Drugs Containing Excipient (Inactive Ingredient) GLYCOL DISTEARATE

Branded drugs containing GLYCOL DISTEARATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Johnson & Johnson Consumer Inc McNeil Consumer Healthcare Division	NIZORAL	ketoconazole	50580-895	GLYCOL DISTEARATE
Kramer Laboratories	NIZORAL	ketoconazole	55505-191	GLYCOL DISTEARATE
Kramer Laboratories	NIZORAL	ketoconazole	55505-192	GLYCOL DISTEARATE
Kramer Laboratories	NIZORAL	ketoconazole	55505-196	GLYCOL DISTEARATE
Kramer Laboratories	NIZORAL	ketoconazole	55505-232	GLYCOL DISTEARATE

Generic drugs containing GLYCOL DISTEARATE excipient

Company	Ingredient	NDC	Excipient
Johnson & Johnson Consumer Inc McNeil Consumer Healthcare Division	ketoconazole	50580-895	GLYCOL DISTEARATE
Kramer Laboratories	ketoconazole	55505-191	GLYCOL DISTEARATE
Kramer Laboratories	ketoconazole	55505-192	GLYCOL DISTEARATE
Kramer Laboratories	ketoconazole	55505-196	GLYCOL DISTEARATE
Kramer Laboratories	ketoconazole	55505-232	GLYCOL DISTEARATE

Glycol Distearate Pharmaceutical Excipient Market Dynamics and Financial Trajectory

Last updated: August 20, 2026

Glycol distearate, also called ethylene glycol distearate or EGDS, is a waxy nonionic surfactant used mainly as a pearlizing, opacifying, emulsion-stabilizing, and viscosity-modifying ingredient. Its commercial base is concentrated in shampoos, body washes, liquid soaps, and other personal-care products. Pharmaceutical demand is smaller and formulation-specific, with limited public evidence of a separately reported pharmaceutical-grade market or standalone supplier revenue.

The financial outlook is therefore tied more closely to specialty surfactants, cosmetics, and contract manufacturing than to conventional pharmaceutical excipient growth. Volume expansion is likely to be modest, while value growth depends on purity, regulatory documentation, supply reliability, and customized dispersion systems.

What is glycol distearate and how is it used in pharmaceuticals?

Glycol distearate is the diester of ethylene glycol and stearic acid. Its primary identifiers include:

Attribute	Data
Common name	Glycol distearate
Alternative name	Ethylene glycol distearate
CAS number	627-83-8
Chemical class	Nonionic fatty-acid ester
Physical form	White to off-white waxy solid or flakes
Functional role	Pearlizer, opacifier, emollient, surfactant, viscosity modifier
Common applications	Shampoos, liquid cleansers, body washes, creams, emulsions
Pharmaceutical use	Topical and liquid formulations where appearance, texture, and dispersion are important
Primary commercial market	Personal care and cosmetics

Glycol distearate is not an active pharmaceutical ingredient. It has no pharmacological target and does not create exclusivity for a finished drug. Its commercial value comes from formulation performance, manufacturing consistency, and regulatory acceptance.

In pharmaceutical formulations, the material can help create a pearlescent appearance, improve sensory properties, stabilize oil-water systems, and adjust viscosity. These functions are most relevant to topical preparations, dermatological products, cleansers, shampoos, and certain liquid dosage forms.

Its use is less common in tablets, capsules, and sterile injectables because its waxy, hydrophobic character is not generally required in those dosage forms.

How large is the glycol distearate market?

No authoritative public source reports a standalone global market size for pharmaceutical-grade glycol distearate. Commercial market studies usually combine it with broader categories such as pearlescent agents, fatty-acid esters, specialty surfactants, emulsifiers, or cosmetic ingredients.

The market should be segmented into three layers:

Market layer	Relative importance	Principal buyers
Personal care and cosmetics	High	Shampoo, cleanser, skin-care, and hair-care manufacturers
Industrial and formulation chemicals	Moderate	Chemical formulators, distributors, private-label manufacturers
Pharmaceutical excipient use	Low to moderate	Topical, dermatological, and liquid-drug manufacturers

The pharmaceutical segment is unlikely to determine global glycol distearate pricing. Personal-care demand establishes the production base, while pharmaceutical customers influence documentation, batch controls, and quality requirements.

A supplier’s glycol distearate revenue is generally embedded within broader sales of surfactants, cosmetic ingredients, emulsifiers, or specialty chemicals. Public companies do not typically disclose revenue by CAS number or by individual excipient.

What is driving demand for glycol distearate?

Is personal-care demand the main growth driver?

Yes. Personal-care products account for the largest visible use of glycol distearate. Demand is linked to:

• Growth in liquid cleansers and shampoos.
• Greater use of pearlized formulations.
• Premiumization of hair-care and skin-care products.
• Expansion of private-label cosmetics.
• Increased demand for mild surfactant systems.
• Product differentiation through appearance and texture.

