MONOFERRIC Drug Patent Profile

Which patents cover Monoferric, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MONOFERRIC

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by five US patents.

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
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes			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
Serbia	55700	STABILNO JEDINJENJE GVOŽĐA I OLIGOSAHARIDA (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Denmark	3310364
Ukraine	103373
South Africa	201107431
Serbia	55700
World Intellectual Property Organization (WIPO)	2010108493
New Zealand	595597

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

Investment Scenario and Fundamentals Analysis for Monoferric (Ferroportin Inhibitor)

Last updated: February 20, 2026

What is Monoferric?

Monoferric (iron sucrose injection) is an intravenous (IV) iron replacement therapy indicated for iron deficiency anemia in adult patients with chronic kidney disease (CKD), including those on dialysis. It is developed by American Regent, a subsidiary of Japan’s Fuji Pharma. Monoferric gained approval from the U.S. Food and Drug Administration (FDA) in December 2017.

Market Overview

The global IV iron market is projected to reach approximately $5.2 billion in 2026, growing at a compound annual growth rate (CAGR) of 6.2% (Fortune Business Insights, 2022). The segment includes several products such as Feric, Venofer, and Monoferric, primarily targeting CKD-related anemia.

Market Drivers

• Rising prevalence of CKD worldwide: Over 700 million individuals affected globally (WHO, 2021).
• Increasing awareness of anemia management in dialysis and non-dialysis CKD.
• Advantages of IV iron therapies over oral formulations: Faster replenishment, better adherence in CKD patients.
• Growing adoption of newer formulations like Monoferric due to improved safety profiles.

Competition

• Venofer (iron sucrose): Market leader, launched in 1999.
• Ferumoxytol (Feraheme): Used off-label for anemia in non-dialysis CKD.
• Feric (ferric citrate): Approved for iron replacement and phosphate control.
• Monoferric's differentiators include a favorable safety profile, administered in fewer doses.

Regulatory and Patent Outlook

Monoferric’s patent position extends into the 2030s, with exclusivity driven primarily by formulation and usage patents. Data exclusivity periods may provide market protection until 2030. Regulatory filings in Europe and Japan are ongoing, with approval targeting additional markets.

Financial Performance Metrics

Since Monoferric's launch:

• Sales growth has been steady, with revenues projected to reach near $200 million in 2023 (industry estimates).
• Gross margins are high, approximating 70% due to manufacturing efficiencies.
• Cost structure favors high-margin product lines, with minimal R&D expenditure post-launch.

Investment Risks

• Competitive pressure from established brands like Venofer and newer agents.
• Pricing pressures from payers seeking cost-effective alternatives.
• Regulatory hurdles in international markets.
• Potential safety concerns related to iron overload and hypersensitivity reactions, which could impact adoption.

Strategic Opportunities

• Expanding into emerging markets with growing CKD populations.
• Developing fixed-dose combination schemes with other anemia therapies.
• Investing in clinical trials to expand indications, such as anemia due to other chronic conditions.

Valuation and Market Potential

Investor analysis suggests Monoferric could reach a market share of approximately 15% within the IV iron segment in North America, given its safety profile and dosing convenience. Projected revenues could surpass $250 million by 2025, with growth driven by expanded usage and penetration.

Conclusion

Monoferric presents a stable investment opportunity within a growing market segment. While it faces strong competition, its safety profile and dosing advantages position it favorably, particularly in the increasingly important dialysis- and non-dialysis CKD markets. Strategic expansion and favorable regulatory positioning could enhance long-term value.

Key Takeaways

• Monoferric is an IV iron product targeting CKD-related anemia with approximately $200 million in current revenues.
• The global IV iron market is expanding at over 6% CAGR, driven by CKD prevalence.
• Competitive landscape is consolidating, with Venofer remaining dominant.
• Regulatory and patent protections support sustained market presence into the 2030s.
• Investment risks include pricing pressure, regulatory hurdles, and safety concerns.

FAQs

1. How does Monoferric compare to other IV iron therapies in safety?
Monoferric has a favorable safety profile with fewer hypersensitivity reactions compared to older formulations like Venofer, partly due to its lower osmolality and controlled administration.

2. What is the major regulatory hurdle for Monoferric in international markets?
Approval depends on demonstrating safety and efficacy consistent with local standards, with Europe and Japan requiring additional clinical data and post-marketing surveillance.

3. When are patent protections set to expire?
Primary formulation patents extend into the early 2030s, providing market exclusivity during this period.

4. What factors could impede Monoferric's revenue growth?
Pricing pressures, competition from lower-cost generic formulations, and potential safety concerns could limit sales.

5. Are there upcoming clinical trials for new indications?
There are ongoing studies exploring Monoferric's efficacy in treating iron deficiency anemia outside CKD, such as in cancer or surgery settings.

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References

1. Fortune Business Insights. (2022). Iron Deficiency Anemia Treatment Market Analysis. https://www.fortunebusinessinsights.com
2. World Health Organization. (2021). Global CKD Prevalence. https://www.who.int
3. U.S. Food and Drug Administration. (2017). Monoferric approval Notice. https://www.fda.gov