Drugs Containing Excipient (Inactive Ingredient) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER

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

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	PREVACID	lansoprazole	0067-6286	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER
L Perrigo Company	PREVACID 24 HR	lansoprazole	0113-6002	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER
Mission Pharmacal Company	THIOLA EC	tiopronin	0178-0901	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER

Generic drugs containing METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER excipient

Company	Ingredient	NDC	Excipient
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	lansoprazole	0067-6286	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER
L Perrigo Company	lansoprazole	0113-6002	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER
Impax Generics	risedronate sodium hemi-pentahydrate	0115-1426	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER

Methacrylic Acid-Ethyl Acrylate Copolymer Market Dynamics and Financial Trajectory

Last updated: September 24, 2026

Methacrylic acid-ethyl acrylate copolymer is an enteric film-forming excipient used primarily in oral solid dosage forms. Its commercial value is driven by delayed-release tablets, capsules, multiparticulates, and aqueous coating systems rather than by standalone pharmaceutical demand. The market has attractive technical barriers but limited public financial transparency. Revenue is concentrated among a small number of qualified suppliers, while pharmaceutical manufacturers face switching costs from reformulation, regulatory documentation, and process validation.

What is methacrylic acid-ethyl acrylate copolymer used for?

Methacrylic acid-ethyl acrylate copolymer is an anionic pH-dependent polymer used to protect active pharmaceutical ingredients from gastric conditions and release them in the intestine.

The principal commercial grades include:

Commercial grade or platform	Typical form	Approximate dissolution trigger	Primary use
EUDRAGIT L 100-55	Dry powder	Above pH 5.5	Enteric tablets, pellets, capsules
EUDRAGIT L 30 D-55	Aqueous dispersion, about 30% solids	Above pH 5.5	Direct aqueous film coating
Kollicoat MAE 30 DP	Aqueous dispersion	Above pH 5.5	Delayed-release coating
Formulated coating systems using the polymer	Ready-to-use or semi-formulated coating	Product-specific	High-throughput pharmaceutical coating

The polymer is generally based on a 1:1 ratio of methacrylic acid to ethyl acrylate. The carboxylic acid groups remain largely unionized in the stomach and become ionized at higher intestinal pH. This change produces dissolution and drug release.

The material is used in:

• Enteric-coated tablets
• Delayed-release capsules
• Multiparticulate pellets
• Taste-masked granules
• Colon-targeted delivery systems
• Moisture-protective and acid-protective coatings
• Modified-release combination products

The polymer is not an active pharmaceutical ingredient. It is not listed as a therapeutic product in the FDA Orange Book and does not generate Paragraph IV litigation or biosimilar exposure.

How large is the methacrylic acid-ethyl acrylate copolymer market?

No audited public market data isolate methacrylic acid-ethyl acrylate copolymer as a standalone excipient segment. Most commercial reports combine it with other acrylic polymers, enteric polymers, coating agents, or pharmaceutical excipients.

A practical market assessment therefore requires separating three layers:

Market layer	Revenue visibility	Principal products
Base polymer	Low	Dry powders and aqueous polymer dispersions
Formulated coating systems	Moderate	Pigmented, plasticized, ready-to-use coatings
Finished dosage forms using the polymer	High at product level, low at polymer level	Delayed-release and enteric products

The addressable market is linked to the broader pharmaceutical coating and oral solid dosage markets. Oral solid dosage forms remain the largest pharmaceutical dosage-form category by product count, creating a durable demand base for enteric polymers. Demand is strongest in generic drugs, proton-pump inhibitors, nonsteroidal anti-inflammatory products, enzyme products, probiotics, and formulations requiring protection from gastric degradation.

A reasonable commercial view is that the base polymer market is a niche specialty excipient segment with low-single-digit to mid-single-digit annual volume growth. Revenue growth can exceed volume growth during periods of raw-material inflation, supply tightness, or increased demand for aqueous systems. Public company disclosures generally do not report sales for this specific copolymer.

What factors are driving market growth?

Growth in delayed-release generic drugs

Generic drug manufacturers use enteric polymers to reproduce reference-product release profiles. Delayed-release products often require a polymer system that is compatible with high-speed coating equipment and can meet dissolution specifications across multiple pH stages.

Demand is supported by:

• Generic proton-pump inhibitors
• Delayed-release anti-inflammatory drugs
• Pancreatic enzyme products
• Oral biologically active molecules requiring gastric protection
• Multiparticulate pediatric formulations
• Fixed-dose combinations with incompatible release requirements

Generic manufacturers often prefer established grades with extensive regulatory history. This favors suppliers with global documentation packages, validated specifications, and technical support.