Glycol distearate is particularly useful in products where manufacturers want a smooth, creamy, or pearlescent appearance without introducing a separate pigment system.

The material is commonly supplied either as a neat ingredient or as part of a pre-dispersed pearlizing concentrate. Concentrated systems can include glycol distearate with surfactants, fatty alcohols, rheology modifiers, or stabilizers. These premixes can command higher margins than commodity-grade flakes because they reduce customer processing requirements.

Does pharmaceutical demand have separate growth characteristics?

Yes. Pharmaceutical demand is more dependent on formulation development and product approvals than on consumer usage. A drug manufacturer may qualify a grade once and then continue purchasing it for years, but volumes per product can be modest.

Demand is supported by:

• Expansion of topical dermatology products.
• Growth in over-the-counter skin and hair treatments.
• Increased use of liquid and semisolid dosage forms.
• Outsourcing to contract development and manufacturing organizations.
• Requirements for reproducible appearance and texture.
• Supplier qualification based on traceability and controlled impurities.

Pharmaceutical customers are less likely to switch suppliers solely on price. Changes can require formulation bridging, stability work, supplier audits, and regulatory documentation.

How does glycol distearate compare with competing excipients?

Glycol distearate competes with other pearlizers, emollients, surfactants, and viscosity modifiers rather than with a single direct substitute.

Alternative	Typical advantage	Limitation compared with glycol distearate
Glycol stearate	Pearlizing and emollient effects	Different melting and dispersion behavior
Glyceryl stearate	Emulsification and skin feel	Does not always provide the same pearlescent appearance
Fatty alcohols	Viscosity and emulsion support	Lower or different optical effect
Mica or mineral pearlizers	Strong visual effect	May alter sensory profile and require pigment handling
Synthetic pearlizing concentrates	Easier processing	Higher cost and greater supplier dependence
Polysorbates	Solubilization and emulsification	Different functional profile and sensory result
PEG esters	Emulsification and compatibility	Different regulatory and formulation considerations

The main competitive advantage of glycol distearate is multifunctionality. It can contribute to appearance, viscosity, emollience, and formulation structure. Its main weakness is processing sensitivity. The material may require controlled heating, adequate dispersion, and careful cooling to achieve consistent crystal structure and visual appearance.

What regulatory status applies to glycol distearate?

Glycol distearate is regulated primarily as an inactive formulation ingredient, cosmetic ingredient, or industrial chemical, depending on the product and jurisdiction.

What is its FDA status?

The FDA Inactive Ingredient Database is the main U.S. reference for excipients used in approved drug products. Inclusion in the database is product- and route-specific and does not constitute a broad approval of every use, concentration, or dosage form.[1]

Glycol distearate should therefore be evaluated by:

1. Whether the exact chemical name or synonym appears in the FDA Inactive Ingredient Database.
2. The route of administration.
3. The maximum potency recorded for the relevant dosage form.
4. The intended concentration and formulation function.
5. The quality documentation for the selected supplier.

The FDA Orange Book does not normally list glycol distearate as an independently protected pharmaceutical product. Orange Book entries identify approved drug products, patents, and regulatory exclusivities associated with finished products, not every excipient used in those products.[2]

Is glycol distearate a USP-NF excipient?

A USP-NF monograph, where applicable, provides identity, purity, and testing requirements. A purchaser should distinguish between:

• A formal pharmacopeial monograph.
• A supplier specification described as pharmaceutical grade.
• Compliance with general USP chapters.
• A cosmetic or technical grade supported only by a certificate of analysis.

Those categories are not interchangeable. Pharmaceutical customers generally require identity testing, assay or ester-value controls, acid value, iodine value where relevant, melting range, water, residual solvents, elemental impurities, microbial limits, and storage data.

What is the European regulatory position?

In Europe, glycol distearate is generally assessed under the regulatory framework applicable to cosmetics, chemicals, and medicinal-product excipients. REACH registration, safety data, classification, labeling, and supply-chain obligations can apply depending on tonnage and the legal entity placing the substance on the market.[3]

For medicinal products, the excipient must be supported through the product’s quality dossier and risk assessment. European excipient expectations emphasize control of composition, impurities, microbial quality where relevant, and supply-chain consistency.[4]

How many patents protect glycol distearate?

Glycol distearate itself has limited patent protection as an established chemical substance. Its core composition is not generally protected by a current composition-of-matter patent.

Patent exposure can still arise from:

• A pharmaceutical formulation containing glycol distearate.
• A specific particle-size or dispersion profile.
• A pearlizing concentrate.
• A manufacturing process.
• A topical composition with a particular active ingredient.
• A combination of glycol distearate with surfactants or polymers.
• A controlled-release or cosmetic delivery system.

