Drugs Containing Excipient (Inactive Ingredient) GLYCERYL BEHENATE

Branded drugs containing GLYCERYL BEHENATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
STAT Rx USA LLC	WELLBUTRIN	bupropion hydrochloride	16590-246	GLYCERYL BEHENATE
STAT RX USA LLC	APLENZIN	bupropion hydrobromide	16590-922	GLYCERYL BEHENATE	2026-06-27
Rebel Distributors Corp	WELLBUTRIN XL	bupropion hydrochloride	21695-137	GLYCERYL BEHENATE

Generic drugs containing GLYCERYL BEHENATE excipient

Company	Ingredient	NDC	Excipient
STAT RX USA LLC	gabapentin	16590-104	GLYCERYL BEHENATE
STAT Rx USA LLC	bupropion hydrochloride	16590-246	GLYCERYL BEHENATE
STAT RX USA LLC	bupropion hydrobromide	16590-922	GLYCERYL BEHENATE

Glyceryl Behenate Market Dynamics, Applications, Suppliers, and Financial Outlook

Last updated: August 1, 2026

Glyceryl behenate is a specialty lipid excipient used mainly in modified-release tablets, lipid-based drug delivery, oral solid-dose manufacturing, cosmetics, and selected food applications. Its commercial value is driven by formulation performance rather than bulk volume. The market has a defensible specialty-excipient profile because pharmaceutical customers qualify suppliers, validate manufacturing performance, and often avoid switching after regulatory approval.

Public companies do not generally report glyceryl behenate revenue as a separate product line. Financial analysis therefore relies on end-market demand, supplier positioning, formulation activity, raw-material costs, and customer qualification barriers rather than audited product-level sales.

What is glyceryl behenate and how is it used?

Glyceryl behenate is a mixture of glycerol esters of behenic acid, generally containing mono-, di-, and tri-glycerides. It is also known by the chemical designation glyceryl tribehenate or glycerol behenate, depending on grade and composition.

Its main pharmaceutical functions are:

Function	Formulation role
Modified-release matrix former	Controls drug diffusion and erosion in sustained-release tablets
Lubricant	Reduces friction during compression and ejection
Lipid carrier	Supports lipid-based oral delivery systems
Taste-masking aid	Helps reduce immediate drug release in some formulations
Tablet coating or processing aid	Improves processing and surface characteristics
Cosmetic structurant	Adds consistency and emollience to creams, balms, and color cosmetics

Glyceryl behenate is particularly relevant when formulators need a hydrophobic matrix that can be processed by direct compression, granulation, or hot-melt techniques. The material can support controlled release without relying exclusively on hydrophilic polymers such as hypromellose.

Which pharmaceutical products use glyceryl behenate?

Glyceryl behenate is used in oral solid-dose products, especially formulations requiring extended or delayed release. The excipient can be used alone or combined with polymers, waxes, surfactants, and other lipids.

Typical applications include:

• Sustained-release tablets
• Multiparticulate pellets
• Granules and minitablets
• Lipid matrix formulations
• Taste-masked oral dosage forms
• Nutraceutical tablets and capsules
• Poorly water-soluble drug formulations
• Direct-compression formulations
• Solid lipid systems

The best commercial opportunities are products with complex release profiles, narrow therapeutic windows, or formulation designs that are difficult to reproduce with a simple immediate-release tablet.

Glyceryl behenate is not generally the primary excipient in conventional high-volume immediate-release tablets. That limits unit demand but supports higher value per kilogram in technically demanding formulations.

Which companies supply glyceryl behenate?

The leading branded pharmaceutical grade is Compritol 888 ATO, supplied by Gattefossé. It is widely recognized as a glyceryl behenate-based excipient for modified-release and lipid-based formulations.

