Drugs Containing Excipient (Inactive Ingredient) PEG-150 DISTEARATE

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Branded drugs containing PEG-150 DISTEARATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Henry Schein Inc	MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%	chlorhexidine gluconate	0404-0175	PEG-150 DISTEARATE
Henry Schein Inc	MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%	chlorhexidine gluconate	0404-0176	PEG-150 DISTEARATE
Henry Schein Inc	MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%	chlorhexidine gluconate	0404-0219	PEG-150 DISTEARATE
Henry Schein Inc	MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%	chlorhexidine gluconate	0404-0220	PEG-150 DISTEARATE
Henry Schein Inc	MAXICLENS CHLORHEXIDINE GLUCONATE LIQUID SOLUTION, 4%	chlorhexidine gluconate	0404-0221	PEG-150 DISTEARATE

Generic drugs containing PEG-150 DISTEARATE excipient

Company	Ingredient	NDC	Excipient
Henry Schein Inc	chlorhexidine gluconate	0404-0175	PEG-150 DISTEARATE
Henry Schein Inc	chlorhexidine gluconate	0404-0176	PEG-150 DISTEARATE
Henry Schein Inc	chlorhexidine gluconate	0404-0219	PEG-150 DISTEARATE
Henry Schein Inc	chlorhexidine gluconate	0404-0220	PEG-150 DISTEARATE
Henry Schein Inc	chlorhexidine gluconate	0404-0221	PEG-150 DISTEARATE

PEG-150 Distearate Market Dynamics, Pharmaceutical Demand, Suppliers, and Financial Outlook

Last updated: October 15, 2026

PEG-150 distearate is a specialty nonionic surfactant and viscosity modifier used mainly in topical, dermatological, cleansing, and personal-care formulations. Its pharmaceutical market is relatively small compared with high-volume excipients such as polyethylene glycol, povidone, cellulose derivatives, and polysorbates. The commercial outlook is stable rather than high-growth, with demand linked to semi-solid dosage forms, liquid cleansers, formulation redesign, and regional manufacturing capacity.

The product’s financial profile is driven by raw-material costs, especially stearic acid and ethylene oxide, rather than by patent exclusivity. No Orange Book-listed drug, Paragraph IV litigation pathway, biosimilar exposure, or meaningful originator-drug patent moat is associated with PEG-150 distearate as an excipient.

What is PEG-150 distearate and how is it used?

PEG-150 distearate is a polyethylene glycol ester of stearic acid. It is also identified as polyethylene glycol 150 distearate, PEG-150 distearate, and polyoxyl 150 distearate in some technical and compendial contexts. The material is generally supplied as a waxy solid, flake, bead, or pastille.

Its primary formulation functions are:

Function	Pharmaceutical application
Viscosity modifier	Creams, lotions, gels, shampoos, liquid cleansers
Nonionic surfactant	Emulsification and solubilization support
Thickener	Topical and dermatological products
Rheology controller	Controlled flow and suspension stability
Texture modifier	Semi-solid and wash-off formulations
Co-emulsifier	Oil-in-water systems and cleansing bases

PEG-150 distearate is used more often in topical and cleansing products than in oral solid-dose medicines. It is particularly relevant where formulators need a nonionic, relatively mild thickener that is compatible with surfactants and broad pH ranges.

The material should not be confused with macrogol 150, polyethylene glycol 150, or PEG 1500. Those materials have different molecular structures, functionality, and formulation behavior.

What is the pharmaceutical market size for PEG-150 distearate?

No reliable public source reports a standalone global revenue figure for PEG-150 distearate. Manufacturers generally report it within broader categories such as specialty surfactants, personal-care ingredients, pharmaceutical excipients, or polyethylene glycol derivatives.

The addressable pharmaceutical market is therefore best assessed through end-use demand rather than a reported product category.

