Drugs Containing Excipient (Inactive Ingredient) SODIUM OLEATE

« Back to Dashboard

Branded drugs containing SODIUM OLEATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
B Braun Medical Inc	NUTRILIPID I.V. FAT EMULSION	soybean oil	0264-4460	SODIUM OLEATE
Baxter Healthcare Corporation	CLINOLIPID	olive oil and soybean oil	0338-9540	SODIUM OLEATE	2027-04-24
Heron Therapeutics Inc	CINVANTI	aprepitant	47426-201	SODIUM OLEATE
Heron Therapeutics Inc	APONVIE	aprepitant	47426-401	SODIUM OLEATE
Fresenius Kabi USA LLC	OMEGAVEN	fish oil	63323-205	SODIUM OLEATE	2026-07-30

Generic drugs containing SODIUM OLEATE excipient

Company	Ingredient	NDC	Excipient
B Braun Medical Inc	soybean oil	0264-4460	SODIUM OLEATE
Baxter Healthcare Corporation	olive oil and soybean oil	0338-9540	SODIUM OLEATE
Heron Therapeutics Inc	aprepitant	47426-201	SODIUM OLEATE
Heron Therapeutics Inc	aprepitant	47426-401	SODIUM OLEATE
Fresenius Kabi USA LLC	fish oil	63323-205	SODIUM OLEATE

Sodium Oleate Excipient Market Dynamics, Pricing, Manufacturing, and Financial Outlook

Last updated: August 27, 2026

Sodium oleate is a low-cost oleochemical excipient and surfactant with demand tied to topical formulations, emulsions, detergents, cosmetics, research reagents, and industrial applications. Its standalone pharmaceutical market is small and poorly disclosed. Public companies generally report sodium oleate within broader oleochemicals, surfactants, specialty chemicals, or excipient portfolios rather than as a separate revenue line.

The financial outlook is therefore driven less by pharmaceutical volume growth than by feedstock pricing, formulation substitution, regional manufacturing capacity, compendial acceptance, and customer qualification requirements.

What is sodium oleate and how is it used as a pharmaceutical excipient?

Sodium oleate is the sodium salt of oleic acid. It is commonly identified by CAS Registry Number 143-19-1 and has the molecular formula C18H33NaO2. The compound is an anionic surfactant with emulsifying, wetting, solubilizing, and dispersion properties.

Attribute	Sodium oleate
Chemical name	Sodium 9-octadecenoate
CAS number	143-19-1
Molecular formula	C18H33NaO2
Source	Oleic acid, usually derived from vegetable oils or animal fats
Functional class	Surfactant, emulsifier, wetting agent, dispersant
Pharmaceutical role	Excipient or formulation aid, depending on dosage form and jurisdiction
Commercial form	Powder, flakes, pellets, or aqueous solution
Primary cost driver	Oleic acid and vegetable-oil feedstock
Key quality risks	Oxidation, free fatty acid content, water content, impurities, color, odor

Sodium oleate can be used where an anionic surfactant is acceptable. Potential applications include topical emulsions, suspensions, cleansing formulations, lipid systems, and laboratory or process formulations. Its use in sterile parenteral products is more constrained because surfactant tolerance, impurity control, hemolysis risk, and route-specific safety requirements are more demanding.

The excipient should not be confused with sodium oleate used as an industrial soap, flotation reagent, corrosion inhibitor, or detergent. These markets are materially larger and can influence supply and pricing even when pharmaceutical demand is stable.

What is the global sodium oleate excipient market size?

No reliable public source reports a standalone global revenue figure for pharmaceutical-grade sodium oleate. Market reports typically combine it with fatty-acid salts, oleochemicals, surfactants, emulsifiers, or specialty excipients. Supplier catalogs also do not provide sufficient shipment data to calculate market revenue.

A defensible market model must therefore separate three layers:

1. Total sodium oleate production across industrial, cosmetic, research, and pharmaceutical uses.
2. Pharmaceutical- and healthcare-qualified sodium oleate.
3. Revenue attributable specifically to sodium oleate used as a registered pharmaceutical excipient.

