Drugs Containing Excipient (Inactive Ingredient) PROPYLENE CARBONATE

Branded drugs containing PROPYLENE CARBONATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
LEO Pharma Inc	PROTOPIC	tacrolimus	50222-203	PROPYLENE CARBONATE
Physicians Total Care Inc	PROTOPIC	tacrolimus	54868-5233	PROPYLENE CARBONATE
Acrotech Biopharma Inc	DIFAMILAST	adquey	72893-017	PROPYLENE CARBONATE	2036-12-31
MEDRx USA Inc	BONDLIDO	lidocaine	83708-111	PROPYLENE CARBONATE

Generic drugs containing PROPYLENE CARBONATE excipient

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	tacrolimus	0093-3429	PROPYLENE CARBONATE
E Fougera & Co a division of Fougera Pharmaceuticals LLC	tacrolimus	0168-0416	PROPYLENE CARBONATE
NORTHSTAR RX LLC	fluocinonide	16714-502	PROPYLENE CARBONATE
Accord Healthcare Inc	tacrolimus	16729-421	PROPYLENE CARBONATE

Propylene Carbonate Excipient Market Dynamics and Financial Trajectory

Last updated: September 24, 2026

Propylene carbonate is a high-purity polar aprotic solvent used selectively in pharmaceutical formulations, topical products, drug-delivery systems, and process applications. Its commercial outlook is driven primarily by lithium-ion battery electrolytes, coatings, polymers, and industrial solvents rather than pharmaceuticals. Pharmaceutical demand is smaller but can generate higher margins when suppliers provide validated purity, trace-metal control, low water content, extractables data, and regulatory documentation.

No public financial reporting isolates propylene carbonate excipient revenue from broader solvent or specialty-chemical portfolios. Market forecasts for total propylene carbonate generally place the global market in the several-hundred-million-dollar range, with growth commonly estimated in the mid-single digits. The pharmaceutical-excipient segment is a small subset of that market and lacks a reliable standalone revenue series.

What is propylene carbonate and why is it used as a pharmaceutical excipient?

Propylene carbonate, also called 4-methyl-1,3-dioxolan-2-one, is a cyclic carbonate with CAS Registry Number 108-32-7. It is a colorless, high-boiling liquid with strong solvency, low volatility relative to many organic solvents, and useful dielectric properties.

Its pharmaceutical value comes from four technical characteristics:

• Strong solvency for selected active pharmaceutical ingredients and excipients.
• High boiling point, approximately 240°C, which supports processing and formulation stability.
• Low vapor pressure compared with conventional volatile solvents.
• Compatibility with certain polymers, lipids, coatings, and transdermal delivery systems.

The compound is used more often as a formulation or process solvent than as a conventional bulk excipient such as lactose, microcrystalline cellulose, polyethylene glycol, or povidone. Potential applications include topical formulations, transdermal systems, ophthalmic or mucosal delivery research, pharmaceutical processing, and specialty drug-delivery vehicles.

Its use is formulation-specific. A manufacturer cannot assume that industrial-grade propylene carbonate is acceptable for a medicinal product. Qualification normally requires control of identity, assay, water, acidity or alkalinity, color, residual starting materials, aldehydes, peroxides, metals, microbial quality where relevant, and extractables from packaging.

How large is the propylene carbonate excipient market?

The pharmaceutical-excipient market for propylene carbonate is not separately reported by public-company filings or standard industry databases. Available market studies usually combine pharmaceutical, battery, coatings, adhesives, polymers, and industrial applications into one propylene carbonate market.

Market characteristic	Assessment
Total propylene carbonate market	Several-hundred-million-dollar global market based on commercial market studies
Pharmaceutical share	Small and not reliably disclosed
Largest demand center	Lithium-ion battery electrolyte and energy-storage applications
Other major uses	Coatings, polymers, adhesives, plastics processing, specialty solvents
Pharmaceutical growth profile	Low-to-mid single digit in mature applications, with episodic upside from new delivery systems
Pricing structure	Commodity-to-specialty depending on purity, documentation, pack size, and validation
Public company disclosure	Generally aggregated within broader chemicals or solvents segments
Market concentration	Higher for validated high-purity grades than for commodity material

The commercial market is bifurcated. Large-volume industrial material competes on feedstock economics, plant utilization, logistics, and regional supply. Pharmaceutical material competes on quality systems, batch consistency, documentation, qualification support, and change-control discipline.

