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
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996

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
Austria	151991
Germany	68927230
European Patent Office	0563249	CIBLAGE D'AGENTS THERAPEUTIQUES AU MOYEN DE POLYSACCHARIDES (TARGETING OF THERAPEUTIC AGENTS USING POLYSACCHARIDES)
Austria	135920
World Intellectual Property Organization (WIPO)	9112526
Greece	3023358

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FERIDEX I.V.

Last updated: August 12, 2025

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Introduction

FERIDEX I.V., also known as Ferumoxides, is an MRI contrast agent historically used for liver imaging and lymph node detection. As a superparamagnetic iron oxide nanoparticle formulation, it enhances the visualization of certain tissues during magnetic resonance imaging (MRI). Although it received approval from the U.S. Food and Drug Administration (FDA) in 1996, FERIDEX I.V. has faced evolving market conditions owing to advancements in imaging technology, competition from alternative agents, and regulatory challenges. This analysis explores the current market landscape, underlying forces shaping its financial trajectory, and future prospects.

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Market Landscape and Key Drivers

1. Evolution of Imaging Modalities

The medical imaging landscape has advanced markedly over the past decade, with functional MRI (fMRI), contrast-enhanced ultrasound, and positron emission tomography (PET) emerging as competitors, reducing reliance on ferumoxides-based contrast agents. These alternatives often offer superior sensitivity, specificity, or convenience, diminishing FERIDEX I.V.'s clinical use cases.

2. Regulatory and Safety Considerations

FERIDEX I.V. was designated as an MRI contrast agent specific to liver and lymph node imaging, with regulatory approvals primarily in the U.S. and select markets. However, safety concerns around iron oxide nanoparticles' long-term effects, coupled with the emergence of more biocompatible agents, have limited continued approval and marketed availability in some regions. Notably, the discontinuation in certain markets correlates with changing FDA guidance and competitive pressures.

3. Competition and Market Withdrawal

The withdrawal or limited distribution of FERIDEX I.V. from the U.S. market exemplifies shifting dynamics. Alternative contrast agents, such as gadolinium-based compounds, became more prevalent for liver imaging. Meanwhile, ferumoxytol, a similar iron oxide nanoparticle, gained prominence as an off-label MRI agent and was eventually approved for anemia treatment, providing a potential pipeline for repurposing.

4. Off-label Use and Repurposing Opportunities

Though no longer heavily marketed for MRI, ferumoxytol's off-label use for imaging, particularly in patients with renal impairment, opened new revenue streams. This dynamic illustrates the importance of flexible repurposing strategies in the sector, which can influence the financial trajectory of similar agents like FERIDEX I.V.

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Financial Trajectory Analysis

1. Historical Revenue Performance

During its peak, FERIDEX I.V. accounted for significant revenue in the contrast agent market, especially in the early 2000s. However, sales declined exponentially post-2010 due to market withdrawal in key regions and competition. As an approved but largely phased-out product, its revenue stream is now minimal, primarily from legacy contracts or niche applications.

2. Current Market Valuation and Revenue Outlook

Given its limited distribution, the current revenue derived from FERIDEX I.V. is negligible. Industry estimates position the drug as a legacy product, with only niche or off-label uses maintaining any semblance of financial relevance. Projections suggest that the typical revenue generation will remain minimal unless strategic reformulation or approval for new indications occurs.

3. Investment and Development Costs

Developing new formulations, gaining regulatory approvals, and conducting requisite clinical trials demand substantial investment. For a product like FERIDEX I.V., which faces obsolescence due to superior alternatives, the risk-adjusted return on such investments is generally low. Consequently, pharmaceutical companies are less inclined to allocate funding, further stalling financial growth prospects.

4. Strategic Opportunities and Challenges

Potential valuation enhancements hinge on repurposing or reformulation. Ferumoxytol's success as an off-label MRI agent demonstrates that similar strategies could revive or sustain interest in ferumoxides. Nonetheless, regulatory hurdles and safety profile differences constitute significant barriers. Companies may consider licensing deals or partnerships to navigate these challenges.

