Drugs Containing Excipient (Inactive Ingredient) KOLLIDON SR

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Branded drugs containing KOLLIDON SR excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Viatris Specialty LLC	LYRICA CR	pregabalin	58151-245	KOLLIDON SR

Generic drugs containing KOLLIDON SR excipient

Company	Ingredient	NDC	Excipient
Dr Reddy’s Laboratories Inc	lamotrigine	43598-550	KOLLIDON SR
Golden State Medical Supply Inc	lamotrigine	51407-060	KOLLIDON SR
Viatris Specialty LLC	pregabalin	58151-245	KOLLIDON SR
Sinotherapeutics Inc	pregabalin	69986-013	KOLLIDON SR

KOLLIDON SR Market Dynamics, Competitive Position and Financial Trajectory

Last updated: August 22, 2026

Kollidon SR is BASF’s directly compressible sustained-release excipient based on a polyvinyl acetate and povidone matrix. Its commercial value comes from formulation performance, manufacturing convenience, and regulatory familiarity rather than from a single drug patent franchise. BASF does not publicly report Kollidon SR revenue, volume, margin, or backlog separately. Its financial trajectory must therefore be assessed through excipient demand, BASF’s pharmaceutical-solutions business, customer adoption, and competition from alternative matrix-forming technologies.

What is Kollidon SR and how is it used?

Kollidon SR is a hydrophilic-lipophilic matrix former used to control drug release from oral solid dosage forms. BASF identifies the material as a polyvinyl acetate and povidone-based excipient designed for sustained-release tablets and capsules.[1]

The material is typically incorporated into formulations through direct compression. Its main commercial advantages are:

• Sustained drug release without complex coating processes.
• Compatibility with direct-compression manufacturing.
• Reduced dependence on wet granulation or multiparticulate coating.
• Applicability across a broad range of active pharmaceutical ingredients.
• Potentially lower process complexity for generic and branded oral solid-dose products.

Kollidon SR is different from immediate-release binders such as standard povidone grades and from superdisintegrants such as crospovidone. It is used to create a matrix that slows drug diffusion and, depending on the formulation, erosion.

What is the composition of Kollidon SR?

Kollidon SR is generally described as a physical mixture of polyvinyl acetate and povidone in an approximately 8:2 ratio. Product specifications, excipient grades, and manufacturing controls are established by BASF and should be confirmed against the current technical and regulatory documentation for the relevant market.[1]

The composition gives the matrix both water-insoluble and water-soluble characteristics. Polyvinyl acetate contributes structural integrity and diffusion control, while povidone supports wetting and pore formation as the tablet hydrates.

What pharmaceutical products use Kollidon SR?

Kollidon SR is used in sustained-release oral dosage forms, including tablets and capsules. Public product documentation generally identifies application classes rather than providing a complete customer or product list. Pharmaceutical companies often treat excipient selection as confidential formulation know-how.

The principal target segments are:

Segment	Relevance to Kollidon SR
Generic extended-release tablets	High
Branded oral modified-release products	High
Reformulated immediate-release products	Moderate
Fixed-dose combinations	Moderate
High-dose poorly soluble drugs	Formulation-dependent
Biologics and injectable drugs	Low
Topical and ophthalmic products	Low

Demand is strongest where a manufacturer needs a scalable matrix system that can be processed by direct compression and transferred across manufacturing sites.

How large is the Kollidon SR market?

No audited public market size exists for Kollidon SR as a standalone product. Market-research estimates for the broader pharmaceutical excipient market cannot be reliably assigned to Kollidon SR because they often combine binders, fillers, disintegrants, coatings, solubilizers, and release-control polymers.

The relevant addressable market is the sustained-release and modified-release excipient segment. Growth drivers include:

1. Continued generic conversion of extended-release products.
2. Lifecycle management through once-daily or twice-daily formulations.
3. Increased use of direct compression.
4. Demand for scalable manufacturing in emerging pharmaceutical markets.
5. Reformulation of products with adherence or dosing-frequency advantages.

