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Last Updated: March 19, 2026

iodine povacrylex; isopropyl alcohol - Profile


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What are the generic 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 3M and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for iodine povacrylex; isopropyl alcohol
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

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
3m DURAPREP iodine povacrylex; isopropyl alcohol SPONGE;TOPICAL 021586-001 Sep 29, 2006 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
3m DURAPREP iodine povacrylex; isopropyl alcohol SPONGE;TOPICAL 021586-002 Sep 29, 2006 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis of Iodine Povacrylex with Isopropyl Alcohol

Last updated: February 20, 2026

What is the Market Status of Iodine Povacrylex with Isopropyl Alcohol?

Iodine povacrylex combined with isopropyl alcohol is a well-established antiseptic used primarily for skin preparation before surgery or invasive procedures. The drug is market-ready and has been in use for decades, with formulations available from multiple manufacturers.

Market penetration is high in hospitals and outpatient surgeries. The product's revenue generation primarily depends on hospital procurement, with geographic markets split mainly across North America, Europe, and parts of Asia-Pacific.

How Do the Basic Fundamentals Support Investment in This Antiseptic?

Revenue Drivers

  • Market size: The global surgical antiseptics market was valued at approximately USD 4.5 billion in 2021, expected to grow at a CAGR of 4% through 2028.

  • Market growth factors:

    • An increasing number of surgeries worldwide.
    • Rising awareness for infection control.
    • Regulatory mandates for antiseptic use in sterile procedures.
  • Pricing: The average wholesale cost per unit (per bottle or ampoule) remains stable, with minimal price fluctuations, reflecting stable margins.

Cost Structure

  • Manufacturing costs: Low due to the availability of raw materials. Iodine povacrylex is synthesized via established chemical processes, and isopropyl alcohol is widely produced.

  • Margins: Gross margins typically between 70-80%, driven by minimal raw material costs and stable demand.

Competitive Landscape

  • Several established pharmaceutical companies produce iodine povacrylex products, but market share is moderately fragmented.
  • New entrants are limited due to manufacturing complexities and regulatory barriers.

Regulatory Considerations

  • Both components hold FDA approval and EMA certification as antiseptics.
  • The product is classified as a medical device or drug, depending on local regulations, which entails registration but relatively straightforward approval processes.

Research and Development

  • Limited ongoing R&D, as the formulation is mature.
  • Focus may shift to formulation improvements, packaging, and alternative delivery mechanisms.

What Are the Investment Risks Associated With This Drug?

  • Regulatory shifts toward non-chemical disinfection methods could reduce demand.
  • Price pressures from generic manufacturers may compress margins.
  • Supply chain disruptions for raw materials could impact availability and costs.
  • Market saturation in developed regions reduces growth potential, shifting focus to emerging markets.

How Does This Asset Compare to Emerging Alternatives?

Aspect Iodine Povacrylex + Isopropyl Alcohol Emerging Alternatives (e.g., chlorhexidine-based)
Market penetration High in hospitals Growing in outpatient settings
Cost Low Potentially higher, especially with new technologies
Efficacy Effective against a broad spectrum Similar, sometimes superior against specific pathogens
Regulatory status Well established Varies; newer products may face longer approval timelines

What Is the Long-term Investment Outlook?

  • Substantial stable revenue from ongoing hospital procurements.
  • Limited growth potential without expanded indications.
  • Potential for price erosion as generics mature.
  • Expansion opportunities exist in emerging markets with growing healthcare infrastructure.

Key Takeaways

  • The formulation is mature with stable demand driven by surgical volume.
  • The drug's revenue depends significantly on hospital procurement budgets.
  • Limited R&D reduces operational risks but constrains growth.
  • Competition from generics and alternative antiseptics presents pricing pressure.
  • Emerging markets present growth opportunities, albeit with regulatory and infrastructure challenges.

FAQ

Q1: Can the demand for iodine povacrylex with isopropyl alcohol increase significantly?
A: Demand is tied to global surgical volumes, which grow steadily. Major increases would require new indications, expanded use cases, or market penetration.

Q2: How susceptible is this drug to regulatory changes?
A: Since it is already approved and well established, regulatory risks are moderate. Shifts toward new antiseptics could impact future demand.

Q3: What impact do supply chain disruptions have on investment?
A: Disruptions could increase raw material costs or cause shortages, affecting margins and timing of sales.

Q4: Are there licensing or patent protections that influence competitiveness?
A: The active formulations are off-patent, making generics available and intensifying price competition.

Q5: What are the main drivers for growth in emerging markets?
A: Increasing healthcare infrastructure, rising surgical procedures, and regulatory acceptance of antiseptics support growth.


References

  1. MarketsandMarkets. (2022). Surgical Antiseptics Market Analysis. Retrieved from https://www.marketsandmarkets.com/
  2. U.S. Food and Drug Administration. (2022). FDA List of Approved Skin Preparation Products. Retrieved from https://www.fda.gov
  3. Grand View Research. (2023). Healthcare Antiseptics Market Report. Retrieved from https://www.grandviewresearch.com

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