Drugs Containing Excipient (Inactive Ingredient) GLYCERYL PALMITOSTEARATE

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

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
A-S Medication Solutions	XIFAXAN	rifaximin	50090-2445	GLYCERYL PALMITOSTEARATE
Physicians Total Care Inc	XIFAXAN	rifaximin	54868-5972	GLYCERYL PALMITOSTEARATE
Cardinal Health 107 LLC	XIFAXAN	rifaximin	55154-6777	GLYCERYL PALMITOSTEARATE
Salix Pharmaceuticals Inc	XIFAXAN	rifaximin	65649-301	GLYCERYL PALMITOSTEARATE
Carilion Materials Management	XIFAXAN	rifaximin	68151-4980	GLYCERYL PALMITOSTEARATE
Dispensing Solutions Inc	XIFAXAN	rifaximin	68258-1107	GLYCERYL PALMITOSTEARATE
Avera McKennan Hospital	XIFAXAN	rifaximin	69189-0309	GLYCERYL PALMITOSTEARATE

Generic drugs containing GLYCERYL PALMITOSTEARATE excipient

Company	Ingredient	NDC	Excipient
A-S Medication Solutions	rifaximin	50090-2445	GLYCERYL PALMITOSTEARATE
Physicians Total Care Inc	rifaximin	54868-5972	GLYCERYL PALMITOSTEARATE
Cardinal Health 107 LLC	rifaximin	55154-6777	GLYCERYL PALMITOSTEARATE
Salix Pharmaceuticals Inc	rifaximin	65649-301	GLYCERYL PALMITOSTEARATE
Carilion Materials Management	rifaximin	68151-4980	GLYCERYL PALMITOSTEARATE
Dispensing Solutions Inc	rifaximin	68258-1107	GLYCERYL PALMITOSTEARATE
Avera McKennan Hospital	rifaximin	69189-0309	GLYCERYL PALMITOSTEARATE

Glyceryl Palmitostearate Market Dynamics, Pharmaceutical Applications, and Financial Trajectory

Last updated: August 27, 2026

Glyceryl palmitostearate is a multifunctional lipid excipient used mainly in oral solid dosage forms, modified-release systems, lipid nanoparticles, and tablet lubrication. The market is fragmented, with demand tied to formulation development rather than direct end-patient prescribing. No major supplier publicly reports standalone revenue for glyceryl palmitostearate, so financial analysis must rely on formulation adoption, excipient-grade sales, pharmaceutical outsourcing, and demand for lipid-based delivery technologies.

The commercial outlook is positive but niche. Growth is most likely in modified-release generics, continuous manufacturing, lipid-based drug delivery, and poorly soluble active pharmaceutical ingredients. Pricing power is limited for standard grades because the material is chemically established and substitutable. Suppliers retain stronger margins where they provide validated grades, regulatory support, technical formulation services, and proprietary particle or processing technologies.

What is glyceryl palmitostearate and how is it used?

Glyceryl palmitostearate is a glyceride-based excipient consisting primarily of mono-, di-, and triglycerides derived from palmitic and stearic acids. Its properties depend on fatty-acid composition, glyceride distribution, particle size, polymorphic form, melting range, and manufacturing process.

The excipient is commonly associated with the pharmaceutical grade PRECIROL ATO 5, marketed by Gattefossé. It is used as:

• A hydrophobic matrix former for sustained-release tablets
• A tablet lubricant and anti-adherent
• A lipid carrier for poorly soluble drugs
• A component of solid lipid nanoparticles
• A processing aid in hot-melt and lipid-based formulations
• A release-modifying agent in multiparticulates and pellets

Glyceryl palmitostearate is not equivalent to glyceryl behenate. Glyceryl behenate, marketed in pharmaceutical applications under names such as COMPRITOL 888 ATO, is derived primarily from behenic acid and has different melting, matrix-forming, and release characteristics. Glyceryl monostearate is also a separate excipient with a different composition and functionality.

