Iodine povacrylex; isopropyl alcohol - Generic Drug Details

What are the generic drug sources for iodine povacrylex; isopropyl alcohol and what is the scope of freedom to operate?

Iodine povacrylex; isopropyl alcohol is the generic ingredient in one branded drug marketed by Solventum and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for iodine povacrylex; isopropyl alcohol

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	iodine povacrylex; isopropyl alcohol at DailyMed

Recent Clinical Trials for iodine povacrylex; isopropyl alcohol

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Diego	Phase 4
3M	N/A
University of Pennsylvania	N/A

See all iodine povacrylex; isopropyl alcohol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for iodine povacrylex; isopropyl alcohol

D08AG	Iodine products
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

US Patents and Regulatory Information for iodine povacrylex; isopropyl alcohol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solventum	DURAPREP	iodine povacrylex; isopropyl alcohol	SPONGE;TOPICAL	021586-002	Sep 29, 2006		OTC	Yes	Yes
Solventum	DURAPREP	iodine povacrylex; isopropyl alcohol	SPONGE;TOPICAL	021586-001	Sep 29, 2006		OTC	Yes	Yes

Iodine Povacrylex and Isopropyl Alcohol Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 3, 2026

Iodine povacrylex 0.7% in 74% isopropyl alcohol is the active antiseptic combination in 3M’s DuraPrep Surgical Solution, now within Solventum’s medical-surgical portfolio following 3M’s health-care separation in April 2024. The product competes primarily with chlorhexidine gluconate in isopropyl alcohol, especially BD’s ChloraPrep, and povidone-iodine products such as Betadine.

DuraPrep has a mature commercial profile. Its demand is linked to surgical procedure volumes, hospital infection-prevention protocols, operating-room standardization, and purchasing contracts rather than prescription growth. Public filings do not disclose DuraPrep revenue separately. The product’s core formulation is old, and no current Orange Book patent or regulatory exclusivity appears to create a material launch barrier. The principal defenses are brand recognition, clinical workflow integration, procurement contracts, manufacturing controls, applicator design, and hospital conversion costs.

What is iodine povacrylex and how is it used?

Iodine povacrylex is an iodine-containing antiseptic complex formulated in high-concentration isopropyl alcohol. DuraPrep Surgical Solution is labeled for preoperative preparation of a patient’s skin before surgery and for preparation before injection. The formulation combines rapid alcohol-mediated antimicrobial activity with persistent iodine activity after application.[1]

Product attribute	DuraPrep Surgical Solution
Active ingredients	Iodine povacrylex 0.7% and isopropyl alcohol 74%
Dosage form	Topical liquid surgical skin preparation
Primary setting	Operating rooms, procedural areas, hospitals, ambulatory surgery centers
Original manufacturer	3M Company
Current health-care owner	Solventum Corporation
Regulatory category	FDA-regulated topical antiseptic drug product
Primary competitors	ChloraPrep, Betadine surgical preparations, generic alcohol-based preps
Administration	Topical, external use only
Key safety issue	Flammability until fully dry

The product is designed for single-use application with a sponge, applicator, or related delivery system. It is not an injectable product and has no biosimilar pathway.

What is the FDA regulatory status of DuraPrep?

DuraPrep is an FDA-approved topical antiseptic product marketed under a drug application rather than as a conventional prescription tablet or injectable. FDA labeling identifies the active ingredients, warnings, directions, contraindications, and flammability precautions.[1]

The product’s regulatory value comes from its established approval, validated manufacturing process, labeling history, and hospital use record. It does not receive the regulatory exclusivity associated with a new chemical entity, orphan drug, pediatric extension, or biologic reference product.

FDA-related issue	Assessment
New chemical entity exclusivity	Not applicable to the mature product
Orphan exclusivity	Not applicable
Biologic exclusivity	Not applicable
Biosimilar reference product	No
Prescription-drug exclusivity	No current exclusivity identified
Orange Book relevance	Relevant for any listed patents; no material current patent barrier identified
Primary regulatory risk	Labeling, manufacturing, quality, flammability, and supply compliance

FDA-approved surgical antiseptics remain subject to postmarket manufacturing and safety oversight. Changes to formulation, container-closure system, applicator, manufacturing site, or labeling can require regulatory submissions even when the core active ingredients do not change.

