Drugs Containing Excipient (Inactive Ingredient) POLYETHYLENE GLYCOL 400

Generic drugs containing POLYETHYLENE GLYCOL 400 excipient

Company	Ingredient	NDC	Excipient
Apotex Corp	bicalutamide	60505-2642	POLYETHYLENE GLYCOL 400

Polyethylene Glycol 400 Market Dynamics and Financial Trajectory

Last updated: August 31, 2026

Polyethylene glycol 400, or PEG 400, is a mature, globally traded pharmaceutical excipient with stable demand and limited product-level intellectual-property risk. Its financial trajectory is driven less by pharmaceutical innovation than by ethylene oxide costs, plant utilization, regulatory compliance, supply-chain concentration, and growth in liquid oral, topical, ophthalmic, and parenteral formulations.

PEG 400 has no meaningful standalone patent exclusivity. Competitive differentiation comes from pharmacopeial compliance, impurity control, documentation, manufacturing reliability, and customer qualification. Public companies generally do not report PEG 400 revenue separately, so market sizing must be inferred from broader polyethylene glycol, specialty chemicals, pharmaceutical excipient, and personal-care ingredient disclosures.

What is polyethylene glycol 400 used for in pharmaceuticals?

PEG 400 is a low-molecular-weight polyethylene glycol, typically supplied as a clear, colorless or nearly colorless, viscous liquid. Its average molecular-weight designation is approximately 400, although commercial material is a distribution of polymer chain lengths rather than a single molecular species.

Attribute	Typical PEG 400 profile
Chemical name	Polyethylene glycol 400
CAS number	25322-68-3
Physical form	Clear, viscous liquid
Average molecular weight	Approximately 380-420
Primary function	Solvent, cosolvent, plasticizer, vehicle, humectant
Major dosage forms	Oral liquids, softgels, topical products, ophthalmic products, parenteral formulations
Key standards	USP-NF, Ph. Eur., BP and other national pharmacopoeias
Manufacturing route	Controlled polymerization of ethylene oxide
Patent status	No meaningful composition-of-matter exclusivity

PEG 400 dissolves a wide range of active pharmaceutical ingredients and is miscible with water and many polar organic solvents. Formulators use it to improve solubility, control viscosity, maintain product homogeneity, and modify the flexibility of gelatin or polymeric dosage forms.

Common pharmaceutical applications include:

• Oral solutions and concentrates
• Liquid and semisolid medicines
• Soft gelatin capsules
• Topical creams, lotions, and ointments
• Ophthalmic and otic products
• Some injectable and parenteral formulations
• Tablet film-coating and granulation systems
• Modified-release and solubility-enhancement platforms

The U.S. FDA Inactive Ingredient Database lists polyethylene glycol in multiple dosage-form and route categories, subject to concentration and formulation-specific precedent.[1]

How large is the PEG 400 pharmaceutical excipient market?

No major public company reports global PEG 400 pharmaceutical sales as a separate financial line. Published market studies usually combine PEG grades, pharmaceutical excipients, specialty chemicals, or end-use sectors. Their estimates are not directly comparable because they use different definitions, geographies, and inclusion criteria.

The most defensible market characterization is qualitative:

1. Pharmaceutical PEG 400 demand is a small portion of total PEG demand.
2. Industrial, personal-care, cosmetic, and household applications create a broader demand base.
3. Pharmaceutical-grade material commands a premium over technical-grade material because of testing, documentation, traceability, and validated manufacturing.
4. Volume growth is generally moderate rather than high.
5. Revenue growth can exceed volume growth during periods of ethylene oxide, energy, freight, or compliance-cost inflation.

Demand is supported by the expansion of liquid medicines, self-administered products, softgels, topical therapies, and formulations for poorly soluble active ingredients. PEG 400 is also used in non-pharmaceutical consumer products, which can provide volume diversification when drug-product demand is flat.

What determines PEG 400 pricing?

PEG 400 pricing reflects a combination of feedstock economics and grade-specific value.

Pricing factor	Financial effect
Ethylene and ethylene oxide costs	Direct effect on manufacturing cost
Natural gas and electricity	Affects polymerization and plant operating costs
Plant operating rates	Low utilization increases unit cost
Logistics and packaging	Important for drums, totes and bulk shipments
Pharmaceutical qualification	Supports price premium
Impurity limits	Raises testing and manufacturing cost
Regional supply balance	Determines local premiums and shortages
Contract structure	Controls pass-through of raw-material changes
Customer validation	Creates switching friction and retention

PEG 400 is normally sold under annual or multiyear supply arrangements to pharmaceutical manufacturers, contract development and manufacturing organizations, excipient distributors, and formulation companies. Spot-market pricing is more relevant for smaller customers and distributors.

Which companies supply pharmaceutical-grade PEG 400?