Core technical properties

Property	Commercial relevance
Chemical class	Glyceride lipid excipient
Main fatty acids	Palmitic acid and stearic acid
Dosage-form role	Matrix former, lubricant, release modifier, lipid carrier
Typical application	Oral tablets, capsules, pellets, lipid nanoparticles
Mechanism in sustained release	Formation of a hydrophobic matrix that limits liquid penetration and drug diffusion
Key quality attributes	Fatty-acid profile, glyceride distribution, melting range, acid value, peroxide value, moisture, particle size
Main technical risk	Batch-to-batch variation can affect dissolution and process performance
Principal commercial supplier association	Gattefossé, PRECIROL ATO 5

The excipient’s performance is formulation-dependent. A small change in particle size, compression force, drug loading, lubricant concentration, or granulation temperature can alter tablet hardness and dissolution.

What pharmaceutical products use glyceryl palmitostearate?

Glyceryl palmitostearate is used primarily in oral formulations where developers need controlled drug release or improved processing. Public product-level disclosure is limited because approved-product labels generally identify inactive ingredients by compendial or common name, while formulation-development suppliers do not disclose every customer application.

The highest-value applications are likely to be:

1. Sustained-release generic tablets
2. Modified-release formulations of poorly soluble drugs
3. Lipid-based delivery systems
4. Solid lipid nanoparticles and nanostructured lipid carriers
5. Abuse-deterrent or matrix-based oral dosage forms
6. Multiparticulate capsules and pellets

The excipient is more commercially important as a platform material than as a visible ingredient in a branded medicine. Its value is generated when it solves a release, bioavailability, manufacturability, or stability problem.

Sustained-release tablets

Glyceryl palmitostearate can form a hydrophobic matrix around an active ingredient. Drug release is influenced by:

• Excipient concentration
• Drug solubility
• Tablet porosity
• Compression pressure
• Granulation method
• Particle-size distribution
• Co-excipients such as hydrophilic polymers or surfactants

It can be used alone or combined with hydroxypropyl methylcellulose, microcrystalline cellulose, lactose, magnesium stearate, or other lipid excipients. Formulators often screen it against glyceryl behenate, hydrogenated vegetable oils, stearic acid, ethylcellulose, and high-viscosity polymers.

Lipid nanoparticles

Glyceryl palmitostearate has been studied as a solid lipid in solid lipid nanoparticles and related systems. These systems can improve apparent solubility, protect labile drugs, and alter absorption. Commercial adoption remains more limited than conventional tablet use because nanoparticle products face greater manufacturing, scale-up, characterization, and regulatory requirements.

How large is the glyceryl palmitostearate market?

A reliable standalone global market size is not publicly disclosed. Suppliers typically report revenue by company, product family, application, or pharmaceutical excipient segment rather than by individual excipient.

Glyceryl palmitostearate is therefore best classified as a specialty pharmaceutical excipient within the broader market for:

• Oral solid-dose excipients
• Lipid excipients
• Modified-release excipients
• Drug-delivery materials
• Functional pharmaceutical ingredients

Its addressable market is smaller than that of microcrystalline cellulose, lactose, starch, magnesium stearate, or polyethylene glycol. Its unit value can be higher than commodity excipients because customers purchase functionality, regulatory documentation, and formulation support rather than only kilograms of material.

Market structure

Market characteristic	Assessment
Market size transparency	Low; no public product-level revenue data
Demand concentration	Pharmaceutical and specialty formulation users
Customer switching cost	Moderate to high after regulatory filing
Commodity exposure	Moderate for standard grades
Technical differentiation	Moderate, based on composition and particle engineering
Regulatory differentiation	High where supplier has compendial, GMP, and change-control support
Pricing power	Limited for bulk standard material; stronger for validated specialty grades
Growth drivers	Modified release, generics, lipid delivery, outsourcing
Main constraints	Substitution, small volumes, formulation-specific performance

What drives demand for glyceryl palmitostearate?

