Drugs Containing Excipient (Inactive Ingredient) POLYETHYLENE GLYCOL 600

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Branded drugs containing POLYETHYLENE GLYCOL 600 excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Family Dollar (FAMILY WELLNESS)	ALL DAY PAIN RELIEF	naproxen sodium	55319-174	POLYETHYLENE GLYCOL 600
Genentech Inc	BONIVA	ibandronate sodium	0004-0186	POLYETHYLENE GLYCOL 6000
Pharmacia & Upjohn Company LLC	AROMASIN	exemestane	0009-7663	POLYETHYLENE GLYCOL 6000
Sanofi-Aventis US LLC	PLAVIX	clopidogrel	0024-1171	POLYETHYLENE GLYCOL 6000

Generic drugs containing POLYETHYLENE GLYCOL 600 excipient

Company	Ingredient	NDC	Excipient
Walgreen Company	diphenhydramine hydrochloride, ibuprofen	0363-0611	POLYETHYLENE GLYCOL 600
Walgreens	ibuprofen, diphenhydramine hcl	0363-0756	POLYETHYLENE GLYCOL 600
WALGREEN CO	ibuprofen and pseudoephedrine hcl	0363-1106	POLYETHYLENE GLYCOL 600
Hikma Pharmaceuticals USA Inc	dipyridamole	0641-2569	POLYETHYLENE GLYCOL 600

Polyethylene Glycol 600 Market Dynamics and Financial Trajectory

Last updated: September 25, 2026

Polyethylene glycol 600, or PEG 600, is a pharmaceutical-grade liquid or semisolid excipient used as a solvent, vehicle, plasticizer, humectant, viscosity modifier, and formulation aid. Its market is tied to ethylene oxide availability, pharmaceutical and personal-care production, regional excipient qualification requirements, and the shift toward liquid, topical, softgel, and modified-release dosage forms.

Public companies generally do not report PEG 600 revenue as a separate line item. Financial analysis therefore requires a bottom-up view based on pharmaceutical excipient demand, supplier capacity, raw-material costs, pricing, qualification barriers, and end-market growth.

What is polyethylene glycol 600 and how is it used in pharmaceuticals?

PEG 600 is a mixture of polyoxyethylene compounds with an average molecular weight near 600. It is identified by CAS No. 25322-68-3 and is commonly described as polyethylene glycol 600, macrogol 600, or PEG 600.

Attribute	PEG 600 profile
Chemical identity	Polyethylene glycol
CAS number	25322-68-3
Typical average molecular weight	Approximately 570-630
Physical form	Viscous liquid or low-melting semisolid, depending on specification and temperature
Pharmaceutical functions	Solvent, carrier, humectant, plasticizer, viscosity modifier
Common dosage-form relevance	Oral liquids, topical preparations, softgels, capsules, creams and ointments
Key quality requirements	Assay, molecular-weight distribution, water content, acidity or alkalinity, ethylene oxide and 1,4-dioxane controls, residue and microbial quality
Main upstream inputs	Ethylene, ethylene oxide and water
Regulatory status	Compendial excipient when conforming to applicable pharmacopoeial standards

PEG 600 is not an active pharmaceutical ingredient. It has no therapeutic exclusivity, Orange Book listing, or standalone drug patent estate. Its commercial value comes from pharmaceutical-grade quality, supply reliability, documentation, and customer qualification.

The United States Pharmacopeia-National Formulary and European Pharmacopoeia recognize polyethylene glycol materials through monographs that address identity, purity, molecular-weight characteristics, and contaminant controls. Suppliers may sell separate grades for pharmaceutical, cosmetic, food, industrial, and technical applications. These grades are not automatically interchangeable.

What pharmaceutical formulations are protected by PEG 600?

PEG 600 is used in formulation systems rather than as a protected active ingredient. Its principal roles include:

Oral and liquid formulations

PEG 600 can act as a co-solvent or vehicle in oral liquids and concentrates. It can improve the solubility or dispersion of poorly water-soluble ingredients and help control viscosity.