Shift toward aqueous film coating

Aqueous dispersions reduce the need for organic solvents and can improve manufacturing safety and environmental performance. EUDRAGIT L 30 D-55 and Kollicoat MAE 30 DP are positioned for direct aqueous coating.

The transition is not automatic. Aqueous systems can require longer drying times, tighter control of inlet temperature and spray rate, and careful management of tack, coalescence, and residual moisture. Manufacturers with existing organic-solvent processes may continue using dry polymer grades or solvent-based systems where equipment and product performance justify the cost.

Increased use of multiparticulate delivery

Pellets and mini-tablets require polymers that can be applied uniformly at low coating thickness while maintaining reliable dissolution. Methacrylic acid-ethyl acrylate copolymer is suitable for fluid-bed coating and related multiparticulate processes.

Multiparticulate dosage forms are important in pediatric, geriatric, and abuse-deterrent formulations. They also allow manufacturers to combine immediate-release and delayed-release populations in one capsule or tablet.

Demand for global regulatory consistency

Large pharmaceutical companies prefer excipients available under recognized pharmacopeial or regulatory frameworks in major markets. Supplier documentation can include:

• Certificate of analysis
• Residual solvent data
• Elemental impurity assessment
• Nitrosamine and mutagenic impurity statements
• Microbiological specifications
• Animal-origin declarations
• Stability data
• Manufacturing-site information
• Change-control procedures

The quality system and regulatory package can be as important as the polymer chemistry when a supplier is being qualified for a global product.

Which companies supply methacrylic acid-ethyl acrylate copolymer?

The principal branded suppliers include Evonik Industries and BASF. Colorcon participates through formulated coating systems and pharmaceutical coating technologies.

Company	Relevant commercial position	Competitive strength
Evonik	EUDRAGIT L 100-55 and L 30 D-55	Strong brand recognition, technical support, global regulatory history
BASF	Kollicoat MAE 30 DP and related coating technologies	Polymer and coating expertise, formulation support
Colorcon	Formulated coating systems and application technologies	Finished coating convenience, process support, pharmaceutical customer access
Regional manufacturers	Selected acrylic polymer and coating products	Price competition, local supply, shorter logistics

Supplier concentration is higher at the qualified pharmaceutical-grade polymer level than at the broader acrylic polymer level. Many chemical producers can manufacture acrylic copolymers, but fewer have the pharmaceutical documentation, particle-size control, residual impurity profile, coating performance, and change-control discipline needed for global drug products.

How does the cost structure affect financial performance?

The cost structure has five principal components:

1. Methacrylic acid and ethyl acrylate monomers
2. Polymerization and dispersion processing
3. Energy and water treatment
4. Pharmaceutical-grade testing and documentation
5. Packaging, warehousing, and global distribution

Raw-material costs are exposed to petrochemical markets, energy prices, plant utilization, and regional logistics. Aqueous dispersions carry higher transport costs because a substantial portion of the shipped product is water. Dry powders have better freight economics but require additional drying and powder-handling operations.

The polymer is a specialty excipient rather than a high-volume commodity. Pricing is therefore influenced by qualification status and supply reliability. Once incorporated into a commercial drug product, the material may remain qualified for many years. This creates customer retention and moderate pricing power, but the supplier must absorb the cost of technical support, audits, stability data, and regulatory change management.

What is the financial trajectory for the market?

The financial trajectory is likely to have four phases.

Near-term trajectory

Near-term revenue should track oral solid dosage production, generic launches, and inventory behavior among pharmaceutical manufacturers. Volume growth is likely to remain modest because the polymer is used in mature dosage-form technologies. Revenue can rise faster than volume when suppliers pass through monomer, energy, labor, or freight inflation.

The most favorable near-term products are aqueous dispersions and technically supported coating systems. They provide greater value per kilogram than unformulated polymer and reduce process-development work for pharmaceutical customers.

Medium-term trajectory

Medium-term growth should come from:

• New delayed-release generic approvals
• Expanded use of multiparticulate products
• Outsourced formulation and coating services
• Growth in emerging pharmaceutical markets
• Replacement of solvent-based coating systems
• Higher use of ready-to-use coating platforms

Pricing should remain disciplined where a supplier has an established grade in a regulated product. Price pressure will be stronger in development-stage products, regional markets, and customers with validated alternative suppliers.