Market segment	Relative importance for PEG-150 distearate	Demand outlook
Topical pharmaceuticals	High	Stable to moderate growth
Dermatology and medicated cleansers	High	Moderate growth
Oral solid dosage	Low	Limited
Parenteral products	Very low	Minimal
Consumer health products	Moderate	Stable
Cosmetics and toiletries	Very high	Larger than pharmaceutical demand
Veterinary topicals	Selective	Moderate regional growth

The commercial center of gravity is the cosmetics and personal-care market. Pharmaceutical sales are usually a smaller portion of total volume, although pharmaceutical-grade material can command a premium because of tighter documentation, lot controls, traceability, and quality agreements.

Which companies manufacture or supply PEG-150 distearate?

Supply is fragmented across multinational chemical companies, regional surfactant producers, and specialty excipient distributors. Public catalogs identify the material under different names and grades, which makes direct market-share comparisons difficult.

Relevant supplier groups include:

1. Large specialty chemical companies with polyethylene glycol ester and nonionic surfactant portfolios.
2. Regional manufacturers in China and India serving cosmetics and pharmaceutical formulators.
3. Contract manufacturers producing custom molecular-weight distributions or tailored fatty-acid ester blends.
4. Distributors that repackage material into pharmaceutical, cosmetic, or laboratory grades.

Companies active in adjacent PEG ester, surfactant, and pharmaceutical excipient markets include BASF, Croda, Clariant, Evonik, Kao, Lubrizol, Galaxy Surfactants, and regional Asian producers. Product-specific availability varies by country and grade. A company’s presence in PEG esters or surfactants does not establish that it supplies PEG-150 distearate in every market.

The most important competitive variables are:

• Ethylene oxide and stearic-acid sourcing.
• Batch-to-batch molecular-weight control.
• Free PEG and free fatty-acid content.
• Residual ethylene oxide and 1,4-dioxane control.
• Heavy-metal and elemental-impurity controls.
• Microbiological quality.
• Supply continuity and dual-site manufacturing.
• Compendial documentation.
• Regulatory support for multinational filings.

How is PEG-150 distearate manufactured?

PEG-150 distearate is generally produced through esterification of a high-molecular-weight polyethylene glycol fraction with stearic acid or a stearic-acid-rich feedstock. Industrial processes must control the degree of esterification, residual unreacted PEG, residual free fatty acid, color, odor, acid value, hydroxyl value, and molecular-weight distribution.

The manufacturing chain typically includes:

1. Production or procurement of polyethylene glycol feedstock.
2. Procurement of stearic acid or a fatty-acid blend.
3. Esterification under controlled temperature and vacuum conditions.
4. Removal of water and volatile byproducts.
5. Filtration, deodorization, and solidification.
6. Flaking, pastillation, or drum handling.
7. Release testing and packaging.

The main manufacturing barriers are process consistency and impurity control, not legally protected technology. The product is technically reproducible, and multiple manufacturers can make functional equivalents. Qualification remains important because changes in molecular-weight distribution or fatty-acid composition can alter viscosity, cloud point, emulsification, melting behavior, and preservative performance.

What is the regulatory status of PEG-150 distearate?

PEG-150 distearate is an excipient rather than an active pharmaceutical ingredient. It does not receive an independent FDA marketing approval. Its regulatory acceptability depends on its use in a finished product and the quality of the supplier’s material.

The FDA Inactive Ingredient Database is a key reference for determining whether an excipient has prior use in approved drug products and identifying route- and dosage-form precedents. The database does not create a blanket authorization for every concentration, route, specification, or supplier. Finished-product sponsors remain responsible for demonstrating safety, quality, and suitability. [1]

In Europe, excipient assessment is tied to the finished medicinal product, the quality dossier, pharmacopoeial compliance where applicable, and risk-based evaluation under EU pharmaceutical rules. The European Medicines Agency’s excipient guidance focuses on quality, safety, and control within the product application. [2]

Relevant regulatory issues include:

• Identity and assay.
• Molecular-weight distribution.
• Degree of esterification.
• Residual solvents and processing impurities.
• Residual ethylene oxide and 1,4-dioxane.
• Elemental impurities.
• Peroxide formation and oxidative stability.
• Microbial quality where applicable.
• Allergen and animal-origin statements.
• Nitrosamine-risk assessment for the finished formulation.
• Change-control documentation.