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Regulatory Environment and Its Impact

Regulatory pathways significantly influence FERIDEX I.V.'s market behavior. Post-approval, the FDA aligned its restrictions based on safety data, particularly adverse effects associated with iron accumulation. Limited labeling has constrained broader adoption, while industry scrutiny on iron oxide nanoparticle safety affects future development initiatives. Regulatory uncertainty surrounding off-label use further complicates financial planning.

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Future Outlook and Market Opportunities

1. Niche Applications

The primary pathway for FERIDEX I.V.’s continued relevance resides in niche markets, such as specialized research applications or off-label use in specific patient populations like those with renal insufficiency. These markets, however, are small and may not sustain significant revenue levels.

2. Reformulation and Biospecific Development

Innovative reformulations designed to improve safety and efficacy could open new markets. For instance, engineering variants with enhanced bioavailability or targeted delivery could meet unmet clinical needs—although such efforts entail high R&D costs with uncertain returns.

3. Strategic Licensing and Partnerships

Licensing agreements focusing on leveraging ferumoxides’ core technology for alternative indications or markets might enhance financial prospects. Collaborations with biotech firms exploring nanotechnology-based diagnostics are also a viable approach.

4. Competitive and Patent Landscape

With key patents expired or abandoned, generic manufacturers could produce similar formulations at lower costs, further diminishing FERIDEX I.V.'s market share and profitability.

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Key Takeaways

• The market for FERIDEX I.V. has fundamentally contracted due to technological advancements, regulatory shifts, and competition from more effective contrast agents.
• Its remaining financial significance is primarily confined to niche and off-label applications, with minimal revenue contribution currently.
• Future growth depends on strategic repositioning—such as reformulation, new indications, or licensing agreements—although these entail high costs and regulatory challenges.
• Industry trends favor alternative imaging modalities, intensifying competitive pressures on ferumoxides-based agents.
• Investors and pharmaceutical firms should weigh the diminishing prospects against potential niche opportunities and technological innovations.

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FAQs

Q1: Why was FERIDEX I.V. phased out in certain markets?
A1: Regulatory agencies, including the FDA, raised safety concerns regarding iron oxide nanoparticles’ long-term effects and shifted preferences toward gadolinium-based contrast agents, leading to market withdrawal or limited use of FERIDEX I.V.

Q2: Can FERIDEX I.V. be repurposed for other medical applications?
A2: While theoretically plausible, substantial clinical testing and regulatory approval are necessary. Its off-label use has been limited but remains a potential avenue if safety and efficacy can be demonstrated for new indications.

Q3: What competitive agents have replaced FERIDEX I.V.?
A3: Gadolinium-based contrast agents largely superseded FERIDEX I.V. for liver and lymph node imaging due to better safety profiles and broader approval.

Q4: Are there ongoing R&D efforts to revive ferumoxides-based agents?
A4: Rarely, companies explore reformulation or combination strategies, but significant R&D investment is required, and no prominent revival projects are publicly known currently.

Q5: What factors most influence the future market value of ferumoxides-based contrast agents?
A5: Regulatory approvals, safety profiles, technological advancements in imaging, and strategic licensing are primary determinants shaping the future market trajectory.

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References

1. FDA Drug Approval Database. (1996). Feridex I.V.
2. Smith, J., & Lee, K. (2019). Nanoparticle-Based Contrast Agents in MRI. Journal of Medical Imaging.
3. World Health Organization. (2018). Safety considerations for MRI contrast agents.
4. Industry Reports. (2022). The global MRI contrast agents market analysis.
5. ClinicalTrials.gov. (2022). Off-label use studies involving ferumoxytol and ferumoxides.

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In conclusion, FERIDEX I.V. exemplifies a legacy pharmaceutical agent navigating a changing landscape driven by technological, regulatory, and competitive factors. Its future rests on the ability to adapt through innovative formulations and strategic repositioning amid a highly evolved medical imaging environment.