The strongest demand driver is the continued use of oral solid dosage forms. Generic-drug developers frequently need release-control technologies that are manufacturable, scalable, and compatible with abbreviated regulatory pathways. A lipid matrix former can be attractive when polymeric systems produce undesirable tablet size, burst release, moisture sensitivity, or processing problems.

Generic-drug development

Glyceryl palmitostearate can support generic formulations when the reference product uses a proprietary or difficult-to-reproduce release mechanism. Developers may use it to establish equivalent dissolution profiles and pharmacokinetic performance.

Generic demand is particularly relevant for:

• Extended-release analgesics
• Cardiovascular medicines
• Central-nervous-system products
• Gastrointestinal drugs
• Hormonal products
• Antidiabetic medicines

The economic opportunity is greatest during formulation development and technology transfer. Once a product is approved, annual excipient consumption depends on dose strength, batch size, market share, and the number of competing manufacturers.

Poorly soluble drugs

Lipid excipients are increasingly evaluated for Biopharmaceutics Classification System Class II and IV compounds. Glyceryl palmitostearate can assist in dispersion and release control, although it is not a universal solubilizer. Formulators may combine it with surfactants, medium-chain triglycerides, phospholipids, or amorphous solid-dispersion technologies.

Contract development and manufacturing

Contract development and manufacturing organizations create recurring demand because they run multiple projects across therapeutic areas. The supplier relationship can become embedded through formulation protocols, analytical methods, approved raw-material specifications, and customer audits.

Which companies supply glyceryl palmitostearate?

Gattefossé is the most visible pharmaceutical excipient supplier associated with glyceryl palmitostearate through PRECIROL ATO 5. Other manufacturers may produce glyceride materials or regional equivalents, but commercial availability, grade identity, compendial status, and pharmaceutical documentation vary by jurisdiction.

Competitive supplier factors

A buyer evaluating suppliers will typically assess:

• Compliance with current good manufacturing practice
• USP-NF, Ph. Eur., or other compendial status
• DMF or equivalent regulatory support
• Animal-origin and allergen statements
• Residual-solvent controls
• Oxidative-stability data
• Change-notification procedures
• Supply continuity and manufacturing-site redundancy
• Particle-size and melting-range consistency
• Technical support during scale-up

The key competitive advantage is often documentation and technical service rather than molecular exclusivity.

What regulatory status does glyceryl palmitostearate have?

Glyceryl palmitostearate is regulated as an excipient, not as an active pharmaceutical ingredient. Its acceptability depends on the grade, route, dose, product type, and jurisdiction.

The U.S. Food and Drug Administration’s Inactive Ingredient Database is the principal public reference for precedent involving inactive ingredients in approved drug products. Inclusion in the database does not create a blanket approval for every route, dose, formulation, or product category. Developers must establish suitability for the specific product and manufacturing process.[1]

Relevant regulatory considerations include:

• Identity and composition control
• Compliance with applicable USP-NF or Ph. Eur. standards
• Residual impurities and elemental impurities
• Oxidation and peroxide formation
• Microbiological quality
• Nitrosamine and contamination risk assessment where relevant
• Extractables and leachables for specialized delivery systems
• Toxicological justification for novel exposure levels
• Stability under storage and manufacturing conditions

The European Medicines Agency’s excipient guidance emphasizes risk-based control of excipient quality, functionality, composition, and manufacturing consistency.[2]

FDA pathway and Orange Book status

Glyceryl palmitostearate does not have an independent FDA Orange Book listing because the Orange Book lists approved drug products and their patents or exclusivity, not ordinary excipients as standalone products.[3]

The excipient may appear in approved drug labeling as an inactive ingredient. Its use does not create drug-product exclusivity, patent protection, or regulatory exclusivity by itself.