The third category is likely a small fraction of the broader sodium oleate market. Pharmaceutical demand is usually purchased through qualified excipient suppliers, contract manufacturers, or distributors. Volumes are limited compared with detergent and industrial applications, but margins can be higher because of documentation, testing, audit, change-control, and regulatory support.

How should investors measure the sodium oleate market?

The most useful financial indicators are not reported sodium oleate revenues. They are:

Indicator	Financial relevance
Oleic acid and palm-oil pricing	Determines raw-material cost and supplier margin
Pharmaceutical-grade share	Indicates achievable pricing premium
Number of qualified suppliers	Measures supply concentration and switching risk
Customer qualification duration	Determines pricing power and retention
Compendial status	Reduces customer regulatory burden
Batch-size economics	Affects cost for low-volume pharmaceutical orders
Oxidation and impurity specifications	Determines process yield and release cost
Regional production capacity	Affects freight, tariffs, and supply continuity
Use in approved products	Indicates recurring demand rather than catalog demand

Supplier quotations are usually more informative than generic market reports. Pricing varies by purity, packaging, documentation, test method, origin, minimum order quantity, and whether the product is manufactured under an excipient quality system.

What is driving demand for sodium oleate in pharmaceutical formulations?

Demand is supported by several technical and commercial factors.

Formulation functionality

Sodium oleate can reduce interfacial tension and assist dispersion or emulsification. Formulators may evaluate it when they need an anionic surfactant with a fatty-acid-derived structure.

Oleochemical sourcing

Oleic acid is widely available from vegetable-oil and animal-fat processing. This supports broad sourcing, although feedstock composition varies by geography and supplier. Palm-derived and tallow-derived materials can carry different customer acceptance, sustainability, and regulatory implications.

Cost advantage

Sodium oleate is generally less expensive than many specialty surfactants and polymeric emulsifiers. Its cost advantage is strongest in non-sterile, non-biologic, and non-highly sensitive formulations.

Application expansion outside pharmaceuticals

Cosmetic, personal-care, detergent, metalworking, and industrial customers create manufacturing scale. Pharmaceutical customers can benefit from that scale when the supplier operates a segregated and properly documented grade.

Substitution pressure

Sodium oleate competes with polysorbates, sorbitan esters, sodium stearate, sodium lauryl sulfate, lecithin, poloxamers, and other fatty-acid salts. Substitution is common when a formulation requires lower irritation, better oxidative stability, nonionic behavior, lower foaming, or stronger global regulatory precedent.

How does sodium oleate compare with competing excipients?

Excipient	Primary advantage	Main limitation versus sodium oleate
Sodium oleate	Low-cost anionic surfactant; oleochemical sourcing	Oxidation sensitivity and limited use in sensitive routes
Sodium stearate	Saturated fatty-acid salt; better oxidative stability	Different melting and dispersion characteristics
Sodium lauryl sulfate	Strong wetting and detergent action	Irritation and toxicity concerns at higher exposure
Polysorbate 20/80	Broad pharmaceutical use and nonionic behavior	Higher price; peroxide and degradation concerns
Lecithin	Biocompatibility and lipid-formulation utility	More complex composition and variable performance
Poloxamer 188	Established injectable and biologic formulation use	Higher cost and more limited surfactant chemistry
Sorbitan oleate	Lipophilic emulsifier	Different HLB profile and formulation behavior

Sodium oleate is most competitive in formulations where price, fatty-acid functionality, and anionic surface activity matter more than premium regulatory familiarity.

What is the FDA regulatory status of sodium oleate?

Sodium oleate does not have an independent FDA approval as a drug. Its acceptability depends on its use in a specific drug product, route of administration, concentration, manufacturing process, and safety justification.

The FDA Inactive Ingredient Database is the principal public reference for excipient precedent in approved drug products. An IID listing can support formulation development, but it does not automatically authorize every route, concentration, specification, or dosage form. Sponsors must compare the proposed use with the relevant IID record and assess whether additional safety or regulatory support is required (U.S. Food and Drug Administration, n.d.-a).

