

The product's market penetration is constrained by the relatively high acquisition cost compared to ferrous salts, which are inexpensive over-the-counter options.

Financial Trajectory and Investment Outlook

The financial trajectory of ferric maltol hinges on:

• Market penetration: Early sales figures suggest slow but steady uptake. Growth depends on expanding awareness among physicians and insurance coverage.

• Pricing strategy: Premium pricing is justified by tolerability. In the US, the average wholesale price (AWP) exceeds $300 per 30-tablet pack, compared to approximately $10 for ferrous sulfate.

• Capacity and supply chain: Sufficient manufacturing capacity is crucial as market demand increases.

• R&D pipeline: Shield Therapeutics is exploring other formulations and indications, such as chronic kidney disease (CKD)-related anemia.

• Patent expiry: The primary patent protection extends until 2027 in the US, with patent challenges and potential generics affecting future revenue streams.

• Competitive pressure: Emergence of new oral iron formulations or biosimilars could reduce market share.

Most revenue growth is projected to occur from 2024 onward, provided that the drug secures broader insurance coverage and physician adoption. Revenue forecasts range from $50 million to $200 million in the next five years, contingent on market expansion success.

Summary of Market Trends and Risks

Aspect	Details
Market valuation (2022)	~$9.8 billion for iron deficiency anemia
Growth rate (2023-2030)	4.2% CAGR
Major competitors	Ferrous salts (ferrous sulfate), IV iron formulations
Patent expiry	2027 in US
Price per 30-tablet pack	~$300 (US), higher than ferrous sulfate (~$10)
Sales (2022)	~$21 million worldwide; US sales ~$3.4 million
Key challenges	Market penetration, reimbursement, generic competition, price sensitivity

Key Takeaways

• Ferric maltol addresses unmet needs in iron deficiency anemia, emphasizing better tolerability over traditional therapies.

• Sales are early-stage, with significant growth potential if commercial expansion and insurance reimbursement improve.

• Competitive pressures, patent expirations, and high pricing limit near-term revenue but offer upside in the medium to longer term with increased adoption.

• Broader market adoption depends on physician awareness, formulary inclusion, and patient acceptance of higher-priced oral therapy.

• Financial outlook remains cautious, with revenue forecasts highly sensitive to market penetration and competitive threats.

FAQs

1. What differentiates ferric maltol from traditional oral iron therapies?

It offers improved gastrointestinal tolerability and fewer side effects, leading to better patient compliance.

2. When does patent protection for ferric maltol expire?

Patent rights are valid until 2027 in the US, after which generic competition could impact sales.

3. How does ferric maltol's cost compare to ferrous sulfate?

It costs about 30 times more per treatment course, which influences payer and patient acceptance.

4. What are the main barriers to market expansion?

Limited insurance reimbursement, physician awareness, and competition from lower-cost generic iron salts.

5. What growth prospects exist beyond iron deficiency anemia?

Research explores additional indications such as iron deficiency in chronic kidney disease and other anemia-related conditions, potentially expanding the market.

References

[1] Research and Markets, "Iron deficiency anemia market," 2023.

[2] WHO, "Global prevalence of anemia," 2021.

[3] Shield Therapeutics Annual Report, 2022.