The relevant patent risk is therefore formulation-specific rather than molecule-specific. A patent search should cover the exact product, dosage form, active ingredient, jurisdiction, and supplier formulation. Searching only “glycol distearate” will overstate or understate risk because patents may claim “fatty-acid esters,” “glycol esters,” or broader functional classes.

Are there Paragraph IV challenges involving glycol distearate?

No meaningful Paragraph IV litigation is expected to center on glycol distearate as an independent ingredient. Paragraph IV certifications apply to patents listed for approved drug products in the FDA Orange Book.[2] An excipient supplier would normally face no Paragraph IV event unless a finished formulation patent specifically covers the excipient combination and a generic applicant challenges that listed patent.

For glycol distearate-containing drugs, the relevant litigation questions are:

• Whether the finished drug has Orange Book-listed patents.
• Whether the claim requires glycol distearate.
• Whether the generic can use a different excipient.
• Whether the patent claims a narrow formulation or a broad composition.
• Whether a Paragraph IV notice has been served.
• Whether litigation creates a 30-month stay.

These issues belong to the finished drug’s patent estate, not to glycol distearate as a standalone chemical.

What manufacturing and intellectual-property barriers affect supply?

The basic chemistry is relatively accessible. Commercial production generally involves esterification of ethylene glycol with stearic acid or stearic-acid-rich feedstocks, followed by purification, solidification, flaking, milling, or blending.

The principal barriers are operational:

Feedstock quality

Stearic acid can vary by animal, vegetable, or mixed origin. Feedstock origin affects impurity profiles, melting behavior, odor, color, and customer acceptability. Pharmaceutical and premium personal-care buyers may require documented origin and controlled sourcing.

Process consistency

Manufacturers must control:

• Esterification conversion.
• Free fatty acid.
• Unreacted ethylene glycol.
• Monoester content.
• Color and odor.
• Melting range.
• Crystal form and particle size.
• Residual catalysts or solvents.

Documentation

Pharmaceutical customers may require:

• GMP-oriented manufacturing controls.
• Change-control commitments.
• Audit rights.
• Stability data.
• Supply continuity plans.
• Allergen, animal-origin, GMO, and BSE/TSE statements.
• Elemental-impurity assessments.
• Residual-solvent statements.
• Country-of-origin and traceability records.

These requirements create qualification barriers even where the underlying chemistry is not difficult to reproduce.

Which companies participate in the glycol distearate supply chain?

The market includes multinational chemical companies, regional specialty-ingredient manufacturers, cosmetic raw-material suppliers, and distributors. Public disclosures rarely identify glycol distearate revenue separately.

The competitive structure generally includes:

1. Large specialty chemical companies with global production, regulatory infrastructure, and broad surfactant portfolios.
2. Regional ester manufacturers competing on cost and flexibility.
3. Cosmetic ingredient companies selling pearlizing systems and blends.
4. Distributors providing local inventory, technical support, and regulatory files.
5. Contract manufacturers producing custom blends for private-label and personal-care customers.

A supplier’s competitive position depends less on a proprietary molecule than on manufacturing footprint, batch reliability, technical service, and ability to support customer audits.

What is the financial trajectory for glycol distearate?

The financial trajectory is best described as stable-to-moderate growth with margin differentiation by grade and application.

Financial factor	Expected effect
Personal-care volume growth	Supports steady baseline demand
Pharmaceutical qualification	Supports higher retention and pricing
Stearic-acid costs	Creates margin volatility
Energy and freight	Affects conversion and delivered cost
Cosmetic premiumization	Supports higher-value blends
Supplier concentration	Can improve pricing for qualified grades
Commodity substitution	Limits long-term pricing power
Regulatory documentation	Raises cost but supports customer retention
Regional manufacturing	Reduces freight exposure
Custom formulations	Improves margins versus neat material

The most attractive economics are likely in pharmaceutical documentation packages, specialty cosmetic grades, and pre-formulated pearlizing concentrates. Standard glycol distearate flakes face greater price competition and lower switching barriers.

What affects supplier profitability?

Gross margin is influenced by:

• Feedstock procurement.
• Batch size.
• Yield and rework.
• Packaging format.
• Regulatory testing.
• Inventory requirements.
• Customer qualification costs.
• Product customization.
• Freight distance.
• Contract duration.

A supplier selling only a standard grade is exposed to input-cost movements and distributor pressure. A supplier that sells a validated, application-specific system has greater pricing control.

Is glycol distearate a major revenue exposure for pharmaceutical companies?

No. For drug manufacturers, glycol distearate is normally a minor cost component. It may be operationally important but financially immaterial relative to the active ingredient, manufacturing, packaging, and regulatory costs.

