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Last Updated: December 12, 2025

FURACIN Drug Patent Profile


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When do Furacin patents expire, and what generic alternatives are available?

Furacin is a drug marketed by Shire and is included in three NDAs.

The generic ingredient in FURACIN is nitrofurazone. There are four drug master file entries for this compound. Additional details are available on the nitrofurazone profile page.

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Summary for FURACIN
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 108
Patent Applications: 5,803
DailyMed Link:FURACIN at DailyMed
Drug patent expirations by year for FURACIN

US Patents and Regulatory Information for FURACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire FURACIN nitrofurazone CREAM;TOPICAL 083789-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shire FURACIN nitrofurazone OINTMENT;TOPICAL 005795-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shire FURACIN nitrofurazone POWDER;TOPICAL 083791-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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 FURACIN (Nitrofurazone): A Comprehensive Analysis

Last updated: July 29, 2025


Introduction

FURACIN, chemically known as nitrofurazone, is a topical antimicrobial agent historically used in the treatment of urinary tract infections, wound care, burn infections, and skin ulcerations. Although its market share has declined with the advent of newer antibiotics and antimicrobial agents, FURACIN continues to maintain niche applications, especially in developing countries. This analysis evaluates the current market dynamics, regulatory environment, competitive landscape, and financial prospects surrounding FURACIN to inform strategic decision-making for stakeholders.


Market Overview and Historical Context

FURACIN was first introduced in the 1950s and rapidly gained favor for its broad-spectrum antimicrobial properties. Its original indications encompassed wound care, burn management, and infection prevention in surgical settings. Over time, the pharmaceutical landscape evolved as safer, more effective, and more convenient antimicrobial options entered the market, leading to a decline in FURACIN's prominence in developed regions.

Despite this, its unique features—such as low systemic toxicity and low resistance development—preserve its relevance in specific markets, particularly where access to advanced antibiotics is limited. The global market for topical antimicrobials was valued at approximately USD 4.5 billion in 2022, with niche products like FURACIN maintaining a modest but steady presence [1].


Current Market Dynamics

1. Regulatory Status and Approvals

FURACIN's regulatory landscape varies globally. In the U.S., the FDA has limited approval for FURACIN's use, primarily restricting it to specific indications or compounding formulations. Conversely, in several emerging markets—such as India, Latin America, and parts of Africa—regulatory agencies have maintained broader approvals driven by clinical experience and cost considerations [2].

The absence of exclusive patent protection since the late 20th century has led to a proliferation of generic manufacturing, stabilizing supply but also constraining pricing power.

2. Competitive Landscape

The antimicrobial wound care arena is saturated with a range of products—from silver-based dressings to advanced antibiotic ointments and antiseptics. While these alternatives often offer superior convenience or efficacy, FURACIN occupies a niche primarily due to its affordability and antimicrobial spectrum.

Recently, innovations in wound care—such as biodegradable dressings with sustained-release antimicrobial agents—have challenged traditional formulations like FURACIN. Nonetheless, its low-cost profile sustains demand in resource-limited settings.

3. Demand Drivers

  • Emerging Markets: Growing healthcare infrastructure and increasing burden of wound infections facilitate steady demand in Asia, Africa, and Latin America.
  • Antibiotic Resistance Concerns: FURACIN’s low propensity for resistance development makes it a viable option where antibiotic stewardship is prioritized.
  • Pandemic Response: COVID-19 spotlighted wound care challenges, reinforcing the need for reliable topical antimicrobials in hospital and community settings.

4. Supply Chain and Manufacturing Trends

Global manufacturers—mainly Indian pharmaceutical companies such as FDC Limited and Cadila Healthcare—produce FURACIN in various formulations. Cost-effective manufacturing and minimal regulatory hurdles in certain jurisdictions allow sustained supply. However, quality assurance and standardization remain critical for maintaining market trust.


Financial Trajectory Analysis

1. Revenue Trends

Given the decline in major markets, FURACIN’s global revenue has stabilized at a modest level. According to industry sources, the compound annual growth rate (CAGR) for FURACIN sales has been approximately 2% over the past five years, reflecting a combination of slow organic growth and stable niche demand [3].

In emerging markets, sales have grown marginally—around 3–4% annually—driven by population growth, expanding healthcare access, and ongoing infection management needs. In contrast, in mature markets like North America and Europe, sales have plateaued or declined.

