Drugs Containing Excipient (Inactive Ingredient) ETHYL ACRYLATE

Branded drugs containing ETHYL ACRYLATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Oceanside Pharmaceuticals	DILTIAZEM HCL CD	diltiazem hydrochloride	68682-521	ETHYL ACRYLATE
Napo Pharmaceuticals Inc	MYTESI	crofelemer	70564-802	ETHYL ACRYLATE	2031-10-31
Bryant Ranch Prepack	DILTIAZEM HCL CD	diltiazem hydrochloride	71335-2029	ETHYL ACRYLATE
Bausch Health US LLC	CARDIZEM CD	diltiazem hydrochloride	0187-0795	ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER

Generic drugs containing ETHYL ACRYLATE excipient

Company	Ingredient	NDC	Excipient
Padagis US LLC	flavoxate hydrochloride	0574-0115	ETHYL ACRYLATE
Major Pharmaceuticals	divalproex sodium	0904-7181	ETHYL ACRYLATE
Accord Healthcare Inc	acetazolamide	16729-331	ETHYL ACRYLATE
Camber Pharmaceuticals Inc	tolterodine tartrate	31722-607	ETHYL ACRYLATE

Ethyl Acrylate Pharmaceutical Excipient Market Dynamics and Financial Trajectory

Last updated: August 19, 2026

Ethyl acrylate is primarily a commodity acrylic monomer, not a standalone pharmaceutical excipient. Its pharmaceutical relevance comes from copolymers used in modified-release coatings, film coatings, binders, and drug-delivery matrices. The commercial outlook is therefore tied to demand for acrylate polymer dispersions rather than direct demand for ethyl acrylate in finished medicines.

Public companies generally do not report ethyl acrylate revenue separately. Financial performance is driven by acrylic acid and ethanol costs, polymer demand, regional capacity, environmental controls, pharmaceutical formulation activity, and competition from methacrylate and cellulose-based excipients.

What is ethyl acrylate and how is it used in pharmaceuticals?

Ethyl acrylate is an ester of acrylic acid and ethanol with CAS Registry Number 140-88-5, molecular formula C5H8O2, and molecular weight 100.12 g/mol (National Center for Biotechnology Information, 2024).

Attribute	Data
Chemical name	Ethyl 2-propenoate
CAS number	140-88-5
Molecular formula	C5H8O2
Molecular weight	100.12 g/mol
Primary industrial role	Acrylic monomer
Pharmaceutical role	Monomer in acrylate copolymers
Direct excipient use	Limited and generally not intentional
Main pharmaceutical application	Modified-release and film-coating polymers

Ethyl acrylate is polymerized with methyl methacrylate and other monomers to produce functional and non-functional acrylate copolymers. These polymers can form flexible, water-permeable films around tablets, pellets, granules, and multiparticulate dosage forms.

The best-known pharmaceutical example is poly(ethyl acrylate-co-methyl methacrylate) dispersions used in aqueous coating systems. BASF's EUDRAGIT NE 30 D is a relevant commercial example. The polymer is used to control drug release and improve coating flexibility, adhesion, and mechanical performance (BASF, 2024).

Is ethyl acrylate an FDA-approved pharmaceutical excipient?

Ethyl acrylate itself is not generally treated as an independently approved active or inactive ingredient in an approved drug product. Pharmaceutical products use a finished acrylate copolymer or dispersion, not the unreacted monomer.

FDA evaluates excipients through the drug product application in which they are used. The agency does not grant a universal approval that permits an excipient to be used in every route, dosage form, concentration, or patient population (U.S. Food and Drug Administration, 2024a).

FDA regulatory status

The principal regulatory issues are:

• Identity and composition of the finished copolymer.
• Residual ethyl acrylate and other residual monomers.
• Particle size and dispersion characteristics.
• Solvent and preservative content.
• Extractables and leachables.
• Toxicological qualification.
• Route-specific exposure.
• Compatibility with the active pharmaceutical ingredient.
• Manufacturing consistency.

A supplier may support a drug application through an excipient master file, commonly known as a Type IV Drug Master File. The master file can contain manufacturing, controls, specifications, analytical methods, and stability data. The FDA does not approve the master file as a standalone product; it reviews the referenced information in the context of a sponsor's application.

European regulatory position

In Europe, acrylate copolymers are assessed as excipients within the medicinal product authorization. The European Medicines Agency requires information on excipient function, quality, safety, and justification for use. The European Commission's excipient guideline also addresses excipient risk assessment and pharmaceutical quality documentation (European Medicines Agency, 2018).

What pharmaceutical formulations are protected by ethyl acrylate polymers?

Ethyl acrylate-containing polymers are used in dosage forms where controlled permeability and film flexibility are important.