Long-term trajectory

Long-term growth is constrained by the maturity of oral solid dosage technology. The polymer is unlikely to become a high-growth pharmaceutical material comparable to biologic excipients, lipid nanoparticles, or advanced injectable delivery systems.

Its long-term value is more defensive than transformational. The polymer benefits from recurring demand, regulatory qualification, and limited supplier substitution. Growth depends on maintaining quality, improving process efficiency, and expanding into specialty release profiles.

Scenario framework

Scenario	Volume growth	Pricing	Revenue outcome	Main drivers
Downside	Flat to 2% annually	Flat or negative	Low growth	Generic pricing pressure, supplier substitution, weak oral solid dosage demand
Base case	3% to 6% annually	Low-single-digit increase	Mid-single-digit growth	Stable delayed-release demand, aqueous coating adoption
Upside	6% to 9% annually	Mid-single-digit increase	High-single-digit growth	Supply concentration, strong generic launches, expanded multiparticulate use

These are analytical market scenarios, not reported company guidance or audited forecasts.

How strong is the patent estate for this excipient?

The base polymer is a mature chemistry with limited standalone patent exclusivity. Commercial differentiation is more likely to arise from:

• Grade-specific particle size
• Dispersion stability
• Plasticizer compatibility
• Coating-process performance
• Manufacturing know-how
• Formulated coating composition
• Use in a specific drug-delivery system
• Process conditions for coating or curing

Older composition patents covering broad methacrylic acid copolymers are generally less important to current market access than manufacturing know-how and customer qualification. Later patents may protect particular formulations, coating combinations, drug-polymer systems, or manufacturing processes.

The relevant IP risk is therefore usually product-specific rather than a broad prohibition on selling the copolymer. A pharmaceutical manufacturer could face patent risk from a drug-release formulation or coating process even when the excipient itself is off-patent.

What is the FDA regulatory status of methacrylic acid-ethyl acrylate copolymer?

The material is regulated as a pharmaceutical excipient when used in drug products. It is not approved as an independent therapeutic product. FDA review occurs through the finished drug application, including the formulation, manufacturing process, specifications, and performance of the dosage form.

Key regulatory considerations include:

• Identity and composition of the copolymer
• Monomer and residual impurity controls
• Particle size or dispersion characteristics
• Microbial quality
• Residual solvents
• Extractables and leachables where relevant
• Compatibility with the active ingredient
• Coating weight gain
• Gastric-stage resistance
• Intestinal-stage dissolution
• Stability under proposed storage conditions

The FDA Inactive Ingredient Database can support excipient precedent analysis, but precedent does not eliminate the sponsor’s obligation to establish suitability in the proposed route, dosage form, strength, and maximum daily exposure (U.S. Food and Drug Administration, n.d.).

What are the Orange Book, Paragraph IV, and biosimilar implications?

There is no direct Orange Book listing for methacrylic acid-ethyl acrylate copolymer as an excipient. The Orange Book lists approved drug products and associated patents, not ordinary excipients as standalone commercial products.

There is also no direct Paragraph IV pathway for challenging the copolymer. Paragraph IV litigation applies to patents listed for an approved reference drug. A generic applicant using this polymer may submit a Paragraph IV certification against patents covering the reference product’s composition, formulation, method of use, or release profile.

Biosimilar risk is not applicable because the material is a synthetic polymer, not a biologic medicine. The relevant competitive risk is substitution among excipient suppliers and coating technologies.

What manufacturing and supply barriers protect suppliers?

The strongest barriers are operational rather than patent-based.

Pharmaceutical qualification

A change in polymer supplier can trigger formulation development, comparative dissolution work, stability studies, process validation, and regulatory reporting. Even chemically similar grades may differ in:

• Molecular-weight distribution
• Acid value
• Particle size
• Viscosity
• Dispersion rheology
• Film formation
• Mechanical strength
• Dissolution onset
• Residual monomer profile

Process compatibility

A polymer that passes compendial identity testing may still perform differently on a commercial coating line. Spray rate, atomization pressure, product temperature, inlet humidity, and curing conditions can alter film continuity and release behavior.

Global manufacturing continuity

Pharmaceutical customers place value on dual-site production, disaster recovery, change-control discipline, and consistent batch performance. Suppliers with global inventory and technical service have an advantage over low-cost regional producers.

How does methacrylic acid-ethyl acrylate copolymer compare with competing enteric polymers?