Pharmaceutical buyers generally require a certificate of analysis, safety data sheet, specification, change-notification commitment, and evidence of GMP-aligned manufacture. The exact documentation burden depends on the dosage form and jurisdiction.

What patents protect PEG-150 distearate?

PEG-150 distearate itself is a mature chemical excipient and is not generally protected by an enforceable, product-specific patent estate. Basic composition and conventional manufacturing concepts are old enough that broad foundational protection is unlikely to create a meaningful barrier to entry.

Patent activity may still arise around:

• Specific topical formulations.
• Drug-excipient combinations.
• Cleansing compositions.
• Controlled-release or mucoadhesive systems.
• Methods for improving skin penetration.
• Low-irritancy surfactant blends.
• Manufacturing processes that reduce impurities.
• Particle engineering or solidification methods.
• Packaging and stability systems.

These patents generally protect the finished formulation or a process, not the underlying right to sell PEG-150 distearate as a commodity excipient.

IP category	Relevance to PEG-150 distearate
Composition-of-matter patent	Low
Excipient manufacturing patent	Low to selective
Topical formulation patent	Moderate
Drug-delivery patent	Moderate in specific products
Trade secret	Moderate for process conditions and purification
Supplier specification	Commercially important but not patent protection
Trademark	Relevant to branded grades, not chemical exclusivity

When does PEG-150 distearate lose exclusivity?

PEG-150 distearate has no conventional drug exclusivity period. It is not subject to New Chemical Entity exclusivity, five-year small-molecule exclusivity, orphan-drug exclusivity, or biologic reference-product exclusivity.

There is also no standard patent-expiration date that determines market entry for the material. Commercial access depends on manufacturing capability, customer qualification, regulatory documentation, and supply agreements.

This distinguishes PEG-150 distearate from an active pharmaceutical ingredient:

Exclusivity issue	PEG-150 distearate
Orange Book listing	No
Paragraph IV certification	No
Abbreviated New Drug Application	Not applicable to the excipient itself
Biosimilar pathway	Not applicable
NCE exclusivity	No
Orphan exclusivity	No
Product-specific patent expiry	Generally no
Supplier qualification period	Commercially significant

What is the Orange Book status of PEG-150 distearate?

PEG-150 distearate is not an Orange Book-listed active ingredient or drug product. The Orange Book identifies approved drug products and related patent and exclusivity information; it does not function as a comprehensive registry of excipients. [3]

As a result:

• There is no PEG-150 distearate Orange Book patent listing.
• There is no Paragraph IV challenge directed at the excipient.
• There is no generic-drug litigation based solely on PEG-150 distearate.
• Patent disputes can still involve a finished product that contains the excipient.

What generic-entry risks exist for products containing PEG-150 distearate?

Generic-entry risk is determined by the active ingredient, dosage form, formulation, and listed patents. PEG-150 distearate can influence formulation similarity, but it rarely creates independent entry protection.

For a topical drug, the main risks include:

• A listed method-of-use patent.
• A formulation patent covering a specific excipient ratio.
• A dermatological delivery system.
• A patent covering particle size, viscosity, or release characteristics.
• Difficulty matching a reference product’s microstructure or sensory profile.
• FDA requirements for comparative characterization of complex topical products.

For conventional creams and cleansers, formulation complexity may delay development without creating a durable legal barrier. A generic manufacturer can often substitute another nonionic surfactant or thickener if the finished product meets quality, performance, and safety requirements.

How strong is the patent estate for PEG-150 distearate?

The direct patent estate is weak. The commercial moat is based on execution rather than exclusivity.

A practical assessment is:

Factor	Strength
Chemical composition protection	Low
Manufacturing reproducibility	Moderate
Supplier qualification barriers	Moderate
Regulatory documentation	Moderate
Switching costs in validated products	Moderate
Customer dependence on one supplier	Low to moderate
IP-based pricing power	Low
Quality-based pricing power	Moderate
Scarcity during supply disruption	Variable

Pharmaceutical customers may resist switching suppliers because excipient changes can trigger stability studies, process validation, regulatory notifications, and comparability work. That creates customer retention even when the material is technically off-patent and available from multiple producers.