Supplier or product family	Market position	Primary relevance
Gattefossé, Compritol 888 ATO	Leading pharmaceutical-grade branded product	Modified release, lipid matrices, direct compression
BASF and other specialty excipient suppliers	Adjacent lipid and formulation technologies	Competing or complementary lipid systems
Regional excipient manufacturers	Price-sensitive and local supply	Generic pharmaceutical and industrial applications
Cosmetic and food ingredient suppliers	Broader ester and lipid portfolios	Cosmetics, personal care, and food uses

Gattefossé has positioned Compritol 888 ATO through formulation support, technical documentation, regulatory information, and application development. That model creates switching costs beyond the physical material. Customers qualify particle size, polymorphism, ester composition, flow, compaction, dissolution performance, and batch consistency.

The relevant competitive market is broader than glyceryl behenate alone. Alternative materials include glyceryl palmitostearate, glyceryl stearate, hydrogenated vegetable oils, carnauba wax, beeswax, stearic acid, polyethylene glycol, ethylcellulose, and hypromellose.

How large is the glyceryl behenate market?

There is no reliable public financial disclosure for a standalone global glyceryl behenate market. Commercial market reports often aggregate glyceryl behenate with pharmaceutical lipids, fatty-acid esters, tablet lubricants, or specialty excipients. Those broader figures should not be treated as glyceryl behenate revenue.

The market is best characterized as:

• Small relative to bulk pharmaceutical excipients
• Higher margin than commodity tablet fillers and binders
• Concentrated among a limited number of qualified suppliers
• Closely tied to oral solid-dose development
• Supported by recurring demand from approved products
• Exposed to customer concentration and formulation substitution

The financial profile resembles a specialty ingredient rather than a commodity chemical. Revenue growth depends more on new product approvals, generic launches, and penetration of complex formulations than on overall tablet volume.

What is driving demand for glyceryl behenate?

Growth in modified-release medicines

Modified-release products use excipient systems to control drug release over several hours or longer. Glyceryl behenate can form a hydrophobic matrix that slows water ingress and drug diffusion. Demand therefore follows development of extended-release products in cardiovascular, central nervous system, metabolic, pain, and gastrointestinal indications.

Generic reformulation and complex generics

Generic manufacturers increasingly pursue products with formulation barriers, including extended-release tablets, multiparticulates, and poorly soluble drugs. Glyceryl behenate can be part of the formulation platform for these products.

The commercial benefit for suppliers is repeat demand after approval. Once an excipient system is embedded in an approved product and supported by process validation, substitution becomes less attractive unless cost savings are material.

Oral delivery of poorly soluble compounds

Lipid excipients can improve wetting, dissolution, and drug dispersion. Glyceryl behenate is not a universal solubilizer, but it can be used in lipid-based and solid-dispersion strategies where the formulation requires a structured lipid matrix.

Nutraceutical and consumer health demand

Nutraceutical tablets, capsules, and functional powders can generate incremental demand. These applications are usually more price-sensitive and have lower regulatory switching costs than pharmaceutical products.

Cosmetics and personal care

Glyceryl behenate provides emolliency and structure in creams, balms, lip products, and other semisolid formulations. Cosmetic demand broadens the customer base but usually produces lower technical barriers than pharmaceutical use.

What factors determine glyceryl behenate pricing?

Pricing is influenced by feedstock, grade, manufacturing complexity, and regulatory documentation.

Cost driver	Financial effect
Behenic acid and vegetable-oil feedstocks	Determines the largest variable-cost component
Hydrogenation and esterification	Affects conversion cost and energy use
Purification and fraction control	Raises cost for pharmaceutical grades
Particle-size engineering	Increases processing and quality-control expense
GMP production	Adds facility, testing, and documentation costs
Regional freight and import duties	Creates geographic price differences
Customer qualification	Supports premium pricing for established brands
Supply concentration	Reduces price transparency and can protect margins

Pharmaceutical-grade glyceryl behenate generally commands a premium over cosmetic or industrial material. The premium reflects certificate-of-analysis requirements, traceability, microbiological controls, residual testing, stability data, technical support, and change-control obligations.