This distinction matters financially. A pharmaceutical-grade sale may command a substantial premium over bulk industrial material, but the addressable volume is much lower. Supplier economics depend on maintaining validated customers and avoiding costly quality events rather than maximizing tonnage.

What is driving demand for propylene carbonate?

Battery and energy-storage demand

The principal growth engine is the use of propylene carbonate in electrolyte systems and related energy-storage applications. Its high dielectric constant and solvent properties make it technically attractive, although its suitability depends on electrode chemistry, graphite compatibility, electrolyte composition, additives, and cell design.

Battery demand affects pharmaceutical buyers in two ways:

1. It increases overall production capacity and supplier investment.
2. It can tighten supply or redirect manufacturing capacity toward higher-volume battery customers.

Battery-sector growth can therefore support lower production costs while also creating allocation and price risks for pharmaceutical customers. Pharmaceutical buyers with small annual volumes may have less negotiating leverage during periods of constrained supply.

Specialty formulation development

Propylene carbonate is relevant to pharmaceutical research where conventional solvents produce inadequate solubility, evaporation, skin penetration, or polymer compatibility. Its use may grow in:

• Transdermal drug delivery.
• Topical formulations containing poorly soluble compounds.
• Long-acting or controlled-release systems.
• Solvent systems for active pharmaceutical ingredients.
• Polymer-based drug-delivery platforms.
• Laboratory and process development applications.

Commercial conversion from formulation research to marketed drug products is slow. The excipient must be justified in the regulatory filing, supported by toxicological and quality data, and tested in the final route and dose context.

Supply-chain regionalization

Pharmaceutical companies are increasing scrutiny of solvent supply continuity, geographic concentration, and change-control practices. This supports demand for qualified secondary sources, regional warehouses, and dual manufacturing locations.

For propylene carbonate, regionalization is more important in Asia-Pacific, where battery production and chemical manufacturing are concentrated. European and North American pharmaceutical companies may pay a premium for local stock, smaller qualified packaging, and technical support.

How does propylene carbonate compare with competing pharmaceutical solvents?

Propylene carbonate competes with solvents selected for solubility, toxicity, volatility, regulatory precedent, and formulation performance.

Solvent or solvent class	Relative advantage	Relative limitation
Propylene carbonate	High solvency, high boiling point, low volatility	Limited compendial and pharmaceutical precedent; formulation-specific safety assessment
Propylene glycol	Strong regulatory familiarity and broad excipient use	Higher viscosity; different solubility and delivery performance
Polyethylene glycol	Extensive pharmaceutical use and formulation flexibility	Molecular-weight and peroxide controls; may alter release properties
Ethanol	Broad regulatory precedent and easy removal	Volatile, flammable, and less suitable for some sustained-release systems
Dimethyl sulfoxide	High penetration and solvency	Odor, tolerability, formulation constraints, and regulatory scrutiny
N-methyl-2-pyrrolidone	Strong solvency	Greater toxicological and regulatory concern in many applications
Ethyl acetate or acetone	Volatile and easy to remove	Flammability, residual-solvent limits, and lower suitability for retained formulations

Propylene carbonate is strongest where low volatility and high solvency are important. It is weaker where regulators or formulation teams favor excipients with extensive human-use precedent.

What is the FDA regulatory status of propylene carbonate?

Propylene carbonate does not have the same broad regulatory status as established excipients such as propylene glycol, glycerin, ethanol, or polyethylene glycol.

FDA and Orange Book status

Propylene carbonate is not a drug substance with an Orange Book patent listing. The FDA Orange Book lists approved drug products and associated patent or exclusivity information; it does not function as a comprehensive excipient registry.[1]

Any FDA acceptance is product-specific and depends on the proposed route, concentration, duration of exposure, patient population, impurity profile, and supporting safety package. A formulation developer should not treat industrial use, catalog availability, or inclusion in a supplier specification as evidence of FDA approval for a particular pharmaceutical application.