The competitive landscape includes large chemical manufacturers, specialty excipient companies, regional producers, and distributors.

Major global and regional suppliers

Companies associated with PEG and pharmaceutical-grade polyethylene glycol products include:

• BASF, including Kollisolv and related pharmaceutical excipient products
• Dow, including Carbowax polyethylene glycol products
• Clariant, including pharmaceutical and specialty polyethylene glycol grades
• Croda and related specialty excipient channels
• India-based manufacturers such as Muby Chemicals, Gujarat-based chemical producers, and excipient specialists
• Chinese producers supplying domestic and export markets
• Regional distributors that repackage or distribute qualified material

Product availability varies by country. A company can be a major PEG producer without being a qualified supplier for a particular pharmaceutical customer. Drug manufacturers often require supplier audits, change-control commitments, batch documentation, stability data, elemental impurity data, residual-solvent information, and validated analytical methods.

BASF identifies polyethylene glycol products as pharmaceutical excipients and markets grades for solubilization, plasticization, and formulation support.[2] Dow markets Carbowax polyethylene glycols across pharmaceutical, personal-care, food, and industrial applications.[3]

How is PEG 400 manufactured, and where are the supply-chain risks?

PEG 400 is produced by polymerizing ethylene oxide, usually with water or a starter molecule and a catalyst. The process creates a distribution of polyethylene glycol chain lengths. Producers then control molecular-weight distribution, remove low-molecular-weight impurities, filter the material, and package it according to the required grade.

Key manufacturing and IP barriers

The principal barriers are operational rather than patent-based:

• Secure access to ethylene oxide
• Safe handling of a hazardous and reactive feedstock
• Polymerization process control
• Removal of ethylene glycol, diethylene glycol, 1,4-dioxane, and other impurities
• Consistent molecular-weight distribution
• Pharmaceutical-grade cleaning and segregation
• Validated analytical testing
• Change-control discipline
• Regulatory documentation
• Reliable bulk and packaged logistics

Ethylene oxide is toxic, flammable, and highly reactive. Production is concentrated in large petrochemical complexes because the required safety systems and feedstock integration create scale advantages. This structure makes PEG 400 vulnerable to outages, turnarounds, force majeure events, and regional transport disruptions.

Pharmaceutical customers also face a qualification barrier. Changing from one PEG 400 supplier to another may require comparative testing, formulation work, stability studies, regulatory assessment, and customer notification. This switching friction supports incumbent suppliers even when the underlying molecule is commoditized.

What FDA regulatory status applies to PEG 400?

PEG 400 is an established inactive ingredient, not an active pharmaceutical ingredient requiring its own FDA approval. Its use is reviewed as part of the finished drug application.

The relevant regulatory framework includes:

• FDA Inactive Ingredient Database precedent
• USP-NF monograph requirements
• Current good manufacturing practice requirements
• Finished-product quality specifications
• Drug Master File or equivalent supplier documentation, where used
• Residual impurity and elemental impurity controls
• Extractables, leachables, and compatibility testing where relevant

The FDA IID does not create a blanket authorization for every concentration, route, or dosage form. A formulation sponsor must establish that the proposed use is suitable for the finished product and supported by safety, quality, and manufacturing data.[1]

The European Pharmacopoeia and British Pharmacopoeia also contain requirements for macrogols and related polyethylene glycol materials. European regulators refer to excipient quality, toxicological assessment, and manufacturing controls through the finished-product authorization process and excipient risk-assessment principles.[4]

What quality risks affect PEG 400?

The main quality concerns are:

• Ethylene glycol and diethylene glycol contamination
• Residual ethylene oxide
• 1,4-dioxane and related process impurities
• Water content
• Acidity or alkalinity
• Molecular-weight distribution
• Peroxide formation during storage
• Elemental impurities
• Microbial quality where the formulation requires control

PEG 400 is not itself a nitrosamine, but impurity control remains relevant in liquid and complex formulations. Manufacturers assess potential interactions between excipients, active ingredients, nitrosating conditions, packaging materials, and process conditions under broader pharmaceutical impurity programs.[5]

What patents protect PEG 400 and its pharmaceutical uses?

PEG 400 itself is not protected by a current composition-of-matter patent. It is a long-established excipient with public-domain chemical identity and widespread commercial use.

Patent protection may still apply to:

• A specific drug formulation containing PEG 400
• A defined concentration range
• A liquid or injectable delivery system
• A softgel composition
• A topical or ophthalmic formulation
• A PEG-based conjugate involving a drug or biologic
• A manufacturing process for a particular finished product
• A method of treating a disease using a PEG 400-containing formulation

These patents protect the product or use, not PEG 400 as a commodity excipient. A formulation patent may be relevant to generic or follow-on competition if PEG 400 is essential to the claimed composition and the proposed product falls within the claims.