A supplier with a validated pharmaceutical grade can maintain pricing even when lower-cost material is available, provided the customer values regulatory continuity and manufacturing reproducibility.

How strong is the patent estate for glyceryl behenate?

Glyceryl behenate itself is an established excipient, not a newly patented active pharmaceutical ingredient. The core material is unlikely to have meaningful composition-of-matter exclusivity in major markets.

The relevant intellectual-property categories are:

1. Formulations using glyceryl behenate as a matrix former.
2. Drug-specific extended-release compositions.
3. Multiparticulate or pellet manufacturing processes.
4. Hot-melt and lipid-processing methods.
5. Combination excipient systems.
6. Drug-excipient ratios and dissolution profiles.
7. Delivery systems for poorly soluble active ingredients.

Patent risk therefore attaches mainly to the finished drug product and formulation architecture, not to the sale of glyceryl behenate as a raw excipient.

A glyceryl behenate supplier may hold trademarks, technical know-how, manufacturing controls, and proprietary particle engineering without owning broad enforceable patent rights over the chemical substance. The practical moat is often qualification and performance data rather than patent exclusivity.

What is the FDA and Orange Book status of glyceryl behenate?

Glyceryl behenate is an inactive pharmaceutical ingredient. It is not an FDA-approved active ingredient and does not receive a standalone Orange Book listing.

The FDA Inactive Ingredient Database is the principal public source for determining whether an excipient has precedent in approved drug products, dosage forms, and routes of administration. The database is used by formulators and ANDA sponsors when assessing inactive-ingredient precedent, although the presence of an excipient in the database does not eliminate the need for product-specific regulatory justification.[1]

The Orange Book lists approved drug products and patent or exclusivity information associated with those products. It does not list excipients as independent products.[2]

For a pharmaceutical-grade supplier, regulatory value comes from:

• DMF or equivalent regulatory support
• Compendial compliance where applicable
• GMP manufacturing
• Change-control procedures
• Impurity and residual-solvent data
• Stability information
• Traceability of raw materials
• Consistent composition and particle-size distribution

When does glyceryl behenate lose exclusivity?

Glyceryl behenate does not have a standalone drug exclusivity period comparable to an active pharmaceutical ingredient. There is no independent Hatch-Waxman exclusivity clock for the excipient.

Exclusivity can instead arise at the drug-product level. An extended-release tablet containing glyceryl behenate may be protected by:

• Drug-substance patents
• Formulation patents
• Method-of-use patents
• Dosage-regimen patents
• Manufacturing-process patents
• Regulatory exclusivity attached to the approved product

Those rights belong to the drug-product sponsor or patent owner and may expire on different dates. The expiration of a formulation patent can enable generic entry without eliminating demand for glyceryl behenate, because generic manufacturers may use the same excipient or a functionally equivalent material.

Are there Paragraph IV challenges involving glyceryl behenate?

Paragraph IV certifications apply to patents listed for an approved drug product, not to an excipient sold independently. A generic sponsor may challenge patents covering an extended-release product that uses glyceryl behenate, but the certification would target the listed drug-product patents.

The commercial consequences are indirect:

• A successful Paragraph IV challenge can accelerate generic entry.
• Generic entry can increase excipient volume.
• Price erosion in the finished drug can pressure formulation costs.
• The generic may retain glyceryl behenate or switch to another lipid system.
• A formulation patent may force redesign around a different excipient ratio or release mechanism.

The excipient supplier therefore benefits from product launches and generic substitution but does not control the patent litigation outcome unless it is also involved in formulation technology or indemnification arrangements.

Does glyceryl behenate face biosimilar risk?

Direct biosimilar risk is negligible. Biosimilars are biologic products and generally use different formulation platforms from oral small-molecule tablets, where glyceryl behenate has its strongest position.

Indirect risk can arise if pharmaceutical development shifts from oral small molecules to injectable biologics, long-acting biologic delivery systems, or other dosage forms that do not use glyceryl behenate. That is a portfolio-level risk rather than a direct substitution threat.

