Last updated: September 23, 2026
Polyethylene glycol 200, commonly identified as PEG 200 or macrogol 200, is a low-molecular-weight polyether used in pharmaceuticals as a solvent, plasticizer, humectant, viscosity modifier, and formulation aid. Its market is mature, fragmented, and price-sensitive. Standalone global revenue for PEG 200 is not publicly reported by major producers; financial analysis therefore relies on broader polyethylene glycol, pharmaceutical excipient, and specialty chemicals data.
Demand is tied to liquid and semisolid dosage forms, topical products, oral solutions, soft-gel systems, veterinary medicines, and industrial applications. The molecule has limited standalone patent protection. Commercial differentiation depends mainly on compendial compliance, impurity control, supply reliability, documentation, and customer qualification.
What is polyethylene glycol 200 used for in pharmaceutical formulations?
PEG 200 is a clear, water-miscible liquid with an average molecular weight near 200 Da. Commercial specifications commonly place its average molecular weight in the approximate range of 190 to 210, although the exact range depends on the supplier and applicable monograph.
| Attribute |
PEG 200 profile |
| Chemical identity |
Polyethylene glycol 200 |
| CAS number |
25322-68-3 |
| Physical form |
Clear, viscous liquid |
| Solubility |
Miscible or highly soluble in water and many polar solvents |
| Pharmaceutical role |
Solvent, plasticizer, humectant, vehicle, viscosity modifier |
| Typical dosage forms |
Oral liquids, topical products, soft gels, semisolids, veterinary formulations |
| Regulatory status |
Established excipient with pharmacopeial and FDA database presence |
| Patent position |
No meaningful composition-of-matter exclusivity |
| Main commercial issue |
Quality consistency and supply economics |
PEG 200 can improve solubility for poorly water-soluble active pharmaceutical ingredients. It is also used to adjust viscosity and water activity in liquid systems. In topical and semisolid products, it can act as a humectant and plasticizer. In soft-gel or capsule formulations, it may be combined with other polyethylene glycol grades, glycerin, propylene glycol, or surfactants.
The principal formulation risks are hygroscopicity, oxidative degradation, peroxide formation, extractables compatibility, and interaction with the active ingredient or packaging system. These risks are managed through supplier specifications, antioxidant controls where appropriate, container selection, and stability testing.
How large is the PEG 200 market?
No major producer publicly discloses a separately audited PEG 200 revenue line. Market reports typically combine PEG 200 with other polyethylene glycol grades or place it within broader pharmaceutical excipient and specialty chemical categories.
The addressable market has three layers:
- Pharmaceutical-grade PEG 200.
- Personal-care and cosmetic-grade PEG 200.
- Technical and industrial-grade material.
Pharmaceutical-grade material commands a premium because customers require compendial testing, traceability, change-control notification, quality agreements, and regulatory documentation. The volume opportunity is smaller than for industrial polyethylene glycols, but the qualification cycle is longer and customer retention is stronger after approval.
| Market driver |
Effect on PEG 200 demand |
| Growth in oral liquid medicines |
Positive |
| Expansion of topical and dermatology products |
Positive |
| Solubility-enhancement demand |
Positive |
| Shift toward biologics |
Mixed; PEG-based formulation use varies by molecule |
| Generic-drug manufacturing |
Positive for cost-efficient excipient systems |
| Raw-material and energy costs |
Negative for margins |
| Substitution by propylene glycol or glycerin |
Negative in price-sensitive formulations |
| Regulatory scrutiny of impurities |
Raises cost but favors qualified suppliers |
Demand growth is likely to track low- to mid-single-digit expansion in pharmaceutical excipients rather than high-growth specialty pharmaceutical rates. Volume growth is more likely to come from emerging-market manufacturing, generic-drug production, and liquid or topical dosage forms than from new molecular-entity launches.
Which companies supply pharmaceutical-grade PEG 200?