The commercial opportunity is strongest where a formulation requires a nonvolatile, water-miscible or partially water-miscible carrier with established pharmaceutical use. PEG 600 may be combined with water, ethanol, propylene glycol, glycerol, higher-molecular-weight PEGs, surfactants, or active ingredients.

Topical and semisolid products

PEG 600 contributes to spreading, moisture retention, consistency, and active-ingredient delivery in creams, gels, ointments, and lotions. It is often used with solid PEG grades to create a defined base with controlled melting and application properties.

Softgels and capsule systems

Liquid PEG grades can function as fill vehicles for softgel products and some hard-capsule formulations. Suitability depends on active-ingredient compatibility, shell interaction, water activity, fill viscosity, and stability.

Manufacturing and processing

PEG 600 can support granulation, coating, dispersion, and processing operations. Its use may be covered by formulation patents held by drug companies, but those patents generally protect the finished medicine, dosage form, composition, or manufacturing process rather than PEG 600 itself.

A search of the FDA Orange Book should not be expected to identify PEG 600 as an active ingredient or standalone listed product. Any patent risk normally arises from the branded drug formulation or delivery technology using the excipient.

How large is the polyethylene glycol 600 market?

A reliable standalone global market size for PEG 600 is not publicly disclosed by major producers or pharmaceutical companies. Most market reports aggregate PEG 200, PEG 300, PEG 400, PEG 600, PEG 1000, PEG 1500, and higher grades into a broader polyethylene glycol market.

The relevant economic market is therefore segmented as follows:

Segment	Main demand drivers	Financial characteristics
Pharmaceutical-grade PEG 600	Prescription drugs, OTC medicines, topical products, softgels	Higher qualification and documentation requirements
Cosmetic-grade PEG 600	Skin care, hair care, personal-care products	Larger volume but greater price competition
Food or specialty grade	Processing aids, additives and specialty formulations	Regulatory and customer-specific
Industrial grade	Lubricants, coatings, plastics, textiles and chemical processing	Large volume, lower unit value
Custom or high-purity grade	Complex formulations and regulated manufacturing	Higher margins, smaller volumes

Pharmaceutical-grade PEG 600 represents a smaller portion of total polyethylene glycol volume than industrial and personal-care applications. It can generate better realized pricing because customers value change control, traceability, validated manufacturing, regulatory support, and batch-to-batch consistency.

What drives PEG 600 demand?

PEG 600 demand is linked to several pharmaceutical and industrial variables.

Growth in liquid and topical dosage forms

Liquid medicines, topical products, softgels, and combination excipient systems create recurring demand for medium-molecular-weight PEGs. PEG 600 is particularly relevant where formulators require a viscous carrier rather than a solid base.

Generic-drug development

Generic manufacturers frequently use established excipients to reduce formulation and regulatory risk. PEG 600 can benefit from generic and OTC product development when it is already accepted in a reference product or supported by established compendial standards.

Generic companies still must demonstrate that the excipient grade, impurity profile, and supplier documentation are appropriate for the proposed product. A change from one supplier to another can require comparability work, stability studies, or regulatory notification.

Pharmaceutical outsourcing

Contract development and manufacturing organizations increasingly make excipient selection decisions for multiple sponsors. This can increase the value of qualified suppliers with global regulatory files, consistent supply, and technical support.

Personal-care demand

Cosmetics and personal care consume substantial quantities of polyethylene glycol materials. This segment can support volume utilization for producers, although it usually produces more price pressure than pharmaceutical demand.

Industrial polyethylene glycol consumption

Industrial applications can affect plant utilization and pricing. When industrial demand weakens, producers may seek higher-value pharmaceutical and specialty channels. When ethylene oxide or polyethylene glycol capacity is tight, pharmaceutical customers may face allocation pressure despite representing a small share of total volume.

