List of Excipients in Branded Drug SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

Generic Drugs Containing SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	sodium ferric gluconate complex in sucrose	0143-9298	BENZYL ALCOHOL
Hikma Pharmaceuticals USA Inc	sodium ferric gluconate complex in sucrose	0143-9298	SUCROSE
Hikma Pharmaceuticals USA Inc	sodium ferric gluconate complex in sucrose	0143-9298	WATER
Hikma Pharmaceuticals USA Inc	sodium ferric gluconate complex in sucrose	0143-9570	BENZYL ALCOHOL
Hikma Pharmaceuticals USA Inc	sodium ferric gluconate complex in sucrose	0143-9570	SUCROSE

What are the Most Frequently-Used Excipients in SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE?

# Of NDCs	Excipient
2	BENZYL ALCOHOL
2	SUCROSE
2	WATER

Last updated: August 16, 2026

ecutive summary: Sodium ferric gluconate complex in sucrose is a mature intravenous iron product with limited formulation-patent protection and substantial generic competition. The commercial opportunity is in differentiated excipient and presentation design rather than exclusivity around the active complex. The strongest strategies are preservative-free single-dose presentations, improved container compatibility, lower extractables, ready-to-administer packaging, and formulations optimized for stability, tolerability, and institutional workflow. The reference product, Ferrlecit, is indicated for iron-deficiency anemia in adults and pediatric patients aged six years and older with chronic kidney disease receiving hemodialysis and supplemental epoetin therapy.[1]

Sodium Ferric Gluconate Complex in Sucrose: Excipient Strategy, Patent Position, and Commercial Opportunities

What is sodium ferric gluconate complex in sucrose?

Sodium ferric gluconate complex in sucrose is an intravenous iron-carbohydrate complex marketed in the United States under the Ferrlecit brand. The product is administered primarily in dialysis settings and supplies 62.5 mg of elemental iron per 5 mL vial or ampule, depending on presentation.[1]

The product is not a conventional small-molecule solution. Its critical quality attributes arise from the interaction of iron, gluconate, sucrose, water, container materials, and processing conditions. The commercial product therefore depends on control of:

• Iron oxidation state and complex structure
• Labile and non-labile iron fractions
• Particle size and colloidal distribution
• pH and osmolality
• Visible and subvisible particulate matter
• Extractables and leachables
• Container closure integrity
• Dilution and infusion compatibility
• Microbial control and preservative exposure

The formulation is delivered intravenously, making excipient selection more restrictive than for oral or topical products. Excipient changes can affect tolerability, iron release, infusion reactions, stability, and comparability to the reference product.

What excipients are used in Ferrlecit and related products?

The reference formulation uses sucrose as part of the iron-carbohydrate complex system. The commercial presentation also contains water for injection and benzyl alcohol in the labeled formulation.[1] The precise regulatory classification of formulation components matters because a component may function as a complexing ligand, stabilizer, solvent, preservative, or process aid even when it is not treated as a conventional inactive ingredient in the same way as an oral tablet excipient.

Core formulation functions

Component or attribute	Primary function	Commercial significance
Ferric gluconate complex	Iron delivery system	Determines elemental iron content, release profile, and clinical performance
Sucrose-associated complex matrix	Colloidal stabilization and iron complex formation	Affects complex integrity, labile iron, and infusion tolerability
Water for injection	Vehicle	Controls concentration, conductivity, and injectable quality
Benzyl alcohol, where present	Antimicrobial preservative	Creates pediatric, neonatal, and preservative-free positioning issues
Container closure	Product protection	Can affect iron adsorption, leachables, oxidation, and particulate generation
pH control	Stability and tolerability	Influences complex behavior and injection-site or systemic tolerability
Nitrogen or oxygen control during processing	Oxidation management	May reduce degradation and container-headspace variability

The most important excipient decision is whether to retain a preserved multi-dose or conventional presentation or develop a preservative-free, single-dose product. A preservative-free option can expand use in pediatric institutions and reduce concerns about benzyl alcohol exposure. It also increases packaging, sterility assurance, and unit-cost requirements.

What formulation patents protect sodium ferric gluconate complex in sucrose?