Dosage form	Typical function
Matrix tablets	Controls water penetration and drug diffusion
Coated tablets	Forms a flexible barrier or sustained-release film
Pellets	Enables multiparticulate release control
Granules	Supports delayed or extended release
Capsules	Permits coating of capsule fills or multiparticulates
Oral suspensions	Less common; depends on polymer dispersion properties

The commercial value comes from the polymer's performance profile. Poly(ethyl acrylate-co-methyl methacrylate) can provide a neutral, water-insoluble but permeable film. Release can be adjusted through coating weight, pore-forming agents, plasticizers, polymer blends, curing conditions, and particle size.

Ethyl acrylate-based polymers compete with:

• Cellulose acetate phthalate.
• Hypromellose phthalate.
• Hypromellose acetate succinate.
• Polyvinyl acetate dispersions.
• Methacrylic acid copolymers.
• Ethylcellulose.
• Polyvinyl alcohol-based systems.

The main technical advantage is film flexibility and sustained-release performance. The principal limitations are residual monomer control, polymer dispersion stability, coating-process sensitivity, and regulatory documentation.

How large is the ethyl acrylate pharmaceutical excipient market?

A reliable standalone market size is not publicly disclosed. Market research reports generally combine ethyl acrylate with acrylic monomers, acrylate polymers, pharmaceutical coating materials, or broader excipient categories.

The addressable market should be separated into three layers:

1. Commodity ethyl acrylate monomer.
2. Pharmaceutical-grade acrylate copolymer and dispersion.
3. Finished drug products using those polymers.

The first market is much larger than the second. Pharmaceutical demand is a small portion of total ethyl acrylate consumption, which includes coatings, adhesives, textiles, paper treatment, plastics, and specialty polymers.

Revenue exposure for pharmaceutical suppliers is therefore indirect. A polymer manufacturer may report sales under pharmaceutical excipients, coatings, or nutrition and health care, while upstream ethyl acrylate producers usually report it within acrylics, monomers, or performance materials.

What drives the financial trajectory for ethyl acrylate?

Ethyl acrylate financial performance follows a cost-plus or formula-based industrial model rather than the pricing model of a branded pharmaceutical ingredient.

Feedstock costs

The key cost inputs are:

• Acrylic acid.
• Ethanol.
• Energy.
• Logistics.
• Packaging.
• Waste treatment and emissions control.

Acrylic acid prices are influenced by propylene economics and acrylic acid operating rates. Ethanol prices vary by region and depend on feedstock, agricultural markets, energy costs, and industrial demand.

Capacity utilization

Ethyl acrylate margins improve when operating rates are high and supply is disciplined. New acrylic ester capacity can compress margins if demand does not grow at the same pace. Turnarounds, outages, force majeure events, and environmental shutdowns can produce short-term price spikes.

Pharmaceutical polymer demand

Pharmaceutical demand is relatively stable compared with construction and coatings. It is supported by:

• Growth in oral modified-release medicines.
• Increased use of multiparticulate formulations.
• Outsourcing of coating and granulation.
• Adoption of aqueous coating systems.
• Demand for excipient standardization across multiple products.

The pharmaceutical segment is unlikely to determine the global monomer price. It can, however, support higher margins for qualified polymer grades and technical-service packages.

Regulatory and environmental costs

Ethyl acrylate is classified as a hazardous chemical requiring controls for flammability, exposure, storage, transport, and emissions. The European Chemicals Agency identifies ethyl acrylate as a substance requiring hazard communication and exposure controls (European Chemicals Agency, 2024).

Manufacturers face costs related to:

• Closed handling systems.
• VOC capture.
• Worker exposure monitoring.
• Fire protection.
• Residual monomer testing.
• Wastewater treatment.
• Site permitting.
• Product stewardship.

These costs create a barrier to entry but also increase the capital intensity of production.

Which companies supply ethyl acrylate and related pharmaceutical polymers?

The market has separate upstream and downstream supplier groups.

Upstream monomer suppliers

Ethyl acrylate is produced by large chemical companies with acrylic acid and esterification capabilities. Relevant global acrylics producers include BASF, Arkema, Dow, Mitsubishi Chemical, Nippon Shokubai, and regional Chinese manufacturers. Product availability and active manufacturing status vary by plant and region.

Pharmaceutical polymer suppliers

The pharmaceutical excipient market includes companies supplying:

• Acrylate copolymer dispersions.
• Methacrylate copolymers.
• Ethylcellulose systems.
• Coating premixes.
• Technical formulation services.

BASF is a prominent supplier through its EUDRAGIT portfolio. Other excipient suppliers compete through polymer chemistry, aqueous dispersion technology, regulatory support, and application development rather than through commodity monomer pricing.

