Last Updated: June 24, 2026

SULFALOID Drug Patent Profile


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Summary for SULFALOID
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 6
DailyMed Link:SULFALOID at DailyMed

US Patents and Regulatory Information for SULFALOID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Pharms SULFALOID trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 080100-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Forest Pharms SULFALOID trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) TABLET;ORAL 080099-001 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 SULFALOID

Last updated: February 8, 2026

Overview

Sulfaloid, marketed under various brand names, is an oral antimicrobial agent primarily used to treat bacterial and protozoal infections. Its active component, sulfamethoxazole, belongs to the sulfonamide class. The drug has maintained a market presence in certain regions but faces evolving competition and regulatory challenges that influence its market dynamics and financial performance.

Market Landscape

  1. Current Usage and Therapeutic Indications

    • Widely prescribed for urinary tract infections, respiratory infections, and certain protozoal diseases.
    • Historically used as part of combination therapy with trimethoprim (e.g., co-trimoxazole).
  2. Market Penetration and Geographic Distribution

    • Dominates in regions with limited access to newer antibiotics.
    • Market share diminishes in developed countries due to regulatory restrictions and antimicrobial resistance concerns.
  3. Competitive Environment

    • Competing drugs: trimethoprim-sulfamethoxazole, doxycycline, and fluoroquinolones.
    • Newer antimicrobials with broader spectra, fewer side effects, and lower resistance profiles are replacing sulfaloid in many indications.
  4. Regulatory and Safety Considerations

    • Renal and hypersensitivity adverse effects restrict its use in specific populations.
    • Some countries have withdrawn or restricted sulfamethoxazole for safety reasons, impacting market accessibility.

Financial Trajectory

  1. Revenue Trends

    • Global sulfaloid market estimated to be valued at approximately $200 million in 2022.
    • Witnessed a compound annual growth rate (CAGR) of around 2% from 2018 to 2022, mainly driven by emerging markets.
  2. Market Drivers

    • Increasing antimicrobial resistance in developing regions sustains demand for older antibiotics.
    • Uniformity of generic manufacturing sustains low prices, supporting sustained volume sales.
  3. Market Constraints

    • Growing antimicrobial stewardship policies limit unnecessary prescriptions.
    • Stringent safety regulations reduce off-label uses and restrict new indications.
  4. Forecast

    • Projected to decline at a CAGR of 1% over the next five years, reaching roughly $180 million by 2027.
    • Growth will be uneven geographically, with stable or increasing markets in regions with limited access to newer alternatives.
  5. Key Players

    • Major generic manufacturers dominate the sulfaloid space.
    • Patent expiration around 2000 led to widespread generic availability.
  6. Research and Development

    • Minimal pipeline activity for sulfaloid as a standalone agent.
    • Focus shifts towards combination therapies and resistance mitigation strategies instead of monotherapy innovation.

Market Challenges and Opportunities

Challenges Opportunities
Resistance development diminishes efficacy Potential reuse in combination therapies in resistant infections
Safety profile restricts broader use Development of safer analogs or delivery systems
Regulatory restrictions Strategic positioning in markets with less stringent regulation

Conclusion

Sulfaloid's market is characterized by modest growth driven by demand in regions with antimicrobial resistance challenges. Increasing safety and resistance concerns limit its broader application, leading to a gradual revenue decline. The segment relies heavily on generic manufacturing, with little innovation activity expected in the short term.


Key Takeaways

  • Sulfaloid remains relevant mainly in areas with antimicrobial resistance issues but faces decline in developed markets.
  • The global market valuation was approximately $200 million in 2022, with a slow decline expected over the next five years.
  • Regulatory restrictions and safety concerns are central to the market's outlook, reducing its therapeutic scope.
  • Generics dominate the manufacturing landscape, contributing to competitive pricing but limiting profit margins.
  • Limited research and development focus on sulfaloid itself, shifting towards combination therapies to counter resistance.

FAQs

  1. What factors are driving the decline of sulfaloid in developed markets?
    Safety concerns, emergence of resistant organisms, and availability of newer antibiotics with better safety profiles reduce sulfaloid's use.

  2. Are there any ongoing efforts to reformulate or improve sulfaloid?
    Most efforts focus on combination therapies or developing resistance mitigation strategies rather than reformulating sulfaloid itself.

  3. Which regions are expected to sustain sulfaloid sales?
    Markets with limited access to newer antibiotics, such as certain parts of Africa, Asia, and Latin America, are expected to maintain steady demand.

  4. How does antimicrobial resistance influence sulfaloid sales?
    Resistance diminishes the drug's efficacy, leading to reduced prescriptions and market share.

  5. What is the outlook for sulfaloid in the next decade?
    A gradual decline in market size with potential stabilization in select regions; innovation is unlikely without new formulations or indications.


References

[1] Markets and Markets. "Antibiotics Market Analysis." 2022.
[2] IMS Health. "Global Antibiotics Sales Data." 2022.
[3] FDA. "Safety Communications Regarding Sulfonamides." 2021.

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