The FDA Inactive Ingredient Database is the relevant public reference for prior use in approved drug products, where listed. The database should be evaluated by route and maximum potency, not merely by compound name.[2]

Compendial position

Publicly available pharmaceutical compendia do not give propylene carbonate the same standardized status as many high-volume excipients. A supplier may therefore need to provide a detailed internal specification rather than rely solely on a USP-NF or Ph. Eur. monograph.

Typical qualification documentation includes:

• Certificate of analysis.
• Manufacturing-process description.
• Residual-solvent profile.
• Elemental impurities assessment under ICH Q3D.
• Mutagenic impurity assessment under ICH M7 where relevant.
• Extractables and leachables data.
• Stability and retest information.
• GMP and quality-system details.
• Change-notification commitments.
• Animal-origin and TSE/BSE statements where applicable.

What patents protect propylene carbonate as an excipient?

The propylene carbonate molecule is an established chemical and is not protected by a basic composition-of-matter patent. Patent risk is concentrated in applications, combinations, processes, and delivery systems.

Formulation patents

Potentially relevant claims may cover:

• A drug product containing propylene carbonate at a defined concentration.
• A transdermal or topical composition using propylene carbonate as a penetration enhancer or solvent.
• A polymer matrix incorporating propylene carbonate.
• A controlled-release formulation with a specific solvent system.
• A pharmaceutical composition combining propylene carbonate with surfactants, polymers, oils, or cosolvents.
• A process that uses propylene carbonate to dissolve or crystallize an active ingredient.

These patents may create commercial restrictions even though the excipient itself is off-patent. The relevant claim is usually directed to the finished product or method of treatment, not to the sale of propylene carbonate as a chemical.

Manufacturing and process patents

Production patents may cover catalyst systems, carbonylation or ring-forming routes, purification methods, and integration with propylene oxide or carbon dioxide feedstocks. These rights are generally relevant to chemical producers rather than pharmaceutical users.

For pharmaceutical buyers, process-patent risk is usually indirect. It can affect the number of qualified suppliers, regional availability, and cost of high-purity grades.

Patent expiration and freedom to operate

There is no single patent expiration date for propylene carbonate as an excipient. Each formulation, manufacturing process, and therapeutic use must be analyzed separately by jurisdiction. The molecule itself is commercially established, but newer delivery-system patents can remain enforceable well after the underlying chemical became generic.

How many patents cover pharmaceutical uses of propylene carbonate?

No authoritative public count captures all pharmaceutical patents that mention propylene carbonate. Patent databases contain references across transdermal systems, topical compositions, drug solubilization, battery materials, polymers, and chemical manufacturing.

A useful patent screen should separate:

1. Claims that require propylene carbonate.
2. Claims that list it as one option among many solvents.
3. Claims covering a finished product that uses it.
4. Expired or abandoned applications.
5. Patent families with enforceable claims in the target country.
6. Patents that cover the active ingredient or device independently of the excipient.

A mere mention in an example does not establish infringement. The commercial question is whether an issued, unexpired claim requires the proposed concentration, dosage form, active ingredient, route, or process.

Which companies supply propylene carbonate for pharmaceutical applications?

The supply base includes large chemical producers, specialty-chemical distributors, and laboratory-reagent companies. Public supplier catalogs often offer propylene carbonate in reagent or high-purity grades, but catalog grade is not equivalent to a validated pharmaceutical excipient.

Relevant supplier categories include:

• Integrated chemical manufacturers with large-scale carbonate production.
• Specialty solvent producers.
• Pharmaceutical raw-material distributors.
• Laboratory-reagent companies.
• Regional chemical manufacturers in China, Japan, South Korea, Europe, and North America.