How do ethylene oxide and raw-material costs affect PEG 600 prices?

PEG 600 pricing is mainly exposed to ethylene oxide economics. Ethylene oxide is produced from ethylene and oxygen through catalytic oxidation. Polyethylene glycol is then manufactured by ethoxylation and controlled polymerization processes.

The key cost variables are:

1. Ethylene prices and regional petrochemical feedstock conditions.
2. Ethylene oxide operating rates and plant outages.
3. Natural-gas and electricity costs.
4. Logistics for hazardous or temperature-sensitive materials.
5. Packaging, storage, and quality-control costs.
6. Regulatory compliance for pharmaceutical production.
7. Capacity utilization across PEG production lines.

Ethylene oxide is hazardous and subject to strict handling requirements. This creates a supply-chain barrier that is more significant than the basic chemistry of PEG 600. Producers need specialized infrastructure, safety systems, validated cleaning and containment procedures, and controlled logistics.

Pharmaceutical PEG 600 prices therefore do not move in direct proportion to ethylene prices. Contract terms, customer qualification, batch size, quality grade, and supply security can have a larger effect on realized margins for pharmaceutical customers.

Which companies supply pharmaceutical-grade PEG 600?

The competitive supplier base includes large chemical producers, specialty excipient manufacturers, and regional pharmaceutical-grade producers. Relevant market participants have included BASF, Clariant, Croda, NOF Corporation, India-based petrochemical and excipient manufacturers, and regional producers in China and other Asian markets.

Supplier participation varies by country and grade. A company may manufacture polyethylene glycol but not offer a product that is qualified for pharmaceutical use in every jurisdiction.

Supplier category	Competitive advantage	Main limitation
Large integrated chemical producer	Feedstock access, global manufacturing, broad portfolio	May prioritize larger contracts and major regions
Specialty excipient supplier	Regulatory support, documentation, customer service	Higher cost structure
Regional producer	Local availability and price competitiveness	Geographic and qualification limitations
Distributor	Inventory and market access	Less control over manufacturing and continuity
Contract manufacturer	Custom specifications and smaller batches	Capacity and scale constraints

The most important competitive variables are not only price. Customers evaluate regulatory history, quality systems, change-control practices, dual sourcing, audit performance, impurity controls, batch size, lead time, and the supplier’s ability to support regulatory filings.

How strong is the PEG 600 manufacturing and intellectual-property barrier?

The direct intellectual-property barrier is moderate to low because PEG 600 is an established chemical with widely known production methods. The stronger barriers are operational and regulatory.

Manufacturing barriers

Ethoxylation requires controlled reaction conditions, specialized equipment, hazardous-material management, and quality controls for residual ethylene oxide and related impurities. Pharmaceutical production adds validated cleaning, traceability, deviation management, stability programs, and controlled packaging.

Quality barriers

Pharmaceutical users may require control of:

• Molecular-weight distribution
• Water content
• Acidity or alkalinity
• Residual ethylene oxide
• 1,4-dioxane
• Ethylene glycol and diethylene glycol
• Color and appearance
• Microbial quality
• Elemental impurities
• Oxidation and storage stability

The exact testing package depends on the pharmacopoeial standard, customer specification, dosage form, and regulatory jurisdiction.

Intellectual-property barriers

Patents may protect:

• A finished drug composition containing PEG 600
• A PEG-based delivery system
• A controlled-release or topical formulation
• A softgel fill composition
• A manufacturing process using a specific PEG grade
• A combination of PEG 600 with a particular active ingredient or surfactant

These rights do not normally create exclusivity over PEG 600 as a commodity excipient. The commercial barrier is customer qualification, not molecule-level patent protection.

What is the FDA regulatory status of PEG 600?

PEG 600 is used as an excipient in FDA-regulated products, subject to its role in the specific formulation and the applicable product pathway. FDA review focuses on the finished product, the excipient’s suitability, the proposed level, route of administration, impurity profile, and supporting safety information.

