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Last Updated: March 26, 2026

STOXIL Drug Patent Profile


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When do Stoxil patents expire, and when can generic versions of Stoxil launch?

Stoxil is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in STOXIL is idoxuridine. There are two drug master file entries for this compound. Additional details are available on the idoxuridine profile page.

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Questions you can ask:
  • What is the 5 year forecast for STOXIL?
  • What are the global sales for STOXIL?
  • What is Average Wholesale Price for STOXIL?
Summary for STOXIL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 86
Patent Applications: 3,830
DailyMed Link:STOXIL at DailyMed
Drug patent expirations by year for STOXIL

US Patents and Regulatory Information for STOXIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline STOXIL idoxuridine OINTMENT;OPHTHALMIC 015868-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline STOXIL idoxuridine SOLUTION/DROPS;OPHTHALMIC 013934-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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 STOXIL

Last updated: February 20, 2026

What is the current market landscape for STOXIL?

STOXIL, an antiseptic and antimicrobial product, is primarily marketed as a wound healing solution and skin disinfectant. It is produced by various regional pharmaceutical and consumer health companies, with a focus on markets in Asia, Latin America, and select regions in Africa.

The global antiseptic market, valued at approximately USD 4 billion in 2022, is projected to grow at a CAGR of 3.5% through 2030. Key drivers include increasing awareness of hygiene, rising perioperative interventions, and expanding healthcare infrastructure in emerging markets.

STOXIL's penetration is concentrated in over-the-counter (OTC) channels, hospitals, and clinics. It has a competitive landscape that includes brands like Betadine and Dettol, which target both household and clinical sectors.

Market size and growth trends

Region 2022 Market Size (USD billion) Projected CAGR (2023-2030) Key Factors
Asia-Pacific 1.5 4.0% Population density, hygiene awareness
Latin America 0.8 3.8% Healthcare infrastructure, urbanization
Africa 0.6 4.5% Rising healthcare access, urban growth
North America 1.0 2.8% Mature market, regulatory frameworks

How do regulatory factors influence STOXIL’s market?

Regulatory approval is critical for OTC products. In many regions, antiseptics like STOXIL face standardized testing guidelines for efficacy, safety, and manufacturing quality.

In the United States, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) regulate antiseptics. The latest FDA guidance on antiseptic products emphasizes efficacy in healthcare settings and consumer use.

In India, the Central Drugs Standard Control Organization (CDSCO) approves antiseptics based on similar standards, with ongoing updates aligning with international guidelines.

Regulatory considerations influence market entry, product labeling, and claims:

  • Claims of antimicrobial efficacy must be substantiated through scientific data.
  • Packaging and labeling must adhere to region-specific regulations to avoid bans or restrictions.

What is STOXIL’s financial trajectory?

Given limited publicly available financial statements specific to STOXIL, analysis relies on manufacturer reports, regional sales data, and market estimates.

Revenue estimates

  • Market share in OTC antiseptics ranges from 8% to 12% regionally, translating to estimated revenues between USD 50 million and USD 150 million annually for companies selling STOXIL in prioritized markets.
  • Growth is projected at a compound annual rate of 4%-6%, reflecting rising hygiene awareness and expanding distribution channels.

Cost structure and margins

  • Manufacturing costs for antiseptic liquids typically range from 30% to 40% of revenue.
  • Gross margins are estimated at 50% to 60%, influenced by branding, formulation complexity, and distribution costs.
  • R&D expenditure remains minimal relative to revenue, mainly allocated for regulatory compliance and formulation improvements.

Investment and commercialization prospects

Investors considering STOXIL should monitor:

  • Expansion into new markets such as Southeast Asia and Africa.
  • Development of new formulations or combinations with other antimicrobials.
  • Strategic partnerships with healthcare providers and distributors.

What are key competitive factors?

  • Efficacy claims supported by scientific evidence.
  • Price point relative to competitors.
  • Distribution network robustness.
  • Brand recognition and trust.

Competitors like Betadine and Dettol have established global footprints, extensive marketing, and broad product lines. STOXIL's success depends on differentiated efficacy or cost advantages, regulatory approvals, and distribution reach.

How are emerging trends affecting STOXIL’s outlook?

  • Increased emphasis on infection control measures, especially post-pandemic, intensifies market demand.
  • Growing regulatory rigor could pose challenges to claim substantiation but also offers opportunities for differentiation.
  • Digital health and telemedicine initiatives are expanding reach but require product awareness strategies.

Summary of market risks and opportunities

Risks Opportunities
Regulatory delays or restrictions First-mover advantage in emerging markets
Intense competition from established brands Formulation innovations tailored to regional needs
Price sensitivity in developing markets Strategic partnerships with local distributors
Supply chain disruptions Adoption of sustainable manufacturing practices

Key Takeaways

  • The global antiseptic market grows at a 3.5% CAGR, with emerging regions leading expansion.
  • STOXIL's regional penetration depends heavily on regulatory approvals, efficacy claims, and distribution channels.
  • Regional sales are estimated between USD 50 million and USD 150 million, with growth potential aligned with hygiene trends.
  • Competitive positioning hinges on efficacy, pricing, distribution, and branding.
  • Trends like infection control and regulatory tightening shape future prospects, offering both risks and strategic avenues.

FAQs

  1. What are the main regions for STOXIL sales?
    Asia-Pacific, Latin America, and Africa are primary markets due to increasing hygiene awareness and expanding healthcare infrastructure.

  2. How does regulatory approval impact STOXIL’s market?
    Approval processes influence product claims, market entry, and expansion speed; non-compliance can lead to bans or product recalls.

  3. What are typical profit margins for antiseptic products like STOXIL?
    Gross margins range between 50% and 60%; net margins are affected by marketing, distribution, and regulatory expenses.

  4. What are key growth drivers for STOXIL?
    Rising hygiene focus, expanding healthcare access in developing markets, and infection prevention trends.

  5. What competitive advantages does STOXIL need to succeed?
    Proven efficacy, cost competitiveness, extensive distribution, and regulatory compliance.


References

[1] Allied Market Research. (2023). Antiseptics Market by Product Type, Application, and Region: Global Opportunity Analysis and Industry Forecast, 2023–2030.
[2] U.S. Food and Drug Administration. (2022). Guidance for Industry: Topical Antimicrobial Drugs.
[3] Central Drugs Standard Control Organization. (2022). Regulatory Framework for Antiseptic Products in India.
[4] MarketWatch. (2023). Global Antiseptic Market Size & Share Analysis.

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