The main constraints are formulation development time, regulatory comparability requirements, supply qualification, and competition from established polymers such as hypromellose.

What is the financial trajectory of Kollidon SR?

BASF does not disclose a separate income statement for Kollidon SR. Public BASF reporting aggregates pharmaceutical excipients within larger business units and does not provide product-level sales, operating profit, pricing, or volume data.[2]

The financial trajectory is therefore best characterized as a specialized, recurring excipient business with limited public visibility:

Financial factor	Likely effect on Kollidon SR
Generic drug launches	Increases volume opportunity
Customer qualification	Creates recurring demand after approval
Raw-material costs	Can pressure gross margin
BASF manufacturing scale	Supports supply reliability
Polymer competition	Limits pricing power
Regulatory documentation	Raises switching costs
Product-level disclosure	Prevents direct revenue verification

Kollidon SR revenue is likely tied to formulation approvals and commercial production volumes rather than spot purchasing. Once incorporated into an approved product, replacement can require formulation studies, stability work, dissolution comparisons, and regulatory documentation. That creates customer retention, although it does not eliminate substitution risk.

BASF’s broader Care Chemicals and pharmaceutical excipient performance is the most relevant corporate financial proxy. BASF reports segment-level financial information, but public filings do not isolate Kollidon SR or the Kollidon brand.[2]

What drives demand for sustained-release excipients?

The strongest demand driver is the pharmaceutical industry’s need to extend product differentiation after the initial immediate-release product has matured. Modified-release formulations can support:

• Reduced dosing frequency.
• More stable plasma concentrations.
• Improved adherence.
• Product-line extensions.
• Generic differentiation.
• Reformulation-based intellectual-property strategies.

Kollidon SR is well positioned where developers want to avoid a coating-heavy manufacturing process. Direct compression can reduce equipment requirements and shorten processing steps, although the final formulation still requires extensive dissolution, stability, content-uniformity, and scale-up work.

Demand is also linked to generic drug development. A generic extended-release product must demonstrate performance against the reference product through dissolution testing and, where required, pharmacokinetic studies. Excipients that produce reproducible release profiles can reduce development risk, but they do not guarantee regulatory approval.

How does Kollidon SR compare with competing excipients?

The principal competitive comparison is with hypromellose-based matrix systems, especially high-viscosity HPMC grades. Other alternatives include ethylcellulose, carbomers, methacrylate copolymers, waxes, lipids, and multiparticulate coating systems.

Attribute	Kollidon SR	HPMC matrix	Ethylcellulose	Coated multiparticulates
Typical processing	Direct compression possible	Direct compression or granulation	Often granulation or coating	Pellet or bead processing
Release mechanism	Polyvinyl acetate-povidone matrix	Gel-layer formation	Diffusion barrier	Coating-controlled release
Formulation flexibility	High for selected APIs	Broad	Broad but process-sensitive	High but more complex
Manufacturing burden	Relatively low	Low to moderate	Moderate	High
Cost position	Premium or specialized	Broadly competitive	Application-dependent	Usually higher
Main risk	Limited supplier choice	Gel strength and variability	Process complexity	Scale-up and coating control

HPMC has the broadest installed base in oral modified-release formulations. Kollidon SR competes by offering a different release mechanism and a direct-compression manufacturing route. Its strongest position is not necessarily lowest cost. It is process simplification and formulation performance.

What regulatory status does Kollidon SR have?

Kollidon SR is a pharmaceutical excipient, not an active drug. It does not have an FDA New Drug Application, biologics license, Orange Book listing, or Hatch-Waxman exclusivity period.

Relevant regulatory records include:

• FDA inactive-ingredient and excipient information.
• United States Pharmacopeia and National Formulary standards where applicable.
• European Pharmacopoeia or other regional compendial references.
• Vendor quality, residual-solvent, elemental-impurity, and animal-origin statements.
• Drug-master-file or equivalent confidential regulatory documentation, where maintained.

