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Last Updated: December 12, 2025

Povidone-iodine - Generic Drug Details


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What are the generic drug 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
Argon Medical DevicesPHASE1
University of Alabama at BirminghamPHASE1
Unitary Enterprise UNITEHPROM BSUPHASE2

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
Becton Dickinson E-Z SCRUB 201 povidone-iodine SPONGE;TOPICAL 019240-001 Nov 29, 1985 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Clinipad E-Z PREP povidone-iodine SOLUTION;TOPICAL 019382-001 Jul 25, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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: An Industry Analysis

Last updated: July 27, 2025


Introduction

Povidone-iodine (PVP-I), a broad-spectrum antiseptic agent, has remained a cornerstone in infection control and wound management for over six decades. Its established efficacy against bacteria, fungi, viruses, and protozoa has sustained its relevance across healthcare, veterinary, and consumer markets. This analysis delves into the current market dynamics and projected financial trajectory of povidone-iodine, considering recent trends, regulatory landscapes, competitive pressures, and emerging opportunities.


Historical Context and Market Overview

Since its development in the 1950s, povidone-iodine has become a globally recognized antiseptic. Its widespread adoption is attributed to its broad antimicrobial coverage, low cost, and relative safety profile. Globally, the compound is available in various formulations, including solutions, ointments, and surgical prepping agents, catering to diverse end-user needs.

The global antiseptic market was valued at approximately USD 6.2 billion in 2021, with povidone-iodine accounting for a significant share, particularly in wound care and disinfectants. Despite the growth, the market faces pressures from newer antimicrobial agents and changing regulatory landscapes, influencing the financial prospects of povidone-iodine.


Market Dynamics Influencing Povidone-Iodine

1. Regulatory and Safety Considerations

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) scrutinize antiseptics for safety, efficacy, and environmental impact. While povidone-iodine enjoys a long-standing approval status, recent scrutiny over iodine-related hypersensitivity, thyroid effects, and environmental persistence has prompted tighter regulations and labeling requirements.

The European Union’s recent emphasis on biocidal product regulation (BPR) and the FDA's reevaluation of over-the-counter (OTC) drug classifications can impact product formulations and availability. Companies must navigate these regulatory frameworks, potentially increasing compliance costs or leading to product formulary adjustments.

2. Competitive Landscape and Innovation

While povidone-iodine’s simplicity and cost-effectiveness sustain its market presence, competition from alcohol-based disinfectants, chlorhexidine, hydrogen peroxide, and emerging antimicrobial agents challenge its dominance. Notably, alcohol-based solutions, known for rapid action, are preferred in many hospital settings, reducing povidone-iodine's market share temporarily.

However, innovations like alcohol-free formulations, sustained-release delivery systems, and combination antiseptics are emerging, offering potential growth avenues. Companies investing in R&D to improve iodine stability, reduce staining, and enhance patient comfort could redefine competitive positioning.

3. Impact of COVID-19 Pandemic

The COVID-19 pandemic temporarily bolstered demand for antiseptics, including povidone-iodine, due to increased hygiene practices. Preoperative antiseptics and surface disinfectants saw heightened consumption, and povidone-iodine's virucidal efficacy against coronaviruses reinforced its importance.

Post-pandemic, demand stabilization is expected, but increased awareness regarding infection control sustains product relevance. Moreover, several studies exploring povidone-iodine’s efficacy as a nasal and oral antiseptic for COVID-19 have opened new consumption pathways, such as within OTC nasal sprays and oral rinses.

4. Market Segments and End-User Trends

  • Healthcare sector: The largest consumer of povidone-iodine, especially in surgical prep, wound care, and disinfection.
  • Consumer market: Over-the-counter antiseptic products, including first aid ointments and mouthwashes.
  • Veterinary applications: Growing adoption for wound treatment in animals.
  • Emerging markets: Rapid expansion driven by improving healthcare infrastructure and public awareness in Asia-Pacific, Africa, and Latin America.