The FDA Inactive Ingredient Database can provide precedent for inactive ingredients used in approved drug products. Database precedent does not automatically authorize every concentration, route, dosage form, or supplier. Sponsors remain responsible for demonstrating suitability in the proposed product.

The FDA’s guidance on pharmaceutical-quality excipients and international excipient standards makes supplier qualification and control of composition central to regulatory risk (U.S. Food and Drug Administration, 2019; United States Pharmacopeia, 2024).

PEG materials also have a broader safety profile that requires attention. Hypersensitivity reactions to PEG have been reported in some clinical contexts, particularly with certain high-molecular-weight PEG-containing products. Risk assessment must consider molecular weight, exposure route, dose, formulation composition, and patient population.

When does PEG 600 lose exclusivity?

PEG 600 has no standard patent-expiration date because it is not a newly patented active pharmaceutical ingredient. It is an established chemical and compendial excipient.

There is no PEG 600 Paragraph IV challenge in the conventional Hatch-Waxman sense. Paragraph IV litigation applies to patents listed in the Orange Book for an approved drug product. A generic company may challenge a drug patent covering a formulation that contains PEG 600, but that is a challenge to the drug product’s patent estate.

The same distinction applies to settlement agreements. PEG 600 suppliers generally do not settle Orange Book litigation over the excipient itself. Settlements can arise between branded and generic drug companies involving a PEG-containing formulation, but those agreements concern the finished product.

What is the commercial and financial trajectory for PEG 600?

The financial trajectory is likely to remain volume-driven with margin differentiation by grade.

Period	Market condition	Expected financial effect
Near term	Feedstock volatility, cautious pharmaceutical inventory management, regional capacity differences	Revenue sensitive to pricing and destocking
Medium term	Stable demand from generics, OTC products, topical medicines and softgels	Moderate volume growth with better stability in qualified pharmaceutical grades
Longer term	More regulated excipient sourcing, supplier consolidation and demand for dual sourcing	Potential premium for reliable, documented supply

Pharmaceutical-grade PEG 600 should have more resilient pricing than technical-grade material because switching suppliers can require qualification work. That pricing protection is limited by the availability of alternative PEG grades, other polyols, propylene glycol, glycerol, liquid paraffin, and formulation-specific substitutes.

The strongest margin opportunity lies in high-purity material sold under long-term quality agreements. Commodity PEG 600 sold through spot channels remains exposed to capacity additions, feedstock costs, import competition, and customer price negotiations.

Revenue exposure for a producer depends on product mix. A company with integrated ethylene oxide production can protect margins through feedstock control. A downstream excipient supplier without upstream integration may face greater cost volatility but can offset it through technical services, regulatory packages, smaller-batch supply, and customer qualification.

How does PEG 600 compare with PEG 400 and higher-molecular-weight PEGs?

Product	Relative molecular weight	Typical commercial positioning	Key formulation distinction
PEG 400	Approximately 380-420	High-volume liquid pharmaceutical and cosmetic grade	Lower viscosity and broader liquid use
PEG 600	Approximately 570-630	Intermediate liquid or semisolid excipient	Higher viscosity and stronger carrier or plasticizer properties
PEG 1000	Approximately 900-1,100	Semisolid or waxy material	Greater structural contribution and higher melting behavior
PEG 3350	Approximately 3,000-3,700	Powder or solid pharmaceutical grade	Common in oral and laxative formulations
PEG 8000 and above	High molecular weight	Solid, specialty and biopharmaceutical uses	Stronger viscosity, binding and structural effects

PEG 400 is usually a closer commercial substitute than PEG 1000 because both can be supplied in liquid or low-melting systems. Substitution depends on viscosity, solubility, stability, active-ingredient compatibility, dosage-form performance, and regulatory precedent.

What generic-entry risks exist for PEG-containing medicines?

PEG 600 does not create a standalone generic-entry barrier. The relevant risks are tied to the product containing it.

