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Last Updated: January 29, 2026

POVIDONE IODINE Drug Patent Profile


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Which patents cover Povidone Iodine, and what generic alternatives are available?

Povidone Iodine is a drug marketed by Allegiance Hlthcare and is included in one NDA.

The generic ingredient in POVIDONE IODINE is povidone-iodine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the povidone-iodine profile page.

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Drug patent expirations by year for POVIDONE IODINE
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Recent Clinical Trials for POVIDONE IODINE

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SponsorPhase
Argon Medical DevicesPHASE1
University of Alabama at BirminghamPHASE1
Unitary Enterprise UNITEHPROM BSUPHASE2

See all POVIDONE IODINE clinical trials

US Patents and Regulatory Information for POVIDONE IODINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allegiance Hlthcare POVIDONE IODINE povidone-iodine SOLUTION;TOPICAL 019522-001 Mar 31, 1989 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 Povidone Iodine

Last updated: January 27, 2026

Executive Summary

Povidone Iodine (PVP-I) is a broad-spectrum antiseptic used extensively in medical, dental, and personal care applications. Its market is influenced by factors such as rising infection control protocols, the COVID-19 pandemic, and regulatory approvals. This analysis outlines the key market drivers, competitive landscape, regulatory environment, and projected financial trajectory. The ongoing global health focus on infection prevention, coupled with increasing demand for antiseptics, positions Povidone Iodine for sustained growth. The global market size was valued at USD 377 million in 2022, with an estimated compound annual growth rate (CAGR) of 4.8% from 2023 to 2030.


What Are the Market Drivers for Povidone Iodine?

Increasing Infection Control Measures

  • Healthcare settings emphasize infection prevention, especially amid the COVID-19 pandemic.
  • PVP-I is recommended by WHO and CDC for preoperative skin preparation and wound disinfection.

Regulatory Approvals and Endorsements

  • Various health authorities approve PVP-I for surgical, wound, and mucous membrane antisepsis.
  • COVID-19 led to expanded indications and emergency use authorizations in certain jurisdictions.

Growing Demand in Emerging Markets

  • Developing countries, with expanding healthcare infrastructure, exhibit increased antiseptic usage.
  • Governments promote hygiene practices to curb infectious diseases.

Product Diversification and Innovations

  • Formulations include wipes, solutions, gels, and nasal sprays, expanding end-use applications.
  • Ongoing R&D aims to improve stability, shelf life, and patient compliance.

Impact of COVID-19 Pandemic

  • Elevated demand for antiseptics, with increased PVP-I usage for nasal decontamination and hand sanitizers.
  • Surge in public and healthcare sector purchasing.

What Are the Challenges Facing Povidone Iodine Market?

Environmental and Safety Concerns

  • Iodine's environmental impact raises sustainability questions.
  • Allergic reactions limit use in some patient populations.

Market Competition

  • Competition from alternatives such as chlorhexidine, alcohol-based disinfectants, and newer antiseptics.

Regulatory Barriers

  • Stringent approval processes delay product launches.
  • Variability in regulatory acceptance across countries.

Pricing Pressures

  • Price competition among generic manufacturers affects profit margins.
  • Cost-based pricing strategies in emerging markets.

Who Are the Major Market Players and Competitive Landscape?

Company Market Share (Est.) Key Products Strategic Movements
Johnson & Johnson ~25% Betadine® solution, ointments Expansion into nasal antiseptics, R&D investment
Novartis AG ~15% Isodine® products Regulatory approvals in new regions, product diversification
Huons Co., Ltd. ~10% PVP-I based wound care products Focus on Asian markets, novel formulations
Reckitt Benckiser ~8% Dettol antiseptics Increasing presence in emerging markets
Local and Generic Players Remaining ~42% Various PVP-I formulations Price competition and regional distribution strategies

Market Concentration: Moderate, with top five players holding approximately 63% market share.


Regulatory Environment Impacting the Market

Global Regulatory Status

  • Povidone Iodine is generally classified as a over-the-counter (OTC) or prescription drug depending on formulation and indication.
  • Notable approvals include the FDA (U.S.), EMA (Europe), and WHO prequalification for certain formulations.

Future Regulatory Trends

  • Increased scrutiny over iodine content and environmental impact.
  • Potential for expanded indications, such as nasal or oral applications, subject to clinical trials and approvals.

