Drugs Containing Excipient (Inactive Ingredient) PEG-400

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Generic drugs containing PEG-400 excipient

Company	Ingredient	NDC	Excipient
A-S Medication Solutions	metformin hydrochloride	50090-2081	PEG-400
A-S Medication Solutions	nabumetone	50090-5294	PEG-400
A-S Medication Solutions	ciprofloxacin hydrochloride	50090-5373	PEG-400
A-S Medication Solutions	zolpidem tartrate	50090-7434	PEG-400
A-S Medication Solutions	ropinirole	50090-7445	PEG-400
A-S Medication Solutions	ketorolac tromethamine	50090-7453	PEG-400
A-S Medication Solutions	metformin hydrochloride	50090-7595	PEG-400

PEG-400 Market Dynamics and Financial Trajectory in Pharmaceutical Excipients

Last updated: October 22, 2026

PEG-400 is a mature, high-volume pharmaceutical excipient with stable demand across oral, topical, liquid, semisolid, and selected parenteral formulations. Its commercial profile is driven more by ethylene oxide, energy, logistics, pharmaceutical-grade capacity, and customer qualification requirements than by drug-patent exclusivity. Revenue growth is likely to track pharmaceutical manufacturing volumes and formulation outsourcing, while margins remain exposed to petrochemical volatility and competition among multinational and regional suppliers.

What is PEG-400 and how is it used in pharmaceuticals?

PEG-400, or polyethylene glycol 400, is a liquid polyethylene glycol with an average molecular weight near 400. It is produced by polymerizing ethylene oxide and controlling the molecular-weight distribution. The material is also known as macrogol 400 in European and international pharmaceutical settings.

PEG-400 is used as:

• A solvent and cosolvent for poorly water-soluble active ingredients
• A plasticizer in films, coatings, capsules, and polymer systems
• A humectant in topical and mucosal products
• A viscosity modifier
• A vehicle in oral liquids, soft gels, creams, ointments, and suppositories
• A processing aid in selected drug-delivery systems

The excipient is listed in major compendia, including the United States Pharmacopeia-National Formulary and the European Pharmacopoeia. Its regulatory acceptance depends on grade, route of administration, impurity profile, manufacturing controls, and the specific formulation context.[1][2]

Which dosage forms use PEG-400?

PEG-400 is especially common in liquid and semisolid dosage forms because it combines water miscibility with relatively low volatility. Typical applications include:

Dosage form	Primary PEG-400 function	Commercial relevance
Oral solutions and suspensions	Solvent, cosolvent, viscosity control	High
Soft gelatin capsules	Vehicle and plasticizer	High
Topical creams and gels	Humectant, solvent, texture modifier	High
Suppositories	Vehicle and release-modifying base	Established
Ophthalmic products	Solvent or viscosity modifier	Selective
Injectable products	Solubilizer or vehicle	Route-specific and highly qualified
Film coatings	Plasticizer	Moderate
Modified-release systems	Polymer or release-control component	Specialized

The strongest demand base is in products where formulation scientists need a liquid, chemically stable, water-compatible excipient that is available in established pharmaceutical grades.

How large is the PEG-400 pharmaceutical market?

Public market reports generally aggregate PEG-400 into broader polyethylene glycol, pharmaceutical excipient, or specialty chemicals categories. They rarely disclose a verifiable standalone market size for pharmaceutical-grade PEG-400. Supplier financial statements also do not generally report PEG-400 revenue separately.

This limits precise market-share calculations. The most defensible market assessment is therefore based on application demand, production economics, supplier participation, and industry structure rather than a single reported market figure.

What is the market structure for pharmaceutical-grade PEG-400?

The market has four structural characteristics:

1. Large chemical producers supply base PEG and pharmaceutical grades.
2. Regional manufacturers compete on price, availability, and regulatory documentation.
3. Distributors maintain inventory and provide smaller-volume access to formulation companies.
4. Contract manufacturers and finished-dose producers qualify multiple sources where supply continuity is important.

Relevant supply-chain participants include large chemical manufacturers such as BASF, Dow, Clariant, Croda, and other regional producers. Product portfolios, ownership, and manufacturing footprints vary by geography and grade. Pharmaceutical buyers often distinguish between industrial, cosmetic, food, and pharmaceutical grades rather than treating all PEG-400 as interchangeable.

What drives PEG-400 demand?

Pharmaceutical demand is tied to finished-dose production, not to a single therapeutic franchise. The principal demand drivers are:

Generic and branded liquid medicines

PEG-400 is widely used in oral liquids, topical products, and other dosage forms with solubility or viscosity requirements. Growth in generic drug manufacturing supports recurring demand, although generic pricing pressure can limit the ability of manufacturers to absorb excipient cost increases.

