Drugs Containing Excipient (Inactive Ingredient) CROSPOVIDONE

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

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Eli Lilly and Company	ZYPREXA	olanzapine	0002-4112	CROSPOVIDONE
Eli Lilly and Company	FOUNDAYO	orforglipron	0002-4178	CROSPOVIDONE	2031-04-01
Eli Lilly and Company	EVISTA	raloxifene hydrochloride	0002-4184	CROSPOVIDONE
ER Squibb & Sons LLC	BARACLUDE	entecavir	0003-1611	CROSPOVIDONE
ER Squibb & Sons LLC	REYATAZ	atazanavir	0003-3624	CROSPOVIDONE
ER Squibb & Sons LLC	EVOTAZ	atazanavir and cobicistat	0003-3641	CROSPOVIDONE	2029-09-03

Generic drugs containing CROSPOVIDONE excipient

Company	Ingredient	NDC	Excipient
Eli Lilly and Company	olanzapine	0002-4112	CROSPOVIDONE
Eli Lilly and Company	orforglipron	0002-4178	CROSPOVIDONE
Eli Lilly and Company	raloxifene hydrochloride	0002-4184	CROSPOVIDONE
ER Squibb & Sons LLC	entecavir	0003-1611	CROSPOVIDONE
ER Squibb & Sons LLC	atazanavir	0003-3624	CROSPOVIDONE
ER Squibb & Sons LLC	atazanavir and cobicistat	0003-3641	CROSPOVIDONE

Crospovidone Market Dynamics, Financial Trajectory, Manufacturers, and Regulatory Outlook

Last updated: September 8, 2026

Crospovidone is a mature, non-therapeutic pharmaceutical excipient used primarily as a superdisintegrant in immediate-release tablets and hard capsules. Demand is tied to generic medicines, over-the-counter products, orally disintegrating tablets, and emerging direct-compression formulations. The market has stable volume characteristics but limited public financial transparency because manufacturers generally report crospovidone within broader pharmaceutical excipient or life-science segments.

The commercial outlook is positive but moderate. Volume growth should track global solid-dose pharmaceutical production, while pricing depends on grade, particle-size distribution, regulatory qualification, supply reliability, and manufacturing location. The strongest barriers are customer qualification, compendial compliance, process consistency, and validated supply chains rather than active composition patents.

What is crospovidone and how is it used?

Crospovidone is a crosslinked form of polyvinylpyrrolidone, also known as crosslinked PVP or crospovidone. It is insoluble in water but rapidly absorbs liquid and swells, allowing tablets to break apart after administration.

The principal uses are:

• Superdisintegrant in immediate-release tablets
• Disintegration aid in hard capsules
• Component of orally disintegrating tablets
• Processing aid in direct-compression formulations
• Carrier or matrix component in selected solid-dose drug-delivery systems

Crospovidone is used at relatively low concentrations, commonly in the approximate range of 2% to 5% of a tablet formulation, although actual levels vary by drug substance, compression force, tablet hardness, particle size, and formulation design.

Manufacturers sell multiple grades differentiated by particle-size distribution, bulk density, porosity, water uptake, and flow properties. These differences affect tablet disintegration, dissolution, compression behavior, and manufacturability.

How large is the crospovidone market?

Public sources do not provide a standardized, audited global revenue figure for crospovidone alone. Commercial market reports often combine crospovidone with other superdisintegrants or with the wider pharmaceutical excipients market. Their estimates differ because of inconsistent definitions, geographic coverage, and treatment of captive production.

The market can be assessed through demand drivers rather than a single reliable figure:

Demand driver	Effect on crospovidone demand
Generic tablet production	Strong positive
Branded immediate-release products	Stable positive
Orally disintegrating tablets	Positive, but formulation-specific
Biologics and injectable drugs	Limited direct effect
Softgels and liquid dosage forms	Limited effect
Direct compression	Positive
Wet granulation	Positive, subject to formulation design
Tablet miniaturization	Positive where rapid disintegration is required
Regional manufacturing expansion	Positive
Substitution by croscarmellose sodium or sodium starch glycolate	Competitive pressure

Crospovidone is a volume-driven excipient. It does not benefit from the same unit-price economics as an active pharmaceutical ingredient or a patented drug. Financial performance depends on recurring customer qualification, plant utilization, product mix, and supply contracts.

Which companies manufacture crospovidone?

The principal global and regional suppliers include Ashland, BASF, JRS Pharma, Boai NKY Pharmaceuticals, and other Asian manufacturers. Product names and manufacturing entities can change through acquisitions, divestitures, or regional distribution agreements.