The core Ferrlecit product is a mature injectable iron formulation. Its original product and formulation protection has largely expired, and current U.S. generic competition limits the practical value of broad composition claims covering sodium ferric gluconate complex in sucrose.

The main patent opportunity is not a broad claim to the active complex. It is a narrower claim directed to a technically differentiated product, such as:

• A defined iron-to-carbohydrate ratio
• A specified molecular-weight or particle-size distribution
• A controlled labile-iron fraction
• A preservative-free formulation with defined stability
• A low-particulate formulation
• A defined container or closure system
• A method for reducing infusion reactions
• A manufacturing process that produces a reproducible complex profile
• A ready-to-use diluted formulation with extended in-use stability
• A formulation compatible with a particular dialysis or infusion device

Patent strength depends on whether the formulation difference is measurable and clinically or technically meaningful. A claim covering only the substitution of one standard parenteral excipient for another is vulnerable to obviousness and lack of unexpected results. A claim tied to improved stability, reduced labile iron, lower particulate burden, or better container compatibility is more defensible.

When does sodium ferric gluconate complex lose exclusivity?

U.S. market exclusivity for sodium ferric gluconate complex in sucrose has already ended. Ferrlecit was approved by the FDA in 1999, and generic products have been approved for the same active ingredient and route of administration.[1,2]

Exclusivity and patent timeline

Event	Timing or status
Ferrlecit U.S. approval	1999
Reference product	Sodium ferric gluconate complex in sucrose injection
Regulatory pathway for later entrants	ANDA approval under the Hatch-Waxman Act
Core market exclusivity	Expired
Broad original product protection	Expired or commercially ineffective against approved generics
Current competitive issue	Product quality, supply, contracting, and differentiated presentation
New-product opportunity	Formulation, device, manufacturing, or use-specific protection

The absence of meaningful core exclusivity does not eliminate commercial value. It shifts value from exclusivity to manufacturing economics, hospital contracting, supply reliability, and clinical workflow.

What is the Orange Book status of Ferrlecit?

Ferrlecit is listed in FDA drug databases as a reference product for sodium ferric gluconate complex in sucrose injection.[2,3] Approved generic products compete with the reference product, and the market is not protected by an active new chemical entity exclusivity period.

An Orange Book listing is important for the historical patent record, but it is not the principal barrier for a new commercial entrant. A new excipient strategy would generally need to establish either:

1. An ANDA-compatible formulation with no meaningful clinical differentiation; or
2. A differentiated drug product requiring a separate 505(b)(2) strategy.

A 505(b)(2) pathway may be relevant when the product differs in preservative content, concentration, container, administration method, dilution requirements, or other formulation characteristics that are not fully covered by the reference product’s labeling. The pathway can reduce development requirements but does not automatically create enforceable market exclusivity.

What excipient strategy has the strongest commercial potential?

1. Preservative-free single-dose presentation

A preservative-free product is the clearest excipient-led opportunity. Removing benzyl alcohol can improve positioning for pediatric hospitals, patients with heightened preservative sensitivity, and institutions seeking standardized single-dose sterile products.

The strategy requires:

• Single-dose container configuration
• Validated aseptic processing or terminal sterilization, where feasible
• Strong container closure integrity
• Stability data without preservative protection
• Control of microbial ingress during preparation and administration
• Clear discard and in-use instructions

The commercial benefit is greatest if the product retains the same elemental iron dose and infusion workflow as the reference product.

2. Ready-to-administer formulation

Dialysis centers and hospitals value reduced pharmacy preparation. A ready-to-administer product could be supplied in a prefilled syringe, small-volume bag, or standardized infusion container.

Potential advantages include:

• Lower compounding labor
• Lower risk of preparation errors
• Reduced occupational exposure
• Faster chair turnover in dialysis units
• More predictable billing and inventory management

The principal technical issue is compatibility with the selected container, tubing, and infusion set. Iron-carbohydrate complexes can interact with surfaces, filters, and tubing materials. A ready-to-use product therefore needs robust adsorption, particulate, and extractables data.

3. Lower-volume, higher-concentration presentation

A higher-concentration formulation could reduce infusion volume and simplify administration. This approach has commercial value in dialysis settings where patients receive repeated intravenous treatments.