What manufacturing and intellectual-property barriers protect suppliers?

The strongest barriers are operational and regulatory.

Manufacturing barriers

Consistent glyceryl behenate requires control over:

• Fatty-acid chain-length distribution
• Esterification profile
• Mono-, di-, and triglyceride content
• Melting range
• Solid-state behavior
• Particle-size distribution
• Moisture and impurity levels
• Powder flow and compressibility

Small changes in ester composition or particle engineering can alter tablet hardness, dissolution, lubrication, and release kinetics. Pharmaceutical customers therefore evaluate the excipient as a process-critical material rather than a generic commodity.

Intellectual-property barriers

Potentially protectable areas include:

• Specific drug-glyceryl behenate compositions
• Release profiles
• Coated multiparticulates
• Manufacturing temperatures and shear conditions
• Particle engineering
• Combination systems with polymers or surfactants

These rights are generally narrower than patents covering a new active ingredient. Their value depends on whether the formulation produces a clinically or commercially important performance advantage.

What licensing deals involve glyceryl behenate?

Public licensing agreements specifically centered on glyceryl behenate are limited. The material is commonly sold through direct supply, distribution, technical-support, or preferred-vendor arrangements rather than headline licensing transactions.

Commercial agreements may include:

• Regional distribution rights
• Pharmaceutical-grade supply agreements
• Joint formulation development
• Technical-service arrangements
• Customer-specific particle engineering
• Dual-sourcing and contingency supply
• Regulatory-support commitments

The absence of public licensing disclosures does not mean the product lacks commercial value. Specialty excipient economics often depend on recurring supply and customer qualification rather than royalty-bearing intellectual property.

How does glyceryl behenate compare with competing excipients?

Excipient	Primary strength	Relative competitive risk to glyceryl behenate
Hypromellose	Established hydrophilic extended-release matrix	High in conventional sustained-release tablets
Glyceryl palmitostearate	Lipid matrix and release control	Direct substitution risk
Hydrogenated vegetable oil	Low-cost hydrophobic matrix	High in price-sensitive products
Carnauba wax	Strong hydrophobic barrier	Moderate, depending on processability
Ethylcellulose	Robust polymeric release control	High in multiparticulate systems
PEG-based systems	Solubilization and hot-melt processing	Moderate
Glyceryl stearate	Lubrication and lipid structuring	Moderate, but performance differs

Glyceryl behenate is strongest where its melting behavior, compaction profile, and release characteristics are validated in a specific formulation. It is weaker where the customer prioritizes lowest cost or can meet the target dissolution profile with a standard polymer.

What is the financial trajectory for glyceryl behenate?

The likely financial trajectory is stable to moderately positive, with growth concentrated in higher-value pharmaceutical applications.

Near-term outlook

Demand should track:

• New extended-release approvals
• Complex generic launches
• Oral dosage-form development
• Nutraceutical production
• Cosmetic lipid demand
• Pharmaceutical outsourcing and regional manufacturing

Near-term margin risk comes from vegetable-oil feedstock volatility, freight costs, energy prices, and customer pressure to qualify alternative suppliers.

Medium-term outlook

The strongest growth opportunity is in differentiated formulation support. Suppliers that provide dissolution modeling, processing guidance, scale-up support, and regulatory packages can capture more value than suppliers selling an undifferentiated lipid powder.

The market may also see wider use in:

• Continuous manufacturing
• Direct compression
• Abuse-deterrent dosage forms
• Multiparticulate delivery
• Pediatric modified-release products
• Fixed-dose combinations

Downside scenarios

Revenue and margins could weaken if:

• Customers move to lower-cost hydrogenated oils.
• Hypromellose or ethylcellulose meets the same release target.
• A major customer redesigns a formulation.
• Feedstock costs rise faster than contract pass-throughs.
• Regional suppliers achieve acceptable pharmaceutical quality.
• Supply interruptions reduce confidence in a single branded grade.

