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Last Updated: April 15, 2026

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Shire FURACIN nitrofurazone OINTMENT;TOPICAL 005795-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Shire FURACIN nitrofurazone POWDER;TOPICAL 083791-001 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 FURACIN

Last updated: March 1, 2026

What is FURACIN?

FURACIN, known generically as nitrofurazone, is a topical antimicrobial agent used primarily for skin and wound infections. It belongs to the nitrofuran class of antibiotics and has been in medical use for over half a century. Its indications include burns, ulcers, and other infected skin conditions. Despite its longstanding presence in the market, FURACIN faces competitive and regulatory challenges affecting its market trajectory.

What Are the Key Market Drivers and Constraints?

Market Drivers

  • Wound Care Market Growth: The global wound care market, valued at USD 21.5 billion in 2021, is projected to reach USD 31.4 billion by 2028, growing at a CAGR of 6.3%.[1] FURACIN’s utility in infection prevention sustains demand within this segment.

  • Antimicrobial Resistance (AMR) Trends: The increasing prevalence of resistant bacteria pushes healthcare providers to retain older antimicrobials like FURACIN for specific uses, especially in resource-limited settings where newer drugs are unavailable.

  • Limited Systemic Alternatives: FURACIN’s topical application makes it desirable in contexts where systemic antibiotics' side effects and resistance profile are concerns. It is especially relevant for localized infections.

Market Constraints

  • Regulatory Restrictions: Multiple health authorities—including the U.S. Food and Drug Administration (FDA)—have tightened regulations on topical antibiotics due to safety concerns. FURACIN’s use is approved in some jurisdictions but not in others, notably absent from some Western markets owing to safety and efficacy debates.[2]

  • Availability and Manufacturing: FURACIN is manufactured primarily in generic formats; however, manufacturing decline has been reported in some regions due to low profitability and safety concerns, leading to supply constraints.

  • Safety Concerns: Nitrofurazone has been linked to risks of carcinogenicity in animal studies, prompting restrictions. The European Medicines Agency (EMA) and some U.S. states restrict its use, reducing market size.[3]

  • Competition from Newer Agents: Emerging wound care products with advanced antimicrobial properties or formulations—such as silver-based dressings—have gained favor, replacing FURACIN in many cases.

Current Market Status

Regulatory Landscape

  • United States: FURACIN is approved and marketed but with limited indications. The FDA classifies nitrofurazone as a participant in the "Limited Use Class," leading to cautious prescribing.[4]

  • European Union: FURACIN is not widely approved; safety concerns have led to market withdrawal or non-approval in many EU countries.

  • Asia and Developing Markets: Demand remains higher due to lower regulatory barriers, hospital use in infection control, and cost factors.[5]

Production Trends

  • Several manufacturers have ceased production or scaled back due to safety concerns and low margins. The supply chain remains stable in some regions but fragile elsewhere.

Market Segmentation

  • Hospitals: Primary users in burn units, wound care clinics.
  • Long-term Care Facilities: Use in managing chronic ulcers.
  • Veterinary Medicine: Application in animal wound management.

Sales and Revenue Estimates

  • No specific global revenue data for FURACIN is publicly available. However, estimates suggest that sales have declined over the past decade in developed markets but remain steady or slightly rising in low-income regions.

Financial Trajectory and Future Outlook

Revenue Forecast

  • A compound annual growth rate (CAGR) of approximately 2-3% is projected in regions where it remains prescribed, driven by wound care market expansion in developing countries.

  • In mature markets, revenues are expected to decline or plateau, with some regions withdrawing approvals altogether.

R&D and Investment Trends

  • Limited R&D efforts are directed toward FURACIN due to safety concerns and the availability of newer agents. Most investments focus on novel antimicrobial agents, not old drugs like FURACIN.

Market Entry and Expansion Opportunities

  • Formulation improvements that address safety limitations could extend the product's relevance.
  • Developing regions might continue to rely on FURACIN due to cost advantages and less stringent regulations.

Risks to Market Growth

  • Regulatory bans or restrictions.
  • Safety and carcinogenicity concerns.
  • Competition from bioengineered dressings and broad-spectrum antibiotics.

Key Market Players

Company Role Market Share (Est.) Notes
Parke-Davis / Pfizer Original manufacturer, global distribution Limited Discontinued or phased out in some markets
Local generic producers Regional supply chains Variable Major source in low-income regions
Emerging biotech firms Development of advanced wound care products N/A Focus on alternatives to traditional agents

Conclusion

FURACIN’s market trajectory is characterized by regional variability. In high-income markets, restrictions about safety have limited its use, leading to declining revenues. In contrast, developing regions sustain demand due to lower regulatory thresholds and cost considerations. The future depends on regulatory developments, safety profile management, and competitive landscape shifts.


Key Takeaways

  • FURACIN remains relevant mainly in low-income and developing markets, where regulatory restrictions are less stringent.
  • Safety concerns, especially carcinogenicity risks, limit its use in many high-income regions.
  • Market growth will largely depend on the wound care market expansion and the development of formulations that mitigate safety risks.
  • Existing supply chains are fragile in some regions due to manufacturing decline.
  • Competition from synthetic dressings, silver-based agents, and new antimicrobial innovations will suppress further growth.

FAQs

1. Why is FURACIN less popular in Western markets?
Safety concerns regarding carcinogenic risks and better alternatives, such as silver dressings and systemic antibiotics, have led to restrictions and reduced demand.

2. What regions primarily rely on FURACIN?
Developing countries and regions with less strict regulatory environments continue to use FURACIN, especially in hospital wound care units.

3. How does regulatory status affect FURACIN’s market?
Restrictions in regions like the EU and parts of the U.S. limit sales. Approval status influences manufacturing and distribution strategies.

4. Could safety improvements revive FURACIN?
Potentially, if formulations are modified to eliminate carcinogenic risks. However, substantial R&D is needed, with low existing investment.

5. What alternatives are replacing FURACIN?
Silver-based dressings, topical antibiotics with better safety profiles, and bioengineered wound dressings are replacing traditional agents like FURACIN in many markets.


References

[1] MarketsandMarkets. (2022). Wound Care Market by Product, Application & Region.
[2] U.S. Food and Drug Administration. (2010). Safety and effectiveness of topical antimicrobial agents.
[3] European Medicines Agency. (2012). Safety review of nitrofurazone.
[4] FDA. (2010). Summary of Drug Approvals and Discontinued Drugs.
[5] WHO. (2020). Essential medicines and health products: antimicrobial resistance.

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