Does PEG 400 create Paragraph IV risk?

PEG 400 does not create Paragraph IV risk by itself. Paragraph IV litigation arises when an abbreviated new drug application challenges a listed patent for a finished drug product. A generic applicant may use PEG 400 without challenging any patent on PEG 400, provided the proposed product does not infringe enforceable patents covering the branded formulation or method of use.

The commercial risk depends on:

• Orange Book-listed formulation patents
• Method-of-use patents
• Label carve-out feasibility
• Bioequivalence requirements
• Whether PEG 400 is present in the reference product
• Whether the formulation claims require a specific PEG grade or concentration
• Whether the generic can substitute another solvent or excipient

For biologics, PEG 400 is generally not the relevant biosimilar issue. Biosimilar litigation typically concerns the biologic active ingredient, manufacturing process, formulation, device, or delivery system. PEGylated biologics can create separate patent questions involving the PEG-drug conjugate, linker, attachment site, or process.

How strong is the PEG 400 patent estate?

The direct patent estate is weak because PEG 400 is an old, broadly available material. The commercial protection around pharmaceutical-grade supply is based on manufacturing capability and customer qualification.

Protection category	Strength for PEG 400
Composition-of-matter patent	None of practical current significance
Excipient identity	Public domain
Manufacturing know-how	Moderate
Impurity-control methods	Moderate, often process-specific
Supplier qualification	Strong commercial switching barrier
Finished-product formulation patents	Potentially strong
Drug-device patents	Relevant in selected delivery systems
Trade secrets	Potentially significant
Regulatory exclusivity	None for the excipient itself

A supplier’s strongest defensible assets are plant design, process control, quality systems, customer-specific specifications, and reliable regulatory support. Those assets can protect margins without blocking competitors through patent litigation.

When does PEG 400 lose exclusivity?

PEG 400 has no relevant regulatory exclusivity period and no upcoming loss-of-exclusivity date. It is already a mature, multisource excipient.

The relevant exclusivity events occur at the finished-drug level:

• New chemical entity exclusivity
• Orphan-drug exclusivity
• Pediatric exclusivity
• Patent expiry
• Settlement-based generic entry dates
• Regulatory exclusivity for certain drug products

A branded drug may lose market protection while PEG 400 remains fully available from multiple suppliers. In that situation, the excipient market may benefit from higher generic volume, but the branded product’s revenue can decline sharply.

What is the financial trajectory for PEG 400 suppliers?

The expected financial trajectory is steady with cyclical margin movement.

Base-case outlook

Volume growth should track pharmaceutical production, liquid-dose expansion, and broader specialty chemical demand. Revenue growth is likely to reflect a combination of modest volume increases and periodic price adjustments. Margins should normalize when ethylene oxide and energy prices stabilize.

Upside drivers

• Greater use of liquid and softgel dosage forms
• Growth in poorly soluble drug formulations
• Increased pharmaceutical manufacturing in India and China
• Supplier qualification by additional multinational customers
• Premium demand for low-impurity and high-documentation grades
• Inventory rebuilding after supply disruptions
• Higher outsourcing by drug developers and CDMOs

Downside drivers

• Ethylene oxide oversupply and lower pass-through pricing
• Weak generic-drug production
• Pharmaceutical plant destocking
• Energy and logistics volatility
• Capacity additions by low-cost regional producers
• Customer substitution with alternative solvents or excipients
• Regulatory findings involving contamination or inadequate change control

Margin structure

PEG 400 is unlikely to produce the margins associated with patented active ingredients or highly differentiated biologic technologies. Pharmaceutical-grade material can generate better margins than industrial PEG because qualification and compliance reduce price comparability. The premium is vulnerable when customers qualify several suppliers or when distributors substitute equivalent grades.

Public-company investors should examine:

• Segment sales for care chemicals, nutrition, or specialty ingredients
• Volume and price/mix disclosures
• Ethylene oxide exposure
• Capacity utilization
• Inventory levels
• Pharmaceutical customer concentration
• Quality-related provisions
• Capital expenditure for specialty-grade capacity
• Regional sales growth

Standalone PEG 400 revenue, gross margin, and EBITDA are generally unavailable in public filings. Any precise global PEG 400 revenue forecast should therefore be treated as a third-party estimate rather than audited company data.

How does PEG 400 compare with PEG 3350?

PEG 400 and PEG 3350 are chemically related but commercially distinct.