Companies associated with propylene carbonate production or commercial distribution have included BASF, Huntsman, Mitsubishi Chemical-related operations, UBE-related chemical businesses, Merck/Sigma-Aldrich, Thermo Fisher Scientific, TCI Chemicals, and regional Asian producers. Product availability, grade designation, and manufacturing source vary by country and time.

The qualification question is not whether a supplier sells propylene carbonate. It is whether the supplier can provide a controlled grade with consistent impurity limits, audited manufacturing, validated analytical methods, and legally reliable supply.

What financial factors determine propylene carbonate pricing?

Pricing is influenced by both commodity and specialty-chemical economics.

Feedstock exposure

Propylene carbonate production is linked to propylene oxide, carbon dioxide, catalysts, energy, and purification costs. Feedstock volatility affects industrial pricing more directly than pharmaceutical demand.

Battery-sector competition

Battery electrolyte demand can absorb large volumes and support producer utilization. During supply shortages, pharmaceutical customers may face longer lead times or allocation pressure. During oversupply, industrial prices may fall without an equivalent reduction in pharmaceutical-grade pricing because qualification and documentation costs remain fixed.

Purity premium

High-purity material may require additional distillation, filtration, packaging, testing, and dedicated handling. Small pharmaceutical batches also carry higher per-kilogram logistics and quality-assurance costs.

Packaging and distribution

Pharmaceutical buyers commonly purchase drums, smaller containers, or customized packaging rather than bulk tank quantities. Packaging, hazardous-goods transport, storage, and regional inventory can materially exceed the underlying chemical cost.

Qualification economics

Once a supplier is approved in a drug product, switching costs become significant. A change may require comparability testing, stability work, regulatory notification, or approval. This creates retention value for qualified suppliers and reduces price elasticity after adoption.

What is the financial trajectory for pharmaceutical propylene carbonate?

The likely financial trajectory is stable but niche, with growth tied to formulation adoption rather than broad pharmaceutical volume expansion.

Period	Expected market behavior
Near term	Battery demand remains the dominant price and capacity variable; pharmaceutical demand remains specialized
Medium term	More regional sourcing and higher documentation requirements support premium grades
Longer term	Growth depends on transdermal, topical, and controlled-delivery products reaching commercialization
Downside scenario	Substitution by propylene glycol, PEGs, ethanol, or other solvents limits pharmaceutical volume
Upside scenario	Successful approval of several drug-delivery products creates recurring demand for validated grade material

Revenue quality is likely better than volume growth. A supplier with a validated pharmaceutical customer base can earn recurring, defensible revenue even when total tonnage is modest. The main risks are substitution, customer concentration, battery-driven supply disruption, and regulatory reluctance to accept limited human-use precedent.

What generic entry risks exist for products using propylene carbonate?

Propylene carbonate does not independently create generic-entry protection. Generic or follow-on competition depends on the patents and regulatory exclusivities covering the active ingredient, dosage form, device, formulation, and method of use.

Paragraph IV challenges

A generic applicant could challenge relevant listed patents through an Abbreviated New Drug Application if the reference product has Orange Book-listed patents. The challenge would target the drug product, not propylene carbonate as a standalone excipient.

Potential arguments may include:

• The formulation patent is invalid.
• The claims are not infringed by the proposed generic.
• The claimed solvent concentration is not essential.
• The patent does not cover the proposed dosage form or route.
• The patent is unenforceable.
• The generic uses a non-infringing substitute solvent.

Litigation and settlements

There is no general Orange Book litigation category for propylene carbonate. Litigation would arise from a specific branded formulation, transdermal system, topical product, or manufacturing process. Settlement terms may include delayed entry, licensed manufacture, geographic restrictions, or permission to use an alternative formulation.

What manufacturing and intellectual-property barriers affect the market?

The primary barriers are operational rather than molecule-level patent barriers:

• Consistent control of water and reactive impurities.
• Low trace-metal content.
• Stability under storage and transport.
• Packaging compatibility.
• Reliable batch-to-batch analytical performance.
• Documentation suitable for regulatory submissions.
• Dual-source qualification.
• Regional change-control compliance.
• Ability to produce small, validated lots without cross-contamination.

