FERUMOXYTOL - Generic Drug Details

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

Ferumoxytol is the generic ingredient in two branded drugs marketed by Covis and Sandoz, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ferumoxytol. Two suppliers are listed for this compound.

Summary for FERUMOXYTOL

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	86
Drug Prices:	Drug price trends for FERUMOXYTOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
What excipients (inactive ingredients) are in FERUMOXYTOL?	FERUMOXYTOL excipients list
DailyMed Link:	FERUMOXYTOL at DailyMed

See drug prices for FERUMOXYTOL

Recent Clinical Trials for FERUMOXYTOL

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

Sponsor	Phase
National Institutes of Health (NIH)	Early Phase 1
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1

See all FERUMOXYTOL clinical trials

Pharmacology for FERUMOXYTOL

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERUMOXYTOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FERAHEME	Injection	ferumoxytol	30 mg/mL, 17 mL single-use vials	022180	1	2015-12-04

US Patents and Regulatory Information for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604-001	Jan 15, 2021	AB	RX	No	No

Expired US Patents for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	6,599,498
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,591,864
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,501,158
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	7,553,479

EU/EMA Drug Approvals for FERUMOXYTOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Rienso	ferumoxytol	EMEA/H/C/002215 Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).	Withdrawn	no	no	no	2012-06-15

FERUMOXYTOL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ferumoxytol

Introduction to Ferumoxytol

Ferumoxytol, marketed under the brand names Feraheme and Rienso, is an intravenous iron replacement therapy used to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD) and other conditions. Here, we will delve into the market dynamics and financial trajectory of ferumoxytol.

Market Size and Growth

The global intravenous iron drugs market, which includes ferumoxytol, has been experiencing significant growth. In 2022, the market size was valued at USD 2.95 billion and is projected to reach USD 6.10 billion by 2031, growing at a CAGR of 8.4% from 2024 to 2031[4].

Segmentation and Market Share

Ferumoxytol falls under the "Others" segment of the intravenous iron drugs market, which includes other types such as iron isomaltoside, ferric gluconate, and ferric pyrophosphate citrate. While ferric carboxymaltose (FCM) dominates the market with a 50.2% revenue share, the "Others" segment, including ferumoxytol, is expected to grow at the fastest CAGR over the forecast period[1].

Key Players and Market Position

AMAG Pharmaceuticals, Inc., now part of Covis Pharma GmbH, is a major player in the market for ferumoxytol. The company has seen significant growth in the sales of Feraheme, with record demand in the U.S. market. For instance, in 2012, AMAG sold approximately 110,000 grams of Feraheme in the U.S., representing a 17% volume growth over 2011[2].

Geographical Presence

The market for ferumoxytol is strong in North America, particularly in the U.S., where it has received FDA approvals for various indications. In 2012, AMAG’s partner, Takeda Pharmaceutical Company Limited, launched ferumoxytol in Canada and several European countries under the brand name Rienso. This geographical expansion has contributed to the revenue growth of ferumoxytol[2].

Regulatory Approvals and Expansions

Regulatory approvals have been a crucial factor in the growth of ferumoxytol. AMAG submitted a supplemental new drug application (sNDA) to the U.S. FDA in December 2012 to expand the label for Feraheme to include all patients with iron deficiency anemia, regardless of the underlying cause. This potential expansion could significantly increase the market opportunity for Feraheme in the U.S.[2].

Financial Performance

In 2012, AMAG reported total revenues of between $21.1 million and $21.5 million for the fourth quarter, with Feraheme U.S. net product revenues contributing between $14.4 million and $14.8 million. This represented a 14% growth in U.S. net product revenues compared to the fourth quarter of 2011. The company also received $33 million in milestone payments related to ex-U.S. approvals and launches, further bolstering its financial position[2].

For 2013, AMAG projected total revenues of between $73 million and $77 million, driven by a combination of price and double-digit volume growth of Feraheme. The company also anticipated reduced operating expenses and increased investments in research and development to support the potential expansion of Feraheme’s label[2].

Challenges and Restraints

Despite the positive growth trajectory, the market for ferumoxytol faces challenges such as the potential for adverse reactions or side effects associated with intravenous iron administration. This risk is a notable restraint that companies must address through ongoing research and development to improve safety profiles[4].

Competitive Landscape

The global intravenous iron drugs market is highly competitive, with key players focusing on research and development, strategic collaborations, and regulatory approvals. Companies like Vifor Pharma, Daiichi Sankyo, and Sanofi are market leaders, while emerging players such as Rockwell Medical and Pharmacosmos are expanding their presence through product diversification and partnerships[1].

Future Outlook

The future outlook for ferumoxytol is promising, driven by the increasing prevalence of iron deficiency anemia, the growing need for effective treatment options, and the expansion of major industry players into new regions. The Asia Pacific region, in particular, is expected to exhibit substantial growth due to government initiatives aimed at healthcare development and the high incidence of IDA in countries like China and India[4].

Key Takeaways

• Market Growth: The global intravenous iron drugs market, including ferumoxytol, is expected to grow significantly, driven by increasing approvals and launches of new IV drugs.
• Regulatory Approvals: Expansions in regulatory approvals, such as the potential broader label for Feraheme, are crucial for market growth.
• Geographical Expansion: North America, particularly the U.S., remains a strong market, with expansion into Europe and Asia Pacific contributing to revenue growth.
• Financial Performance: AMAG Pharmaceuticals has seen record demand and revenue growth for Feraheme, with projections for continued growth.
• Challenges: The risk of adverse reactions is a notable restraint that companies must address through ongoing research and development.

FAQs

1. What is ferumoxytol used for? Ferumoxytol is used to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD) and other conditions.

2. Who are the major players in the ferumoxytol market? Major players include AMAG Pharmaceuticals (now part of Covis Pharma GmbH), Vifor Pharma, Daiichi Sankyo, and Sanofi.

3. What is the current market size and growth rate of the intravenous iron drugs market? The global intravenous iron drugs market was valued at USD 2.95 billion in 2022 and is projected to grow at a CAGR of 8.4% from 2024 to 2031.

4. What are the key factors driving the growth of the ferumoxytol market? Key factors include the increasing prevalence of iron deficiency anemia, the growing need for effective treatment options, and the expansion of major industry players into new regions.

5. What are the potential challenges facing the ferumoxytol market? The potential for adverse reactions or side effects associated with intravenous iron administration is a notable restraint.

Cited Sources

1. Grand View Research - Intravenous Iron Drugs Market Size And Share Report, 2030
2. Business Wire - AMAG Pharmaceuticals Provides Business Update
3. Market Research Intellect - Intraveno (IV) Iron Drugs Market Size, Scope And Forecast Report
4. SkyQuest Technology - Intravenous Iron Drugs Market Size, Share, Trends & Forecast | 2031