The financial exposure is greater for excipient and specialty-chemical suppliers than for drug sponsors. A supply interruption can still create disproportionate costs if reformulation, stability testing, or regulatory filing changes are required.

What generic entry risks exist for glycol distearate-containing drugs?

Generic entry risk depends on the finished product, not on the excipient alone.

A generic applicant can often avoid formulation patents by using:

• A different pearlizer.
• A different surfactant system.
• A different viscosity modifier.
• A different grade of glycol distearate.
• A formulation that delivers equivalent performance without the claimed excipient.

Risk increases where a patent claims a narrow combination that is difficult to reproduce without glycol distearate or where the excipient is essential to a claimed physical property.

For topical products, bioequivalence and sameness requirements can make formulation design complex. However, the existence of glycol distearate in the reference product does not automatically block a generic launch.

What biosimilar risk applies to glycol distearate?

Biosimilar risk is limited. Glycol distearate is not a biologic and does not create biosimilar exclusivity.

It could appear in a non-sterile topical or supportive formulation associated with a biologic product, but the ingredient would remain a formulation component. Biosimilar competition would be governed by the reference biologic’s patent estate, regulatory exclusivity, interchangeability considerations, and manufacturing platform.

What geographic markets matter most?

Demand is concentrated in regions with large personal-care, pharmaceutical, and chemical manufacturing bases.

Region	Market characteristics
North America	Strong regulatory expectations, OTC and dermatology demand, established distribution
Europe	High documentation standards, sustainability scrutiny, sophisticated cosmetics sector
China	Large manufacturing base and expanding domestic personal-care demand
India	Growing pharmaceutical and cosmetic manufacturing, cost-sensitive sourcing
Japan and South Korea	Advanced personal-care formulations and quality-sensitive customers
Southeast Asia	Expanding consumer products manufacturing and regional supply chains

Regional price differences reflect freight, tariffs, stearic-acid availability, inventory strategy, and local regulatory support.

What is the outlook for glycol distearate?

Glycol distearate is likely to remain a durable specialty excipient rather than become a high-growth pharmaceutical ingredient. The strongest opportunities are in:

• Pearlizing concentrates.
• Mild personal-care systems.
• Dermatological and topical products.
• High-purity, traceable grades.
• Animal-origin-free or vegetable-derived supply.
• Custom blends with controlled viscosity and appearance.
• Regional supply agreements that reduce disruption risk.

The main threats are replacement by alternative pearlizers, customer migration to pre-formulated systems, raw-material volatility, and limited ability to differentiate standard-grade material.

Key Takeaways

• Glycol distearate is a nonionic fatty-acid ester used mainly as a pearlizer, opacifier, emollient, and viscosity modifier.
• Personal care is the dominant demand center; pharmaceutical use is smaller and formulation-specific.
• No reliable public source establishes a standalone pharmaceutical glycol distearate market size or supplier revenue line.
• The core chemical has limited standalone patent protection; formulation, process, and combination patents are more relevant.
• Orange Book and Paragraph IV issues arise only through specific finished drug products.
• Biosimilar risk is not directly relevant because glycol distearate is not a biologic or active ingredient.
• Pharmaceutical-grade value comes from documentation, traceability, batch consistency, and qualification status.
• Standard grades face commodity pressure, while custom blends and validated pharmaceutical grades offer stronger margins.
• Financial performance is linked to personal-care volumes, stearic-acid costs, energy, logistics, and supplier differentiation.
• Generic launch risk depends on the reference product’s formulation and patent claims, not on glycol distearate alone.

FAQs

Is glycol distearate the same as glycol stearate?

No. Glycol distearate is the diester of ethylene glycol and stearic acid. Glycol stearate generally refers to the monoester. Their melting behavior, formulation role, and performance are different.

Is glycol distearate safe for use in topical pharmaceutical products?

Safety depends on concentration, route, impurity profile, and the finished formulation. The relevant assessment must cover the specific grade and intended use rather than rely solely on the ingredient name.

Can glycol distearate be used in oral medicines?

Potential use depends on applicable regulatory and pharmacopeial requirements, exposure, dosage form, and product-specific justification. Its most established commercial role is in non-sterile topical and personal-care formulations.

Does glycol distearate require GMP manufacturing?

The requirement depends on its use and the customer’s quality system. A pharmaceutical customer may require excipient controls aligned with GMP expectations even when the supplier is not manufacturing an active ingredient.

What is the main procurement risk for glycol distearate?

The main risk is inconsistent material performance caused by variation in fatty-acid feedstock, ester composition, melting range, color, particle size, or dispersion behavior. Supplier qualification and change control are central to mitigating that risk.

References

1. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
3. European Chemicals Agency. (n.d.). REACH registration and substance information. https://echa.europa.eu/information-on-chemicals
4. European Commission. (2015). Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. Official Journal of the European Union.