2. Profitability and Pricing Dynamics

FURACIN’s low-cost manufacturing enables high margins for producers with existing infrastructure, though intense price competition among generics constrains profitability at the global level. Average pricing per unit ranges from USD 0.50 to USD 2, depending on formulation and region.

Strategic pricing optimization in developing countries—particularly through volume expansion—can enhance revenues. However, pricing pressures and regulatory controls in certain markets restrict significant margin expansion.

3. Future Revenue Projections

Analysts project FURACIN’s global sales to remain stable over the next 5–7 years, with slight growth in developing markets offsetting declines elsewhere. An estimated CAGR of approximately 1.5–2% is expected, with potential upside from expanding applications in wound care and emerging resistance challenges in pathogens.


Market Challenges and Opportunities

Challenges:

  • Evolving Clinical Guidelines: Tighter regulations and updated clinical guidelines favor newer, evidence-based antimicrobials, reducing FURACIN’s appeal.
  • Resistance and Safety Concerns: While FURACIN boasts low resistance, safety concerns—such as potential cytotoxicity—have led to decreased use in some regions.
  • Competition from Advanced Dressings: Silver- and iodine-based dressings often surpass FURACIN in efficacy and convenience, impacting market share.

Opportunities:

  • Segmented Market Focus: Targeting resource-limited healthcare settings where cost is a primary driver.
  • Product Innovation: Developing proprietary formulations with sustained-release or combined antimicrobial properties.
  • Regulatory Expansion: Securing approvals for additional indications can open new revenue streams in wound management and burn treatment.
  • Partnerships and Licensing: Collaborations with global health organizations could facilitate distribution in underserved areas.

Regulatory and Patent Landscape

As a generic product, FURACIN's patent exclusivity has long expired, with no significant proprietary barriers. Regulatory prospects hinge primarily on compliance with quality standards. Countries that rely on local manufacturing often permit off-label or compounded formulations, impacting the formal market dynamics.

The absence of significant regulatory hurdles in certain jurisdictions offers avenues for continued production and sales, but also implies limited pricing power.


Impact of External Factors

  • Global Health Policies: Increasing emphasis on antibiotic stewardship can influence prescribing practices, potentially reducing FURACIN utilization.
  • Clinical Evidence: Emerging data on antimicrobial resistance and safety may either bolster or diminish FURACIN’s role.
  • Economic Conditions: Healthcare budgets and procurement policies in developing economies significantly shape market potential.

Key Takeaways

  • FURACIN remains a niche yet stable player in the topical antimicrobial market, predominantly serving resource-limited regions.
  • Market growth prospects are modest, with a focus on maintaining supply and expanding indications through regulatory approvals.
  • Competitive pressures from advanced wound care products challenge FURACIN’s market share but can be mitigated through targeted positioning.
  • Profitability depends on cost-efficient manufacturing and strategic pricing, especially in the developing world.
  • External factors such as evolving clinical guidelines, resistance patterns, and health policies will critically influence its long-term trajectory.

Conclusion

The financial and market outlook for FURACIN exhibits resilience rooted in its affordability, safety profile, and niche applications. While its growth prospects are constrained by regulatory and competitive landscapes, targeted expansion strategies in underserved markets and product innovation can sustain its revenue streams. Stakeholders must monitor evolving clinical and regulatory trends to optimize investment and strategic positioning.


FAQs

1. What are the primary applications of FURACIN today?
FURACIN is mainly used in wound care, burn treatments, and infection prevention, especially in regions with limited access to newer antibiotics.

2. Is FURACIN still under patent protection?
No. FURACIN’s patent expired decades ago; it is widely available as a generic product.

3. How does FURACIN compare with modern antimicrobial agents?
While effective, FURACIN generally offers lower convenience and efficacy compared to advanced dressings and antibiotics, but remains cost-effective.

4. What are the main challenges facing FURACIN’s market growth?
Challenges include regulatory restrictions, competition from superior products, concerns over safety and efficacy, and evolving clinical guidelines discouraging its use.

5. What opportunities exist to expand FURACIN’s market?
Expanding indications, improving formulations, entering new regulatory markets, and leveraging partnerships in low-income regions present growth opportunities.


References

[1] Market Research Future, "Global Topical Antimicrobials Market," 2022.
[2] World Health Organization, "Antimicrobial Resistance and Global Stewardship," 2021.
[3] Industry Reports, "Pharmaceutical Market Overview," 2022.

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