Company	Representative product family or market position	Commercial relevance
Ashland	Polyplasdone crospovidone	Major global excipient supplier with strong regulatory support
BASF	Kollidon CL and related PVP products	Integrated PVP portfolio and global pharmaceutical customer base
JRS Pharma	VIVAPHARM crospovidone products	Broad excipient portfolio and strong formulation support
Boai NKY Pharmaceuticals	Pharmaceutical PVP and crospovidone products	Important Asian manufacturing and export supplier
Regional manufacturers	Multiple generic crospovidone grades	Price competition and regional supply diversification

Ashland’s Polyplasdone range and BASF’s Kollidon CL range are among the best-known branded products. JRS Pharma competes through excipient breadth, technical support, and formulation services. Asian suppliers compete on price, capacity, and proximity to customers in China, India, and other manufacturing markets.

The competitive landscape is fragmented below the leading multinational suppliers. Pharmaceutical customers often maintain dual sourcing, but switching requires comparative testing, supplier audits, regulatory documentation, and process validation.

How does crospovidone compare with other superdisintegrants?

Crospovidone competes mainly with croscarmellose sodium and sodium starch glycolate.

Attribute	Crospovidone	Croscarmellose sodium	Sodium starch glycolate
Chemical basis	Crosslinked polyvinylpyrrolidone	Crosslinked cellulose derivative	Crosslinked modified starch
Solubility behavior	Insoluble, rapid swelling and wicking	Insoluble, swelling and wicking	Insoluble, high swelling
Typical use	Immediate-release tablets and capsules	Immediate-release tablets	Immediate-release tablets
Sensitivity to compression	Can retain strong performance under suitable conditions	Formulation-dependent	Formulation-dependent
Common selection factor	Rapid disintegration and compatibility	Cost, established performance	High swelling and cost
Main commercial risk	Supplier qualification and price	Substitution in standard formulations	Substitution in standard formulations

The choice is formulation-specific. Crospovidone can be preferred where rapid liquid uptake, low gelling tendency, or favorable performance under direct compression is required. Croscarmellose sodium and sodium starch glycolate remain credible substitutes in many standard tablet formulations.

Substitution is easier for new products than for approved commercial products. For an established medicine, changing the disintegrant may require comparative dissolution, stability work, process validation, and a regulatory filing depending on the jurisdiction and scale of the change.

What are the main market dynamics affecting crospovidone?

Generic drug expansion

Generic tablets represent the largest structural demand base. Crospovidone is used in products containing analgesics, antihypertensives, anti-infectives, central nervous system drugs, gastrointestinal medicines, and many other active ingredients.

Generic manufacturers are under sustained cost pressure. This favors qualified lower-cost suppliers, but excipient cost is usually a small part of total tablet cost. A low-priced alternative cannot displace an incumbent easily if it creates production variability or regulatory work.

Growth in direct compression

Direct compression can reduce processing steps and improve manufacturing efficiency. Crospovidone grades with suitable flow, compressibility, and particle engineering can benefit from this trend.

Excipient suppliers compete on functional performance, not only chemical identity. Technical data on disintegration time, dissolution, compactibility, moisture behavior, and compatibility can support premium pricing.

Orally disintegrating tablets

Orally disintegrating tablets require fast breakup and acceptable mouthfeel. Crospovidone may be used in these formulations, although taste masking, tablet strength, porosity, and manufacturing method determine the final excipient selection.

This segment is commercially attractive but smaller than the broad immediate-release tablet market. It is unlikely to transform total crospovidone demand without wider adoption of orally disintegrating dosage forms.

Supply-chain localization

Pharmaceutical manufacturers increasingly seek regional or dual sources for critical excipients. Crospovidone benefits from this trend because qualification of an alternative supplier can take months or years.

Regional production can reduce freight exposure and geopolitical risk. It also increases price competition, particularly where local suppliers meet relevant compendial and quality requirements.

Raw-material exposure

Crospovidone production depends on polyvinylpyrrolidone chemistry and related upstream raw materials. Costs can be affected by energy, labor, packaging, transport, and chemical-feedstock pricing. Because excipient contracts often have annual or negotiated pricing, manufacturers may experience margin pressure when input costs rise faster than selling prices.

What is the financial trajectory for crospovidone suppliers?

Crospovidone revenue is generally not reported as a separate line item. The most useful public indicators are the pharmaceutical excipient segment results of major suppliers.

Financial factor	Expected effect
Higher generic tablet volumes	Supports revenue growth
Mix shift toward premium grades	Supports gross margin
Chinese and Indian capacity expansion	Pressures price
Customer inventory destocking	Creates short-term volatility
Energy and chemical-cost inflation	Pressures margin
Long-term supply contracts	Improves revenue visibility
Regulatory support and documentation	Supports customer retention
Plant utilization	Strong effect on operating leverage

Ashland reports within broader life-science and specialty-materials categories rather than separately disclosing Polyplasdone revenue. BASF similarly reports pharmaceutical excipients within wider nutrition, care chemicals, and related business structures. JRS Pharma is privately held and does not provide the same level of public financial detail as a listed company.