The FDA Inactive Ingredient Database is relevant to excipient precedent, but inclusion does not constitute approval of every concentration, route, dosage form, or formulation.[3] A drug sponsor remains responsible for demonstrating the suitability and safety of the complete formulation.

Does Kollidon SR have Orange Book protection?

No. Orange Book patents and exclusivity attach to approved drug products, not to excipients as standalone materials. Kollidon SR can appear indirectly in drug-product patent claims, formulation claims, or regulatory submissions, but BASF’s excipient itself is not listed in the Orange Book.

What patents protect Kollidon SR?

The commercial position of Kollidon SR is not equivalent to a conventional drug patent estate. Protection may arise from:

• BASF composition and manufacturing patents.
• Trade secrets covering polymer selection, particle engineering, and blending.
• Product specifications and quality systems.
• Customer formulation patents.
• Drug-product patents covering sustained-release compositions.
• Method-of-use claims directed to specific active ingredients.

Publicly available product information does not establish a complete, current global patent list for Kollidon SR. A definitive patent-expiration analysis would require a live search of patent-family records, continuation status, national-stage filings, assignments, terminal disclaimers, and opposition proceedings.

The practical barrier to substitution is often technical qualification rather than patent exclusion. A competing excipient may be legally available but commercially unattractive if it changes dissolution, tablet hardness, stability, or bioequivalence performance.

Are Paragraph IV challenges or generic litigation relevant?

Paragraph IV litigation is not directed at Kollidon SR as an excipient. It becomes relevant when a drug product using Kollidon SR is submitted as an abbreviated new drug application and challenges patents listed for the reference product.

Potential litigation issues include:

• Whether the formulation patent requires Kollidon SR specifically.
• Whether the generic uses an equivalent or non-infringing matrix.
• Whether release-control limitations are met.
• Whether a method-of-use patent covers the proposed dosing regimen.
• Whether a product-by-process or manufacturing limitation is enforceable.

A generic manufacturer can use a different excipient, the same excipient, or a functionally equivalent matrix, subject to formulation and regulatory requirements. BASF’s ownership or supply of Kollidon SR does not itself determine infringement.

What manufacturing and intellectual-property barriers affect supply?

The primary manufacturing barriers are polymer quality, particle-size control, blend uniformity, moisture management, and batch-to-batch release performance. Pharmaceutical customers also evaluate:

• Global supply continuity.
• Change-control procedures.
• Site qualification.
• Compendial compliance.
• Audit history.
• Extractables and leachables data.
• Residual impurities.
• Regulatory notification practices.

BASF’s scale and established pharmaceutical-excipient infrastructure create a qualification advantage. The countervailing risk is supplier concentration. If a customer has qualified only Kollidon SR, a supply interruption may require a new excipient qualification and potentially a reformulation program.

Which companies compete with BASF in sustained-release excipients?

Competition comes from excipient manufacturers and from drug developers’ internal formulation platforms. Relevant competitive categories include:

• HPMC suppliers such as Dow and Shin-Etsu.
• Ethylcellulose suppliers such as Colorcon and other specialty-material manufacturers.
• Methacrylate polymer suppliers such as Evonik.
• Cellulose-derivative suppliers including Ashland.
• Polyvinyl alcohol, carbomer, wax, and lipid-excipient suppliers.

The competitive landscape is application-specific. A customer may select Kollidon SR for direct compression, HPMC for broad formulation familiarity, ethylcellulose for diffusion control, or a coating polymer for multiparticulate delivery.

What licensing deals and settlement agreements affect Kollidon SR?

No major public licensing deal or settlement agreement specific to Kollidon SR is established in the cited public materials. Pharmaceutical customers may have private supply agreements, technical-service arrangements, or formulation licenses, but these are generally not disclosed.

