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Last Updated: March 26, 2026

SULFAIR FORTE Drug Patent Profile


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

Sulfair Forte is a drug marketed by Pharmafair and is included in one NDA.

The generic ingredient in SULFAIR FORTE is sulfacetamide sodium. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sulfair Forte

A generic version of SULFAIR FORTE was approved as sulfacetamide sodium by CHARTWELL RX on October 18th, 1988.

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Questions you can ask:
  • What is the 5 year forecast for SULFAIR FORTE?
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Summary for SULFAIR FORTE
Drug patent expirations by year for SULFAIR FORTE

US Patents and Regulatory Information for SULFAIR FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair SULFAIR FORTE sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 088385-001 Oct 13, 1983 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 Sulfair Forte

Last updated: February 13, 2026

Overview
Sulfair Forte is a prescription medication primarily used for treating bacterial infections caused by susceptible organisms. It contains a combination of sulfadiazine and trimethoprim, which work synergistically to inhibit bacterial growth. The drug has a history of use in various jurisdictions, with ongoing patents and regulatory statuses influencing its market presence.

Global Market Landscape
The global antibiotic market was valued at approximately $50 billion in 2022, with a compound annual growth rate (CAGR) estimated around 3% through 2028. Sulfa drugs represent a subset with an aging but still relevant market segment, particularly in regions where newer antibiotics are less accessible.

Market Demand Drivers

  • Antimicrobial Resistance (AMR): Rising AMR has increased demand for existing antibiotics, including sulfadiazine-based formulations.
  • Regulatory Approvals: Patent expirations have led to generic production, increasing accessibility.
  • Infection Prevalence: Urinary tract infections, skin infections, and other bacterial illnesses sustain steady demand in outpatient settings.
  • Global Health Initiatives: Programs targeting infectious diseases in low- and middle-income countries bolster demand in these markets.

Market Challenges

  • Resistance Development: Resistance to sulfamethoxazole and trimethoprim can limit clinical efficacy.
  • Availability of Alternatives: Broader-spectrum antibiotics and newer agents influence prescribing patterns.
  • Regulatory Environment: Varying approval statuses, especially in Europe and the U.S., impact commercialization.

Patent and Regulatory Status
Sulfair Forte's patent protections have largely expired, leading to increased generics. Regulatory agencies like the FDA and EMA approve sulfadiazine and trimethoprim formulations for multiple indications. In emerging markets, registration and approval timelines vary, affecting market penetration.

Market Size and Growth Projections
While precise sales figures for Sulfair Forte are unavailable due to generic competition, estimates suggest:

  • Regional Variations: Higher sales volumes in South Asia and Africa, where infections are prevalent and access to newer antibiotics is limited.
  • Revenue Estimates: For companies holding rights or marketing rights, annual revenues could range from $10 million to $50 million globally, depending on brand recognition and formulary inclusion.

Competitive Landscape

  • Generic Manufacturers: Multiple companies produce sulfadiazine and trimethoprim combinations, leading to significant price pressure.
  • Brand Presence: Limited branded offerings; most are marketed as generics.
  • Emerging Alternatives: Topical and other systemic antibiotics targeting similar infections are gaining market share.

Financial Trajectory and Key Factors

Aspect Impact Notes
Patent expiration Lowers prices Generics dominate post-expiry
Regulatory approvals Facilitates access Approval varies by region
Market penetration Influenced by healthcare infrastructure Emerging markets present growth opportunities
Resistance trends May reduce effective market Requires ongoing surveillance
Pricing strategies Critical for profitability Price competition intensifies due to generics

Projection for 2023-2028
Assuming consistent market conditions, revenues for Sulfair Forte or similar formulations could see modest growth driven by increased access in developing nations and persistent demand for effective antimicrobials. However, growth rates are limited by resistance challenges and competition from newer antibiotics. Annual sales growth might average 1-2% globally, with regional disparities.

Conclusion
Sulfair Forte remains a stable albeit niche component of the antimicrobial market. Its financial health depends on regional demand, resistance patterns, and regulatory environments. Overall, the market is mature, with growth constrained by evolving resistance and a shift toward newer antibiotics in developed regions. Opportunities persist mainly in underserved markets where antibiotics remain essential.


Key Takeaways

  • Sulfair Forte's market is heavily influenced by generics and resistance patterns.
  • Global sales are steady but constrained by competition and regulatory factors.
  • Emerging markets offer growth potential due to high infection rates and limited alternatives.
  • Future growth hinges on addressing resistance issues and expanding access.
  • Companies should monitor regional regulatory developments for market entry or expansion.

FAQs

  1. What are the primary therapeutic indications for Sulfair Forte?
    Sulfair Forte is used for bacterial infections such as urinary tract infections, skin infections, and certain eye infections caused by susceptible bacteria.

  2. How has patent expiration affected Sulfair Forte’s market?
    Patent expiration has led to increased generic manufacturing, lowering prices and reducing brand-specific sales.

  3. Are there concerns regarding resistance to Sulfair Forte?
    Yes, resistance development to sulfadiazine and trimethoprim can reduce clinical efficacy, impacting sales and prescribing patterns.

  4. Which regions present the most growth opportunities for Sulfair Forte?
    Emerging markets in South Asia, Africa, and parts of Southeast Asia offer growth due to high infection rates and limited access to newer antibiotics.

  5. What are the main factors influencing Sulfair Forte’s future revenues?
    Market demand driven by infection prevalence, resistance trends, regulatory approvals, and pricing strategies are key factors.

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