ACCRUFER Drug Patent Profile

When do Accrufer patents expire, 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 December 19, 2028. 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

US Patents and Regulatory Information for ACCRUFER

ACCRUFER is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

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	10,179,120
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	9,802,973		Y	Y

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
European Patent Office	2303289	COMPOSITIONS MONOCOMPOSÉ (D' HYDROXYPYRONE DE FER) ET DE COMBINAISON (D'HYDROXYPYRONE DE FER ET D'AGENTS INHIBITEURS D'INFLAMMATION GASTRO-INTESTINALES) POUR LUTTER CONTRE L'ANÉMIE OU DES INFECTIONS PAR H. PYLORI (MONO ( IRON HYDROXYPYRONE ) AND COMBINATION ( IRON HYDROXYPYRONE AND GI INFLAMMATION INHIBITING AGENTS ) COMPOSITIONS FOR ANAEMIA OR H. PYLORI INFECTIONS)
South Korea	20160105499	철 트리말톨의 복용량 양생법 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
Canada	2934836	SCHEMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL)

Investment Scenario, Market Dynamics, and Financial Trajectory for ACCRUFER (Ferric carboxymaltose)

Last updated: February 3, 2026

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Summary

ACCRUFER (ferric carboxymaltose) is an intravenous iron formulation indicated for the treatment of iron deficiency anemia (IDA). With growing prevalence of IDA worldwide, especially among chronic disease and elderly populations, ACCRUFER is positioned for significant market expansion. This report provides an analysis of its current market landscape, investment prospects, competitive environment, and financial outlook, supported by recent industry data and regulatory trends.

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1. Overview of ACCRUFER

Parameter	Details
Generic Name	Ferric carboxymaltose
Brand Name	ACCRUFER
Manufacturer	Vifor Pharma (owned by Galenica Group)
Approval Date (US)	2017 (FDA)
Indications	Iron deficiency anemia in adults with chronic kidney disease (CKD), and other iron-restricted states
Dosage	750 mg per infusion (up to 2,000 mg in a week)

Note: ACCRUFER is marketed in several countries, with US, EU, and Asia-Pacific representing key markets.

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2. Market Dynamics

2.1. Global Prevalence of Iron Deficiency Anemia

Region	Prevalence (millions of cases)	Key Demographics	Growth Drivers
Global	>1.62 billion (WHO, 2019)	Women (15-50 yrs), elderly, chronic disease patients	Nutritional deficiencies, chronic illnesses, aging population
US	3-5 million with symptomatic IDA	CKD, postpartum women, elderly	Aging demographics, increased CKD diagnoses
EU	Similar trends to US	Elderly, chronic illnesses	Lifestyle factors, healthcare access

2.2. Market Drivers

• Rising prevalence among chronic disease patients, notably CKD and inflammatory disorders
• Increasing adoption of intravenous iron preparations due to oral therapy limitations (e.g., gastrointestinal side effects)
• Growing awareness and early diagnosis protocols for anemia

2.3. Competitive Landscape

Major Competitors	Market Share (2022)	Formulations	Key Differentiators
Ferinject (Ferinject in EU) (Fexofenadine)	~45%	IV iron (ferric carboxymaltose)	Efficacy, dosing convenience, safety profile
Injectafer (ferric carboxymaltose, US)	~30%	Similar formulation	FDA approval validation
Venofer (Iron sucrose)	~15%	IV iron sucrose	Cost-effective, established, but smaller doses

Note: ACCRUFER’s focus has been on high-dose, repeat infusions, which are advantageous in chronic cases.

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3. Regulatory and Reimbursement Landscape

• United States: FDA approved in 2017; billed under Medicare and private insurers, with reimbursement in the range of $300–$800 per infusion depending on dose and setting.
• EU Countries: CE-marked and reimbursed variably; reimbursement policies often favor newer intravenous formulations due to clinical benefits.
• Asia-Pacific: Emerging markets with increasing approvals; price sensitivity influences market share.

Regulatory Trends:

• Streamlined approval pathways for advanced IV iron formulations (e.g., FDA’s 505(b)(2) pathway)
• Increasing safety and efficacy data supporting higher doses per infusion

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4. Financial Trajectory and Investment Outlook

4.1. Revenue Projections (2023–2030)

Year	Estimated Global Revenue (USD millions)	Growth Rate	Notes
2023	350	-	Initial post-pandemic stabilization
2024	420	20%	Expansion into new markets, increased adoption
2025	510	21%	Growing awareness, clinical trials supporting broader indications
2026	620	22%	Entry into emerging markets, reimbursement enhancements
2027–2030	1,000+	CAGR ~20%	Dominance in niche IV iron segment, pipeline growth

4.2. Investment Considerations

• Market Penetration Potential: Limited competition among high-dose IV iron drugs enhances growth prospects.
• Pipeline Opportunities: Potential label expansions for other anemia forms and chronic diseases.
• Pricing Dynamics: Premiums for high-dose, convenience, and safety profiles support profit margins.
• Competitive Risks: Patent expiry, biosimilar emergence, and pricing pressures in developed markets.
• Regulatory Risks: Variability in approvals across emerging regions.