Which generic launch scenarios affect glyceryl behenate demand?

Generic scenario	Effect on glyceryl behenate
Generic copies the reference formulation	Volume increases if the same excipient is selected
Generic designs around a formulation patent	Volume may remain stable or decline if another matrix is used
Multiple ANDA entrants launch	Unit demand can rise while finished-drug pricing falls
Reference product loses market share	Demand depends on generic formulation choices
Complex generic fails bioequivalence	Delays excipient demand
Supplier is qualified by several manufacturers	Recurring demand becomes more resilient

The most favorable scenario is broad generic adoption of a validated glyceryl behenate platform. The least favorable is successful redesign around a cheaper excipient with equivalent dissolution and manufacturing performance.

What geographic markets are most important?

North America and Europe remain important because of mature generic markets, extensive regulatory precedent, and demand for high-quality pharmaceutical excipients. India and China are significant growth markets because of pharmaceutical manufacturing scale, generic production, and expanding domestic drug consumption.

Regional competition is strongest where local manufacturers can provide:

• GMP documentation
• Consistent batch quality
• Regulatory support
• Competitive freight economics
• Reliable supply continuity

A supplier’s geographic advantage depends on both production location and the regulatory acceptability of its manufacturing site. Pharmaceutical customers may prefer a higher-priced supplier with established documentation over a lower-priced source that requires extensive qualification.

Key Takeaways

• Glyceryl behenate is a specialty lipid excipient used primarily in modified-release and lipid-based oral formulations.
• Gattefossé’s Compritol 888 ATO is a leading branded pharmaceutical-grade product.
• Public companies do not disclose glyceryl behenate revenue separately, so standalone market-size estimates require caution.
• The commercial moat comes from qualification, formulation data, manufacturing consistency, and regulatory support.
• Glyceryl behenate has no independent Orange Book listing or standalone drug exclusivity period.
• Paragraph IV litigation can affect demand indirectly through patents covering finished extended-release products.
• Direct biosimilar risk is minimal because glyceryl behenate is used mainly in oral small-molecule formulations.
• The main substitutes are hypromellose, ethylcellulose, glyceryl palmitostearate, hydrogenated vegetable oils, and carnauba wax.
• Financial growth is most likely in complex generics, modified-release products, direct compression, and technical formulation services.
• Feedstock costs, supplier qualification, and customer-specific formulation performance are the principal margin drivers.

FAQs About Glyceryl Behenate

Is glyceryl behenate the same as Compritol 888 ATO?

Compritol 888 ATO is a branded pharmaceutical-grade glyceryl behenate product supplied by Gattefossé. The commercial grade includes controlled composition and specifications that may not be identical to every material sold under the generic name glyceryl behenate.

Is glyceryl behenate a lubricant or a release-control excipient?

It can perform both functions. In many tablet formulations, its principal commercial value is as a hydrophobic matrix former for modified release, while it also contributes lubrication during compression.

Can glyceryl behenate be replaced without a new drug application?

A change may require regulatory assessment because excipient composition, level, particle size, and processing can affect dissolution and bioequivalence. The filing pathway depends on the approved product, the scale of the change, and applicable FDA requirements.

Does glyceryl behenate have a public drug master file?

Pharmaceutical suppliers may maintain drug master files or equivalent regulatory packages, but the existence, number, and accessibility of a specific file should be verified through the supplier and applicable regulatory records.

Is glyceryl behenate a high-margin excipient?

Pharmaceutical-grade material can support specialty-excipient margins because of qualification and technical-support requirements. Margins are lower in cosmetic, food, and industrial applications where customers are more price-sensitive and switching barriers are weaker.

References

1. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-database-iid

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: The Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

3. Gattefossé. (n.d.). Compritol 888 ATO: Glyceryl behenate for pharmaceutical applications. https://www.gattefosse.com

4. United States Pharmacopeia. (n.d.). United States Pharmacopeia and National Formulary. U.S. Pharmacopeial Convention.

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