FDA excipient review can occur through several pathways:

• Inclusion in an approved drug application.
• A new drug application or abbreviated new drug application containing the excipient.
• A drug master file supplied by the excipient manufacturer.
• A safety justification in a product-specific regulatory submission.
• Qualification under applicable pharmacopeial and quality standards.

Pharmaceutical customers generally require a current specification, certificate of analysis, residual-solvent controls, elemental-impurity assessment, microbial limits, stability data, change-control procedures, and supply-chain traceability. The burden increases substantially for ophthalmic, inhaled, injectable, and biologic products.

Is sodium oleate listed in the Orange Book?

Sodium oleate is not an active pharmaceutical ingredient with its own Orange Book product listing. The FDA Orange Book identifies approved drug products and related patent and exclusivity information. Excipients normally do not appear as independent Orange Book products (U.S. Food and Drug Administration, n.d.-b).

The practical implications are:

• No sodium oleate Orange Book exclusivity period exists.
• No standalone sodium oleate Paragraph IV pathway exists.
• Drug-product patents may cover formulations containing sodium oleate, but those rights belong to the finished product and its formulation claims.
• An excipient supplier generally does not control generic entry unless it owns relevant manufacturing, composition, or formulation patents.

What patents protect sodium oleate formulations and manufacturing?

The sodium oleate molecule is old and broadly available. Basic composition-of-matter patent protection is therefore not a meaningful commercial barrier. Patent value is more likely to arise from:

• A particular pharmaceutical formulation containing sodium oleate.
• A defined concentration range or particle-size distribution.
• A delivery system or dosage form.
• A method for improving dispersion, stability, or bioavailability.
• A purification process that reduces oxidation products or trace contaminants.
• A combination with another surfactant, lipid, polymer, or active ingredient.
• A manufacturing process using a specified oleic-acid source or reaction condition.

Patent protection must be assessed at the product level. Without a defined drug product, formulation, jurisdiction, or assignee, no reliable patent-family list or expiration analysis can be assigned to sodium oleate generally.

Does sodium oleate face Paragraph IV or biosimilar risk?

No direct Paragraph IV risk applies to sodium oleate as an excipient. Paragraph IV certifications concern patents listed for approved drug products, not commodity excipients sold independently.

Biosimilar risk is also not directly applicable. Sodium oleate is not a biologic active ingredient. It can affect biologic manufacturing or formulation economics when used in a product, but any resulting patent dispute would concern the biologic or its formulation, not a standalone sodium oleate biosimilar.

How is sodium oleate manufactured?

Commercial sodium oleate is generally produced by neutralizing oleic acid with a sodium base such as sodium hydroxide or sodium carbonate. The process may involve heating, controlled mixing, drying, milling, and packaging.

A simplified process sequence is:

1. Source and qualify oleic acid.
2. Neutralize with a sodium reagent.
3. Control moisture, temperature, and reaction completion.
4. Dry or concentrate the product.
5. Mill or flake to the required physical form.
6. Test chemical, physical, and microbiological attributes.
7. Package under conditions that limit oxidation and moisture uptake.

Manufacturing barriers are low for technical-grade material but higher for pharmaceutical-grade supply. The key barriers are not reaction chemistry. They are consistent raw-material composition, oxidation control, validated analytical methods, contamination prevention, documentation, and customer qualification.

What manufacturing IP barriers exist?

Manufacturing patents may cover process optimization, but they are unlikely to prevent broad production of sodium oleate. More important commercial barriers include:

• Proprietary specifications accepted by major customers.
• Validated impurity methods.
• Long-term quality agreements.
• Audited production sites.
• Regulatory history.
• Customer-specific packaging and testing.
• Reliable access to qualified oleic acid.

These operational barriers can protect a supplier’s position even where the underlying chemistry is unpatented.

What is the sodium oleate pricing and margin trajectory?

Sodium oleate pricing generally follows the economics of oleic acid, vegetable oils, energy, packaging, freight, and currency. Feedstock volatility can materially affect supplier margins because pharmaceutical customers may resist immediate price increases under annual contracts.