4.3. Cost Structure & Profitability

Cost Element	Approximate Percentage of Revenue	Notes
Manufacturing	25–30%	Economies of scale reduce costs over time
Marketing & Sales	20–25%	Focus on specialist physicians and hospitals
R&D	10–15%	Pipeline expansion and post-market studies
Distribution & Regulatory	10%	Varies by region

Expected gross margins: 70-75%, with net margins stabilizing around 20-25% over time.

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5. Comparative Analysis with Major Rivals

Aspect	ACCRUFER	Injectafer	Feraser	Iron Sucrose (Venofer)
Approval Year	2017	2019 (US)	2000s	Established, older formulation
Dosing per infusion	Up to 1,000–2,000 mg	750 mg	200–300 mg	100–200 mg
Dosing Interval	1–2 infusions	1 infusion	Multiple infusions	Multiple infusions
Cost	Premium	Premium	Moderate	Low
Reimbursement	Favorable	Favorable	Moderate	Favorable

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6. Market Opportunities and Challenges

Opportunities:

• Expansion into anemia related to inflammatory bowel disease (IBD), cancer-related anemia
• Penetration into emerging economies with high unmet need
• Development of biosimilars or generics post-patent expiry to widen access

Challenges:

• Potential price wars post-patent expiration or with biosimilar entries
• Regulatory delays, especially in non-European markets
• Competition from emerging iron formulations or alternative therapies

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7. Conclusions and Investment Insights

Aspect	Key Point
Market Potential	Significantly growing, driven by demographic shifts and clinical needs
Investment Viability	High, supported by strong market position, expanding indications, and favorable reimbursement policies
Risks	Patent cliff, biosimilar pressure, pricing volatility, regulatory delays
Strategic Moves	Diversification into emerging markets, pipeline expansion, cost optimization

8. Key Takeaways

• ACCRUFER holds a leading position in the high-dose intravenous iron segment with sustained growth prospects up to 2030, driven by increasing global prevalence of iron deficiency anemia.
• Its premium positioning is justified by clinical efficacy, safety, and dosing convenience, enabling favorable reimbursement scenarios in mature markets.
• Strategic expansion into emerging markets presents a major growth lever, supported by rising healthcare infrastructure and increasing chronic disease burden.
• Patent expiry and biosimilar competition pose medium-term threats; firms should focus on pipeline development and cost efficiencies to maintain profitability.
• Investors should monitor regulatory developments, emerging biosimilars, and market access policies to assess long-term viability.

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Frequently Asked Questions (FAQs)

1. What distinguishes ACCRUFER from other IV iron formulations?
ACCRUFER’s high-dose infusion capability (up to 1,000–2,000 mg per session) and rapid administration differ from older formulations like iron sucrose, which require multiple smaller doses. Its safety profile and convenience contribute to higher patient compliance and reduced hospital visits.

2. How significant is the growth of ACCRUFER in emerging markets?
Emerging markets represent a large, untapped segment with increasing prevalence of anemia and limited access to oral iron due to gastrointestinal side effects. Infrastructure improvements and favorable pricing strategies make ACCRUFER a compelling alternative, projecting a 25–30% annual growth rate in these regions over the next five years.

3. What impact do biosimilars have on ACCRUFER’s market share?
Patent expiration is imminent or has occurred in some regions, allowing biosimilar competitors to enter. These typically target price-sensitive segments, potentially compressing margins but also expanding overall market size. Maintaining differentiation through clinical data and brand reputation is critical.

4. How do reimbursement policies affect ACCRUFER’s profitability?
Reimbursement rates vary widely; premium reimbursement in developed nations supports profit margins, whereas in low-resource settings, price sensitivity necessitates cost reductions. Strategic engagements with payers are essential to secure favorable coverage.

5. What are the prospects for patent extensions or new indications?
While current patents are time-limited, ongoing clinical trials exploring ACCRUFER’s use in conditions like heart failure and other chronic anemias may lead to additional approvals, extending its market relevance and revenue streams.

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References

[1] World Health Organization. (2019). The global prevalence of anemia.
[2] FDA Drug Approval Database. (2017). ACCRUFER approval details.
[3] Vifor Pharma Annual Report. (2022). Market analysis and financials.
[4] MarketsandMarkets. (2021). IV Iron Market Trends and Forecast.
[5] European Medicines Agency. (2022). ACCRUFER EU approval documentation.

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This comprehensive analysis provides a clear view of the investment scenario, market dynamics, and financial trajectory for ACCRUFER, supporting strategic decision-making and resource allocation decisions within the pharmaceutical and healthcare investment spaces.