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Last Updated: March 26, 2026

POVIDONE-IODINE - Generic Drug Details


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What are the generic sources for povidone-iodine and what is the scope of patent protection?

Povidone-iodine is the generic ingredient in six branded drugs marketed by Alcon Pharms Ltd, Clinipad, Allegiance Hlthcare, and Becton Dickinson, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for povidone-iodine. One supplier is listed for this compound.

Summary for POVIDONE-IODINE
Drug Prices for POVIDONE-IODINE

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Recent Clinical Trials for POVIDONE-IODINE

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

SponsorPhase
University of Alabama at BirminghamPHASE1
Argon Medical DevicesPHASE1
University of PlymouthEARLY_PHASE1

See all POVIDONE-IODINE clinical trials

Medical Subject Heading (MeSH) Categories for POVIDONE-IODINE

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
Alcon Pharms Ltd BETADINE povidone-iodine SOLUTION/DROPS;OPHTHALMIC 018634-001 Dec 17, 1986 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Clinipad E-Z PREP povidone-iodine SPONGE;TOPICAL 019382-002 Jul 25, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson E-Z SCRUB 201 povidone-iodine SPONGE;TOPICAL 019240-001 Nov 29, 1985 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Clinipad E-Z PREP 220 povidone-iodine SPONGE;TOPICAL 019382-003 Jul 25, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Clinipad E-Z PREP povidone-iodine SOLUTION;TOPICAL 019382-001 Jul 25, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson E-Z SCRUB 241 povidone-iodine SPONGE;TOPICAL 019476-001 Jan 7, 1987 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Allegiance Hlthcare POVIDONE IODINE povidone-iodine SOLUTION;TOPICAL 019522-001 Mar 31, 1989 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: February 20, 2026

What is the Current Market Size and Growth Rate for Povidone-Iodine?

Povidone-iodine (PVP-I) is a broad-spectrum antiseptic used in wound care, surgical prep, and disinfectants. The global market was valued at approximately USD 300 million in 2021. Compound annual growth rate (CAGR) estimates ranging from 4% to 6% project the market reaching USD 400-500 million by 2027. Drivers include rising infection control needs, increased surgical procedures, and adoption of antimicrobial agents amid COVID-19.

Year Market Value (USD Million) CAGR (Estimated)
2021 300 -
2025 370-425 ~5%
2027 400-500 ~4-6%

What Are the Supply Chain and Manufacturing Trends?

Conventional manufacturing relies on iodine, organic carriers, and stabilizers. Major producers include manufacturers in India, China, and Europe. Supply chain disruptions caused by geopolitical tensions and sourcing difficulties, particularly during the COVID-19 pandemic, led to shortages and regulatory scrutiny in certain markets.

Manufacturers are investing in process optimization and quality assurance. They are also exploring alternative sources and regional manufacturing to reduce dependency.

What Are the Key Market Segments and Geographic Trends?

Segments:

  • Medical: Surgical scrubs, wound disinfectants, preoperative skin prepping (accounts for over 80% of demand)
  • Veterinary: Similar applications in animal wound care
  • Household: Disinfectant products, though a smaller share

Geographic Trends:

  • North America: Largest market, driven by high healthcare spending, infection control standards, and COVID-19 response.
  • Europe: Significant due to widespread hospital protocols.
  • Asia-Pacific: Fastest-growing segment with CAGR estimated at 6%, supported by expanding healthcare infrastructure and professional use.

What Are the Pricing and Reimbursement Dynamics?

Pricing varies by formulation and placement. Over-the-counter (OTC) products in retail channels average USD 2-5 per bottle, while hospital-grade solutions can reach USD 20-50 per pack. Reimbursement is primarily via government or private healthcare coverage, particularly in developed markets; in emerging markets, out-of-pocket costs predominate.

Regulatory approval processes influence pricing and market entry. In the US, PVP-I products are classified as over-the-counter drugs, enabling direct consumer access.

What Are the Regulatory and Competitive Challenges?

Regulatory agencies, including the US FDA and European EMA, require data confirming safety, efficacy, and quality for pharmaceutical-grade products. The presence of generic manufacturers intensifies price competition.

Concerns over iodine absorption limits in specific populations and allergic reactions influence formulations and usage protocols. Competition includes both branded and generic solutions, with some companies developing related antiseptics to expand market share.

What Does the Financial Trajectory Look Like Moving Forward?

Revenue growth is driven by increased application in surgical and infection control markets and rising healthcare expenditure globally. Investment in R&D is expected to focus on formulation improvements, sustained-release products, and novel delivery systems.

Margins are expected to remain stable in mature markets but could face pressure from generic competition. Companies are exploring niche applications, such as anti-viral products for pandemics, to diversify revenue streams.

Key Market Drivers

  • Rising global surgical procedures
  • Increasing emphasis on infection prevention
  • Growing demand in emerging markets
  • Product innovation and formulations

Risks and Limitations

  • Regulatory hurdles and product approvals
  • Competition from alternative antiseptics
  • Supply chain vulnerabilities
  • Adverse effects and safety concerns in specific populations

Summary

Povidone-iodine maintains a stable but gradually expanding market, with growth prospects driven by global healthcare needs and product innovation. The market is influenced by regulatory environment, supply chain conditions, and competitive dynamics between branded and generic manufacturers.

Key Takeaways

  • The market size for povidone-iodine approached USD 300 million in 2021, with an expected CAGR of 4-6% through 2027.
  • North America leads, but Asia-Pacific exhibits fastest growth, primarily through expanding healthcare infrastructure.
  • Price points vary by formulation, with reimbursement models shaping access.
  • Supply chain issues and regulatory standards are recent challenges affecting supply and competitiveness.
  • R&D investment focuses on stability, delivery modalities, and antiviral applications.

FAQs

1. What are the top factors influencing povidone-iodine sales growth?

Increased surgical procedures, infection control protocols, and pandemic-related demand.

2. How does regulatory approval impact market entry?

Strict safety and efficacy data requirements delay entry but ensure market acceptance once approved.

3. What are the common formulations of povidone-iodine?

Liquid solutions, ointments, and scrub preparations. New formulations include sustained-release variants.

4. How do supply chain disruptions affect the market?

They cause shortages, impact pricing, and slow market growth, especially during crises like COVID-19.

5. What future trends could alter povidone-iodine's market trajectory?

Development of antiviral formulations, increased use in non-traditional applications, and adoption in emerging markets.


References

[1] Markets and Markets. (2022). Povidone-iodine Market by Product Type, Application, Region - Global Forecast to 2027.

[2] Grand View Research. (2021). Antiseptic Market Size, Share & Trends Analysis Report.

[3] US Food and Drug Administration. (2022). Over-the-counter drug monographs for antiseptics.

[4] Pharmaceutical Commerce. (2021). Supply Chain Challenges in Antiseptic Manufacturing.

[5] World Health Organization. (2020). Infection prevention and control during health care.

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