What patents protect iodine povacrylex and isopropyl alcohol?

The commercial patent estate for the original iodine povacrylex/isopropyl alcohol formulation is mature. Any foundational patents covering the formulation or basic surgical-preparation use would generally have expired or reached the end of their normal enforceable life.

The more relevant current intellectual-property categories are:

1. Applicator and delivery systems.
2. Packaging and container-closure systems.
3. Formulation stability and dispensing characteristics.
4. Manufacturing methods.
5. Surgical drape or integrated-preparation systems.
6. Brand, trade dress, and hospital-contract positioning.

The formulation itself has limited apparent patent exclusivity value because iodine povacrylex and isopropyl alcohol are established antiseptic ingredients. A competitor would still need to satisfy FDA requirements for its own product, demonstrate acceptable quality and performance, and obtain hospital adoption.

What is the Orange Book status of DuraPrep?

The Orange Book is the relevant FDA source for patents listed against approved drug applications.[2] A current commercial assessment should distinguish between:

• patents listed against the drug application;
• expired formulation patents;
• unlisted patents covering applicators or manufacturing;
• trademarks and trade dress;
• regulatory exclusivity, which is separate from patent protection.

No currently enforceable Orange Book patent is publicly apparent as a central barrier to competition for the basic iodine povacrylex/isopropyl alcohol formulation. That reduces the likelihood that a Paragraph IV challenge would target a high-value, unexpired composition patent.

A potential generic or 505(b)(2) applicant would more likely compete through product approval, manufacturing scale, pricing, and purchasing access than through a patent litigation strategy.

When does iodine povacrylex lose exclusivity?

The core product has already lost any meaningful new-product exclusivity associated with its original market entry. The remaining commercial protection is market-based rather than exclusivity-based.

Exclusivity category	Current implication
New chemical entity	Expired or not applicable
Five-year NCE exclusivity	Not relevant to this mature formulation
Three-year clinical-investigation exclusivity	No current indication of a controlling period
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current controlling period identified
Patent exclusivity	No material current barrier identified for the basic formulation
Trademark protection	Potentially ongoing for DuraPrep branding
Trade-secret protection	Potentially relevant to process and quality systems
Contractual exclusivity	May exist in hospital or group-purchasing agreements

The practical result is open therapeutic competition. A generic entrant would not need to wait for a near-term patent cliff if it can satisfy FDA requirements and secure distribution.

How does DuraPrep compare with ChloraPrep and Betadine?

DuraPrep’s closest commercial comparator is ChloraPrep, which uses chlorhexidine gluconate in isopropyl alcohol. Betadine uses povidone-iodine-based chemistry and is available in several surgical and procedural formats.

Attribute	DuraPrep	ChloraPrep	Betadine surgical preparations
Core antiseptic	Iodine povacrylex	Chlorhexidine gluconate	Povidone-iodine
Alcohol component	74% isopropyl alcohol	Commonly alcohol-based, product-specific concentration	Product-specific; some formulations are aqueous or alcohol-based
Persistent activity	Iodine-based residual activity	Chlorhexidine residual activity	Iodine-based activity
Main buyer	Hospitals and surgery centers	Hospitals and surgery centers	Hospitals, clinics, surgery centers, retail channels
Commercial positioning	Surgical skin preparation with residual iodine	Rapid, persistent chlorhexidine-based preparation	Broad iodine antiseptic franchise
Key competitive variable	Procedure protocol, applicator, contract pricing	Clinical preference and institutional standards	Price, familiarity, broad product range
Main safety issue	Flammability and iodine-related precautions	Flammability and chlorhexidine hypersensitivity	Iodine sensitivity, thyroid-related precautions in specific populations

Clinical guidelines have often favored alcohol-based antiseptic preparations when appropriate, but institutional selection depends on the procedure, patient population, anatomical site, contraindications, operating-room policy, and comparative evidence.[3] No single antiseptic dominates every use case.

Chlorhexidine products have gained share in many institutional protocols because of their persistent activity and clinical evidence in selected procedures. DuraPrep retains a position where iodine chemistry, product familiarity, applicator design, or hospital protocol supports use.

What market dynamics affect iodine povacrylex sales?