The persistent demand in healthcare renders the sector relatively resilient. However, the transition towards alcohol-based and alternative antiseptics in some regions could influence future growth rates.


Financial Trajectory and Market Forecast

1. Revenue Trends and Growth Projections

Forecasts project the global antiseptic market CAGR at approximately 4-6% from 2022 to 2030 [1]. Povidone-iodine’s segment is expected to grow at a slightly conservative CAGR of around 3-4%, driven by steady demand in surgical and wound care and recent interest in its virucidal properties.

Emerging markets are anticipated to outpace developed regions, with Asia-Pacific predicted to lead growth due to expanding healthcare infrastructure and population size. Furthermore, the integration of povidone-iodine into novel formulations (e.g., nasal sprays, oral rinses) could add incremental revenue streams.

2. Key Revenue Drivers

  • Increasing adoption in wound management: Continued emphasis on infection prevention elevates demand in hospitals and clinics.
  • COVID-19 related applications: Nasal and oral antiseptics have gained popularity, potentially creating new markets.
  • Regulatory approvals and formulation innovations: More convenience-oriented and patient-friendly products can expand consumer usage.
  • Growing awareness in emerging markets: Healthcare expansion supports increased procurement of antiseptic products.

3. Challenges and Market Risks

  • Stringent regulations: Increasing environmental and safety regulations could restrict or raise costs.
  • Market cannibalization: Competition from advanced antiseptics and disinfectants may suppress growth.
  • Supply chain vulnerabilities: Raw material shortages, especially iodine sources, could disrupt manufacturing.
  • Environmental concerns: Iodine runoff and waste management issues necessitate sustainable practices, potentially increasing operating costs.

4. Strategic Outlook

To capitalize on growth opportunities, companies should focus on formulation innovation, developing biocompatible and environmentally sustainable products. Expanding into OTC markets and emerging economies will be crucial, alongside strategic collaborations for R&D and distribution channels.


Conclusion

Povidone-iodine remains a vital antiseptic with a robust, yet moderate, financial trajectory over the next decade. While competitive pressures and regulatory factors pose challenges, ongoing innovations and situational factors, like the COVID-19 pandemic, sustain its market relevance. Key to future growth will be regulatory navigation, product differentiation, and expansion into new formulations and geographic markets.


Key Takeaways

  • Povidone-iodine's broad-spectrum efficacy sustains its role in healthcare and consumer markets amid evolving competition.
  • Regulatory scrutiny on safety and environmental impact necessitates adaptive product development and compliance strategies.
  • The COVID-19 pandemic temporarily boosted demand, with potential for sustained interest in novel applications like nasal and oral antiseptics.
  • Growth is expected to be driven primarily by emerging markets, innovation in product formulations, and expanded OTC applications.
  • Market participants should focus on sustainable manufacturing, strategic partnerships, and product differentiation to optimize financial outcomes.

FAQs

1. What factors primarily influence the demand for povidone-iodine?
Demand hinges on infection control practices, regulatory compliance, innovation in formulations, and emerging health crises like pandemics.

2. How does regulatory environment affect the povidone-iodine market?
Strict regulations around safety, environmental impact, and product labeling influence manufacturing costs, product formulations, and market access strategies.

3. What emerging applications could future growth in povidone-iodine markets come from?
Nasal sprays, oral rinses, and OTC antiseptic products tailored for viral mitigation and consumer convenience are promising growth avenues.

4. How competitive is the povidone-iodine market?
While still substantial, the market faces stiff competition from alcohol-based disinfectants, chlorhexidine, and emerging antimicrobial agents, prompting innovation-driven differentiation.

5. What strategies will maximize profitability in povidone-iodine markets?
Focusing on formulation innovation, expanding into untapped markets, aligning with regulatory shifts, and diversifying applications are key strategies.


References

[1] MarketsandMarkets, "Antiseptics Market by Product, End User, and Region: Global Forecast to 2030," 2022.

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