The risk is that increasing concentration can change:

• Osmolality
• Viscosity
• Complex stability
• Free iron levels
• Infusion tolerability
• Container interaction
• Precipitation behavior after dilution

A concentration increase should be supported by comparative data on iron speciation, labile iron, infusion reactions, and administration time.

4. Improved container and closure system

A container-focused strategy may provide stronger intellectual-property differentiation than a conventional excipient substitution. Candidate features include:

• Low-iron-sorption glass or polymer
• Low-extractable elastomer stopper
• Reduced oxygen-permeability closure
• Light-protective packaging
• Prefilled delivery system
• Single-dose unit designed for dialysis workflow

Container claims can be combined with formulation claims when the interaction between the formulation and packaging produces a measurable stability benefit.

5. Improved dilution and in-use stability

The label directs dilution and administration under defined conditions.[1] A product with extended stability after dilution could reduce pharmacy waste and improve scheduling flexibility. Relevant variables include:

• Diluent selection
• Dilution concentration
• Storage temperature
• Light exposure
• Time to administration
• Infusion-set compatibility
• Visible and subvisible particles
• Iron release profile

This strategy is commercially attractive but requires disciplined claim drafting. A patent should identify the specific concentration, diluent, storage period, container, and quality threshold rather than claim “improved stability” in general terms.

How strong is the patent estate for sodium ferric gluconate complex in sucrose?

The core patent estate is weak for exclusivity purposes because the reference product is old and generic products are established. A new entrant should not assume that broad claims to sodium ferric gluconate complex, sucrose, or intravenous iron administration will block competitors.

Relative strength of potential claim categories

Claim category	Likely commercial strength	Reason
Broad composition containing ferric gluconate and sucrose	Low	Closely associated with the mature reference product
Preservative-free formulation	Moderate	Useful if supported by stability and product-quality advantages
Specific particle-size or iron-release profile	Moderate to high	Stronger when linked to reproducible performance
Container-formulation combination	Moderate	Depends on demonstrated compatibility benefit
Ready-to-administer presentation	Moderate	May support product differentiation, but design-around risk is high
Manufacturing process	Moderate	Stronger when process parameters determine a unique complex profile
Method of use in dialysis	Low to moderate	Broad use claims face prior-art and obviousness challenges
Reduced infusion reaction method	Potentially high	Requires credible clinical or pharmacologic evidence

Patent term is also a constraint. A new U.S. application filed on a differentiated formulation generally receives a 20-year term from the earliest nonprovisional priority date, subject to patent-term adjustment and any applicable extension. A late-filed formulation patent may expire after the commercial opportunity has matured unless the product has clear differentiation and rapid adoption.

Which companies are challenging or competing with Ferrlecit?

The competitive set includes the reference product, authorized or conventional generics, and alternative intravenous iron products.

Product	Active iron system	Typical market position
Ferrlecit	Sodium ferric gluconate complex in sucrose	Reference product; dialysis-focused
Generic sodium ferric gluconate complex in sucrose	Same active complex	Price competition and formulary substitution
Venofer	Iron sucrose	Major alternative intravenous iron
Feraheme	Ferumoxytol	Higher-dose alternative with different administration profile
Injectafer	Ferric carboxymaltose	High-dose replacement and outpatient use
Monoferric	Ferric derisomaltose	Large-dose replacement and reduced administration frequency

The closest direct competitors are generic sodium ferric gluconate products and iron sucrose. Ferric carboxymaltose, ferumoxytol, and ferric derisomaltose compete by reducing administration frequency or increasing dose per treatment rather than by matching Ferrlecit’s exact formulation.

What generic entry risks exist for a new sodium ferric gluconate product?

A new generic entrant faces relatively low patent risk but meaningful commercial and technical risk.

Regulatory risks

The FDA may focus on:

• Equivalence to the reference product
• Elemental iron content
• Complex characterization
• Batch-to-batch consistency
• Sterility and endotoxin control
• Particulate matter
• Extractables and leachables
• Preservative content
• Stability after dilution
• Container closure integrity

Iron-carbohydrate complexes are more difficult to characterize than simple aqueous solutions. The sponsor must establish that the proposed product is sufficiently comparable in clinically relevant attributes, even where conventional small-molecule bioequivalence methods do not fully describe the product.

