Drugs Containing Excipient (Inactive Ingredient) EUDRAGIT RS 30

EUDRAGIT RS 30 Market Dynamics and Financial Trajectory

Last updated: August 24, 2026

EUDRAGIT RS 30 D is Evonik’s aqueous dispersion of ammonio methacrylate copolymer Type B, used to control drug release in oral solid dosage forms. Its commercial position is supported by established formulation performance, broad use in modified-release products, and switching costs created by regulatory filings and manufacturing validation. Evonik does not publicly disclose product-level revenue, volume, pricing, or margins for EUDRAGIT RS 30 D. Its financial trajectory must therefore be assessed through Evonik’s Health Care business, pharmaceutical excipient demand, formulation trends, and competitive substitution.

What is EUDRAGIT RS 30 D used for?

EUDRAGIT RS 30 D is a 30% aqueous dispersion of a water-insoluble, permeable ammonio methacrylate copolymer. It is used primarily as a sustained-release and controlled-release coating for tablets, multiparticulates, pellets, granules, and capsules.[1]

The polymer forms a film that permits limited diffusion of water and dissolved drug. Release is controlled through:

• Polymer-film thickness
• Surface area of coated particles
• Drug solubility
• Pore-forming excipients
• Plasticizer selection
• Coating process conditions
• Dosage-form geometry

EUDRAGIT RS 30 D is distinct from EUDRAGIT RL grades. RS grades have lower quaternary ammonium content and lower permeability than RL grades. Formulators may combine the two grades to tune release rates.

Attribute	EUDRAGIT RS 30 D
Manufacturer	Evonik Operations GmbH
Dosage form	Aqueous polymer dispersion
Polymer class	Ammonio methacrylate copolymer Type B
Nominal solids content	Approximately 30%
Primary function	Sustained and controlled release
Main applications	Tablets, pellets, granules, multiparticulates
Route	Primarily oral
Regulatory category	Pharmaceutical excipient
Drug status	Not an active pharmaceutical ingredient
Orange Book status	No standalone listing
FDA exclusivity	None as an excipient
Biosimilar relevance	None directly

The product is usually selected when a formulation requires a relatively robust, water-insoluble film with controlled permeability rather than immediate release.

How does EUDRAGIT RS 30 D compare with competing release-control excipients?

EUDRAGIT RS 30 D competes with both chemically similar acrylic polymers and functionally similar release-control systems.

Product or platform	Supplier	Chemistry or technology	Competitive position
EUDRAGIT RS 30 D	Evonik	Ammonio methacrylate copolymer Type B	Controlled-permeability aqueous film coating
EUDRAGIT RL 30 D	Evonik	More permeable ammonio methacrylate copolymer	Used for faster release or blending with RS grades
EUDRAGIT NE 30 D	Evonik	Neutral methacrylate copolymer dispersion	Sustained release without ionic permeability control
Kollicoat SR 30 D	BASF	Polyvinyl acetate dispersion	Aqueous sustained-release coating alternative
Surelease	Colorcon	Ethylcellulose dispersion	Ethylcellulose-based controlled release
Aquacoat ECD	DuPont or legacy FMC-associated supply chains, depending on market and ownership	Ethylcellulose dispersion	Established aqueous ethylcellulose platform
Ethylcellulose powder	Multiple suppliers	Cellulose ether	Organic-solvent or dry-process alternative
Hypromellose	Multiple suppliers	Cellulose ether	Matrix tablets and hydrophilic coatings

EUDRAGIT RS 30 D has an advantage in formulations where the sponsor already has internal know-how, historical dissolution data, and regulatory precedent for the polymer. The main substitution risk comes from projects designed around simpler hydrophilic matrix systems, lower-cost cellulose derivatives, or alternative aqueous dispersions.

The economic comparison is rarely based only on price per kilogram. Total formulation cost includes coating time, solvent or water handling, yield loss, equipment utilization, analytical testing, stability work, and regulatory change-control requirements.

What market dynamics affect EUDRAGIT RS 30 D demand?

Demand is linked to the volume of modified-release oral medicines rather than to a single therapeutic area. The most relevant market drivers are the following.