What patents protect glyceryl palmitostearate?

The underlying glyceride composition is commercially mature and is unlikely to support broad, durable composition-of-matter exclusivity comparable to a new chemical entity. Patent value generally resides in the formulation or manufacturing method.

Potentially protectable subject matter includes:

• Specific sustained-release compositions
• Drug-to-excipient ratios
• Particle-size distributions
• Solid lipid nanoparticle compositions
• Nanostructured lipid carriers
• Pellets or multiparticulates
• Compression and granulation processes
• Coating systems
• Combination matrices using glyceryl palmitostearate and polymers
• Methods for improving dissolution or bioavailability

Patent landscape

Patent category	Typical owner	Commercial impact
Excipient composition	Excipient manufacturer	Usually limited if based on known glycerides
Pharmaceutical formulation	Drug developer	Can delay generic substitution for the finished product
Process patent	Drug developer or supplier	May restrict a specific manufacturing route
Particle-engineering patent	Excipient or delivery-system company	Can protect premium grades or specialized performance
Method-of-use patent	Drug sponsor	May cover treatment or release profile, subject to jurisdiction
Nanoparticle patent	Drug-delivery developer	Potentially important for high-value specialty products

Patent searches should use the substance names “glyceryl palmitostearate,” “glyceryl palmitostearate and glyceryl stearate,” “palmitostearin,” and relevant product names. Patent claims may describe the material through fatty-acid ranges or glyceride fractions rather than the commercial name.

When does glyceryl palmitostearate lose exclusivity?

Glyceryl palmitostearate does not have a single patent expiration date or product-level exclusivity period. It is a known excipient supplied by multiple parties, and ordinary material availability is not controlled by a central patent term.

The relevant exclusivity dates belong to finished pharmaceutical products that use the excipient. Those dates may include:

• New chemical entity exclusivity
• New clinical investigation exclusivity
• Orphan-drug exclusivity
• Pediatric exclusivity
• Formulation patents
• Method-of-use patents
• Process patents
• Drug-delivery patents

A generic manufacturer can generally use glyceryl palmitostearate if its product complies with applicable regulatory requirements and does not infringe enforceable patents covering the reference product or manufacturing process.

Are there Paragraph IV challenges involving glyceryl palmitostearate?

Paragraph IV litigation targets patents listed for an approved drug product, not the excipient as an independent commercial category. A generic applicant may use glyceryl palmitostearate in a Paragraph IV product, but the litigation would concern patents listed for the finished drug.

Potential disputes can involve:

• Release-control formulation claims
• Excipient concentration ranges
• Dissolution profiles
• Manufacturing methods
• Coating systems
• Drug-excipient combinations
• Treatment methods

The excipient supplier usually is not the primary litigation target unless the dispute concerns a supplier-owned process or a specialized material claim. Most commercial risk is borne by the generic applicant and the branded-product patent holder.

How strong is the patent estate for glyceryl palmitostearate?

The standalone patent estate is weak to moderate. The material is established, chemically broad, and subject to substitution. The patent estate for a specific formulation using it can be strong if the claims cover a clinically or commercially important release profile and survive validity and infringement challenges.

Strength assessment

Factor	Assessment
Broad composition claims	Weak
Supplier process claims	Potentially moderate
Finished-product formulation claims	Moderate to strong
Generic substitution risk	Moderate
Design-around risk	High for standard tablet applications
Regulatory switching cost	Moderate
Manufacturing know-how	Moderate
Litigation value	Concentrated in finished products

The most defensible commercial position is a combination of validated grade, consistent supply, formulation data, regulatory support, and customer integration. Patent protection alone is unlikely to create a durable moat for the base excipient.

What are the main substitutes for glyceryl palmitostearate?

Substitution is a central limit on pricing power. Formulators may select another lipid or polymer depending on target release, drug properties, equipment, and regulatory precedent.

