FERIDEX I.V. Drug Patent Profile

Which patents cover Feridex I.v., and what generic alternatives are available?

Feridex I.v. is a drug marketed by Amag Pharms Inc and is included in one NDA.

The generic ingredient in FERIDEX I.V. is ferumoxides. Additional details are available on the ferumoxides profile page.

Summary for FERIDEX I.V.

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	8
DailyMed Link:	FERIDEX I.V. at DailyMed

US Patents and Regulatory Information for FERIDEX I.V.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996		DISCN	No	No

Expired US Patents for FERIDEX I.V.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	4,770,183
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,219,554
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	4,827,945
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,102,652
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,055,288

International Patents for FERIDEX I.V.

See the table below for patents covering FERIDEX I.V. around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	68926708
Israel	114116
European Patent Office	0578765
Germany	3751918
Austria	142891

Market Dynamics and Financial Trajectory for FERIDEX I.V.

Last updated: February 20, 2026

FERIDEX I.V. (ferumoxides injection) was developed as a magnetic resonance imaging (MRI) contrast agent for detecting liver tumors. Its market presence has declined as new alternatives have emerged, with regulatory and commercial factors influencing its trajectory.

Overview of FERIDEX I.V.

FERIDEX I.V. was FDA-approved in 1997 for hepatic imaging. It is a superparamagnetic iron oxide nanoparticle used to visualize liver lesions via MRI, especially for identifying hepatocellular carcinoma and metastases. Manufactured by AMAG Pharmaceuticals, the product was once a leading agent in MRI hepatology diagnostics.

Market Landscape

Decline in Market Share

The use of FERIDEX I.V. has sharply declined since 2013, primarily due to:

• Regulatory withdrawals: In the U.S., AMAG Pharmaceuticals voluntarily withdrew FERIDEX I.V. from the market in 2017 over manufacturing issues and declining sales (AMAG, 2017).
• Emergence of new agents: Contrast agents such as gadoxetic acid (Eovist/Primovist) and gadolinium-based contrast agents dominate the liver imaging segment because of improved imaging capabilities, safety profiles, and broader indications.

Competition and Substitutes

Table 1 summarizes the bioavailability, safety, and market share of main competitors:

Agent	Type	FDA Status (2023)	Market Share	Main Advantages	Main Disadvantages
FERIDEX I.V.	Iron oxide nanoparticle	Withdrawn (2017)	<1%	Historically effective for liver imaging	Market exit, discontinued
Gadoxetic Acid (Eovist)	Gadoxetic acid-based MRI	Approved (2004)	~60%	Hepatocyte-specific enhancement	Costly, contraindications
Gadolinium Agents	Gadolinium-based	Widely used	~30%	Versatile, general MRI applications	Nephrogenic systemic fibrosis (rare)
Iron oxide alternatives	Other nanoparticle agents	Various (limited)	<10%	Emerging, limited data	Limited approval, research-stage

Regulatory and Commercial Factors

The U.S. market has seen no new approvals for ferumoxides or similar iron oxide agents since FERIDEX’s withdrawal. Conversely, Europe approved similar agents, like Clariscan (GE Healthcare), which are used off-label for hepatic imaging but lack the same market penetration.

Clinical Adoption Trends

Physicians favor agents with broader indications, minimal safety concerns, and expanded clinical data. The shift away from ferumoxides was driven by:

• Regulatory withdrawal: regulatory agency actions, such as the FDA's 2017 suspension, reduced market access.
• Commercial decline: decreased production leading to supply shortages and reduced R&D investment.
• Technological improvements: MRI advancements reduce reliance on specific contrast agents.

Financial Trajectory Analysis

Past Revenue and Market Penetration

At its peak, FERIDEX generated approximately $60 million annually for AMAG Pharmaceuticals in the early 2000s (AMAG Annual Reports, 2005-2010). Post-2010, revenue declined sharply, culminating in the 2017 withdrawal.

Current Market Valuation

With the product off-market, FERIDEX’s direct revenue contributions are null. The landscape now values the liver MRI contrast agent market at approximately $1.2 billion globally, with gadoxetic acid holding the largest share (Decision Resources, 2022).

R&D and Investment Trends

No new R&D investments target ferumoxides; however, interest persists in iron oxide nanoparticles for targeted drug delivery and theranostics, though these are not direct competitors for FERIDEX's original indication.

Future Financial Outlook

The prospects for FERIDEX as a commercial product are nonexistent in the near term, given regulatory status, market adoption, and technological shifts. For companies interested in iron oxide-based contrast agents, the focus is on innovative formulations for off-label uses or other diagnostic applications, which may hold niche market value.

Regulatory Environment Overview

• FDA: Withdrawn in 2017; no current approvals.
• European Union: Certain iron oxide agents remain authorized with off-label hepatic indications.
• Global prospects: Limited growth potential due to safety concerns over iron nanoparticles and emerging competitors.

Key Takeaways

• FERIDEX I.V. ceased U.S. sales in 2017 after regulatory withdrawal, with negligible current market activity.
• The liver MRI contrast agent sector has shifted toward gadoxetic acid and gadolinium-based agents, which dominate due to superior imaging and safety profiles.
• The company’s revenue impact from FERIDEX has collapsed, with an estimated $0 for recent years.
• Research persists in iron oxide nanoparticles for other indications but not as direct competitors in hepatic imaging.
• The regulatory landscape constrains the revival of ferumoxides in key markets, limiting future commercial prospects.

FAQs

1. Is FERIDEX I.V. available outside the U.S.?
   Limited data suggest some European approvals for similar iron oxide agents, but FERIDEX itself has not been reintroduced post-2017 in any market.

2. Can FERIDEX I.V. be used off-label for liver imaging?
   No. The FDA withdrawal prohibits its marketing and use in the U.S. for any indication.

3. Are there ongoing R&D efforts for ferumoxides or similar agents?
   Limited; focus is on nanotechnology applications in targeted therapy and diagnostics, not on re-commercializing FERIDEX.

4. What are the main safety concerns with iron oxide contrast agents?
   Patients with iron metabolism disorders, allergies, or kidney impairment face risks like iron overload or allergic reactions, though safety profiles are generally robust for approved agents.

5. What is the outlook for nanoparticle-based contrast agents?
   Growth is limited; regulatory hurdles and safety concerns slow development. Emerging trends favor gadolinium agents and new molecular imaging modalities.

References

1. AMAG Pharmaceuticals. (2017). Press release: Voluntary market withdrawal of FERIDEX I.V. Retrieved from https://www.amagpharma.com
2. Decision Resources. (2022). Global MRI contrast agent market analysis.
3. FDA. (2017). Notice of market withdrawal: FERIDEX I.V. Retrieved from https://www.fda.gov
4. AMAG Pharmaceuticals. (2005-2010). Annual Reports.
5. European Medicines Agency. (2021). List of authorized iron oxide nanoparticles.