Poorly soluble active ingredients

The growing use of poorly water-soluble active pharmaceutical ingredients supports demand for cosolvents and solubilization systems. PEG-400 competes with propylene glycol, glycerin, ethanol, polysorbates, PEG derivatives, cyclodextrins, and proprietary solubilizer systems.

Outsourced pharmaceutical manufacturing

Contract development and manufacturing organizations often support multiple products using common excipient platforms. This can increase demand for standardized, compendial excipients and favor suppliers that provide qualification packages, audit support, and global regulatory documentation.

Topical and consumer-health products

Dermatology, wound care, personal-care-adjacent products, and over-the-counter medicines use PEG-400 as a solvent, humectant, and texture modifier. This broadens the demand base beyond prescription medicines.

Biopharmaceutical and advanced-delivery applications

PEG chemistry is important in drug delivery, but PEG-400 should not be equated with high-value PEGylation reagents or long-chain pharmaceutical polymers. Demand for PEG-400 may benefit from broader formulation activity, but it does not capture the economics of proprietary PEGylated biologics or specialized polymer systems.

How do raw materials and manufacturing affect PEG-400 margins?

PEG-400 economics are exposed to ethylene oxide and energy prices. Ethylene oxide is produced from ethylene and requires tightly controlled handling because of its toxicity and flammability. Production therefore has meaningful safety, environmental, maintenance, and compliance costs.

Cost factor	Effect on PEG-400 economics
Ethylene and ethylene oxide	Primary feedstock exposure
Natural gas and electricity	Affects steam, utilities, and plant operation
Plant utilization	Influences fixed-cost absorption
Hazardous-material compliance	Raises operating and capital costs
Purification and testing	Separates pharmaceutical grade from commodity material
Packaging and logistics	Significant for drums, totes, and temperature-sensitive distribution
Quality documentation	Increases qualification and batch-release cost

Pharmaceutical-grade production requires controls over impurities, residuals, microbial quality where applicable, traceability, change notification, and batch consistency. A producer may manufacture the same nominal PEG molecular-weight grade for several markets, but pharmaceutical customers typically require separate documentation and supplier qualification.

What is the financial trajectory for PEG-400 suppliers?

PEG-400 is likely to produce steady, moderate revenue growth rather than high-growth pharmaceutical margins. The product is mature, widely available, and subject to substitution. Financial performance is shaped by the following variables:

Financial variable	Expected impact
Pharmaceutical volume growth	Supports baseline revenue
Price pass-through	Determines gross-margin protection
Feedstock inflation	Can compress margins before repricing
Capacity utilization	Improves earnings leverage
Product mix	Pharmaceutical grades generally support better value than industrial grades
Regional supply tightness	Can create temporary price increases
Qualification barriers	Protect incumbent suppliers
Competition from substitutes	Limits long-term pricing power

Large diversified chemical companies may protect margins through portfolio management, integrated feedstock positions, and global production. Smaller or regional manufacturers may compete through lower overhead, local inventory, shorter lead times, or customer-specific documentation.

PEG-400 revenue is unlikely to become a material standalone earnings driver for the largest diversified chemical companies. Its financial importance is greater at specialty-excipient distributors, regional manufacturers, and contract formulators where pharmaceutical-grade excipients represent a larger share of revenue.

How does PEG-400 pricing behave?

PEG-400 pricing typically reflects a combination of:

• Ethylene oxide and energy costs
• Contract versus spot purchasing
• Geographic freight and storage costs
• Grade and certification requirements
• Order size and packaging
• Supply availability
• Customer qualification status

Pharmaceutical buyers often pay a premium for qualified grade, but that premium does not eliminate price competition. Large customers can negotiate annual contracts, dual-source supply, and indexed pricing. Smaller buyers are more exposed to distributor markups and short-term availability.

What regulatory status does PEG-400 have?

PEG-400 is an established excipient rather than an active pharmaceutical ingredient. The FDA Inactive Ingredient Database provides a reference point for prior use of excipients in approved drug products, including route- and dosage-form-specific precedent.[3]

Regulatory review focuses on:

• Identity and molecular-weight distribution
• Ethylene oxide and related process impurities
• Diethylene glycol and other low-molecular-weight impurities
• Residual solvents and elemental impurities
• Microbial quality where relevant
• Route-specific tolerability
• Extractables and leachables in packaging systems
• Manufacturing change control
• Compliance with applicable pharmacopeial standards

A listing in the FDA Inactive Ingredient Database does not create a blanket approval for every concentration, route, or formulation. Sponsors remain responsible for demonstrating that the excipient is suitable for the proposed use.

Are there FDA Orange Book patents for PEG-400?

No. PEG-400 itself is not an innovator drug and does not have an Orange Book patent estate. The FDA Orange Book lists patents and exclusivity associated with approved drug products, not general excipient ownership.[4]

PEG-400 may appear in a formulation covered by a drug patent, but that patent would protect the finished product, formulation, dosage regimen, or method of use rather than PEG-400 as a standalone commodity.