Growth in modified-release generic products

Generic manufacturers use controlled-release excipients to replicate reference products and develop differentiated dosage forms. A polymer with established technical documentation can reduce development risk. Demand is strongest where the reference product uses a multiparticulate, pellet, matrix-coated, or reservoir-based release design.

Expansion of oral solid dosage forms

Tablets, capsules, pellets, and granules remain central to generic and branded pharmaceutical manufacturing. This supports demand for coating polymers even when new molecular-entity launches are limited.

Formulation outsourcing

Contract development and manufacturing organizations increasingly develop and produce modified-release products for multiple sponsors. This can increase excipient demand because one validated platform may be used across several customer programs.

Preference for aqueous processing

Aqueous dispersions reduce dependence on organic solvents and can simplify environmental, worker-safety, and facility requirements. EUDRAGIT RS 30 D benefits when manufacturers replace solvent-based coating systems with water-based processes.

Regulatory and quality requirements

Pharmaceutical manufacturers increasingly require full documentation covering elemental impurities, residual solvents, microbial quality, extractables, leachables, supply continuity, and change control. Established excipient suppliers generally have an advantage over lower-cost suppliers with limited regulatory infrastructure.

Cost pressure from generic manufacturers

Generic-drug pricing pressure creates incentives to reduce coating weight, shorten processing time, consolidate suppliers, and substitute lower-cost polymers. EUDRAGIT RS 30 D therefore competes in a market where technical performance supports pricing, but procurement teams continue to test alternative sources.

What is the financial trajectory of EUDRAGIT RS 30 D?

No public source identifies EUDRAGIT RS 30 D revenue, gross margin, annual volume, average selling price, or customer concentration. Evonik reports financial results by business line and segment, not by individual excipient grade.[2]

The most relevant financial indicators are:

Financial indicator	Public visibility
EUDRAGIT RS 30 D revenue	Not disclosed
Product-level operating margin	Not disclosed
Product volume	Not disclosed
Product price per kilogram	Not disclosed
Evonik Health Care sales	Reported at business-unit or segment level
Evonik pharmaceutical excipient growth	Discussed qualitatively and at broader portfolio level
Customer concentration	Not disclosed
Manufacturing cost	Not disclosed

The likely financial trajectory is mature and recurring rather than driven by rapid unit growth. EUDRAGIT RS 30 D is an established platform excipient. Its value is generated through repeat orders, high switching costs, technical support, and use across multiple products and geographies.

Revenue growth can come from:

1. New generic controlled-release launches.
2. Conversion from solvent-based to aqueous coating.
3. Expansion of contract manufacturing capacity.
4. Increased use in multiparticulate dosage forms.
5. Geographic expansion in emerging pharmaceutical markets.
6. Price increases tied to energy, labor, logistics, and quality-system costs.

Revenue pressure can come from:

1. Substitution by ethylcellulose or polyvinyl acetate systems.
2. Reformulation into hydrophilic matrix tablets.
3. Generic-drug price erosion.
4. Procurement consolidation.
5. Production interruptions or allocation events.
6. Customers qualifying second-source excipients.

Evonik’s broader Specialty Additives and Health Care performance provides context but cannot be converted into EUDRAGIT RS 30 D revenue without internal allocation data. Annual reports identify portfolio, segment, and company-level trends, but they do not separate EUDRAGIT grades.[2][3]

What regulatory status applies to EUDRAGIT RS 30 D?

EUDRAGIT RS 30 D is an excipient, not an FDA-approved drug. It does not receive New Drug Application approval, patent-term extension, pediatric exclusivity, or regulatory exclusivity as a standalone material.

Its regulatory relevance arises within individual drug applications. A finished product sponsor must identify the excipient, establish its function and level, and support its quality and suitability in the relevant dosage form.

The FDA Inactive Ingredient Database provides a reference point for inactive ingredients used in approved drug products, but an excipient’s presence in the database does not create approval for every route, dose, or formulation.[4]

Key regulatory considerations include:

• Identity and chemical characterization
• Residual monomers and process impurities
• Microbial quality
• Particle and dispersion characteristics
• Batch-to-batch consistency
• Plasticizer and colorant compatibility
• Stability under storage and processing
• Coating-process validation
• Supplier change control
• Compendial and customer-specific testing

European pharmaceutical manufacturers also assess excipient quality under EU requirements for formal information on excipients in the marketing authorization dossier.[5]

What patents protect EUDRAGIT RS 30 D?