The likely financial trajectory is therefore:

1. Low-to-mid single-digit volume growth in established markets.
2. Faster growth in selected emerging markets with expanding oral-solid manufacturing.
3. Stable but competitive pricing for standard grades.
4. Better margins for premium grades with differentiated functionality and regulatory support.
5. Periodic revenue volatility from distributor destocking and pharmaceutical customer inventory management.

The product is unlikely to generate drug-like margins because it has no protected clinical indication, no reimbursement leverage, and extensive substitution options. Its financial value comes from repeat demand, qualification costs, manufacturing reliability, and portfolio cross-selling.

What FDA regulatory status applies to crospovidone?

Crospovidone is an established pharmaceutical excipient, not an active drug substance. The FDA does not approve crospovidone through a standalone new drug application.

Regulatory status is established through:

• Inclusion in an approved drug product
• Compliance with relevant United States Pharmacopeia and National Formulary standards
• Supplier quality systems
• Drug Master File or equivalent confidential technical documentation where used
• Customer qualification and pharmaceutical development data
• Compliance with applicable current good manufacturing practice requirements

The FDA’s Inactive Ingredient Database is a key reference for prior use in approved products. The database identifies inactive ingredients by route, dosage form, and maximum potency information where available, but inclusion does not constitute a blanket approval for every formulation or route of administration. Manufacturers remain responsible for product-specific safety, quality, and performance.

Crospovidone is also covered by major international compendia, including the European Pharmacopoeia and Japanese Pharmacopoeia in relevant editions. Customers typically assess compendial conformity, residual monomers, elemental impurities, microbiological quality, particle size, moisture, and extractables or leachables where applicable.

What patents protect crospovidone?

The core composition of crospovidone is mature and is not generally protected by a currently enforceable foundational composition patent. Commercial protection is more likely to arise from:

• Manufacturing processes
• Crosslinking methods
• Particle-size control
• Porosity and bulk-density engineering
• Co-processing with other excipients
• Specialized tablet formulations
• Delivery systems using crospovidone
• Product-specific trademarks and technical know-how

Patent rights may exist for particular processes or formulations, but they do not create a single global exclusivity barrier around all crospovidone production. Rights must be assessed by jurisdiction, claim scope, filing date, prosecution history, maintenance status, and ownership.

Is crospovidone listed in the Orange Book?

No. Crospovidone is an excipient and is not listed as an FDA Orange Book reference product. The Orange Book covers approved drug products and patent or exclusivity information associated with those products, not standalone excipient protection.

Are there Paragraph IV challenges involving crospovidone?

Paragraph IV litigation applies to abbreviated new drug applications that challenge patents listed for a branded drug product. It does not apply to crospovidone as an excipient.

A generic drug containing crospovidone may be involved in Paragraph IV litigation over the active ingredient, formulation, method of treatment, dosage regimen, or drug-device combination. That litigation does not establish exclusivity over the excipient itself.

What formulation and method-of-use patents involve crospovidone?

Crospovidone can appear in patents claiming:

• Immediate-release tablets
• Orally disintegrating tablets
• Taste-masked formulations
• Abuse-deterrent dosage forms
• Fixed-dose combinations
• Multiparticulate systems
• Fast-dissolving films or granules
• Specific ratios of excipients
• Compression and granulation processes

These claims are usually directed to the drug product or dosage form rather than crospovidone alone. The commercial risk depends on whether the patent requires a particular crospovidone grade, particle-size range, concentration, manufacturing step, or functional result.

A formulation patent can limit use of a crospovidone-containing product even when the excipient itself is freely available. Conversely, a supplier can sell crospovidone without infringing a drug-product patent if the supplier does not practice the claimed formulation or process.

What licensing deals and settlement agreements affect crospovidone?

Public licensing and settlement agreements specifically covering crospovidone are uncommon. Excipient manufacturers typically sell through direct supply contracts, distributors, technical-service agreements, and quality agreements rather than patent licenses.

Settlement agreements involving generic drugs may permit launch of a product containing crospovidone before expiration of branded-drug patents. Those agreements generally concern the active pharmaceutical product and do not transfer or restrict ownership of crospovidone technology.

Confidential supply and quality agreements can still have commercial importance. They may include minimum volumes, change-control restrictions, audit rights, geographic supply provisions, and notification periods for manufacturing changes.