The principal supplier group includes large integrated chemical companies, specialty excipient producers, and regional manufacturers.
| Supplier or supplier group |
Relevant capability |
| BASF |
Pharmaceutical-grade polyethylene glycol products, including Kollisolv and macrogol grades |
| Dow |
CARBOWAX Sentry pharmaceutical and personal-care polyethylene glycol grades |
| Clariant |
Specialty ingredients and pharmaceutical excipient distribution |
| Croda |
Pharmaceutical excipient and formulation ingredient portfolio |
| NOF Corporation |
Polyethylene glycol and PEG-derived specialty materials |
| Indian and Chinese manufacturers |
Cost-competitive pharmaceutical and industrial grades |
| Regional distributors |
Local inventory, repackaging, and regulatory support |
BASF and Dow benefit from scale, global manufacturing, established quality systems, and broad product portfolios. Regional producers compete through lower prices, shorter regional supply chains, and flexible packaging or batch sizes.
The strongest commercial position is usually held by the supplier whose material is already approved in a customer’s formulation. Switching suppliers can trigger comparative testing, stability work, regulatory notifications, and manufacturing validation. That creates a practical barrier even where the underlying chemical is commoditized.
What is the FDA regulatory status of PEG 200?
PEG 200 is an excipient rather than an active pharmaceutical ingredient. It does not receive standalone FDA approval in the same manner as a finished drug. Its regulatory acceptability depends on its use in a particular drug product and on the quality of the supplied material.
The FDA Inactive Ingredient Database is the main public reference for inactive ingredients used in approved drug products. PEG entries may be listed by dosage form, route, and maximum potency rather than by a single universal approval status (U.S. Food and Drug Administration, n.d.-a).
Relevant regulatory controls include:
- USP-NF or other applicable pharmacopeial compliance.
- Identity, assay, water, acidity or alkalinity, residue, and impurity testing.
- Control of ethylene oxide, 1,4-dioxane, heavy metals, and peroxide-related impurities where applicable.
- Good manufacturing practice controls.
- Supplier qualification and change-control procedures.
- Stability and compatibility data in the finished dosage form.
PEG 200 should not be confused with PEGylated biologics. In PEGylated drugs, polyethylene glycol is chemically attached to an active molecule or biologic. PEG 200 used as an excipient is a low-molecular-weight formulation ingredient and does not create the same clinical, immunogenicity, or regulatory issues as covalently attached PEG chains.
What is the Orange Book status of polyethylene glycol 200?
PEG 200 has no standalone Orange Book listing because it is not an approved drug product or active pharmaceutical ingredient with independent therapeutic labeling. The Orange Book lists approved finished drug products, patents, and exclusivity information associated with those products, not ordinary excipients sold as raw materials (U.S. Food and Drug Administration, n.d.-b).
A finished drug containing PEG 200 may have Orange Book-listed patents covering:
- The active pharmaceutical ingredient.
- A particular formulation.
- A dosage form.
- A method of treatment.
- A manufacturing process.
- A combination of excipients and active ingredients.
Those rights would attach to the finished drug or formulation owner, not to PEG 200 as a chemical substance.
What patents protect PEG 200?
The basic PEG 200 molecule is an old, widely used chemical. Composition-of-matter patent protection is not commercially relevant. Any historical patent rights covering polyethylene glycol manufacture or purification are expected to have expired.
Current intellectual-property value is concentrated in downstream applications:
| Patent category |
Relevance to PEG 200 |
| Composition of matter |
Minimal or expired |
| Manufacturing process |
Potentially relevant to purity, molecular-weight distribution, or low-peroxide material |
| Formulation patent |
Relevant when PEG 200 is part of a specific drug composition |
| Method-of-use patent |
Relevant to a finished medicine, not the excipient alone |
| Packaging or delivery system |
Possible in specialty dosage forms |
| Trade secret |
Important for purification, quality control, and process economics |
A supplier may protect manufacturing know-how through trade secrets rather than patents. This can include control of molecular-weight distribution, catalyst residues, aldehydes, peroxides, color bodies, and trace contaminants.
How strong is the patent estate for PEG 200?
The standalone patent estate is weak because PEG 200 is an established chemical with broad substitution options. The commercial moat is operational rather than legal.
A supplier’s defensibility depends on:
- Qualification in regulated pharmaceutical manufacturing.
- Consistent molecular-weight distribution.
- Low impurity and peroxide levels.
- Validated analytical methods.
- Global regulatory files.
- Reliable production capacity.
- Customer-specific technical support.