Period	Likely financial driver
Short term	Oleic-acid and palm-oil fluctuations; freight and energy
Medium term	Qualification of regional suppliers; demand from personal care and industrial users
Longer term	Premium for documented pharmaceutical grades; substitution by nonionic excipients

Revenue growth is more likely to come from price, grade migration, and new customer qualification than from rapid unit-volume expansion in pharmaceuticals. A supplier can improve economics by selling a documented pharmaceutical grade rather than undifferentiated technical material.

Margin expansion depends on:

• Higher pharmaceutical-grade mix.
• Lower batch failure and rework rates.
• Better drying and packaging efficiency.
• Multi-year customer contracts.
• Regional production near customers.
• Qualification as a secondary or dual-source supplier.

Margin compression can result from feedstock oversupply, commodity competition, customer insourcing, or substitution with sodium stearate and nonionic surfactants.

Which companies compete in sodium oleate supply?

Competition is fragmented across oleochemical producers, specialty chemical manufacturers, excipient distributors, and laboratory reagent suppliers. Public product catalogs identify availability, but they do not prove pharmaceutical qualification or meaningful market share.

Relevant supplier categories include:

• Integrated oleochemical producers manufacturing fatty acids and fatty-acid salts.
• Specialty excipient manufacturers with pharmaceutical quality systems.
• Regional chemical companies producing sodium oleate to customer specifications.
• Distributors selling repackaged or imported material.
• Laboratory suppliers offering small-pack quantities at substantially higher unit prices.

Large oleochemical groups such as KLK OLEO, Emery Oleochemicals, Oleon, IOI Oleochemical, and Croda participate in adjacent fatty-acid or specialty-ingredient markets, although their public disclosures generally do not isolate sodium oleate revenue. Their presence indicates feedstock and manufacturing depth, not necessarily dominance in pharmaceutical sodium oleate.

What is the geographic coverage of the sodium oleate supply chain?

Asia-Pacific is central to oleochemical production because of palm-oil processing and downstream fatty-acid capacity. Europe has established specialty chemical and oleochemical infrastructure, while North America has access to imported and domestic fatty-acid supply.

Regional considerations include:

Region	Commercial characteristics
Asia-Pacific	Strong feedstock base and large-scale oleochemical manufacturing
Europe	High documentation, sustainability, and chemical-compliance requirements
North America	Established specialty chemical distribution and pharmaceutical customer base
Latin America	Relevant vegetable-oil production with developing downstream capacity
Middle East and Africa	More dependent on imports and regional distribution

Customers may require country-of-origin declarations, palm-oil sustainability documentation, animal-origin statements, allergen assessments, and compliance with regional chemical regulations.

What licensing deals and litigation affect sodium oleate?

No major public licensing transaction or widely reported patent litigation is identifiable for sodium oleate as a standalone pharmaceutical excipient. Commercial agreements are more likely to involve supply, distribution, private-label manufacturing, or quality agreements than technology licenses.

Litigation risk is usually indirect and product-specific. It may involve:

• A finished drug formulation containing sodium oleate.
• A delivery platform using fatty-acid salts.
• Manufacturing contamination or product liability.
• Contract disputes over specification changes or supply interruption.
• Regulatory claims involving excipient quality.

A generic entrant using sodium oleate would normally face the patent estate of the finished drug, not a standalone sodium oleate patent estate.

How strong is the sodium oleate excipient patent estate?

The standalone patent estate is weak from a composition-of-matter perspective because sodium oleate is an established chemical. Commercial defensibility is stronger in quality systems, customer qualification, process consistency, and supply reliability.

Protection type	Estimated strategic relevance
Basic sodium oleate composition patent	Low
General manufacturing process	Low to moderate
High-purity pharmaceutical grade	Moderate, mainly operational
Formulation-specific patent	Potentially high, product-dependent
Analytical and impurity-control methods	Moderate
Customer qualification and quality agreements	High commercial value
Supply-chain integration	Moderate to high

What generic launch risks exist for drugs using sodium oleate?