Drug-specific settlement agreements can affect products that use Kollidon SR, particularly where a generic company agrees to delayed entry or a licensed launch. Those agreements concern the drug’s patents and commercialization rights, not the excipient’s standalone market position.

What generic launch risks exist for Kollidon SR customers?

Generic customers face four primary risks:

1. Release-profile failure during development or scale-up.
2. Bioequivalence failure despite acceptable in vitro dissolution.
3. Supply interruption or manufacturing-site change.
4. Patent infringement based on the finished drug product.

Kollidon SR can reduce process complexity, but it does not remove the need for API-specific formulation optimization. Drug load, solubility, particle size, compression force, tablet geometry, and dose strength can materially change release behavior.

How strong is the commercial position of Kollidon SR?

Kollidon SR has a defensible niche rather than a dominant excipient position. Its strengths are:

• Recognized BASF brand and technical support.
• Established use in sustained-release oral dosage forms.
• Direct-compression suitability.
• Switching costs after customer qualification.
• Relevance to generic and lifecycle-management programs.

Its weaknesses are:

• No publicly disclosed product-level financial data.
• Strong competition from HPMC and other matrix systems.
• Dependence on customer formulation success.
• Limited visibility into patent life and exclusivity.
• Exposure to pharmaceutical development cycles.

The product’s financial trajectory should therefore be modeled as stable-to-growing with pharmaceutical modified-release demand, but not as a separately verifiable high-growth franchise. Volume growth can occur without equivalent revenue growth if customers negotiate price reductions or switch to lower-cost polymers.

Key Takeaways

• Kollidon SR is a BASF sustained-release excipient based on polyvinyl acetate and povidone.
• Its core use is direct-compression matrix tablets and other oral modified-release dosage forms.
• BASF does not disclose Kollidon SR revenue, profit, volume, or customer-level financial data.
• The product competes mainly with HPMC, ethylcellulose, methacrylate polymers, and multiparticulate coating systems.
• Its commercial moat comes from formulation qualification, technical performance, regulatory documentation, and supply reliability.
• Kollidon SR has no standalone Orange Book listing, Hatch-Waxman exclusivity, or Paragraph IV exposure.
• Drug-product patents, not excipient ownership, determine most litigation and generic-entry risk.
• Growth depends on generic extended-release launches, lifecycle reformulation, and continued adoption of direct compression.
• The main risks are supplier concentration, polymer substitution, pricing pressure, and failure of API-specific release or bioequivalence studies.

FAQs

Is Kollidon SR the same as povidone?

No. Kollidon SR is a polyvinyl acetate-povidone matrix system. Standard povidone grades are primarily used as binders, solubilizers, or film-forming excipients and do not provide the same sustained-release function.

Can HPMC replace Kollidon SR?

Sometimes. HPMC may replace Kollidon SR in selected formulations, but substitution requires renewed development work because hydration, gel formation, dissolution, tablet strength, and pharmacokinetic performance can change.

Is Kollidon SR suitable for high-dose drugs?

It can be, but suitability depends on dose, drug solubility, particle size, target release period, tablet size, and the required release mechanism. High-dose products may face tablet-size and drug-loading limitations.

Does BASF manufacture Kollidon SR globally?

BASF markets pharmaceutical excipients through its global organization, but the applicable manufacturing site, supply route, and regulatory filing depend on the product grade and customer market. Site and supply-chain details should be verified in current BASF quality documentation.

Can a competitor make a functionally equivalent excipient?

A competitor can develop an alternative matrix former, but equivalence requires technical performance, regulatory support, customer qualification, and commercial supply capability. Functional similarity does not establish interchangeability.

References

1. BASF. (n.d.). Kollidon SR: Technical information and pharmaceutical excipient applications. BASF SE.

2. BASF SE. (2024). BASF report 2023. Ludwigshafen, Germany: BASF SE.

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

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

5. European Directorate for the Quality of Medicines & HealthCare. (2024). European Pharmacopoeia. Strasbourg, France: Council of Europe.