FERRIC DERISOMALTOSE - Generic Drug Details

What are the generic 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 fifty-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for FERRIC DERISOMALTOSE

International Patents:	59
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	22
Patent Applications:	6
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

Constraining patent/regulatory exclusivity:

8,815,301

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
Children's Hospital Los Angeles	Phase 4
China-Japan Friendship Hospital	Phase 4
Oregon Health and Science University	Early Phase 1

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	8,815,301		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	12,030,962		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	8,815,301		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	11,851,504		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	12,030,962		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	11,633,489

International Patents for FERRIC DERISOMALTOSE

Country	Patent Number	Title	Estimated Expiration
Canada	2756580	COMPOSE OLIGOSACCHARIDE STABLE ASSOCIE AU FER (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Mexico	2011009936	UN COMPUESTO DE OLIGOSACARIDO DE HIERRO ESTABLE. (A STABLE IRON OLIGOSACCHARIDE COMPOUND.)
China	116999459	用于治疗胎儿或婴儿铁缺乏的铁碳水化合物复合物 (Iron carbohydrate complexes for treatment of iron deficiency in fetuses or infants)
Serbia	61104	OLIGOSAHARID I POSTUPAK NJEGOVE PRIPREME (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
South Africa	201707463	IRON CARBOHYDRATE COMPLEX FOR TREATMENT OF IRON DEFICIENCY OF A FETUS OR AN INFANT
Eurasian Patent Organization	201190214	СТАБИЛЬНОЕ ЖЕЛЕЗО-ОЛИГОСАХАРИДНОЕ СОЕДИНЕНИЕ
Japan	2018518497	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 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

FERRIC DERISOMALTOSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ferric Derisomaltose

Market Overview

The global intravenous iron drugs market, which includes ferric derisomaltose, is experiencing significant growth driven by increasing incidence of chronic kidney disease (CKD), cancer, and other conditions that lead to iron deficiency anemia (IDA). Here are the key dynamics and financial projections for ferric derisomaltose.

Market Size and Growth

The global intravenous iron drugs market was estimated at USD 3.03 billion in 2023 and is expected to expand at a CAGR of 9.2% from 2024 to 2030, reaching approximately USD 4.8 billion by 2030[1][3][4].

Segment Performance

Ferric derisomaltose, along with other intravenous iron drugs, is a crucial segment in this market. While ferric carboxymaltose (FCM) currently dominates the market with a revenue share of 50.2% in 2023, the "others" segment, which includes ferric derisomaltose, is expected to grow at the fastest CAGR over the forecast period[1][3].

Regional Outlook

North America, particularly the U.S., holds the largest share of the intravenous iron drugs market, accounting for 49.2% in 2023. However, regions like Asia-Pacific, including Japan and China, are witnessing rapid growth. For instance, Pharmacosmos A/S announced that MonoVer (ferric derisomaltose) received national coverage in Japan, marking its entry into the third-largest pharmaceutical market globally[1][3].

Product Approval and Expansion

Ferric derisomaltose has gained significant regulatory approvals. In January 2020, Pharmacosmos Therapeutics Inc. received U.S. FDA approval for its ferric derisomaltose injection for treating iron deficiency anemia in adult patients. This approval has expanded the geographical presence of ferric derisomaltose, enhancing its market footprint[1][4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of ferric derisomaltose. The IRONMAN trial, for example, showed that intravenous ferric derisomaltose reduced recurrent hospital admissions for heart failure and cardiovascular death in patients with heart failure and iron deficiency. This trial highlighted the long-term benefits of ferric derisomaltose with minimal adverse events[2].

Competitive Landscape

The market for intravenous iron drugs is competitive, with several key players. Pharmacosmos, the manufacturer of ferric derisomaltose, is one of the major players, along with others like AMAG Pharmaceuticals, Sanofi, and Rockwell Medical. These companies are continuously expanding their product offerings and geographical reach, contributing to the market's growth[1][3].