The principal commercial protection is likely based on trademark rights, know-how, manufacturing capability, quality systems, regulatory documentation, and customer qualification rather than a single blocking patent on the mature product grade.

"EUDRAGIT" is a registered brand associated with Evonik’s pharmaceutical polymer portfolio. Trademark protection prevents confusing use of the brand but does not prevent competitors from selling functionally similar methacrylate polymers under different names.

Relevant intellectual-property layers include:

IP layer	Relevance to EUDRAGIT RS 30 D
Trademark	Protects the EUDRAGIT name and product branding
Composition patents	May protect specific polymer compositions or substitution patterns where still active
Process patents	May cover polymerization, dispersion, particle-size control, or film formation
Formulation patents	May cover use in a particular drug product
Manufacturing know-how	Controls consistency, impurity profile, and scale-up
Regulatory files	Support customer qualification and reduce switching
Trade secrets	May cover process parameters and quality controls

A competitor can potentially offer an alternative ammonio methacrylate dispersion without using the EUDRAGIT mark. Freedom-to-operate analysis must therefore examine current patent families, national-stage status, claim scope, and expiration dates. No universal Orange Book patent list exists for EUDRAGIT RS 30 D itself.

When does EUDRAGIT RS 30 D lose exclusivity?

EUDRAGIT RS 30 D does not have a single FDA exclusivity expiration date. Drug exclusivity applies to approved medicinal products, not generally to excipients.

Any composition or process patents associated with a particular EUDRAGIT grade expire according to their individual filing and priority dates. The commercial product can remain on the market after patent expiration if Evonik retains manufacturing, quality, brand, and customer advantages.

This structure differs from an active pharmaceutical ingredient:

Issue	EUDRAGIT RS 30 D	Small-molecule drug
Orange Book listing	No	Often yes
Paragraph IV challenge	No direct pathway	Yes, for listed patents
FDA product exclusivity	None as an excipient	Possible
Patent-term extension	Not applicable to excipient as such	Potentially applicable
Generic substitution	Technical and regulatory substitution	ANDA substitution after approval
Primary competitive barrier	Quality, know-how, qualification, supply	Patent and regulatory exclusivity

What generic entry risks exist for EUDRAGIT RS 30 D?

Generic entry risk operates indirectly. A generic manufacturer does not challenge EUDRAGIT RS 30 D through a Paragraph IV certification. Instead, it may qualify a competing polymer while developing an ANDA or other regulatory submission.

The principal risks are:

• A supplier offers a chemically similar acrylic dispersion.
• A customer develops a formulation using BASF Kollicoat SR 30 D.
• Ethylcellulose replaces the acrylic polymer.
• A hydrophilic matrix eliminates the need for a functional coating.
• A customer dual-sources the polymer to improve negotiating leverage.
• A product sponsor changes formulation after a manufacturing transfer.

Switching costs remain meaningful. A change in polymer can require comparative dissolution, process revalidation, stability studies, bioequivalence assessment, and regulatory reporting. The barrier is highest for approved products with narrow release specifications or complex multiparticulate systems.

Which companies compete with Evonik in controlled-release excipients?

The main competitive groups include Evonik, BASF, Colorcon, Ashland, and suppliers of cellulose derivatives and specialty coating systems.

Evonik’s advantage is portfolio breadth across enteric, sustained-release, taste-masking, and immediate-release polymers. BASF competes through Kollicoat polymers and broader formulation excipients. Colorcon competes through coating systems, technical service, and integrated formulation support. Cellulose-ether suppliers compete where formulators prioritize established matrix technologies, low cost, or simplified processing.

Competition is local as well as global. Regional excipient distributors and qualified manufacturers can gain share where customers prioritize short lead times, local inventory, and lower delivered cost.

What manufacturing and supply-chain barriers affect the product?

