MONOFERRIC Drug Patent Profile

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

Monoferric is a drug marketed by Pharmacosmos and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-three patent family members in twenty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Monoferric

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MONOFERRIC

International Patents:	63
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Drug Prices:	Drug price information for MONOFERRIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MONOFERRIC
What excipients (inactive ingredients) are in MONOFERRIC?	MONOFERRIC excipients list
DailyMed Link:	MONOFERRIC at DailyMed

See drug prices for MONOFERRIC

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

Constraining patent/regulatory exclusivity:

8,815,301

NDA:

208171

Dosage:

SOLUTION;INTRAVENOUS

^*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 MONOFERRIC

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

Sponsor	Phase
University of Saskatchewan	PHASE3
Oregon Health and Science University	Early Phase 1
Alberta Health Services, Calgary	Phase 3

See all MONOFERRIC clinical trials

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by five US patents.

This potential generic entry date is based on patent 8,815,301.

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
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	10,414,831		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	8,815,301		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	10,414,831		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	11,851,504		Y	Y

International Patents for MONOFERRIC

When does loss-of-exclusivity occur for MONOFERRIC?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

New Zealand

Philippines

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 MONOFERRIC around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	595597	A STABLE IRON OLIGOSACCHARIDE COMPOUND
South Korea	101580348
European Patent Office	3156075	OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
European Patent Office	3821910	OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
China	107820428	用于治疗胎儿或婴儿铁缺乏的铁碳水化合物复合物 (IRON CARBOHYDRATE COMPLEX FOR TREATMENT OF IRON DEFICIENCY OF A FETUS OR AN INFANT)
Japan	2022169561	胎児又は小児の鉄欠乏症の治療のための鉄炭水化物複合体

Supplementary Protection Certificates for MONOFERRIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2411053	C02411053/01	Switzerland		PRODUCT NAME: FERRUM (III) UT FERRI ISOMALTOSIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67001 26.08.2019

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MONOFERRIC

Last updated: November 19, 2025

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Introduction

Monoferric (ferric derisomaltose) emerges as a pivotal therapeutic in the management of iron deficiency anemia (IDA). With a focus on clinical efficacy, safety profile, and market adoption, understanding its market dynamics and financial trajectory is crucial for stakeholders across pharma, healthcare providers, and investors. This article delineates the factors shaping Monoferric’s market landscape, anticipated revenue streams, competitive positioning, and future outlook within the broader iron deficiency treatment domain.

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Product Overview and Clinical Significance

Monoferric is an intravenous (IV) iron preparation developed by Pharmacosmos, designed to address iron deficiency anemia across diverse patient populations, including chronic kidney disease (CKD) patients, those undergoing chemotherapy, or experiencing gastrointestinal bleeding. It offers a single-dose administration, enabling rapid replenishment of iron stores, which confers advantages over traditional oral iron therapies and older IV formulations requiring multiple doses.

Clinically, Monoferric demonstrates high tolerability, low immunogenicity, and improved iron repletion efficiency, aligning with evolving standards for patient-centric anemia management. Regulatory approvals in multiple regions, notably the United States (FDA), European Union (EMA), and other markets, underpin its growing acceptance.

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Market Dynamics

1. Growing Prevalence of Iron Deficiency Anemia

Globally, the prevalence of IDA is on the rise, fueled by aging populations, increased prevalence of chronic conditions, and nutritional deficiencies. The World Health Organization estimates that anemia affects approximately 1.8 billion people worldwide, with iron deficiency being the predominant cause [1].

This prevalence fuels demand for efficacious treatment options, positioning intravenous iron therapies like Monoferric as essential tools, especially for patients unresponsive or intolerant to oral supplementation. The expanding patient pool underpins a sustained, long-term growth trajectory.

2. Advancements in IV Iron Therapy and Market Adoption

The shift from oral to IV iron formulations has been driven by superior efficacy, faster recovery of iron levels, and better tolerability in select patient groups. Monoferric's single-dose regimen enhances compliance, reduces healthcare visits, and lowers administrative costs, encouraging its adoption.

Market adoption is also bolstered by clinical guidelines increasingly endorsing IV iron options for specific patient subsets, including those with CKD, inflammatory bowel disease, and chemotherapy-induced anemia.

3. Competitive Landscape and Differentiation

Monoferric faces competition from established IV iron therapies, including Venofer (iron sucrose), Fer injectables like FeraMAX, and newer agents such as Injectafer (ferric carboxymaltose). Key differentiation factors include:

• Single-dose convenience: Monoferric typically allows one infusion for full iron repletion, unlike others requiring multiple sessions.
• Safety profile: Demonstrates low risk of anaphylaxis and infusion reactions.
• Cost-effectiveness: By minimizing dosing sessions, Monoferric can reduce treatment costs.

Despite this, market penetration varies across regions, often influenced by formulary preferences, physician familiarity, and reimbursement policies.

4. Regulatory and Reimbursement Landscape

Approval and reimbursement significantly influence market reach. Monoferric’s approval pathway has benefited from broad clinical trial data demonstrating efficacy and safety. In the US, its addition to formulary listings and positive payor coverage accelerate uptake. Similar trends are observable in European markets.

