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Last Updated: December 12, 2025

Iodine povacrylex; isopropyl alcohol - Generic Drug Details


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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 3M 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
Recent Clinical Trials for iodine povacrylex; isopropyl alcohol

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

SponsorPhase
University of California, San DiegoPhase 4
University of PennsylvaniaN/A
3MN/A

See all iodine povacrylex; isopropyl alcohol clinical trials

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

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 021586-002 Sep 29, 2006 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Iodine Povacrylex; Isopropyl Alcohol

Last updated: July 28, 2025

Introduction

Iodine povacrylex; isopropyl alcohol represents a combined antiseptic formulation heavily used in healthcare settings for skin disinfection prior to invasive procedures, surgical preparations, and general antisepsis. The formulation’s efficacy, safety profile, and regulatory approvals shape its market positioning, influencing the ongoing market dynamics and forecasted financial trajectory.

Market Overview

The global antiseptic and disinfectant market was valued at approximately USD 16 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030, driven by rising healthcare-associated infections (HAIs), increasing surgical procedures, and heightened hygiene awareness post-pandemic [1].

Iodine povacrylex combined with isopropyl alcohol constitutes a significant subset within topical antiseptics, benefiting from its rapid bactericidal activity and broad-spectrum efficacy. Notably, products like Betadine™ (povidone-iodine formulations) underline the prominence of iodine-based antiseptics, although povacrylex formulations are distinguished by enhanced stability and skin tolerability.

Market Drivers

1. Rising Healthcare-Associated Infections (HAIs):
Global reports indicate that HAIs affect hundreds of millions annually, with disinfection protocols integral to mitigation [2]. The demand for reliable antiseptics like iodine povacrylex increases, especially amid rising antimicrobial resistance (AMR).

2. Surgical and Procedural Volume Growth:
Advancements in minimally invasive surgeries and an aging population with chronic conditions elevate the need for effective skin preparation, boosting demand for rapid-acting antiseptics.

3. Regulatory Approvals and Guidelines:
Regulatory bodies such as the FDA and EMA endorse povidone-iodine formulations, reinforcing market confidence. Ongoing updates to clinical guidelines further sustain the use of iodine-based antiseptics.

4. Consumer and Institutional Hygiene Practices:
Pandemic-driven emphasis on hygiene has broadened the acceptance and preference for alcohol-based antiseptics, including formulations combining povacrylex and isopropyl alcohol, heightening their use in outpatient and community settings.

Market Challenges

1. Competitive Landscape:
The antiseptic market includes chlorhexidine, alcohol-based solutions, and innovative disinfectants. The entry of newer agents with longer-lasting activity or better tolerability could impede iodine povacrylex's market share.

2. Skin Sensitivity and Allergic Reactions:
Potential for skin irritation or allergic responses influences clinician and patient preferences, especially in repeated or prolonged use scenarios.

3. Supply Chain and Raw Material Constraints:
Volatility in raw iodine supply and manufacturing complexities can impact production costs and availability, affecting pricing strategies and profitability.

Financial Trajectory and Commercialization Outlook

Revenue Projections:
Major pharmaceutical companies manufacturing iodine povacrylex formulations, such as Becton Dickinson, are positioned to experience steady revenue streams driven by institutional demand. With an estimated market size for iodine-based antiseptics surging in tandem with the broader disinfectant market, revenues from this segment may grow at a CAGR of approximately 4-6% over the next five years [3].

Pricing Trends:
Increased manufacturing efficiencies and competition are expected to keep prices relatively stable, although geopolitical factors and raw material costs could induce fluctuations.

Market Penetration and Expansion Strategies:
Expansion into emerging markets, especially Asia-Pacific, where healthcare infrastructure improves rapidly, presents significant revenue opportunities. Additionally, product innovations, such as formulations with enhanced tolerability and extended residual activity, could command premium pricing.

Regulatory and Patent Landscape

Patent protections for specific formulations or delivery systems, along with approvals for new indications, influence market exclusivity and revenue prospects. However, patent expirations for older formulations may lead to generic proliferation, exerting downward pressure on prices and margins.

Future Trends and Opportunities

  • Innovative Formulations: Development of povacrylex-based antiseptics with extended antimicrobial activity, reduced allergenicity, or combined capacities (e.g., antimicrobial and healing promotion).

  • Digital and Data-Driven Market Strategies: Use of real-world evidence (RWE) and post-market surveillance data to support marketing claims and expanding indications.

  • Sustainability: Incorporation of environmentally friendly manufacturing practices could appeal to institutional buyers prioritizing sustainability.

Key Market Players

  • Becton Dickinson: Known for Betadine™ products, including povidone-iodine formulations.
  • 3M Healthcare: Offers integrated surgical and antiseptic solutions.
  • Mundipharma: Produces alcohol-based antiseptics with povacrylex components.
  • Local and regional manufacturers: Expanding the market reach in emerging economies.

Conclusion

The market for iodine povacrylex combined with isopropyl alcohol remains resilient, driven by robust demand across healthcare sectors, ongoing regulatory support, and the global emphasis on infection control. While competitive pressures and raw material challenges exist, innovation, geographic expansion, and strategic partnerships position the product for continued growth. The financial trajectory indicates a stable yet opportunistic outlook, with strategic investments in formulation and market expansion poised to generate significant returns.


Key Takeaways

  • The antiseptic market is poised for steady growth, with iodine povacrylex formulations benefiting from their broad-spectrum efficacy and regulatory endorsement.
  • Rising HAIs, procedural volumes, and hygiene awareness are key drivers; however, competition from other antiseptics necessitates ongoing innovation.
  • Raw material supply chains and patent expirations are critical factors shaping pricing and market exclusivity.
  • Emerging markets offer significant growth opportunities, especially through localized manufacturing and tailored formulations.
  • Strategic investments in product innovation and sustainability can enable market leaders to sustain competitive advantage.

FAQs

1. How does iodine povacrylex compare to other antiseptics like chlorhexidine?
Iodine povacrylex offers rapid and broad-spectrum antimicrobial activity with proven efficacy in preoperative skin preparation. Chlorhexidine, while longer-lasting and less allergenic, may be less effective against spores and certain bacteria. Choice depends on procedural needs, patient factors, and institutional protocols.

2. What are the key regulatory considerations for iodine povacrylex formulations?
Regulatory agencies require demonstration of safety, efficacy, and quality standards. In the U.S., FDA approval or clearance is essential, typically supported by clinical data. Manufacturers must adhere to Good Manufacturing Practices (GMP) and address concerns related to skin irritation and systemic absorption.

3. What are the main challenges faced by manufacturers of iodine povacrylex products?
Supply chain disruptions for raw iodine, competition from alternative antiseptics, evolving regulatory standards, and consumer preference shifts towards alcohol-based and chlorhexidine products pose ongoing challenges.

4. How is the COVID-19 pandemic influencing the demand for iodine-based antiseptics?
While the pandemic heightened overall hygiene practices, initial shortages and supply chain issues temporarily constrained market growth. Long-term, increased awareness of infection control sustains demand, especially in healthcare and community settings.

5. What are future innovation prospects in iodine povacrylex formulations?
Developments focus on extending antimicrobial residual activity, improving tolerability, reducing skin irritation, and incorporating environmentally sustainable manufacturing processes, positioning these products for expanded use and higher acceptance.


References

[1] MarketsandMarkets. Disinfectants and Sanitizers Market by Type. 2022.
[2] WHO. Global Action on Antimicrobial Resistance. 2015.
[3] Grand View Research. Antiseptics Market Size & Trends. 2022.

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