What generic entry risks exist for crospovidone suppliers?

Crospovidone has low direct patent risk but meaningful commercial and operational risk.

The main risks are:

• Substitution by croscarmellose sodium or sodium starch glycolate
• Price competition from regional suppliers
• Customer consolidation of excipient vendors
• Qualification delays for new drug products
• Pharmaceutical inventory destocking
• Failure to meet compendial or customer-specific specifications
• Manufacturing interruption
• Regulatory scrutiny of changes in raw materials or process controls
• Loss of a major generic customer after formulation redesign

The most defensible supplier position combines validated performance, consistent batch characteristics, regulatory documentation, global supply, and formulation support. Product branding alone is less durable than demonstrated process value.

How strong is the crospovidone patent estate?

The patent estate is weak at the foundational product level and stronger at the process and formulation level.

Patent layer	Relative strength
Core crospovidone composition	Low
Basic use as a tablet disintegrant	Low
Manufacturing process	Moderate, jurisdiction-specific
Particle engineering	Moderate
Co-processed excipient systems	Moderate to high for narrow claims
Drug-specific formulation	Potentially high
Method-of-use claims	Product-specific
Trademark and technical know-how	Commercial rather than patent exclusivity

Freedom-to-operate analysis must therefore focus on specific manufacturing routes and customer formulations. A generic crospovidone supplier is unlikely to face a single patent blocking the entire market, but a particular process or engineered grade can fall within narrower claims.

What is the outlook for crospovidone through 2030?

Crospovidone should remain a stable growth excipient through 2030, supported by oral-solid dosage manufacturing, generic medicines, and demand for efficient tablet processing.

The market is likely to divide into two tiers:

• Standard grades competing primarily on price and supply reliability
• Premium grades competing on particle engineering, performance data, regulatory support, and global availability

Revenue growth should be strongest in Asia-Pacific and other regions expanding pharmaceutical manufacturing capacity. North America and Europe should remain important for premium products, technical qualification, and regulated-market supply.

No major technology is likely to eliminate crospovidone demand. Substitution will continue at the formulation level, but the broad market is mature and diversified. Supplier earnings will depend more on product mix, plant utilization, pricing discipline, and customer retention than on patent expiry.

Key Takeaways

• Crospovidone is a mature crosslinked polyvinylpyrrolidone excipient used mainly as a tablet superdisintegrant.
• Generic and over-the-counter solid-dose medicines are the primary demand base.
• Ashland, BASF, JRS Pharma, and Asian manufacturers are major competitive participants.
• Public companies do not generally disclose crospovidone revenue separately, so financial analysis relies on broader excipient and life-science segment data.
• The foundational composition is generally not protected by a meaningful current global patent barrier.
• Process, particle-engineering, co-processing, and drug-specific formulation patents can create narrower risks.
• Crospovidone has no standalone Orange Book listing and is not subject to Paragraph IV challenges as an excipient.
• The strongest commercial barriers are qualification, consistency, regulatory documentation, and supply reliability.
• The outlook through 2030 is stable to moderately positive, with pricing pressure in standard grades and better economics for engineered products.

FAQs

Is crospovidone the same as povidone?

No. Povidone is generally water-soluble polyvinylpyrrolidone. Crospovidone is crosslinked, water-insoluble polyvinylpyrrolidone used mainly as a disintegrant.

Can crospovidone be replaced without regulatory approval?

A replacement may require formulation studies, comparative dissolution, stability testing, process validation, and a regulatory filing. The required action depends on the product, jurisdiction, change level, and applicable post-approval change rules.

Which excipient competes most directly with crospovidone?

Croscarmellose sodium is the closest broad commercial substitute. Sodium starch glycolate is another widely used alternative.

Does crospovidone create supply risk for generic drug manufacturers?

Yes. Supply risk can arise from limited qualified sources, manufacturing changes, batch variability, transport interruptions, or failure to meet customer-specific particle and performance specifications.

Is crospovidone suitable for biologic drug products?

Its principal use is in oral solid dosage forms, while most biologic products are injectable or otherwise non-solid. Crospovidone therefore has limited direct exposure to biologics growth.

References

1. Ashland Global Holdings Inc. (2023). Annual report for the fiscal year ended September 30, 2023. Ashland Global Holdings Inc.

2. BASF SE. (2023). BASF report 2023. BASF SE.

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

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

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

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

7. JRS Pharma. (2024). Pharmaceutical excipients and formulation solutions. JRS Pharma.

8. BASF. (2024). Kollidon pharmaceutical excipients: Technical product information. BASF SE.

9. Ashland. (2024). Polyplasdone crospovidone: Pharmaceutical excipient product information. Ashland Global Holdings Inc.