Reimbursement policies, particularly in the US under Medicare and private insurers, incentivize usage of efficient IV iron therapies, supporting Monoferric’s growth.

5. Emerging Market Trends and Future Potentials

The global shift toward outpatient infusion services, telemedicine, and efficient anemia management strategies signals a transformative market environment. Additionally, expanding indications—such as anemia among cancer patients and in surgical settings—may further augment demand.

Advancements in drug delivery technology, biosimilar competition, and broader approval in emerging markets like Asia-Pacific and Latin America offer substantial growth opportunities.

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Financial Trajectory Analysis

1. Revenue Potential and Market Size Estimation

Estimating the financial forecast hinges on several variables:

• Prevalence and target population size: An estimated 1.8 billion women globally, along with a significant subset of men and specific patient groups, are potential candidates for IV iron therapy.
• Adoption rate: Increasing physician confidence and clinical guideline endorsements could lead to substantial shifts from oral to IV iron.
• Pricing strategies: Monoferric’s premium positioning due to convenience and safety supports higher per-unit pricing relative to older formulations.

Laboratory data and market research suggest the global IV iron market, valued around USD 1.7 billion in 2021, is projected to grow at a CAGR exceeding 10% through 2028 [2]. Monoferric's contribution may reach 10-15% of the IV iron segment, translating into multi-hundred-million-dollar revenue streams in developed markets over the next 5-7 years, contingent upon market penetration.

2. Market Penetration and Growth Drivers

Key growth drivers include:

• Expanding indications: Beyond CKD and chemotherapy-induced anemia, application in surgical anemia, postpartum anemia, and other chronic conditions.
• Regional expansion: Penetration into emerging markets with high unmet needs, facilitated by strategic partnerships and local regulatory approvals.
• Healthcare delivery models: Outpatient infusion centers and mobile health initiatives improve access and utilization.

Historical data indicates that monoclonal companies in similarly positioned markets experienced initial slow adoption, followed by rapid growth as clinical familiarity increased. Monoferric's market trajectory is poised for acceleration with continued clinical confirmatory data and increased provider education.

3. Pricing Strategies and Reimbursement Impact

Premium pricing, supported by clinical advantages, will balance with payor negotiations and formulary placements. The US market, controlled by payer policies and hospital procurement contracts, will be pivotal. As reimbursement structures favor treatments reducing overall care costs, Monoferric’s financial outlook benefits.

4. Challenges and Risks

Potential risks include competitive pressure from biosimilars and generics, regulatory shifts, and safety concerns impacting clinician confidence. Additionally, economic disruptions or healthcare policy changes could alter reimbursement dynamics.

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Future Outlook

The future financial trajectory for Monoferric appears promising, with projections indicating steady growth driven by increasing diagnosis rates, broader indications, and regional expansion. An emphasis on clinical evidence, strategic positioning, and adaptive pricing will be vital in capitalizing on the expanding IV iron market.

The long-term value will be contingent on:

• Continued clinical validation
• Market penetration strategies
• Regulatory approvals in emerging markets
• Navigating reimbursement landscapes efficiently

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Key Takeaways

• Market growth driven by rising global anemia prevalence and a shift toward IV iron therapies as a preferred treatment modality.
• Monoferric’s single-dose convenience and safety profile position it favorably against older formulations, catalyzing adoption.
• Revenue potential is substantial, with forecasts pointing toward a multi-hundred-million-dollar contribution in leading markets within five years.
• Regional expansion and broader indication approvals will be crucial for sustained growth.
• Competitive landscape and reimbursement policies pose challenges but also opportunities for strategic positioning.

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FAQs

1. What are Monoferric’s primary advantages over older IV iron therapies?
Monoferric offers a single-dose infusion, reducing treatment sessions, which enhances patient compliance and healthcare efficiency. Its favorable safety profile minimizes adverse reactions, making it suitable for a broad patient population.

2. What markets are most promising for Monoferric’s growth?
Developed markets such as the US and Europe currently lead, but emerging regions like Asia-Pacific and Latin America hold significant future potential due to unmet needs and increasing health infrastructure.

3. How does reimbursement influence Monoferric’s market penetration?
Positive coverage and formulary inclusion accelerate adoption, especially in outpatient settings. Reimbursement schemes favor treatments that reduce overall care costs, benefiting Monoferric’s uptake.

4. What are the main competitors to Monoferric, and how does it differentiate?
Competitors include Venofer and Injectafer. Monoferric differentiates itself through single-dose administration, strong safety data, and cost-effectiveness.

5. What future developments could impact Monoferric’s financial trajectory?
New clinical indications, regulatory approvals, biosimilar competition, and technological innovations in drug delivery could influence revenue streams, either positively or negatively.

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References

[1] World Health Organization. "Anaemia Fact Sheet." 2021.
[2] Grand View Research. "Intravenous Iron Drugs Market Size, Share & Trends Analysis." 2022.