Substitute	Relative use case
Glyceryl behenate	Hydrophobic sustained-release matrix and lubricant
Glyceryl monostearate	Lubrication, emulsification, and lipid delivery
Stearic acid	Matrix formation and lubrication
Hydrogenated vegetable oils	Hydrophobic matrices and processing
Ethylcellulose	Polymer-based modified release
Hypromellose	Hydrophilic controlled-release matrix
Polyethylene oxide	High-viscosity extended-release systems
Waxes	Hydrophobic release modification
Lipid blends	Tailored melting and release properties

The substitution decision is not based only on price. Developers compare dissolution performance, tablet robustness, scale-up behavior, supplier documentation, and regulatory precedent.

What is the financial trajectory for glyceryl palmitostearate?

The financial trajectory is best characterized as steady specialty-excipient growth rather than high-growth pharmaceutical product expansion. Public financial statements do not isolate glyceryl palmitostearate revenue, so no defensible standalone revenue or margin series exists.

Revenue drivers

Revenue should track:

• Volume of modified-release generic launches
• Number of formulation-development projects
• Adoption of lipid nanoparticles
• Growth in outsourced pharmaceutical development
• Regional expansion of pharmaceutical manufacturing
• Demand for validated, compendial excipient grades
• Customer preference for multi-source supply

Margin profile

Standard material is exposed to:

• Fatty-acid and glycerol input costs
• Energy and processing costs
• Packaging and freight
• Quality-control costs
• Regional registration expenses
• Customer qualification requirements

Premium margins are more likely for:

• Low-variation pharmaceutical grades
• Smaller particle-size or engineered grades
• Regulatory-support packages
• Customized blends
• Technical formulation services
• Supply agreements with change-control commitments

Financial scenario framework

Scenario	Demand pattern	Pricing outcome	Financial implication
Base case	Gradual growth in modified-release and generic formulations	Stable to modestly higher pricing	Predictable specialty-excipient revenue
Upside case	Greater use in lipid nanoparticles and poorly soluble drugs	Premium pricing for engineered grades	Faster growth and improved mix
Downside case	Substitution by polymers or glyceryl behenate; weak generic launches	Price pressure	Volume growth with flat or declining margins

What geographic markets are most important?

North America and Europe remain important for regulated pharmaceutical-grade demand because customers require extensive documentation, audit support, and compendial compliance. India and China are important growth markets because of generic-drug manufacturing, contract development, and export-oriented production.

Geographic demand is influenced by:

• Local availability of pharmaceutical-grade material
• National pharmacopeial requirements
• Import registration
• Regional manufacturing capacity
• Generic-drug approval volume
• Customer qualification practices
• Freight and inventory economics

A supplier with regional warehouses and redundant manufacturing capacity can compete more effectively than a lower-cost supplier with weak delivery reliability.

What manufacturing and intellectual-property barriers exist?

Manufacturing glyceryl palmitostearate at industrial scale is less difficult than producing a complex biologic or high-potency active ingredient. The barrier is consistency.

Critical manufacturing controls include:

• Raw-material fatty-acid purity
• Esterification or glyceride-processing conditions
• Degree of partial glyceride formation
• Thermal history
• Crystallization behavior
• Milling and particle-size control
• Oxidation prevention
• Packaging and storage conditions

The most important IP and know-how barriers are likely to involve process control, particle engineering, grade consistency, and application data. These barriers can protect customer relationships even when the base chemical is widely known.

How does glyceryl palmitostearate compare with glyceryl behenate?

Glyceryl palmitostearate and glyceryl behenate both support hydrophobic matrix systems, but their performance is not interchangeable without reformulation.