Polymer	Typical release behavior	Main advantage	Main limitation
Methacrylic acid-ethyl acrylate copolymer	Dissolves above about pH 5.5	Strong enteric performance and broad commercial adoption	Requires coating-process control
Methacrylic acid-methyl methacrylate copolymer	Grade-dependent, often higher pH threshold	Tunable release and complementary grades	May require different intestinal release target
Cellulose acetate phthalate	Enteric release	Long regulatory history	Processing and stability limitations in some systems
Hypromellose phthalate	Enteric release	Established cellulose-based alternative	Different film and dissolution behavior
Polyvinyl acetate phthalate	Enteric release	Useful for selected formulations	Less common in some global coating platforms

The polymer competes on dissolution performance, processability, supplier support, and total cost of qualification. A lower raw-material price does not necessarily produce a lower total cost if the substitute requires reformulation or new stability work.

What generic launch risks exist?

Generic manufacturers using the polymer face four principal risks:

1. The reference product may use a protected release profile or coating process.
2. Small changes in polymer grade may alter dissolution performance.
3. Supplier changes may require regulatory assessment or supplemental filings.
4. Supply interruptions can delay batch release or commercial launch.

The most likely generic launch strategy is to use an established polymer grade with documented regulatory precedent, then design the coating process around the reference product’s dissolution profile. The commercial risk is higher for complex multiparticulate products than for conventional enteric tablets because coating uniformity and population-level release variability are harder to control.

What is the competitive outlook?

The market should remain concentrated, technically differentiated, and moderately growing. Evonik has a strong position through the EUDRAGIT brand and broad formulation platform. BASF competes through polymer chemistry and coating technology. Colorcon captures value further downstream through formulated coating systems and process services.

The main competitive threats are:

• Lower-cost regional acrylic polymers
• In-house formulation of coating systems
• Alternative enteric polymers
• Reduced use of delayed-release products
• Procurement pressure from large generic manufacturers
• Dual sourcing by multinational drug companies

The strongest commercial opportunity is not the sale of undifferentiated polymer powder. It is the combination of polymer, ready-to-use coating technology, regulatory support, and process troubleshooting.

Key Takeaways

• Methacrylic acid-ethyl acrylate copolymer is a mature, specialized enteric excipient used mainly in oral delayed-release products.
• The market has no reliable public standalone revenue figure because suppliers report it within broader pharmaceutical excipient or coating businesses.
• Base-case revenue growth is likely to track low-single-digit to mid-single-digit annual volume expansion, with pricing affected by monomer, energy, and logistics costs.
• Evonik and BASF are the principal branded polymer suppliers, while Colorcon competes in formulated coating systems.
• Supplier qualification, process performance, and regulatory documentation create stronger barriers than broad composition patents.
• There is no direct Orange Book, Paragraph IV, or biosimilar exposure for the excipient itself.
• The most attractive commercial segment is aqueous, technically supported, ready-to-use coating technology.
• Generic drug launches, multiparticulate formulations, and delayed-release products provide the main demand base.
• The market is defensive and recurring, but unlikely to deliver the growth profile of advanced biologic or injectable excipient platforms.

FAQs

Is methacrylic acid-ethyl acrylate copolymer the same as EUDRAGIT L 30 D-55?

EUDRAGIT L 30 D-55 is a branded aqueous dispersion based on methacrylic acid-ethyl acrylate copolymer. It is not identical in physical form to the dry-powder grade EUDRAGIT L 100-55.

Does methacrylic acid-ethyl acrylate copolymer dissolve in the stomach?

It is designed to resist dissolution under gastric conditions and dissolve after exposure to a higher intestinal pH, generally above approximately 5.5.

Can pharmaceutical manufacturers switch suppliers without reformulating?

A supplier switch may require comparative testing, process qualification, stability assessment, and regulatory review. Chemical similarity does not establish equivalent coating performance.

Is this copolymer suitable for biologic drug delivery?

It can be used in oral delivery research involving biologically active compounds, but the excipient does not solve the absorption and degradation challenges associated with most biologics.

What is the main investment risk in this excipient market?

The main risk is limited category growth combined with procurement pressure from large generic manufacturers. Supplier concentration and qualification barriers support margins, but alternative polymers and regional competitors can limit pricing power.

References

BASF. (n.d.). Kollicoat MAE 30 DP: Technical information and pharmaceutical applications. BASF SE.

Colorcon. (n.d.). Film coating systems and modified-release technologies. Colorcon, Inc.

Evonik Industries AG. (n.d.). EUDRAGIT polymers for pharmaceutical applications. Evonik Industries AG.

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

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

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