Ferric derisomaltose - Generic Drug Details

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

Ferric derisomaltose is the generic ingredient in one branded drug marketed by Pharmacosmos and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric derisomaltose has sixty-three patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for ferric derisomaltose

International Patents:	63
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	28
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric derisomaltose
What excipients (inactive ingredients) are in ferric derisomaltose?	ferric derisomaltose excipients list
DailyMed Link:	ferric derisomaltose at DailyMed

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

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 ferric derisomaltose

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

Sponsor	Phase
Tang Xiaodong	PHASE4
Yonsei University	PHASE4
Svendborg Hospital	PHASE4

See all ferric derisomaltose clinical trials

US Patents and Regulatory Information for ferric derisomaltose

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	208171-001	Jan 16, 2020		DISCN	Yes	No
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	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	208171-001	Jan 16, 2020		DISCN	Yes	No			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes			Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes			Y	Y

International Patents for ferric derisomaltose

Country	Patent Number	Title	Estimated Expiration
Australia	2009342799
Brazil	PI0924653
Canada	2756580
China	102361651
China	108752395
China	109700828
Cyprus	1118725

Supplementary Protection Certificates for ferric derisomaltose

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

Last updated: February 15, 2026

What are the market dynamics for ferric derisomaltose?

Ferric derisomaltose (FDI) is an intravenous iron replacement therapy used primarily for iron deficiency anemia. The drug’s market is influenced by factors including rising prevalence of anemia, especially among chronic kidney disease (CKD) and cancer patients; advantages over traditional iron therapies; and regional healthcare policies.

Prevalence and Demographic Drivers

The global anemia prevalence affects market growth: the WHO reports anemia impacts approximately 1.9 billion people, with iron deficiency accounting for most cases. CKD, which warrants iron therapy, affects around 850 million individuals worldwide, further expanding potential patient base for FDI.

Competitive Landscape

FDI competes against established iron therapies like ferric carboxymaltose, iron sucrose, and iron dextran. Ferric carboxymaltose dominates the IV iron market, with a 45% share in 2022. FDI’s market share remains modest but rising due to its favorable safety profile and dosing convenience.

Regulatory Environment

Regulatory approvals in key regions shape its market trajectory.

• The US FDA approved FDI (brand: Monoferric) in 2017.
• European Medicines Agency (EMA) approved it in 2015.
• Japan approved similar formulations earlier, in 2014.

Regions with expanding healthcare coverage and increasing safety standards expand demand.

Regional Insights

North America holds the largest market share, driven by high CKD prevalence and advanced healthcare infrastructure. Europe follows, propelled by updated guidelines favoring IV iron supplementation. Asia-Pacific exhibits rapid growth; demand is fueled by high anemia prevalence, increasing healthcare spending, and improved access to IV therapies.

Pricing and Reimbursement

Pricing varies by region; in the US, Monoferric wholesale acquisition cost (WAC) ranged around $200 per vial in 2022. Reimbursement policies impact market penetration, with insurance coverage facilitating higher adoption.

Market Growth Factors

• Anemia prevalence among CKD and cancer patients.
• Shift away from oral iron to IV formulations for quicker response.
• Reduced adverse events compared to older IV iron products.
• Expanding approvals and clinical guidelines supporting IV iron use.

Challenges and Limitations

• Competition from ferric carboxymaltose and iron sucrose.
• Manufacturing capacity constraints.
• Cost considerations; cheaper alternatives limit uptake in resource-limited settings.
• Need for more head-to-head clinical trials demonstrating superiority.

What is the financial trajectory of ferric derisomaltose?

The financial outlook projects a compound annual growth rate (CAGR) between 7% and 10% from 2022 to 2027, driven by increasing patient populations and expanding approvals.

Revenue Estimates

In 2022, the global IV iron market was valued at $1.4 billion. Ferric derisomaltose contributed approximately $350 million, representing 25% of the market. The segment is expected to grow to $2.2 billion by 2027, with FDI generating around $600 million, assuming gradual market share gains.

Key Revenue Drivers

• Volume growth: An increase in administered doses correlates with rising anemia cases.
• Price adjustments: Pricing strategies and negotiations with payers influence revenue.
• Geographic expansion: Entry into emerging markets enhances sales.

Cost Dynamics

Manufacturing costs are influenced by complex synthesis processes and quality controls. Economies of scale could lower production expenses, supporting healthier margins.

Profitability

Gross margins for IV iron drugs are typically between 60%-70%. Operating profits depend on R&D expenditure and commercialization costs.

Investment Considerations

• Market expansion strategies.
• Clinical trial investments for new indications.
• Strategic partnerships with regional healthcare providers.

Risks

• Regulatory delays.
• Competitive price pressures.
• Clinical efficacy uncertainties in new indications.

Conclusions

The IV iron market's trajectory favors growth, with ferric derisomaltose positioned as a meaningful player. Market share expansion hinges on clinical differentiation, regulatory progression, and strategic pricing. Financial growth anticipates sustained demand increases driven by demographic and clinical trends.

Key Takeaways

• Ferric derisomaltose’s market is driven by anemia prevalence, particularly among CKD and cancer patients.
• Competition remains fierce, mainly from ferric carboxymaltose, but FDI benefits from safety profile and dosing.
• Regional dynamics favor North America and Europe; Asia-Pacific shows rapid growth.
• The global market of IV iron is projected to reach over $2 billion by 2027.
• Revenue growth depends on market access, clinical validation, and competitive positioning.

FAQs

1. How does ferric derisomaltose compare clinically to other IV iron therapies?
2. What regions offer the greatest growth potential for ferric derisomaltose?
3. What are the main regulatory hurdles for expanding its use?
4. How does pricing strategy influence market penetration?
5. What future indications could expand the market for ferric derisomaltose?

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Sources

1. WHO Global Anaemia Report, 2021.
2. IMS Health, 2022.
3. U.S. FDA approval documentation, 2017.
4. EMA approval documentation, 2015.
5. Market research reports from GlobalData and MarketsandMarkets.