- Long-term supply agreements.
Formulation patents can create indirect demand protection. For example, a branded drug may claim a specific ratio of PEG 200, active ingredient, surfactant, and water to improve solubility or stability. Such a patent may delay generic substitution if the formulation is difficult to design around. It does not prevent a competitor from selling PEG 200 to other customers.
Are there Paragraph IV challenges involving PEG 200?
There are no Paragraph IV challenges to PEG 200 itself because PEG 200 is not a listed drug product. Paragraph IV litigation concerns an abbreviated new drug application that challenges patents listed for a branded drug in the FDA Orange Book.
PEG 200 may appear indirectly in a Paragraph IV dispute where a branded formulation patent claims a drug product containing PEG 200. The generic applicant could challenge the patent, design around the claimed excipient ratio, or argue non-infringement. The litigation risk would attach to the finished drug formulation and its patents.
What patent litigation and settlement agreements affect PEG 200?
No standalone PEG 200 patent litigation or settlement market is expected because the material is an established excipient rather than a proprietary medicine. Relevant disputes are more likely to involve:
- Finished dosage-form patents.
- Excipient combinations.
- Solubility-enhancement systems.
- Soft-gel or liquid-filled capsule technologies.
- Manufacturing processes for high-purity PEG materials.
- Supplier quality or change-control obligations.
Settlement agreements in pharmaceutical litigation may permit generic entry before patent expiry while requiring restrictions on formulation, manufacturing, or launch timing. Such agreements can influence demand for pharmaceutical-grade PEG 200, but the terms generally remain tied to the branded drug and are not specific to the excipient market.
When does PEG 200 lose exclusivity?
PEG 200 has no meaningful current regulatory exclusivity period. It is an established excipient available from multiple manufacturers.
The relevant exclusivity dates are instead associated with the finished drug using PEG 200. A branded product may have five-year new-chemical-entity exclusivity, three-year clinical-investigation exclusivity, orphan-drug exclusivity, pediatric exclusivity, and patent protection. None of those periods grants the brand owner ownership of PEG 200.
Generic entry can therefore occur while a formulation supplier continues selling PEG 200 to both brand and generic manufacturers, subject to ordinary supplier qualification and contractual restrictions.
What generic-entry risks exist for PEG 200 suppliers?
Generic-drug growth is generally positive for PEG 200 volume but negative for pricing. Generic manufacturers tend to seek multi-source supply and negotiate aggressively. The most likely commercial outcomes are:
| Scenario |
Effect on PEG 200 suppliers |
| Brand-only formulation growth |
Higher margins, lower volume |
| Generic entry with same formulation |
Higher volume, lower price |
| Dual sourcing by generic manufacturers |
Lower switching barriers and weaker pricing |
| Regulatory shortage or logistics disruption |
Temporary pricing support |
| Substitution by glycerin or propylene glycol |
Volume and margin pressure |
| Complex formulation requiring tight specifications |
Higher retention and premium pricing |
The largest risk is substitution, not patent invalidation. Formulators can often replace PEG 200 with propylene glycol, glycerin, ethanol, PEG 400, PEG 600, or a custom solvent blend, subject to safety, stability, and regulatory constraints.
How does PEG 200 compare with PEG 400, glycerin, and propylene glycol?
| Excipient |
Relative molecular weight |
Typical formulation role |
Commercial comparison |
| PEG 200 |
About 200 |
Low-viscosity solvent, humectant, plasticizer |
More fluid; useful where lower viscosity is required |
| PEG 400 |
About 400 |
Solvent, vehicle, plasticizer |
More widely used in liquid and semisolid products |
| PEG 600 |
About 600 |
Viscosity modifier, binder, semisolid vehicle |
Higher viscosity and stronger body |
| Glycerin |
92.09 |
Humectant, solvent, plasticizer |
Low cost; different sensory and hygroscopicity profile |
| Propylene glycol |
76.10 |
Solvent, humectant, preservative aid |
Strong substitute in many liquid systems |
PEG 400 is the closest commercial comparator within the PEG family and generally has broader pharmaceutical use. PEG 200 remains useful when a lower-viscosity vehicle or a particular solvent balance is required.
What is the financial trajectory for PEG 200?