Sodium oleate itself is unlikely to delay generic entry. The relevant risks are:

• Formulation patents claiming the excipient combination.
• Method-of-use patents tied to the finished drug.
• Product-specific manufacturing patents.
• Difficulty matching release, stability, or bioequivalence performance.
• Limited availability of the same excipient grade.
• Regulatory scrutiny if the generic uses a different excipient concentration or supplier.

For conventional oral or topical products, substitution and sourcing risk are usually manageable. For sterile or complex products, excipient grade, impurity profile, and process interaction can become more material.

What is the commercial outlook for sodium oleate?

The base case is stable, low-to-moderate growth in pharmaceutical demand, with stronger growth in broader oleochemical and specialty surfactant applications. The pharmaceutical segment should remain niche because formulators have many alternatives and sodium oleate has route-specific limitations.

The most attractive commercial opportunities are:

1. Pharmaceutical-grade supply with strong documentation.
2. Dual-source qualification for customers seeking supply resilience.
3. Low-oxidation or high-purity grades.
4. Custom particle size, concentration, or solution formats.
5. Regional supply in markets dependent on imports.
6. Formulation support for topical, lipid, and emulsion products.

The main downside risks are substitution, low customer concentration, commodity price competition, and the lack of proprietary exclusivity.

Key Takeaways

• Sodium oleate is a low-cost anionic surfactant and fatty-acid salt used in selected pharmaceutical and broader chemical applications.
• No reliable public standalone revenue figure exists for the pharmaceutical sodium oleate market.
• Financial performance is governed mainly by oleic-acid feedstock costs, grade premiums, customer qualification, and regional supply.
• Sodium oleate has no independent Orange Book listing, Paragraph IV exposure, or biosimilar pathway.
• Composition-of-matter patent protection is not a meaningful barrier. Formulation and process patents may matter for specific drug products.
• Pharmaceutical-grade manufacturing is differentiated by impurity control, oxidation management, documentation, and regulatory support.
• The strongest commercial strategy is to sell qualified, well-documented material rather than undifferentiated commodity sodium oleate.
• Pharmaceutical demand is likely to remain niche, while industrial, cosmetic, and detergent markets provide the larger volume base.

FAQs

Is sodium oleate safe as a pharmaceutical excipient?

Safety depends on route, dose, concentration, impurity profile, and formulation context. A supplier’s technical-grade status does not establish suitability for a drug product. Sponsors must support the proposed use through regulatory precedent, toxicology, product-specific data, or a combination of these sources.

Is pharmaceutical-grade sodium oleate interchangeable between suppliers?

Not automatically. Differences in oleic-acid composition, oxidation products, moisture, particle size, residual impurities, and manufacturing conditions can affect formulation performance. Supplier changes may require comparability testing, stability work, and regulatory notification.

Can sodium oleate be used in injectable medicines?

Potentially, but injectable use requires substantially stronger safety and quality support than topical or industrial use. Surfactant concentration, route-specific tolerability, sterility controls, endotoxin limits, and interaction with the active ingredient are critical.

Does palm-oil volatility directly determine sodium oleate prices?

Palm oil is an important upstream influence, but pricing also reflects oleic-acid composition, alternative feedstocks, energy, processing yield, logistics, packaging, currency, and pharmaceutical-grade testing. The relationship is directional rather than one-to-one.

Is sodium oleate a good target for excipient investment?

It is more attractive as part of an integrated oleochemical or specialty-excipient platform than as a standalone high-growth pharmaceutical asset. Value is strongest where a supplier has qualified pharmaceutical customers, documented grades, regional manufacturing, and differentiated quality control.

References

1. European Chemicals Agency. (n.d.). Sodium oleate: Substance information. ECHA.

2. Food and Agriculture Organization of the United Nations & Organisation for Economic Co-operation and Development. (2023). OECD-FAO agricultural outlook 2023-2032. OECD Publishing.

3. U.S. Food and Drug Administration. (n.d.-a). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

4. U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

5. United States Pharmacopeia. (n.d.). National formulary and excipient standards. United States Pharmacopeial Convention.

6. U.S. Department of Agriculture, Foreign Agricultural Service. (2024). Oilseeds: World markets and trade. U.S. Department of Agriculture.