What patents protect PEG-400?

No broad, commercially meaningful composition patent is expected to control ordinary PEG-400 manufacture as a mature chemical material. Relevant intellectual-property rights are more likely to cover:

• Manufacturing processes
• Catalyst systems
• Molecular-weight distribution control
• Purification methods
• Low-impurity grades
• Specific pharmaceutical formulations
• Drug-delivery systems
• PEG derivatives or conjugates
• Packaging and handling systems

These rights are distinct from exclusivity over PEG-400 itself. A supplier may retain manufacturing know-how or trade secrets even where basic composition claims are expired or unavailable.

What manufacturing barriers protect suppliers?

The strongest barriers are operational and quality-based:

1. Safe handling of ethylene oxide.
2. Consistent control of molecular-weight distribution.
3. Pharmaceutical-grade purification.
4. Validated analytical methods.
5. Auditable quality systems.
6. Reliable global supply.
7. Customer qualification and change-control history.

These barriers can make switching suppliers costly even when the underlying chemistry is not proprietary.

When does PEG-400 lose exclusivity?

PEG-400 has no single patent-expiration date or regulatory exclusivity date. It is a mature excipient available from multiple producers. Commercial access is constrained by grade qualification, supply contracts, and customer-specific approval rather than by a central patent monopoly.

The relevant exclusivity timelines are product-specific:

Asset	Exclusivity framework
PEG-400 commodity material	No central patent exclusivity
Pharmaceutical-grade PEG-400	Supplier quality and qualification barriers
Drug formulation containing PEG-400	Drug-product patents and regulatory exclusivity
PEG-based delivery system	Possible formulation, device, or process patents
PEGylated active ingredient	Product-specific patents and biologic or drug exclusivity

Which companies compete in pharmaceutical-grade PEG-400?

Competition includes integrated chemical producers, specialty-excipient manufacturers, regional suppliers, and distributors. The relevant competitive dimensions are not limited to price.

Competitive factor	Why it matters
Compendial compliance	Supports regulatory submissions
Global manufacturing	Reduces single-site risk
Batch consistency	Limits reformulation risk
Regulatory support	Simplifies customer audits
Supply continuity	Reduces production interruptions
Packaging options	Supports different customer volumes
Change notification	Protects approved formulations
Technical service	Helps resolve formulation issues

BASF and Dow have historically been important in polyethylene glycol and related chemical markets. Clariant, Croda, and regional manufacturers participate in specialty and pharmaceutical excipient supply, while distributors extend access to smaller pharmaceutical companies. Market position varies by region, product specification, plant ownership, and current commercial agreements.

What generic entry risks exist for drugs containing PEG-400?

PEG-400 does not independently create generic-entry risk. Generic competition depends on the drug product’s active ingredient, formulation, delivery system, method of use, regulatory pathway, and patent status.

What happens in a Paragraph IV challenge?

A Paragraph IV certification concerns patents listed for an approved drug product in the Orange Book. A generic applicant may argue that a listed patent is invalid, unenforceable, or not infringed. PEG-400 can become relevant if the listed patent claims a formulation containing PEG-400, but the excipient alone does not create the challenge.

Potential litigation issues include:

• Whether PEG-400 is required by the claims
• Whether the generic uses the claimed concentration range
• Whether the formulation has the claimed release profile
• Whether a method-of-use claim covers the proposed label
• Whether a formulation patent is valid and enforceable

What patent litigation and settlement agreements affect PEG-400?

There is no single PEG-400 patent-litigation docket comparable to the litigation surrounding branded drugs. Disputes generally arise at the finished-product level. Relevant litigation may involve formulation patents, drug-delivery systems, soft-gel technology, topical compositions, or combinations of PEG-400 with an active ingredient.

Settlement agreements in such cases may establish an authorized generic launch date, a license, a royalty, or restrictions on the generic product. The settlement concerns the drug product and does not grant the originator control over the broader PEG-400 market.

What biosimilar risk exists for PEG-400?

PEG-400 has no direct biosimilar risk because it is not a biologic. Biosimilar development can indirectly affect demand where PEG-400 is used in formulations of biologic products, but the impact depends on the formulation and delivery platform.

Biosimilar substitution may reduce unit volumes for an individual branded biologic while increasing total market volume through broader access. PEG-400 demand is therefore more likely to follow aggregate manufacturing activity than the revenue trajectory of one biologic brand.

How does PEG-400 compare with competing excipients?