The financial trajectory is likely to be stable rather than high-growth. Revenue should follow pharmaceutical production, topical medicine demand, and excipient outsourcing. Margin performance will depend more on feedstock costs, plant utilization, energy prices, and regional competition than on intellectual property.
Key financial indicators include:
- Ethylene oxide and petrochemical feedstock pricing.
- Electricity, steam, and transport costs.
- Pharmaceutical-grade capacity utilization.
- Regional price spreads between China, India, Europe, and North America.
- Share of sales from regulated pharmaceutical grades.
- Customer concentration.
- Contract duration and pass-through mechanisms.
- Cost of quality systems and regulatory documentation.
Integrated producers have an advantage because they can manage upstream feedstocks and manufacture multiple PEG grades in the same network. Smaller producers can remain competitive where they offer local inventory, smaller batches, or customer-specific documentation.
The most attractive segment is high-purity, low-peroxide, fully documented pharmaceutical material. Commodity-grade PEG 200 faces more direct price competition and weaker customer retention.
What geographic markets offer the strongest growth?
Asia-Pacific is the main volume-growth region because it combines expanding generic-drug production, local pharmaceutical manufacturing, and lower-cost excipient production. India is important for generic-drug and contract-manufacturing demand. China is important as both a production base and a domestic pharmaceutical market.
North America and Europe remain higher-value markets because suppliers must meet stringent quality, documentation, and change-control requirements. Growth is slower, but customer qualification and compliance requirements support pricing stability.
Global supply risk comes from:
- Concentration of upstream ethylene oxide production.
- Port and shipping disruptions.
- Regulatory restrictions on chemical plants.
- Batch failures and contamination events.
- Extended customer requalification timelines.
- Limited availability of validated pharmaceutical-grade alternatives.
Key Takeaways
- PEG 200 is a mature, multi-source pharmaceutical excipient with no meaningful standalone patent exclusivity.
- It is used mainly as a solvent, humectant, plasticizer, and viscosity-control ingredient.
- Standalone PEG 200 market revenue is not publicly disclosed; broader PEG and excipient data are the appropriate financial proxies.
- Pharmaceutical-grade material earns a premium through quality, documentation, and qualification rather than patent protection.
- BASF, Dow, Clariant, Croda, NOF, and regional Asian suppliers are important participants.
- PEG 200 has no independent Orange Book listing and is not subject to Paragraph IV challenges as an excipient.
- Formulation patents may create indirect demand protection for finished drugs containing PEG 200.
- Generic entry generally increases volume while pressuring price.
- PEG 400, glycerin, and propylene glycol are the principal substitutes.
- The expected financial trajectory is steady, with low- to mid-single-digit demand growth and margin sensitivity to feedstocks and regional competition.
FAQs
Is PEG 200 the same as macrogol 200?
Yes. PEG 200 and macrogol 200 generally refer to the same class of low-molecular-weight polyethylene glycol, although commercial specifications and pharmacopeial naming conventions may differ.
Is PEG 200 safe for oral pharmaceutical use?
Its acceptability depends on the dosage, route, product formulation, impurity profile, and applicable regulatory requirements. Finished-drug manufacturers must establish suitability in the specific formulation.
Can PEG 200 be replaced by PEG 400?
Sometimes. PEG 400 has higher viscosity and a different formulation profile, so substitution requires comparative solubility, stability, manufacturability, and sensory testing.
Does PEG 200 require a drug master file?
A drug master file may be used by a supplier to support confidential manufacturing information, but the requirement depends on the customer, jurisdiction, product, and regulatory filing strategy.
Is pharmaceutical-grade PEG 200 materially different from industrial PEG 200?
Yes. The chemical identity is similar, but pharmaceutical-grade material requires tighter controls on impurities, traceability, manufacturing practices, testing, packaging, and change notification.
References
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BASF SE. (n.d.). Kollisolv PEG product information. BASF.
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Dow Inc. (n.d.). CARBOWAX Sentry polyethylene glycol product information. Dow.
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European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia. Council of Europe.
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United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP.
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U.S. Food and Drug Administration. (n.d.-a). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
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U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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U.S. Food and Drug Administration. (2023). Current good manufacturing practice for drugs. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