What factors are driving PEG-150 distearate demand?

Demand is tied to several formulation and industry trends.

Growth in topical and dermatology products

Topical products use rheology modifiers and surfactants to control spreadability, suspension, wash-off behavior, and skin feel. Growth in dermatology, antifungal, antiseptic, acne, and consumer-health products supports demand for specialty excipients.

Expansion of contract manufacturing

Contract development and manufacturing organizations increasingly support regional and multinational topical products. These companies often maintain approved excipient lists and require multiple qualified suppliers, supporting demand for documented pharmaceutical grades.

Pressure to reduce formulation complexity

Formulators favor multifunctional excipients that provide viscosity control and surfactant performance in one material. PEG-150 distearate can reduce the number of separate rheology and emulsification inputs in some systems.

Raw-material volatility

Stearic acid prices are linked to palm, tallow, and other oleochemical feedstocks. Ethylene oxide prices reflect petrochemical costs, plant outages, and regional supply-demand conditions. These inputs can create margin volatility even when end-market demand is stable.

Regulatory scrutiny of impurities

Residual ethylene oxide and 1,4-dioxane can increase testing and purification costs. Suppliers with stronger analytical controls may gain share in regulated pharmaceutical accounts.

What is the financial trajectory for PEG-150 distearate?

The likely financial trajectory is low-single-digit volume growth with periodic price volatility rather than rapid expansion. Pharmaceutical revenue should grow more slowly than the broader personal-care market because the pharmaceutical application base is narrower and substitution is possible.

Period	Likely financial pattern
Near term	Stable demand; margin sensitivity to oleochemicals and energy
Medium term	Moderate growth from topical, dermatology, and contract manufacturing
Long term	Broad substitution pressure; premium for validated pharmaceutical grades
Downside case	Raw-material inflation, supplier consolidation, or replacement by alternative rheology modifiers
Upside case	Increased use in complex topical and cleansing drug products

Public-company reporting generally does not isolate PEG-150 distearate revenue. Investors should therefore track the following proxy indicators:

• Specialty excipient revenue.
• Pharmaceutical and personal-care surfactant growth.
• Polyethylene glycol and fatty-acid derivative volumes.
• Gross-margin movement in specialty ingredients.
• Capacity additions in India and China.
• Ethylene oxide and stearic-acid pricing.
• Customer qualification wins.
• Regulatory upgrades and pharmaceutical-grade launches.
• Supplier consolidation.

A supplier with a broad portfolio and integrated raw-material access is more likely to protect margins than a distributor or single-product manufacturer. Product differentiation depends on quality, supply assurance, and regulatory support rather than patent exclusivity.

How does PEG-150 distearate compare with competing excipients?

Excipient	Primary advantage	Main limitation	Competitive position
PEG-150 distearate	Thickening plus nonionic surfactant function	Limited oral and parenteral use	Strong in topical and cleansing systems
Polysorbate 60	Established emulsifier	Oxidation and impurity concerns	Broad pharmaceutical familiarity
Polysorbate 80	Strong emulsification	Oxidative degradation and regulatory scrutiny	More common in biologics and injectables
Cetostearyl alcohol	Effective consistency agent	Less multifunctional	Lower-cost topical alternative
Carbomer	High viscosity at low use level	Sensitive to electrolytes and neutralization	Strong gel-forming competitor
Hydroxyethyl cellulose	Water-soluble rheology modifier	Different sensory and surfactant profile	Common topical substitute
Sodium lauryl sulfate	Strong cleansing and wetting	Higher irritation potential	Less suitable for mild formulations
PEG stearates	Emulsification and texture control	Grade-dependent performance	Closest chemical substitute

PEG-150 distearate is most competitive where the formulator values mildness, nonionic behavior, and combined viscosity and surfactant functionality. It is less competitive where cost, high-yield thickening, injectable compatibility, or strong gel formation dominates.