Attribute	PEG 400	PEG 3350
Physical form	Liquid	Solid or waxy solid
Typical use	Solvent and vehicle	Osmotic laxative and formulation excipient
Average molecular weight	Approximately 400	Approximately 3,350
Pharmaceutical positioning	Broad formulation aid	Laxative, bowel-preparation and specialty formulations
Supply economics	More closely linked to liquid PEG grades	More dependent on higher-molecular-weight production and particle specifications
Regulatory profile	Inactive ingredient in many dosage forms	Active ingredient in approved laxative products and excipient in formulations
Patent risk	Finished-formulation dependent	Finished-product and formulation dependent

PEG 400 generally has broader excipient utility. PEG 3350 has greater exposure to consumer health and over-the-counter laxative demand. A supplier with both grades can diversify across prescription, generic, over-the-counter, and industrial markets.

What licensing deals and litigation affect PEG 400?

There is no widely recognized licensing market for PEG 400 itself. Suppliers typically sell under commercial supply agreements rather than licensing the molecule. Licensing can arise in finished products using PEG 400, including drug-delivery technologies, softgel platforms, controlled-release systems, and specialty topical formulations.

There is no major, globally material patent litigation centered on PEG 400 as an excipient. Litigation risk is more likely to involve:

• A branded drug formulation containing PEG 400
• Alleged infringement of concentration or composition claims
• Supplier quality failures
• Contract disputes over specifications or change control
• Product liability claims involving contamination
• Regulatory enforcement related to adulteration or mislabeling

The absence of direct PEG 400 patent litigation reduces legal barriers to supply but increases price competition among qualified manufacturers.

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

Generic entry risk is determined by the finished product, not by the excipient.

Risk is higher when:

• PEG 400 is used as a nonessential solvent that can be replaced
• The branded product has few enforceable formulation claims
• The active ingredient is already off patent
• The product is a simple oral liquid
• The generic can demonstrate bioequivalence with a different inactive-ingredient system
• The reference product has limited device or delivery-system protection

Risk is lower when:

• PEG 400 concentration materially affects absorption or tolerability
• The product is an ophthalmic, injectable, or complex topical formulation
• The formulation contains multiple interdependent excipients
• The patent claims a narrow solvent system
• The product requires specialized stability or viscosity performance
• Manufacturing and analytical equivalence are difficult to demonstrate

For PEG 400 suppliers, generic entry can reduce branded-drug volumes but expand total unit production because generic manufacturers often compete aggressively on price and volume.

Key Takeaways

• PEG 400 is a mature, multisource pharmaceutical excipient with no practical composition-of-matter exclusivity.
• Its core functions are solvent, cosolvent, vehicle, plasticizer, humectant, and viscosity modifier.
• Demand is stable and diversified across pharmaceuticals, personal care, cosmetics, and industrial applications.
• Financial performance is tied to ethylene oxide, energy, logistics, plant utilization, and pharmaceutical-grade compliance.
• Public companies generally do not disclose PEG 400 revenue separately.
• The strongest commercial barriers are supplier qualification, impurity control, manufacturing reliability, and regulatory documentation.
• Paragraph IV risk applies to finished drugs containing PEG 400, not to PEG 400 itself.
• PEG 400 is more broadly used as a formulation excipient than PEG 3350, which has greater exposure to laxative and consumer-health products.
• Direct patent litigation and licensing activity for PEG 400 are limited.
• The medium-term outlook is moderate volume growth with cyclical pricing and margin volatility.

FAQs

Is PEG 400 a pharmaceutical active ingredient?

No. PEG 400 is generally an inactive pharmaceutical ingredient, although different polyethylene glycol grades can have active-drug status in products such as laxatives.

Can pharmaceutical manufacturers switch PEG 400 suppliers without regulatory work?

Usually not without assessment. A supplier change may require comparative testing, quality documentation, stability review, change-control evaluation, and regulatory notification or approval depending on the product and jurisdiction.

Is PEG 400 interchangeable with propylene glycol?

Not automatically. Both can function as solvents or cosolvents, but they differ in viscosity, solubility behavior, toxicology, moisture sensitivity, and formulation performance.

Does PEG 400 create a nitrosamine risk?

PEG 400 is not itself a nitrosamine. The relevant assessment concerns impurities, manufacturing residues, formulation chemistry, packaging, and potential interactions under the conditions of the specific drug product.

Which pharmaceutical applications have the strongest PEG 400 growth potential?

Liquid oral medicines, softgels, topical products, ophthalmic formulations, and solubility-enhancement systems have the clearest demand potential. Growth depends on product approvals, generic manufacturing volumes, and the availability of alternative excipients.

References

1. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
2. BASF. (n.d.). Kollisolv pharmaceutical excipients. https://pharma.basf.com/
3. Dow. (n.d.). CARBOWAX polyethylene glycols. https://www.dow.com/
4. European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia. Council of Europe. https://www.edqm.eu/
5. U.S. Food and Drug Administration. (2024). Control of nitrosamine impurities in human drugs: Guidance for industry. https://www.fda.gov/-drugs/