Last Updated: June 9, 2026

Sodium ferric gluconate complex - Generic Drug Details


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What are the generic drug sources for sodium ferric gluconate complex and what is the scope of patent protection?

Sodium ferric gluconate complex is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and Hikma, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for sodium ferric gluconate complex. Two suppliers are listed for this compound.

Summary for sodium ferric gluconate complex
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 2
Clinical Trials: 9
What excipients (inactive ingredients) are in sodium ferric gluconate complex?sodium ferric gluconate complex excipients list
DailyMed Link:sodium ferric gluconate complex at DailyMed
Recent Clinical Trials for sodium ferric gluconate complex

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

SponsorPhase
Rambam Health Care CampusPhase 4
University of MarylandPhase 4
University of Maryland, BaltimorePhase 4

See all sodium ferric gluconate complex clinical trials

Pharmacology for sodium ferric gluconate complex

US Patents and Regulatory Information for sodium ferric gluconate complex

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE sodium ferric gluconate complex INJECTABLE;INJECTION 078215-001 Mar 31, 2011 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us FERRLECIT sodium ferric gluconate complex INJECTABLE;INJECTION 020955-001 Feb 18, 1999 AB RX Yes Yes ⤷  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

Sodium Ferric Gluconate Complex: Market Dynamics and Financial Trajectory

Last updated: April 27, 2026

What is the sodium ferric gluconate complex market and how does it behave across regions?

Sodium ferric gluconate complex is an IV iron replacement product used to treat iron deficiency when oral therapy is inadequate or when rapid repletion is clinically indicated. Market behavior is shaped by (1) dosing unit economics per gram of iron delivered, (2) competitive positioning against other IV iron regimens, (3) reimbursement design for infusions, and (4) hospital-administered drug purchasing dynamics.

Demand drivers

  • Chronic anemia prevalence and kidney disease burden: Sustained incidence of anemia-related conditions supports steady baseline demand in dialysis and non-dialysis settings.
  • Shift toward fewer, higher-dose administrations: Competitive IV iron products with large single-dose capabilities (or shorter chair time) tend to gain formulary leverage where infusion throughput is prioritized.
  • Hospital formulary governance: Contracting cycles and restricted formularies can delay or accelerate adoption independently of clinical uptake.
  • Safety and monitoring protocols: Low-risk safety profiles reduce friction, but facility-specific pharmacovigilance requirements still affect throughput and selection.

Core purchasing and utilization patterns

  • Primary channel: Hospital and specialty pharmacy dispensing for infusion administration.
  • Procurement mechanism: Group purchasing organization (GPO) contracts, tenders, and institutional conversion from “starter” to “mainstay” products after early utilization data.
  • Usage trigger: Clinical pathways for iron deficiency anemia and dialysis-associated anemia, plus perioperative iron deficiency management.

Competitive set that influences pricing and volume

Sodium ferric gluconate complex competes in the IV iron class, where the primary basis of competition is delivered elemental iron per infusion event, turnaround time, and net price after contracting rebates. The competitive pressure is structurally persistent because payers and hospitals evaluate IV iron as a substitute category.

Competitive axis Sodium ferric gluconate complex exposure What typically wins in IV iron formularies
Infusion convenience Typically faces preference shifts toward regimens that allow larger single administrations Larger dose per visit, shorter chair time
Net price after contracts Margin volatility tied to contracting and rebate structure Lowest delivered cost per gram and per treatment course
Utilization standardization Adoption depends on facility iron deficiency pathways Standard protocols that reduce variability
Safety workflow fit Operational fit depends on monitoring and adverse-event handling Straightforward administration and fewer operational constraints

How is the financial trajectory shaped by competition, dosing, and reimbursement?

The financial trajectory of sodium ferric gluconate complex tends to follow a class-driven pattern: steady underlying anemia care demand, offset by intense within-class substitution and periodic contract renegotiations.

Revenue mechanics that determine trajectory

  1. Volume sensitivity to formulary status

    • If it is the contracted default, revenue tracks anemia-related utilization.
    • If it loses formulary position to a single-dose or higher-dose alternative, volume can compress quickly.
  2. Pricing sensitivity to net contract economics

    • Published list prices often diverge from net realized prices due to discounts, rebates, and tender pricing.
    • Any net price compression from contracting or conversion can dominate unit economics even if clinical usage is stable.
  3. Dose delivery and per-treatment counting

    • IV iron products are evaluated by elemental iron delivered and “course cost,” not by brand name.
    • Products with fewer administrations reduce non-drug costs (nursing time and chair utilization). This can shift the hospital’s total cost-of-care even if the drug’s unit price is higher.
  4. Reimbursement constraints

    • In infusion settings, reimbursement design often emphasizes administration codes and bundled care. Hospitals optimize to maximize throughput and reduce the number of billable events needed for completion of iron repletion.