Financial Projections

The segment including ferric derisomaltose is expected to see significant financial growth. The global intravenous iron drugs market is projected to reach USD 4.8 billion by 2030, growing at a CAGR of 7.4% from 2022 to 2030. Ferric carboxymaltose, while dominant, will also see growth, but the "others" segment, which includes ferric derisomaltose, is anticipated to grow at a faster rate due to its increasing adoption and clinical benefits[1][3][4].

Cost-Utility Analysis

A cost-utility analysis comparing ferric derisomaltose (FDI) and ferric carboxymaltose (FCM) in Chinese patients with IDA showed that FDI could improve patient quality of life and reduce direct healthcare expenditure. This analysis suggests that ferric derisomaltose may offer a more cost-effective option in certain patient populations, further boosting its market potential[5].

Government Initiatives and Research

Government initiatives and ongoing research in the field of intravenous iron drugs are also driving market growth. For instance, the approval of Monofer (ferric derisomaltose) by the National Medical Products Administration (NMPA) in China in February 2021 highlights the regulatory support for such products[4].

Target Patient Population

Ferric derisomaltose is particularly beneficial for patients with iron deficiency anemia who are unresponsive to oral iron treatment or require rapid iron replenishment. This includes patients with CKD, cancer, inflammatory bowel disease, and heart failure, among others. The increasing incidence of these conditions is expected to drive the demand for ferric derisomaltose[1][3][4].

Global Market Penetration

Low- and mid-income countries present lucrative opportunities for the penetration of intravenous iron drugs, including ferric derisomaltose. As healthcare infrastructure improves in these regions, the demand for effective and safe intravenous iron treatments is expected to rise[3].

Key Takeaways

• Market Growth: The global intravenous iron drugs market, including ferric derisomaltose, is expected to grow significantly, reaching USD 4.8 billion by 2030.
• Clinical Efficacy: Ferric derisomaltose has demonstrated efficacy and safety in clinical trials, reducing hospital admissions and cardiovascular events.
• Regulatory Approvals: Recent FDA and NMPA approvals have expanded the market footprint of ferric derisomaltose.
• Cost-Utility: Ferric derisomaltose may offer a more cost-effective option compared to other intravenous iron drugs in certain patient populations.
• Target Population: The drug is beneficial for patients with IDA who are unresponsive to oral iron or require rapid iron replenishment.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the intravenous iron drugs market? A: The global intravenous iron drugs market was estimated at USD 3.03 billion in 2023[1].

Q: Which segment dominates the intravenous iron drugs market? A: The ferric carboxymaltose (FCM) segment currently dominates the market, but the "others" segment, including ferric derisomaltose, is expected to grow at the fastest CAGR[1][3].

Q: What are the key applications of ferric derisomaltose? A: Ferric derisomaltose is used in the treatment of iron deficiency anemia in patients with CKD, cancer, inflammatory bowel disease, and heart failure, among others[1][3][4].

Q: What are the regulatory approvals for ferric derisomaltose? A: Ferric derisomaltose has received approvals from the U.S. FDA and the National Medical Products Administration (NMPA) in China[1][4].

Q: How does ferric derisomaltose compare to other intravenous iron drugs in terms of cost-utility? A: Ferric derisomaltose may offer a more cost-effective option compared to ferric carboxymaltose in certain patient populations, improving patient quality of life and reducing healthcare expenditure[5].

Sources Cited

1. Grand View Research: Intravenous Iron Drugs Market Size And Share Report, 2030.
2. The Lancet: Intravenous ferric derisomaltose in patients with heart failure and ...
3. GlobeNewswire: Global Intravenous (IV) Iron Drugs Market to Reach $4.8 Billion by 2030.
4. Mordor Intelligence: Intravenous Iron Drugs Market - Size & Trends.
5. medRxiv: A Cost-utility Analysis of Ferric Derisomaltose versus ...