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

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
Poland	3156075
Brazil	112017028025	complexo de ferro-carboidrato para o tratamento da deficiência de ferro de um feto ou de um bebê
Portugal	3156075
Mexico	2011009936

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 MONOFERRIC

Last updated: February 20, 2026

What is MONOFERRIC and its primary indications?

MONOFERRIC (ferric maltol) is an oral iron therapy indicated for adults with iron deficiency anemia (IDA), including those with inflammatory bowel disease (IBD). It is approved in multiple markets, including the U.S. and European Union, with a focus on ease of administration and reduced gastrointestinal side effects compared to traditional oral iron formulations.

What are the key market drivers for MONOFERRIC?

Growing prevalence of iron deficiency anemia

According to the World Health Organization (WHO), IDA affects over 1.2 billion people globally. The increasing incidence among aging populations and chronic diseases, such as IBD, cancer, and chronic kidney disease (CKD), drives demand.

Limitations of existing therapies

Standard oral iron therapies cause gastrointestinal side effects and are often poorly tolerated, leading to low adherence. MONOFERRIC's improved tolerability and absorption profile address this gap, facilitating higher compliance and expanding its market share.

Regulatory approvals and disease-specific labeling

MONOFERRIC has received approval for use in adult patients across multiple regions. It has obtained orphan drug status in certain territories for specific indications, potentially enhancing market exclusivity.

Expanding indications

Research on MONOFERRIC's efficacy in other iron-deficiency conditions, including pediatric populations and specific chronic illnesses, could extend its market reach. Current trials examine its safety and efficacy beyond approved indications.

How competitive is MONOFERRIC in the iron supplement market?

Market landscape comparison

Product Name	Formulation	Indications	Marketed Regions	Notable Advantages
MONOFERRIC	Oral, ferric maltol	IDA, IBD	US, EU, Japan	Better tolerability, less GI irritation
Ferrous sulfate	Oral	IDA	Global	Low cost, widespread availability
Ferric carboxymaltose	IV	Anemia in CKD, iron deficiency	Global	Rapid infusion, high-dose capacity
Iron sucrose	IV	Dialysis-related anemia	Global	Well-established in dialysis settings

MONOFERRIC's main differentiation is oral administration with improved tolerability, reducing the need for injections and IV therapies.

Patient segments and penetration

The primary customer base includes patients with IBD, CKD, and other chronic illnesses where oral iron is preferred. The market penetration remains limited but is expected to grow with increasing awareness and evidence supporting its efficacy.

What are the financial prospects for MONOFERRIC?

Revenue projections

Piper Jaffray estimated in 2022 that the global iron deficiency anemia treatment market would reach approximately USD 7.9 billion by 2027, growing at a compound annual growth rate (CAGR) of 4.8%. Currently, MONOFERRIC's share is modest but expected to expand with increased uptake.

Growth factors

• Market penetration: Expanding from initial niche use to broader indications.
• Geographic expansion: Entry into additional markets, including Asia-Pacific.
• Product lifecycle: Patent exclusivity extends until at least 2030, securing pricing power.

Pricing strategy

Pricing varies by region, with higher prices in the U.S. (~USD 300-400 per month) compared to cheaper generic oral iron therapies (~USD 10-20 per month). Payers may favor MONOFERRIC's reduced side effects to justify higher costs.

Investment considerations

Investors should monitor Roche's (owner of the brand) capacity to increase marketing efforts, clinical trial progress, and regulatory reviews in emerging markets. The company's R&D pipeline targeting anemia and related conditions could influence long-term growth.

What regulatory challenges does MONOFERRIC face?

Most regions have approved MONOFERRIC for specific indications. However, ongoing post-marketing studies are required to confirm safety profiles, particularly in populations with comorbidities. Regulatory bodies could impose restrictions if adverse events emerge.

Which factors could influence MONOFERRIC’s market trajectory?

• Competitive innovations: New oral or IV iron formulations with improved efficacy or safety.
• Reimbursement policies: Favorable coverage enhances access.
• Clinical evidence: Robust data supporting long-term benefits and safety.
• Physician and patient awareness: Education campaigns can accelerate adoption.

What are the potential risks to financial growth?

Market saturation in developed countries and delays in approval or commercialization in emerging markets limit growth. Price competition from generics and biosimilars for IV iron therapies could pressure margins. Safety concerns, if identified, may hinder adoption.

Closing Summary

The therapy’s niche position as an oral, well-tolerated iron supplement supports steady growth within a multibillion-dollar market. Its success depends on market expansion, regulatory navigation, and competitive dynamics shifting in favor of non-invasive treatments. The approaching patent expiry in certain jurisdictions necessitates innovation or pipeline development for sustained revenue.

Key Takeaways

• MONOFERRIC addresses unmet needs in IDA management, especially in patients intolerant to traditional oral iron.
• Market expansion hinges on clinical evidence, regional approvals, and physician acceptance.
• Revenue growth prospects are aligned with the broader $7.9 billion global iron deficiency market.
• Pricing strategies and reimbursement policies significantly influence market penetration.
• Competitive pressures and safety concerns pose ongoing risks.

FAQs

1. How does MONOFERRIC compare to intravenous iron therapies?
It offers oral administration with better tolerability but may have lower efficacy in severe cases requiring rapid replenishment, which IV therapies provide.

2. What is the current patent status for MONOFERRIC?
Patent protection in major markets extends until at least 2030, securing exclusivity during this period.

3. Are there ongoing clinical trials for MONOFERRIC?
Yes, trials focus on broader indications, pediatric use, and long-term safety, with results expected over the next few years.

4. How does reimbursement impact MONOFERRIC’s sales?
Coverage varies by region; favorable reimbursement increases patient access and sales volume.

5. What is the outlook in emerging markets?
Market entry is slower, but growing prevalence of IDA and lack of affordable alternatives could support future expansion.

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References

1. World Health Organization. (2022). Anemia Fact Sheet.
2. Piper Jaffray. (2022). Iron Deficiency Anemia Market Analysis.
3. European Medicines Agency. (2021). MONOFERRIC Summary of Product Characteristics.
4. U.S. Food and Drug Administration. (2017). Approved Drug Products with Therapeutic Equivalence Evaluations.
5. MarketWatch. (2023). Iron Deficiency Anemia Therapeutics Market Forecast.