Excipient	Main advantage	Main limitation
PEG-400	Water miscibility and broad formulation utility	Potential tolerability and impurity concerns at higher exposure
Propylene glycol	Common solvent with broad use	Different tolerability and regulatory constraints
Glycerin	Humectant and sweetening properties	Higher viscosity and distinct sensory profile
Ethanol	Strong solvent and volatility	Flammability and route limitations
Polysorbates	Effective solubilization and emulsification	Oxidative degradation and impurity concerns
Cyclodextrins	Solubility enhancement for selected APIs	Higher cost and molecule-specific performance
PEG 3350	Higher molecular weight and laxative use	Solid or semisolid behavior differs from PEG-400

Formulators choose among these materials based on solubility, viscosity, stability, route, taste, tolerability, packaging, and regulatory precedent. PEG-400 is strongest where a liquid, nonvolatile, water-compatible vehicle is required.

What is the geographic outlook for PEG-400?

North America and Europe have mature pharmaceutical-excipient demand and stringent supplier qualification requirements. Asia-Pacific is likely to provide the strongest volume growth because of expanding generic manufacturing, contract development, domestic pharmaceutical production, and excipient localization.

Regional risks include:

• Uneven compendial standards
• Variable supplier quality systems
• Import dependence
• Port and freight disruptions
• Different change-notification expectations
• Local registration requirements
• Concentration of production in petrochemical hubs

Global pharmaceutical companies increasingly favor dual sourcing, regional inventory, and qualified secondary suppliers. This supports demand for producers that can provide equivalent documentation across jurisdictions.

What is the outlook for PEG-400 through the next business cycle?

The base case is stable volume growth with periodic price volatility. Revenue should expand with pharmaceutical production, especially oral liquids, topical medicines, soft gels, and outsourced manufacturing. Margin performance will depend on the speed of price pass-through relative to ethylene oxide and energy inflation.

Base-case outlook

• Moderate pharmaceutical demand growth
• Continued substitution pressure
• Stable use in mature formulations
• Periodic feedstock-driven price increases
• Greater emphasis on dual sourcing
• Limited opportunity for sustained monopoly pricing

Upside scenario

Higher demand could result from increased production of poorly soluble drugs, growth in liquid and topical formulations, stronger contract-manufacturing activity, and regional supply disruptions that improve supplier pricing.

Downside scenario

Revenue and margins could weaken if pharmaceutical production slows, customers reformulate toward lower-cost solvents, excess capacity increases, or feedstock costs rise faster than contract repricing.

Key Takeaways

• PEG-400 is a mature, globally available pharmaceutical excipient.
• Its main uses are as a solvent, cosolvent, humectant, plasticizer, and viscosity modifier.
• The market lacks a reliable public standalone revenue figure because suppliers report PEG within broader chemical or excipient categories.
• Financial performance is driven by pharmaceutical volumes, ethylene oxide costs, capacity utilization, grade premiums, and supply reliability.
• PEG-400 has no central Orange Book listing, Paragraph IV exposure, biosimilar pathway, or single exclusivity date.
• The strongest competitive barriers are pharmaceutical-grade quality systems, validated manufacturing, customer qualification, and supply continuity.
• Generic-entry risk attaches to drug formulations containing PEG-400, not to the excipient itself.
• Asia-Pacific is the most likely region for incremental volume growth, while North America and Europe remain important high-compliance markets.
• The expected financial trajectory is moderate growth with cyclical margin volatility rather than high-growth pharmaceutical economics.

FAQs

Is PEG-400 considered an active pharmaceutical ingredient?

No. PEG-400 is generally used as an inactive ingredient or excipient. It can be pharmacologically active at certain doses and in specific products, but its principal pharmaceutical role is formulation support.

Is PEG-400 the same as polyethylene glycol 3350?

No. Both are polyethylene glycols, but they differ in average molecular weight, physical properties, viscosity, and typical applications. PEG-400 is a liquid, while PEG 3350 is a substantially higher-molecular-weight material.

Can pharmaceutical companies switch PEG-400 suppliers without new approval?

Not automatically. A supplier change may require comparability testing, regulatory assessment, customer qualification, stability data, and change-control documentation. The required steps depend on the product, jurisdiction, specification, and significance of the change.

Does PEG-400 create a barrier to generic drug approval?

Usually no. PEG-400 is generally a well-established excipient. A generic applicant may still need to demonstrate formulation equivalence, impurity control, stability, and route-specific suitability.

Is pharmaceutical-grade PEG-400 more profitable than industrial-grade PEG-400?

It can command a premium because of testing, documentation, qualification, and quality-system requirements. The premium is constrained by the availability of competing suppliers and the ability of customers to qualify alternate sources.

References

1. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary: Polyethylene glycol monograph. United States Pharmacopeial Convention.

2. European Directorate for the Quality of Medicines & HealthCare. (2024). European Pharmacopoeia: Macrogols monograph. Council of Europe.

3. U.S. Food and Drug Administration. (2024). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book