Generic-entry risks can include:

• Formulation patents covering the PEG-based vehicle
• Method-of-use patents
• Process patents
• Device or delivery-system patents
• Clinical or regulatory exclusivity
• Difficulty matching dissolution, release, stability, or topical performance
• Supplier-specific impurity or particle-profile differences
• Limited availability of qualified pharmaceutical-grade material

For ordinary immediate-release products, PEG 600 is usually a manageable excipient. It can become more important in modified-release, topical, softgel, and poorly soluble drug formulations where the excipient affects bioavailability or product performance.

What is the investment outlook for PEG 600?

PEG 600 is a defensive specialty-chemical and excipient product rather than a high-growth pharmaceutical asset. Its investment case depends on:

• Stable pharmaceutical and OTC demand
• Customer retention after qualification
• Production integration with ethylene oxide
• Ability to pass through feedstock costs
• Compliance with global pharmacopeial standards
• Regional supply security
• Capacity discipline
• Growth in specialty and high-purity grades

The main downside risks are commodity-price pressure, substitution by other solvents and polyols, excess capacity, regulatory restrictions on impurities, and weak industrial demand. The main upside factors are pharmaceutical outsourcing, growth in liquid and topical formulations, supplier consolidation, and increased demand for dual-sourced excipients.

Key Takeaways

• PEG 600 is an established pharmaceutical excipient with no standalone patent or Orange Book exclusivity.
• Its market is linked to ethylene oxide, ethylene, pharmaceutical formulation demand, and supplier qualification.
• Public companies generally do not disclose PEG 600 revenue separately, so standalone market-size and revenue forecasts require estimation.
• Pharmaceutical-grade material commands a premium because of regulatory documentation, impurity controls, quality systems, and customer switching costs.
• Generic and OTC products support recurring demand, while softgels, topical medicines, and liquid formulations provide formulation-specific growth.
• Manufacturing barriers are greater than intellectual-property barriers.
• PEG-containing drug patents may create product-specific generic-entry risk, but those patents do not monopolize PEG 600 itself.
• Financial performance should be assessed through grade mix, capacity utilization, feedstock exposure, geographic coverage, and customer qualification status.

FAQs

Is PEG 600 the same as macrogol 600?

Yes. PEG 600 and macrogol 600 are different naming conventions for a polyethylene glycol material with an average molecular weight near 600.

Is PEG 600 listed in the Orange Book?

No. PEG 600 is an excipient, not an active pharmaceutical ingredient listed as a standalone drug. A finished drug containing PEG 600 may have Orange Book-listed patents.

Can PEG 400 replace PEG 600?

Sometimes. The substitution depends on viscosity, solubility, stability, dosage form, active-ingredient compatibility, and regulatory support. A formulation change may require development and regulatory evaluation.

Does PEG 600 create biosimilar risk?

PEG 600 itself does not create biosimilar risk. PEGylated biologics may involve separate patent, immunogenicity, comparability, and regulatory issues tied to the biologic and PEG-conjugation technology.

Which factors most affect PEG 600 profit margins?

The main factors are ethylene oxide costs, plant utilization, pharmaceutical-grade mix, customer qualification, regional pricing, logistics, impurity-control requirements, and the supplier’s ability to pass through raw-material changes.

References

1. European Directorate for the Quality of Medicines & HealthCare. (2024). European Pharmacopoeia (11th ed.). Council of Europe.

2. U.S. Food and Drug Administration. (2019). Drug products, including biological products, that contain nanomaterials: Guidance for industry. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (2024). Inactive ingredient database. U.S. Department of Health and Human Services.

4. United States Pharmacopeia. (2024). United States Pharmacopeia and National Formulary. U.S. Pharmacopeial Convention.

5. BASF SE. (2024). Pharmaceutical excipients and polyethylene glycol product information. BASF.

6. Croda International Plc. (2024). Pharmaceutical excipients technical information. Croda International.