The market is driven by procedure volumes and hospital purchasing economics.

Surgical volume

Demand rises with inpatient operations, outpatient procedures, catheter placements, interventional procedures, and ambulatory surgery. The shift from inpatient to outpatient care can support unit demand if more procedures require standardized preoperative skin preparation.

Infection-prevention protocols

Hospitals frequently standardize skin preparation products across operating rooms to reduce training complexity and procurement fragmentation. A product with established clinical use can retain share even when technically substitutable products are available.

Group purchasing organizations

GPO contracts and integrated delivery networks can compress prices while improving volume predictability. Contract awards can move substantial demand between DuraPrep, ChloraPrep, Betadine, and private-label products.

Form factor and workflow

The applicator is commercially important. A product that dispenses consistently, reduces preparation time, limits spills, and integrates with surgical drapes can command a premium over a chemically similar bulk solution.

Safety and operating-room policy

Alcohol-based preparations require complete drying before draping, ignition sources, or electrosurgical procedures. Hospitals may select different products for neonates, mucosal surfaces, damaged skin, or patients with known hypersensitivity risks.

Supply reliability

Shortages, manufacturing interruptions, packaging constraints, and shipping problems can cause rapid hospital conversion. Once a competitor is validated and added to purchasing systems, some displaced volume may not return.

What financial trajectory does DuraPrep have?

DuraPrep revenue is not separately reported by 3M or Solventum. Public financial statements report results at broader segment or business-unit levels, preventing a reliable product-level revenue, margin, or market-share calculation.[4,5]

The financial trajectory is therefore best assessed through commercial drivers:

Financial factor	Expected effect
Surgical procedure growth	Supports unit demand
Hospital price pressure	Limits average selling price
GPO contracting	Improves volume visibility but reduces price
Product maturity	Supports cash generation but limits premium growth
ChloraPrep competition	Creates share and pricing pressure
Private-label entry	Raises price erosion risk
Applicator innovation	Can protect premium pricing
Manufacturing scale	Supports margin if utilization remains high
Regulatory quality events	Can create abrupt revenue loss
Solventum separation	Changes reporting ownership, not necessarily product demand

The product is more likely to generate stable mature-product cash flow than high-growth pharmaceutical revenue. Its economics depend on recurring procedural consumption, low unit cost relative to surgery, and institutional reorder behavior. Growth is likely to track procedure activity and contract wins rather than new indications.

Solventum’s Medical Surgical business includes a wider portfolio than DuraPrep. Segment-level results cannot be attributed to the product without internal management disclosure. Investor models should avoid treating segment revenue as DuraPrep revenue.

Which companies are challenging iodine povacrylex in the market?

The competitive field includes established multinational manufacturers and lower-cost suppliers.

BD

BD’s ChloraPrep is the most direct branded alternative in many hospital skin-preparation protocols. Its competitive strength comes from clinical familiarity, institutional contracts, and broad distribution.

Kenvue and Betadine suppliers

Betadine is a widely recognized povidone-iodine brand. Its broad channel presence and range of formulations make it a significant alternative, although the active chemistry and use profile differ from iodine povacrylex.

Generic and private-label manufacturers

Generic manufacturers can compete through alcohol-based iodine or povidone-iodine products, subject to the applicable FDA regulatory pathway. Their main advantages are price and supply flexibility. Their limitations can include less-established clinical positioning, fewer applicator options, and weaker hospital-contract coverage.

Solventum

Solventum inherits DuraPrep’s brand, regulatory history, manufacturing infrastructure, and customer relationships. The separation from 3M gives the product a more focused health-care corporate owner but also places greater importance on portfolio-level profitability and capital allocation.

What generic launch risks exist?

Generic entry risk is moderate for the chemistry and higher for the commercial franchise.

A competitor could face the following barriers:

• FDA approval of a comparable topical antiseptic;
• demonstration of formulation identity or suitability under the applicable pathway;
• validated microbial performance;
• container and applicator compatibility;
• flammability labeling and controls;
• manufacturing-site compliance;
• hospital product evaluation;
• GPO and integrated-network contracting;
• supply reliability during conversions.

The lack of a strong current patent barrier increases the probability of competition over time. The absence of a patent barrier does not guarantee rapid substitution. Hospitals often retain approved products because conversion requires clinical review, staff training, inventory replacement, formulary changes, and operating-room implementation.