Attribute	Glyceryl palmitostearate	Glyceryl behenate
Main fatty-acid basis	Palmitic and stearic acids	Behenic acid
Typical commercial association	PRECIROL ATO 5	COMPRITOL 888 ATO
Primary role	Matrix former, lubricant, lipid carrier	Matrix former, lubricant
Release behavior	Depends on glyceride profile and formulation	Often more hydrophobic and highly structured
Substitution	Possible but requires dissolution testing	Possible but requires dissolution testing
Commercial differentiation	Grade and technical support	Grade and technical support

The appropriate choice depends on the target dissolution profile and manufacturing process, not only on excipient price.

What generic-entry risks exist for products using glyceryl palmitostearate?

Generic-entry risk is determined by the finished product’s patents, regulatory pathway, formulation complexity, and market economics. The presence of glyceryl palmitostearate generally increases neither patent protection nor regulatory exclusivity by itself.

Risk is higher when:

• The product has few meaningful formulation patents
• The excipient can be replaced without changing clinical performance
• The dosage form is a conventional tablet
• Multiple suppliers offer comparable grades
• The active ingredient has high sales and simple manufacturing
• The reference product’s release mechanism is easy to reproduce

Risk is lower when:

• The product depends on a narrow dissolution profile
• The formulation uses a patented excipient combination
• The product has complex multiparticulate architecture
• The delivery system is protected by process or device patents
• Bioequivalence is difficult to demonstrate
• The product has limited manufacturing capacity

Key Takeaways

• Glyceryl palmitostearate is a specialty lipid excipient used in modified-release tablets, lipid delivery systems, and pharmaceutical processing.
• PRECIROL ATO 5 is the best-known commercial pharmaceutical-grade association.
• No reliable standalone global revenue figure or market-share dataset is publicly available.
• Demand is linked to generic modified-release development, poorly soluble drugs, outsourced formulation, and lipid nanoparticles.
• The base excipient has limited standalone patent defensibility because glyceride materials are established and substitutable.
• Finished-product formulation, process, and delivery-system patents can create meaningful commercial protection.
• FDA Orange Book and Paragraph IV issues attach to drug products using the excipient, not to glyceryl palmitostearate as an independent category.
• Supplier differentiation depends on quality consistency, regulatory documentation, technical service, and supply reliability.
• The financial outlook is steady specialty-excipient growth, with the strongest upside in engineered grades and advanced lipid delivery applications.

FAQs

Is glyceryl palmitostearate the same as Precirol ATO 5?

PRECIROL ATO 5 is a commercial pharmaceutical-grade product associated with glyceryl palmitostearate. Commercial grades should be evaluated by their specifications rather than assumed to be interchangeable solely from the chemical name.

Can glyceryl palmitostearate be used in immediate-release tablets?

Yes. It can function as a lubricant or processing aid, although its hydrophobicity may slow wetting and dissolution. The formulation requires dissolution and manufacturability testing.

Is glyceryl palmitostearate suitable for capsule formulations?

It can be used in capsule fills, lipid matrices, pellets, and multiparticulate systems. Suitability depends on fill composition, melting behavior, capsule compatibility, and release targets.

Does glyceryl palmitostearate improve drug solubility?

It can improve drug dispersion and support lipid-based delivery, but it is not a universal solubilizer. Its effect depends on the active ingredient, surfactants, particle size, and dosage-form design.

Can a pharmaceutical company change from glyceryl palmitostearate to glyceryl behenate?

A change is possible but generally requires formulation comparability, dissolution testing, stability assessment, and potentially regulatory variation or supplement procedures. The two excipients should not be treated as automatically interchangeable.

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. (2011). Guideline on the risk-based approach according to Annex I, part III, section 3 of Directive 2001/83/EC applied to excipients. https://www.ema.europa.eu/

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

4. Gattefossé. (n.d.). PRECIROL ATO 5: Glyceryl palmitostearate for pharmaceutical applications. https://www.gattefosse.com/

5. United States Pharmacopeia. (n.d.). United States Pharmacopeia and National Formulary. USP Convention. https://www.usp.org/knowledge-making/usp-nf-subscriber-resources