Financial Trajectory: Revenue Projections and Market Growth

Historical Revenue (2022)

Region Revenue (USD millions) Share of Market Key Drivers
North America 110 29% COVID-19, hospital usage, surgical applications
Europe 85 23% Surgical antiseptic demand, healthcare infrastructure
Asia-Pacific 130 34% Growing healthcare access, infection control initiatives
Rest of World 52 14% Emerging markets, local manufacturing

Projected Market Growth (2023-2030)

Year Market Size (USD millions) CAGR Notes
2023 397 4.8% Post-pandemic stabilization
2025 470 5.2% Increased regulatory approvals, product innovations
2030 635 4.8% Continued expansion into emerging markets, new indications

Factors Supporting Growth

  • Adoption of PVP-I in nasal sprays for COVID-19 prophylaxis and treatment.
  • Growth in dental health applications, with formulations targeted at mucosal antisepsis.
  • Increasing use in veterinary medicine and water purification in rural areas.

How Does Povidone Iodine Compare to Alternative Antiseptics?

Attribute Povidone Iodine Chlorhexidine Alcohol-based Disinfectants Hydrogen Peroxide
Spectrum of Activity Broad, including fungi, viruses Bactericidal, residual effect Bactericidal, rapid action Broad, including viruses
Usage Duration Long-lasting but requires contact time Extended residual activity Short, needs frequent application Short, immediate effect
Safety Profile Allergic reactions possible, stains skin Generally safe, rare allergies Skin dryness, irritation Can cause tissue damage
Environmental Impact Concerns over iodine runoff Minimal Flammable, VOC emissions Biodegradable but reactive

What Are the Future Opportunities for Investing in Povidone Iodine?

  • Expansion into New Indications: Nasal and oral antiseptics, hand sanitizers, and mucosal applications.
  • Product Innovations: Development of formulations with improved stability and patient compliance.
  • Emerging Markets: Growing healthcare investments in Asia, Africa, and Latin America.
  • Increased Regulatory Approvals: Facilitating wider adoption and higher product sales.

FAQs

1. What are the key factors driving demand for Povidone Iodine globally?
Rising emphasis on infection prevention, increased surgical procedures, COVID-19-related nasal and oral antiseptics, and expanding healthcare infrastructure in emerging markets.

2. Are there any regulatory concerns affecting Povidone Iodine products?
Yes. Variations in approval status across regions, environmental impact concerns, and safety regulations influence product availability and formulation approval.

3. How does the competition landscape look for Povidone Iodine?
It is moderately concentrated, with top players including Johnson & Johnson and Novartis. Competition from other antiseptics like chlorhexidine and alcohol-based disinfectants is significant.

4. What are the growth prospects in emerging markets?
Highly promising due to expanding healthcare infrastructure, increased hygiene awareness, and government initiatives. CAGR projections suggest sustained growth.

5. What innovations could impact the Povidone Iodine market?
New formulations suitable for mucosal applications, nasal sprays, and convenient delivery methods; environmentally friendly production processes; and expanded clinical indications.


Key Takeaways

  • Market Drivers: Infection control needs, COVID-19 pandemic, and product diversification underpin growth prospects.
  • Market Size & Growth: The global Povidone Iodine market was USD 377M in 2022, with an expected CAGR of 4.8% through 2030.
  • Regional Insights: Asia-Pacific leads regional demand, followed by North America and Europe.
  • Competitive Dynamics: Concentrated with key global players focusing on innovation and regulatory expansion.
  • Regulatory Landscape: Ongoing approvals and safety regulations shape product availability.
  • Investment Opportunities: Emerging markets, new indications, and sustainable formulations represent expansion avenues.

By understanding these market dynamics, stakeholders can align strategies to capitalize on growth opportunities while navigating regulatory and competitive challenges in the Povidone Iodine market.


References

[1] Grand View Research, "Povidone Iodine Market Size, Share & Trends Analysis Report," 2022.
[2] WHO, "Guidelines on Hand Hygiene in Health Care," 2009.
[3] U.S. Food and Drug Administration (FDA), "Over-the-Counter Monographs," 2023.
[4] MarketsandMarkets, "Antiseptics and Disinfectants Market," 2023.
[5] Reuters, "Healthcare Investment Trends in Asia," 2022.

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