What manufacturing and intellectual-property barriers remain?

Manufacturing barriers are more significant than active-ingredient scarcity. The product requires controlled blending, iodine stability management, packaging compatibility, fill-volume accuracy, and consistent applicator performance. The high alcohol content creates transportation, storage, labeling, and fire-safety requirements.

Potentially defensible assets include:

• validated production processes;
• supplier qualification;
• quality-control specifications;
• packaging configurations;
• proprietary applicator designs;
• process know-how;
• hospital implementation materials;
• trademarks and trade dress.

These protections can preserve share but usually do not create pharmaceutical-style exclusivity. A competitor with a compliant manufacturing network and hospital distribution can enter without reproducing every feature of the incumbent product.

What patent litigation and settlement activity affects DuraPrep?

No major, currently controlling Paragraph IV litigation or settlement affecting the basic iodine povacrylex/isopropyl alcohol formulation is identified in the public record reviewed for this analysis. The absence of such litigation is consistent with a mature formulation whose principal patents, if any, are no longer central to market access.

Future disputes are more likely to involve:

• applicator patents;
• packaging technology;
• manufacturing processes;
• trade dress;
• product labeling;
• supply or distribution contracts;
• alleged infringement by a private-label or branded competitor.

How does the geographic opportunity differ?

The United States is commercially important because of its large surgical market, hospital purchasing infrastructure, and FDA-regulated product standards. Europe and other developed markets have comparable demand for operating-room antiseptics but may apply different device, biocide, medicinal-product, labeling, and procurement rules.

Geographic expansion depends on:

• local regulatory classification;
• registration requirements;
• alcohol transport and storage rules;
• hospital procurement structures;
• reimbursement and tender pricing;
• local competitors;
• product naming and labeling;
• manufacturing and distribution capacity.

A product’s U.S. approval does not automatically establish authorization in Europe, Canada, Japan, or emerging markets.

Key Takeaways

• Iodine povacrylex 0.7% in 74% isopropyl alcohol is the active combination in DuraPrep Surgical Solution.
• Solventum owns the product following the 2024 separation of 3M’s health-care operations.
• DuraPrep is a mature surgical antiseptic, not a growth-stage pharmaceutical asset.
• Public filings do not disclose DuraPrep revenue separately.
• The core formulation has no apparent current patent barrier that would support a significant exclusivity cliff.
• ChloraPrep is the principal branded competitor; Betadine and private-label products add price and protocol pressure.
• Hospital contracts, applicator design, manufacturing reliability, and clinical workflow are more important than patent exclusivity.
• Generic entry risk is commercially real but operationally slower than a typical tablet generic launch.
• Revenue should be modeled from surgical procedure volumes, contract retention, pricing, and share rather than from prescription data.
• Biosimilar risk is irrelevant because the product is a nonbiologic topical antiseptic.

FAQs

Is iodine povacrylex the same as povidone-iodine?

No. Iodine povacrylex and povidone-iodine are different iodine-containing antiseptic systems, although both release iodine and are used for skin disinfection.

Is DuraPrep available as a generic?

Comparable iodine- or alcohol-based surgical preparations may compete with DuraPrep, but generic availability depends on the specific formulation, applicator, regulatory pathway, and FDA approval status.

Does DuraPrep have a biosimilar competitor?

No. Biosimilars apply to biological reference products. DuraPrep is a topical antiseptic drug product.

What is the main commercial threat to DuraPrep?

The main threat is institutional conversion to chlorhexidine-alcohol products, combined with GPO price pressure and private-label competition.

Can DuraPrep revenue be isolated from Solventum financial statements?

No. Solventum reports broader business and segment results rather than separate DuraPrep revenue, units, or product-level operating margins.

References

1. U.S. Food and Drug Administration. (n.d.). DuraPrep surgical solution, iodine povacrylex 0.7% and isopropyl alcohol 74% labeling. FDA Drugs@FDA.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. World Health Organization. (2016). Global guidelines for the prevention of surgical site infection. World Health Organization.

4. 3M Company. (2024). 2023 annual report. 3M.

5. Solventum Corporation. (2024). Annual report and securities filings. Solventum.