What litigation and licensing issues affect PEG-150 distearate?

No major public litigation pattern is associated with PEG-150 distearate as a standalone excipient. Paragraph IV litigation, biosimilar disputes, and Orange Book settlements do not apply to the chemical itself.

Licensing is more likely to involve:

• Distributor agreements.
• Territory restrictions.
• Private-label manufacturing.
• Pharmaceutical-grade quality agreements.
• Long-term supply contracts.
• Custom specification arrangements.
• Technology licenses for impurity reduction or process control.

The main legal exposure for a pharmaceutical company is therefore in the finished formulation, supplier representations, change control, quality failures, and product liability. A formulation patent may restrict a specific combination even when the excipient remains freely available.

What geographic markets have the strongest opportunity?

North America and Europe offer higher documentation requirements and better pricing for pharmaceutical-grade material. India and China have stronger production-cost advantages and expanding domestic pharmaceutical manufacturing. Southeast Asia has growing personal-care and contract-manufacturing demand.

Region	Market characteristics
United States	High documentation burden; topical and consumer-health demand
Europe	Strong excipient quality requirements; sustainability scrutiny
India	Growing pharmaceutical manufacturing; competitive production costs
China	Large chemical base; broad supplier field; variable qualification standards
Japan and South Korea	High quality expectations; specialty formulation demand
Latin America	Import-dependent in many markets; distributor-led sales
Middle East and Africa	Smaller base; growth tied to imported finished products

Geographic diversification reduces exposure to plant outages, freight disruption, and local regulatory changes. Buyers increasingly prefer at least two qualified sources for critical excipients.

Key Takeaways

• PEG-150 distearate is a specialty excipient used mainly in topical, dermatological, cleansing, and personal-care formulations.
• The pharmaceutical market is smaller than the cosmetics market and is not reported as a distinct public revenue category.
• No meaningful standalone patent, Orange Book, Paragraph IV, or biosimilar exclusivity applies to the excipient.
• Commercial advantage comes from quality consistency, impurity control, pharmaceutical documentation, and supply reliability.
• Demand should track moderate growth in topical medicines and contract manufacturing, with raw-material volatility affecting margins.
• The principal competitors are polysorbates, carbomers, cellulose derivatives, fatty alcohols, and other PEG stearates.
• Finished-product formulation patents may restrict specific drug products even though PEG-150 distearate itself is broadly available.
• Supplier qualification and regulatory change control create moderate switching costs and the strongest practical customer-retention barrier.

FAQs about PEG-150 distearate

Is PEG-150 distearate safe for pharmaceutical use?

It can be used as an excipient when the finished product is appropriately formulated, manufactured, and supported by safety and quality data. Safety depends on route, concentration, impurity profile, and product exposure.

Is PEG-150 distearate the same as PEG 1500?

No. PEG-150 distearate is an esterified polyethylene glycol surfactant and thickener. PEG 1500 is a polyethylene glycol polymer with different functionality and formulation behavior.

Can PEG-150 distearate be used in injectable drugs?

Its principal use is topical and cleansing formulations. Injectable use would require route-specific safety justification, suitable specifications, and regulatory acceptance; it is not a routine parenteral excipient.

Does PEG-150 distearate create a generic-drug barrier?

Usually not. It may contribute to formulation performance, but generic-entry protection normally depends on active-ingredient patents, formulation patents, method-of-use claims, or complex-product requirements.

Which quality tests matter most when buying PEG-150 distearate?

Identity, assay, molecular-weight distribution, degree of esterification, acid value, hydroxyl value, free PEG, free fatty acid, residual ethylene oxide, 1,4-dioxane, water, color, microbial quality, and lot-to-lot viscosity are central purchasing controls.

References

1. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

2. European Medicines Agency. (2016). Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product. https://www.ema.europa.eu/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

4. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP Convention.

5. European Directorate for the Quality of Medicines & HealthCare. (2024). European Pharmacopoeia. Council of Europe.