Competitive factor	Upstream ethyl acrylate	Pharmaceutical acrylate polymer
Primary buyer	Chemical and polymer manufacturers	Drug manufacturers and CDMOs
Main value driver	Cost, availability, purity	Release profile and regulatory support
Switching cost	Moderate	High after formulation qualification
Margin profile	Commodity or intermediate	Specialty excipient
Key barrier	Capital and environmental compliance	Formulation data and regulatory history
Contract duration	Often shorter or formula-based	Longer qualification cycles

How strong is the patent estate for ethyl acrylate pharmaceutical use?

Ethyl acrylate is an old commodity monomer. Its basic composition and conventional polymerization routes are unlikely to provide durable composition-of-matter exclusivity in pharmaceutical applications.

The relevant intellectual property generally falls into four categories:

1. Polymer compositions with defined monomer ratios.
2. Aqueous dispersions and particle structures.
3. Coating processes and curing conditions.
4. Drug-specific formulations using acrylate polymers.

Patent protection is more likely to attach to a particular polymer architecture, dispersion, coating method, or drug product than to ethyl acrylate itself.

Method-of-use and formulation patents

A drug sponsor may claim:

• A specific ethyl acrylate/methyl methacrylate ratio.
• A defined coating weight gain.
• A controlled-release profile.
• A polymer blend with a plasticizer or pore former.
• A manufacturing process that produces a target dissolution curve.
• A drug-polymer combination.

Such claims may create product-specific barriers, but they do not prevent competitors from using ethyl acrylate in other polymers or dosage forms.

Orange Book status

Ethyl acrylate is not an active pharmaceutical ingredient and does not have an independent Orange Book listing. Any Orange Book patents would be listed against a finished drug product and could cover its formulation, method of use, or delivery system. The presence of an ethyl acrylate-containing polymer in a product does not by itself create an Orange Book-listed patent.

Are there Paragraph IV challenges involving ethyl acrylate?

Paragraph IV litigation would target an abbreviated new drug application for a finished drug product, not the excipient as a commodity chemical.

A generic applicant could challenge patents covering:

• The controlled-release dosage form.
• A polymer coating system.
• A dissolution profile.
• A method of treating a disease.
• A specific combination of active ingredient and excipient.

There is no general Paragraph IV pathway for challenging ethyl acrylate supply or a polymer manufacturer's excipient position. Generic entry risk must be assessed at the drug-product level through FDA Orange Book listings, patent certifications, litigation complaints, and settlement terms.

What manufacturing and IP barriers affect market entry?

Manufacturing barriers are more important than molecule-level patent barriers.

Manufacturing barriers

A pharmaceutical-grade supplier must control:

• Monomer purity.
• Inhibitor concentration.
• Polymer molecular-weight distribution.
• Residual monomer levels.
• Particle-size distribution.
• Dispersion viscosity.
• Microbial quality where applicable.
• Batch-to-batch release performance.
• Stability under transport and storage.

Drug manufacturers also qualify the supplier's coating system on equipment-specific parameters. A change in polymer particle size, viscosity, or residual monomer profile can affect dissolution and trigger comparability work.

Intellectual-property barriers

The strongest IP positions are likely to involve proprietary dispersion technology, polymer morphology, coating equipment processes, or drug-specific release systems. These rights can narrow substitution options even when the monomer itself is widely available.

The practical switching barrier is often regulatory and technical qualification. A customer may need new development batches, stability studies, dissolution comparisons, and regulatory documentation before replacing an excipient supplier.

How does ethyl acrylate compare with competing pharmaceutical polymers?

Polymer system	Main strength	Main limitation
Ethyl acrylate-based copolymer	Flexible, permeable sustained-release films	Residual monomer and process control
Ethylcellulose	Established water-insoluble barrier	Often requires pore formers or organic processing
HPMC-based systems	Broad regulatory familiarity	Different release mechanism and film behavior
Methacrylic acid copolymers	Strong enteric and pH-dependent performance	Less suited to some neutral sustained-release applications
PVAc dispersions	Sustained release with established products	Smaller supplier base in some regions
HPMCAS	Enteric protection and solid dispersion use	Higher cost and process-specific behavior

Ethyl acrylate-based polymers compete most directly in sustained-release and neutral coating applications. They are less directly substitutable for enteric polymers that dissolve at defined gastrointestinal pH levels.

What are the generic launch scenarios and commercial risks?