Expected trajectory pattern in practice

  • Early-to-mid lifecycle: Higher uptake when a facility standardizes iron replacement protocols.
  • Mature market: Growth caps, with revenue stability more dependent on contracts and substitution control than on new patient population.
  • Late lifecycle: Greater downward pressure as competing IV irons consolidate preferred positions through contracting and switching.

What are the key market dynamics that move share and margins?

1) Contracting cycles and “conversion risk”

IV iron drug selection is often managed through procurement schedules rather than clinical changes. Sodium ferric gluconate complex can experience step-changes in revenue around contract renewals, tender awards, and formulary updates.

Impact pathways

  • Win formulary: volume stabilizes and can grow if it aligns with local care pathways.
  • Lose formulary: volume declines even if clinical efficacy remains comparable.

2) Treatment course economics

Hospitals evaluate the all-in cost of achieving iron repletion, considering:

  • number of infusion visits
  • chair time and nursing workload
  • monitoring requirements
  • pharmacy handling and wastage patterns

Products that reduce visit count often gain preference because they lower operational burden.

3) Safety perception and operational workflows

Infusion products compete on safety profiles and the operational effort needed to manage hypersensitivity risk. Lower administrative friction supports sustained usage in high-throughput infusion centers.

4) Dialysis segment versus broader anemia management

Dialysis centers often have more standardized iron management protocols, which can support continuity of use. Outside dialysis, switching can happen faster due to broader provider variation and formulary dynamics.

How does product positioning translate to investment-relevant financial signals?

For business and investment analysis, sodium ferric gluconate complex financial trajectory should be interpreted through three actionable lenses: (1) share stability, (2) net pricing resilience, and (3) throughput-driven substitution risk.

Share stability indicators (what to track)

  • formulary presence by hospital system and dialysis provider
  • contracting renewal outcomes
  • documented switching events in dispensing and infusion utilization

Net pricing resilience indicators (what to track)

  • realized price versus list price
  • rebate intensity changes
  • tender pricing and allocation policies

Substitution risk indicators (what to track)

  • increased adoption of higher-dose or shorter-course IV iron regimens
  • infusion service operational changes targeting reduced chair time
  • changes to clinical pathways for iron deficiency anemia

What is the likely market evolution for the sodium ferric gluconate complex class?

The IV iron segment continues to evolve toward regimens that reduce administration burden and support operational efficiency. In that environment, sodium ferric gluconate complex typically faces:

  • chronic substitution pressure within the same therapeutic class
  • pricing compression when competitors secure preferred access through contracts
  • growth constraints once formularies standardize on a narrower list of products

This creates a financial trajectory characterized by stable demand at the class level but constrained brand-level growth, with earnings more sensitive to contracting than to underlying anemia incidence alone.

Key Takeaways

  • Sodium ferric gluconate complex operates in a mature, hospital-administered IV iron market where revenue and margin trajectory track formulary status and contract economics more than new demand creation.
  • The dominant market dynamics are within-class substitution driven by infusion visit count, chair time, and delivered elemental iron per course, which affects net realized pricing and volume.
  • Financial trajectory is typically step-like around contracting cycles, with the main downside risk coming from switches to higher-dose or fewer-administration alternatives and the main upside coming from sustained preferred formulary inclusion.

FAQs

  1. Is sodium ferric gluconate complex primarily a hospital product?
    Yes. IV iron is commonly administered in hospital and infusion settings, with selection governed by institutional formularies and infusion workflow.

  2. What drives revenue changes for sodium ferric gluconate complex?
    The largest drivers are formulary status, tender/contract outcomes, and net pricing versus competitors for achieving iron repletion.

  3. How does dosing and administration frequency affect competitiveness?
    Hospitals optimize for total treatment course cost, including chair time and infusion visit count. Regimens that reduce visits can displace alternatives even when clinical equivalence exists.

  4. Does dialysis care change market dynamics?
    Yes. Dialysis centers often use standardized protocols, which can sustain utilization, while non-dialysis settings can switch faster based on local formularies and provider practice.

  5. What operational factor most influences switching away from IV iron products?
    Infusion workflow efficiency, especially chair time and the number of administrations needed to complete iron repletion.

References

[1] FDA. Drug Approval Package: Ferrlecit (sodium ferric gluconate complex). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. Ferrlecit (sodium ferric gluconate complex) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] National Kidney Foundation. Iron Deficiency in Chronic Kidney Disease. https://www.kidney.org/

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