For drug-delivery applications, the formulation itself may be more defensible than the excipient. A company can protect a specific composition, concentration range, release profile, or manufacturing process, while competitors remain free to purchase and use propylene carbonate outside the patent claims.

How does propylene carbonate compare with other specialty pharmaceutical excipients?

Propylene carbonate has a stronger commercial position as a specialty solvent than as a mainstream excipient. It benefits from industrial scale and battery-related production, but its pharmaceutical regulatory precedent is narrower than that of propylene glycol or polyethylene glycol.

Metric	Propylene carbonate	Established excipients
Industrial scale	High	Varies
Pharmaceutical precedent	Limited to moderate, application-specific	Often broad
Basic molecule patent risk	Low	Generally low
Formulation patent risk	Moderate in delivery systems	Moderate
Supplier qualification burden	High	Lower for compendial grades
Price sensitivity	Moderate for bulk, lower after qualification	Depends on grade
Substitution risk	Meaningful	Lower for highly standardized uses
Battery-sector exposure	High	Usually absent

Key Takeaways

• Propylene carbonate is a specialty solvent with selective pharmaceutical use, not a mainstream high-volume excipient.
• Battery electrolytes and industrial applications determine total market growth, pricing, and capacity.
• Pharmaceutical-grade revenue is likely small relative to the total propylene carbonate market but can carry higher margins.
• The molecule itself is established and not protected by a basic composition patent.
• Patent risk is concentrated in formulations, drug-delivery systems, manufacturing processes, and methods of use.
• There is no general Orange Book exclusivity for propylene carbonate as an excipient.
• FDA acceptability is product-specific and depends on route, dose, impurity profile, and supporting safety data.
• The strongest commercial barriers are supplier qualification, documentation, quality consistency, and regulatory change control.
• Substitution by propylene glycol, polyethylene glycol, ethanol, and other solvents limits pharmaceutical volume growth.
• The most attractive suppliers are those able to combine industrial-scale production with validated pharmaceutical-grade documentation and reliable regional supply.

FAQs

Is propylene carbonate listed as an inactive ingredient by the FDA?

FDA inactive-ingredient status must be confirmed in the current Inactive Ingredient Database by route, dosage form, and maximum potency. A listing, where present, does not establish universal acceptability for all pharmaceutical uses.[2]

Is propylene carbonate a USP or Ph. Eur. excipient?

Propylene carbonate does not have the same broad compendial position as widely used excipients such as propylene glycol, ethanol, glycerin, or polyethylene glycol. Product developers may need supplier-specific specifications and additional qualification data.

Can propylene carbonate be used in a transdermal patch?

It can be evaluated as a solvent or penetration-enhancing component in transdermal systems. Commercial use depends on skin tolerability, dose exposure, adhesive compatibility, stability, extractables, and regulatory support.

Does propylene carbonate have a Drug Master File?

A supplier may maintain a confidential regulatory file or technical package, but Drug Master File availability is supplier-specific and is not a property of the chemical itself.

Is propylene carbonate vulnerable to pharmaceutical substitution?

Yes. Substitution risk is material because formulation developers can evaluate propylene glycol, polyethylene glycol, ethanol, dimethyl sulfoxide, glycols, esters, and other solvent systems. The risk is lower after a finished drug product has completed development and supplier qualification.

References

1. U.S. Food and Drug Administration. (2024). 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

2. U.S. Food and Drug Administration. (2024). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

3. European Chemicals Agency. (n.d.). Propylene carbonate: Substance information. https://echa.europa.eu/

4. International Council for Harmonisation. (2023). ICH Q3C(R8): Impurities: Guideline for residual solvents. https://www.ich.org/page/quality-guidelines

5. International Council for Harmonisation. (2022). ICH Q3D(R2): Guideline for elemental impurities. https://www.ich.org/page/quality-guidelines

6. International Council for Harmonisation. (2023). ICH M7(R2): Assessment and control of DNA reactive impurities in pharmaceuticals to limit potential carcinogenic risk. https://www.ich.org/page/quality-guidelines

7. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. Rockville, MD: United States Pharmacopeial Convention.