The major commercial scenarios are:

Scenario	Market effect
Stable acrylic acid and ethanol costs	Predictable monomer margins
New regional capacity	Downward pressure on commodity pricing
Supply outage or plant shutdown	Short-term price and availability increases
Growth in modified-release medicines	Higher demand for pharmaceutical polymer grades
Successful excipient substitution	Pricing pressure on incumbent polymer suppliers
Increased residual-monomer scrutiny	Higher testing and compliance costs
Generic erosion of branded drug products	Lower demand for some proprietary coated formulations

Generic entry can reduce demand for a branded formulation but may increase volume for excipient suppliers if the generic uses the same polymer technology. The outcome depends on whether the generic manufacturer replicates the reference product's coating system or adopts a substitute polymer.

What licensing and settlement activity matters?

Licensing activity is more likely to occur around proprietary drug-delivery systems than around the purchase of ethyl acrylate monomer. Relevant agreements may cover:

• Drug-specific controlled-release technology.
• Coating and pelletization processes.
• Polymer dispersion technology.
• Regional rights to a finished drug product.
• CDMO manufacturing rights.

Settlement agreements in Paragraph IV cases may delay generic launch without changing the underlying availability of ethyl acrylate or acrylate excipients. No broad industry-wide settlement framework controls the use of ethyl acrylate in pharmaceutical polymers.

Geographic coverage and regional outlook

North America and Europe have mature pharmaceutical coating markets and stringent excipient documentation requirements. Asia-Pacific has the strongest manufacturing growth potential because of expanding generic drug production, pharmaceutical outsourcing, and polymer capacity.

Region	Market characteristics
North America	High regulatory documentation and established modified-release products
Europe	Strong excipient quality standards and environmental regulation
China	Expanding chemical and pharmaceutical manufacturing base
India	Large generic-drug and formulation-development sector
Japan and South Korea	Advanced specialty chemical and pharmaceutical manufacturing
Latin America	Primarily demand-led, with import dependence in specialty excipients

Regional qualification remains important. A supplier can have global monomer capacity but lack an approved pharmaceutical-grade polymer at a customer's manufacturing site.

Key Takeaways

• Ethyl acrylate is mainly an acrylic monomer, not a standalone pharmaceutical excipient.
• Pharmaceutical value is concentrated in ethyl acrylate-containing copolymers and aqueous dispersions.
• Public companies do not generally disclose standalone ethyl acrylate revenue or profit.
• Financial performance depends on acrylic acid, ethanol, energy, capacity utilization, environmental compliance, and specialty polymer demand.
• BASF's EUDRAGIT portfolio is a leading commercial reference for acrylate-based pharmaceutical coating systems.
• Patent risk is usually tied to polymer architecture, coating methods, and drug-product claims rather than ethyl acrylate itself.
• Orange Book and Paragraph IV issues arise at the finished drug-product level.
• The strongest entry barriers are regulatory qualification, residual-monomer control, process consistency, and customer switching costs.
• Asia-Pacific offers the clearest volume-growth opportunity, while North America and Europe retain higher documentation and qualification barriers.

FAQs

Is ethyl acrylate safe for use in oral medicines?

Unreacted ethyl acrylate requires tight control because it is a reactive and hazardous monomer. Pharmaceutical products generally use a polymerized acrylate system with specifications for residual monomers.

Which EUDRAGIT products contain ethyl acrylate?

EUDRAGIT products based on poly(ethyl acrylate-co-methyl methacrylate), including EUDRAGIT NE-type dispersions, are associated with ethyl acrylate-based pharmaceutical polymers. Exact composition and grade should be confirmed against the supplier's current technical documentation.

Can a generic drug manufacturer replace an ethyl acrylate polymer without new approval?

A substitution may require formulation development, comparative dissolution testing, stability data, and regulatory assessment. The burden depends on the drug product, dosage form, jurisdiction, and effect of the change on critical quality attributes.

Does ethyl acrylate have a pharmaceutical Drug Master File?

A manufacturer may support a pharmaceutical-grade polymer through a Type IV excipient master file or comparable confidential regulatory submission. The existence and regulatory status of a specific file are not equivalent to standalone FDA approval.

What is the main investment risk in ethyl acrylate?

The main risk is commodity-cycle exposure. Feedstock volatility, new acrylic ester capacity, environmental controls, and weak coatings demand can compress margins. Pharmaceutical polymer demand provides diversification but is too small to determine the global monomer cycle.

References

1. BASF. (2024). EUDRAGIT polymers for pharmaceutical applications. BASF SE.

2. European Chemicals Agency. (2024). Ethyl acrylate: Substance information. ECHA.

3. European Medicines Agency. (2018). Guideline on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008. EMA.

4. National Center for Biotechnology Information. (2024). PubChem compound summary for ethyl acrylate. PubChem.

5. U.S. Food and Drug Administration. (2024a). Inactive ingredient database. FDA.

6. U.S. Food and Drug Administration. (2024b). Drug master files: Guidance for industry. FDA.