EUDRAGIT RS 30 D requires controlled polymer synthesis and dispersion processing. Commercial quality depends on molecular characteristics, substitution level, particle-size distribution, solids content, viscosity, microbial control, and film-forming performance.

Supply-chain barriers include:

• Specialized raw-material sourcing
• Polymerization capacity
• Dispersion stability during transport
• Temperature and storage control
• Site qualification
• Global regulatory change management
• Batch-release testing
• Customer-specific specifications

A supply interruption could affect customers with limited validated alternatives. That creates pricing power during constrained periods, but prolonged disruption would accelerate second-source qualification and substitution.

What licensing deals or settlement agreements affect EUDRAGIT RS 30 D?

No major public licensing deal or patent settlement specifically tied to EUDRAGIT RS 30 D is identified in the cited public materials. Commercial arrangements are more likely to involve distribution, technical service, contract manufacturing, or customer supply agreements than public patent settlements.

Drug-product licensing agreements can include formulations that use EUDRAGIT polymers, but those agreements generally do not disclose the excipient’s economics or create exclusivity for EUDRAGIT RS 30 D.

What is the outlook for EUDRAGIT RS 30 D?

The product has a stable position in controlled-release formulation, but its growth rate is likely to track mature pharmaceutical excipient markets rather than high-growth specialty-drug markets.

The strongest outlook exists in:

• Modified-release generics
• Multiparticulate oral dosage forms
• Aqueous coating conversion
• Outsourced pharmaceutical development
• Emerging-market manufacturing expansion
• Products requiring reproducible release control

The main downside risks are formulation simplification, polymer substitution, customer procurement pressure, and the absence of product-level exclusivity. Evonik’s long-term value is tied to technical reliability and portfolio integration rather than patent exclusivity alone.

Key Takeaways

• EUDRAGIT RS 30 D is an aqueous ammonio methacrylate copolymer dispersion used for sustained-release coatings.
• Evonik does not disclose product-level revenue, margins, volume, or pricing.
• The financial profile is likely mature, recurring, and specification-driven.
• There is no standalone Orange Book listing, Paragraph IV pathway, or FDA exclusivity period for the excipient.
• Competitive alternatives include Kollicoat SR 30 D, Surelease, Aquacoat, ethylcellulose, and hydrophilic matrix technologies.
• The main commercial barriers are formulation know-how, validated manufacturing processes, regulatory documentation, and customer qualification.
• Patent protection may cover specific compositions or processes, but brand, know-how, quality, and supply reliability are central to the product’s market position.
• Generic entry threatens Evonik indirectly through customer substitution and second-source qualification.
• Demand should remain linked to controlled-release generics, oral solid dosage forms, and aqueous coating technologies.

FAQs About EUDRAGIT RS 30 D

Is EUDRAGIT RS 30 D an active pharmaceutical ingredient?

No. It is a pharmaceutical excipient used to control drug release and does not provide the therapeutic activity of the finished medicine.

Can a generic manufacturer use EUDRAGIT RS 30 D in an ANDA?

Yes. A generic manufacturer can use the excipient in an ANDA if the formulation, manufacturing process, quality controls, and finished product satisfy FDA requirements.

Is EUDRAGIT RS 30 D interchangeable with EUDRAGIT RL 30 D?

No. RS and RL grades have different permeability characteristics. They may be used separately or blended, but substitution requires formulation and dissolution work.

Does EUDRAGIT RS 30 D require an organic solvent?

No. The product is supplied as an aqueous dispersion. The coating process still requires appropriate drying, film formation, plasticization, and equipment controls.

Who owns EUDRAGIT RS 30 D?

The EUDRAGIT pharmaceutical polymer brand is associated with Evonik Operations GmbH and its Health Care business.[1]

References

1. Evonik Operations GmbH. (n.d.). EUDRAGIT polymers for pharmaceutical applications. Evonik Industries.
2. Evonik Industries AG. (2023). Annual report 2023. Evonik Industries.
3. Evonik Industries AG. (2022). Annual report 2022. Evonik Industries.
4. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database. FDA.
5. European Medicines Agency. (2016). Guideline on the chemistry of active substances. EMA.