Commercial risks

Price erosion is likely because generic competition already exists. A new entrant needs one of the following:

• Lower cost of goods
• Reliable supply during shortages
• A preservative-free presentation
• A ready-to-use delivery system
• Contracting advantages for dialysis providers
• Better packaging and inventory efficiency
• A differentiated 505(b)(2) product with targeted exclusivity

What licensing and partnership opportunities exist?

Licensing opportunities are more likely to involve manufacturing, packaging, or distribution than rights to the expired core Ferrlecit technology.

Potential transaction structures include:

• Contract manufacturing of sterile iron complexes
• Regional rights for generic injectable iron products
• Co-development of preservative-free presentations
• Hospital or dialysis-network supply agreements
• Device partnerships for prefilled syringes or infusion bags
• Technology licenses for container systems
• Formulation development partnerships focused on stability and particulate control

A license is most defensible when it transfers a protected manufacturing process, validated container system, proprietary analytical method, or established regulatory package. A license covering only the active ingredient and basic sucrose formulation has limited strategic value.

What revenue exposure and market opportunities matter most?

Revenue exposure is concentrated in dialysis and hospital infusion channels. The product’s repeated-use profile creates predictable demand, but purchasing is sensitive to reimbursement, formulary status, shortages, and contracting.

The largest commercial opportunities are:

1. Institutional supply contracts with dialysis providers
2. Preservative-free pediatric and hospital presentations
3. Ready-to-administer products that reduce pharmacy labor
4. Higher-concentration products that reduce administration burden
5. Reliable supply of generic product during manufacturing disruptions
6. International markets where intravenous iron access is expanding
7. Contract manufacturing for private-label injectable iron products

The commercial ceiling is constrained by competition from newer high-dose intravenous irons. A differentiated sodium ferric gluconate product is more likely to win on cost and workflow than on premium clinical pricing.

Key Takeaways

• Sodium ferric gluconate complex in sucrose is a mature intravenous iron product with expired core exclusivity and established generic competition.
• The strongest commercial strategy is excipient and presentation differentiation, not a broad composition claim.
• Preservative-free, single-dose packaging is the clearest opportunity.
• Ready-to-administer formats can create value by reducing pharmacy and dialysis-center labor.
• Container closure, particulate control, dilution stability, and labile-iron management are central technical priorities.
• A 505(b)(2) strategy may be relevant for meaningful formulation or administration differences.
• Patent claims should focus on measurable formulation, manufacturing, container, or performance attributes.
• The primary commercial risks are price erosion, complex-product comparability, supply reliability, and substitution by higher-dose intravenous iron products.

FAQs about sodium ferric gluconate excipients and commercial strategy

Can benzyl alcohol be removed from sodium ferric gluconate injection?

Yes, a preservative-free single-dose formulation is a technically and commercially plausible development strategy. Removing benzyl alcohol requires new sterility, stability, container closure, and in-use data.

Is sucrose an excipient or part of the active iron complex?

Sucrose is associated with the iron-carbohydrate complex system and may not be treated solely as a conventional inactive ingredient. Regulatory classification depends on the product’s formulation and manufacturing description.

Can a new excipient create patent protection for Ferrlecit?

An excipient alone rarely creates strong patent protection. The best claims link the excipient or packaging system to a defined technical result, such as reduced labile iron, improved stability, lower particulate burden, or improved tolerability.

Would a higher-concentration product require a new FDA application?

A materially different concentration, preservative profile, container, or administration method may require a 505(b)(2) application rather than a conventional ANDA, depending on the proposed product and FDA requirements.

Which intravenous iron competitor poses the greatest commercial threat?

Generic iron sucrose is the closest cost competitor. Ferric carboxymaltose, ferumoxytol, and ferric derisomaltose pose a greater workflow threat because they can provide larger iron doses with fewer administrations.

References

1. U.S. Food and Drug Administration. (2024). Ferrlecit (sodium ferric gluconate complex in sucrose) injection prescribing information. FDA.
2. U.S. Food and Drug Administration. (2024). Drugs@FDA: Ferrlecit application and approval history. FDA.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.
4. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP.