Last Updated: May 10, 2026

Ferumoxides - Generic Drug Details


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

Ferumoxides is the generic ingredient in one branded drug marketed by Amag Pharms Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ferumoxides
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 7
DailyMed Link:ferumoxides at DailyMed

US Patents and Regulatory Information for ferumoxides

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ferumoxides

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 ⤷  Start Trial ⤷  Start Trial
Amag Pharms Inc FERIDEX I.V. ferumoxides INJECTABLE;INJECTION 020416-001 Aug 30, 1996 ⤷  Start Trial ⤷  Start Trial
Amag Pharms Inc FERIDEX I.V. ferumoxides INJECTABLE;INJECTION 020416-001 Aug 30, 1996 ⤷  Start Trial ⤷  Start Trial
Amag Pharms Inc FERIDEX I.V. ferumoxides INJECTABLE;INJECTION 020416-001 Aug 30, 1996 ⤷  Start Trial ⤷  Start Trial
Amag Pharms Inc FERIDEX I.V. ferumoxides INJECTABLE;INJECTION 020416-001 Aug 30, 1996 ⤷  Start Trial ⤷  Start Trial
Amag Pharms Inc FERIDEX I.V. ferumoxides INJECTABLE;INJECTION 020416-001 Aug 30, 1996 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market dynamics and financial trajectory for FERUMOXIDES

Last updated: April 24, 2026

What is FERUMOXIDES’ commercial and regulatory footprint?

Ferumoxides is an injectable superparamagnetic iron oxide (SPIO) used in medical imaging. The commercial product name most commonly tied to ferumoxides is FERIDEX (including FERIDEX I.V., depending on market history and jurisdiction). It is used as an iron replacement and as an imaging agent, historically with liver/spleen lesion visualization and related indications. Product reach has been shaped by (1) replacement of older SPIO imaging workflows by newer imaging modalities and agents, (2) patent and exclusivity expiry dynamics, and (3) supply and manufacturing continuity in the branded SPIO segment.

From a market-structure standpoint, ferumoxides is not a high-volume, large-oncology-blockbuster type drug. Its demand has historically depended on imaging protocols, hospital adoption, reimbursement coverage, and availability of SPIO alternatives rather than on longitudinal patient treatment cycles typical of chronic therapeutics.

How does the market demand profile drive financial outcomes?

Ferumoxides demand behaves like a procedure-linked product rather than a therapy-adherence product. That changes the financial trajectory in three ways:

  1. Volume sensitivity to imaging practice patterns

    • Hospital imaging committees and radiology departments shift protocols based on clinical evidence, workflow efficiency, and total cost of care.
    • New agents and imaging approaches (including different contrast paradigms) can displace SPIO use even when ferumoxides retains clinical roles.
  2. Reimbursement and procurement cycle risk

    • Imaging products are purchased through tender and formulary cycles.
    • Budget pressure can delay adoption or reduce utilization even when clinical use remains.
  3. Product continuity risk in niche specialty injectables

    • SPIO production is specialized.
    • Any manufacturing disruption can quickly affect site inventories and downstream revenue.

Financial trajectory, in practice, therefore tends to look like: peak during established workflow dominance, then gradual decline or stagnation as practice shifts, followed by step changes from supply stability and competitive offerings.

What are the competitive and substitution forces?

Ferumoxides sits in a contrast-agent landscape where substitution can come from multiple directions:

  • Competing iron oxide imaging agents with different performance characteristics, dosing regimens, and label scope.
  • Alternative MRI contrast agents that reduce or eliminate SPIO usage in certain diagnostic pathways.
  • Clinical guideline updates that re-rank imaging preferences.

Because ferumoxides use is tightly linked to imaging indications rather than to durable treatment plans, substitution tends to translate quickly into revenue erosion when a site changes protocols.

How do pricing and commercialization dynamics typically evolve for ferumoxides?

Pricing for imaging agents is constrained by:

  • negotiated hospital and group purchasing organization rates,
  • reimbursement edits and coding coverage,
  • competitive ASP pressure within the contrast-agent class.

After exclusivity ends or when procurement shifts to competitors, branded products often see:

  • lower net realizations (even if list price changes are limited),
  • contract-based volume concessions,
  • higher discounting for market share retention.

Given ferumoxides’ niche footprint, net revenue volatility is usually driven more by utilization and tender outcomes than by pricing power.

What does the financial trajectory generally look like post-peak?

For drugs like ferumoxides, the post-peak shape typically follows:

  • revenue plateau when imaging utilization stabilizes under existing protocols,
  • downward drift when SPIO use declines due to substitution and workflow changes,
  • lumpiness tied to supply, recalls, or manufacturing events (which can temporarily create demand shocks),
  • flooring when demand persists in specific imaging niches even under broader displacement.

This pattern matters for investors and R&D planners because it implies that:

  • late-stage expansion is often harder than in therapeutic franchises,
  • competitive differentiation must map to defined imaging decision points,
  • revenue is more sensitive to center-level adoption cycles than to patient population growth.

What does patent and exclusivity logic imply for FERUMOXIDES economics?

Ferumoxides’ economics are influenced by exclusivity windows tied to manufacturing, formulation, and use. Once exclusivity expires, market dynamics tend to move toward:

  • competing SPIO products,
  • generic-like substitution depending on regulatory pathway and manufacturability,
  • pricing compression in tender-driven procurement.

In practice, imaging-agent markets often show faster margin degradation after exclusivity than chronic specialty markets because procurement teams switch on cost and availability.

Market outlook: where growth can still come from

Growth is possible but usually limited to:

  • re-labeling or refined clinical use within existing imaging indications,
  • renewed guideline positioning in specific patient subgroups,
  • supply stabilization that restores predictable availability,
  • competitive displacement reversal when alternatives face limitations.

Without a new “must-use” clinical pathway, ferumoxides revenue typically does not re-accelerate to blockbuster behavior.

Financial trajectory signals to monitor

For FERUMOXIDES-style specialty imaging products, the best leading indicators are not pipeline endpoints but operational and market signals:

  • hospital formularies and radiology procurement updates,
  • total imaging contrast utilization trends by MRI modality mix,
  • ASP/net price changes tied to tender cycles,
  • supply continuity metrics and product availability,
  • label or guideline updates that affect lesion detection or organ imaging workflows.

Comparable dynamics: imaging agents with niche utilization

SPIO products often share:

  • smaller absolute revenue size versus large chronic medicines,
  • higher sensitivity to protocol change,
  • margin pressure after exclusivity,
  • revenue volatility driven by supply and procurement.

This means financial trajectories can remain stable for periods even while structural demand declines slowly in the background.

Key takeaways

  • FERUMOXIDES is a procedure-linked imaging agent, so revenue tracks imaging protocol adoption more than patient population growth.
  • Market demand is substitution-sensitive; MRI workflow shifts and competing agents can erode utilization without the need for major clinical failures.
  • Financial trajectory typically follows a post-peak plateau then gradual decline, with inflection points driven by procurement and supply continuity.
  • Pricing power is constrained by tender-based purchasing and reimbursement coverage, making net realization pressure likely post-exclusivity.
  • The most actionable indicators are formularies, imaging utilization mix, ASP/net realizations, and product availability rather than therapeutic pipeline events.

FAQs

1) Is FERUMOXIDES a high-volume commercial product?

No. Ferumoxides is a specialty injectable used in imaging workflows, so it behaves like a niche, procedure-linked product rather than a mass-market therapy.

2) What most affects FERUMOXIDES revenue: pricing or utilization?

Utilization typically dominates because adoption depends on imaging protocols, center procurement cycles, and substitute availability; pricing is largely constrained by contracting and reimbursement.

3) How does substitution risk work for ferumoxides?

Radiology centers shift contrast agent choices based on clinical guidance, workflow efficiency, and economic procurement. Once SPIO use declines in a protocol, revenue can fall quickly.

4) What operational factor can create revenue shocks?

Supply continuity. For specialty injectables, manufacturing disruptions can impact inventory and cause temporary utilization gaps that show up directly in revenue.

5) Does ferumoxides have clear growth levers?

Growth is most likely through refined label positioning within defined imaging indications, protocol reinstatement in specific patient subgroups, and stable availability that sustains usage where it already exists.


References

[1] FDA. “FERIDEX I.V. (ferumoxides) label and information.” U.S. Food and Drug Administration. (Accessed via FDA product labeling archive).
[2] EMA. “Ferumoxides: product information and assessment documents.” European Medicines Agency. (Accessed via EMA product database).
[3] PubMed. “Ferumoxides (iron oxide) contrast imaging clinical use and comparative studies.” National Library of Medicine. (Accessed via PubMed).

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