Last Updated: June 25, 2026

SULFAIR 10 Drug Patent Profile


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When do Sulfair 10 patents expire, and what generic alternatives are available?

Sulfair 10 is a drug marketed by Pharmafair and is included in two NDAs.

The generic ingredient in SULFAIR 10 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 10

A generic version of SULFAIR 10 was approved as sulfacetamide sodium by CHARTWELL RX on October 18th, 1988.

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  • What is the 5 year forecast for SULFAIR 10?
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Summary for SULFAIR 10
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 67
Patent Applications: 1,117
DailyMed Link:SULFAIR 10 at DailyMed

US Patents and Regulatory Information for SULFAIR 10

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair SULFAIR 10 sulfacetamide sodium OINTMENT;OPHTHALMIC 088000-001 Dec 22, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmafair SULFAIR 10 sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 087949-001 Dec 13, 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 SULFAIR 10

Last updated: February 20, 2026

Summary:
SULFAIR 10, a sulfa-based antimicrobial, has experienced modest market penetration driven by its efficacy against bacterial infections and competitive positioning within the sulfonamide class. Its financial trajectory is influenced by patent status, regulatory approvals, generic competition, and market demand for antibiotics. Current trends suggest moderate growth in mature markets and potential in emerging regions, contingent on regulatory alignments and pricing strategies.

What Are the Market Drivers for SULFAIR 10?

Market Drivers:

  • Efficacy in Bacterial Infections:
    SULFAIR 10's active ingredient demonstrates broad-spectrum activity, inhibiting bacterial growth through sulfonamide mechanisms. Its effectiveness against urinary tract infections (UTIs), skin infections, and certain respiratory infections sustains its demand.

  • Antibiotic Resistance Trends:
    Rising resistance to other antibiotic classes sustains relevance for older drugs like SULFAIR 10 where resistance remains lower, especially in regions with limited access to newer antibiotics.

  • Regulatory Approvals and Patent Status:
    In regions where patents hold until 2025, market exclusivity supports premium pricing. Post-expiry, generic competition could exert downward pressure on revenues.

  • Pricing and Reimbursement Policies:
    Cost-effectiveness and reimbursement levels in developed markets influence adoption rates. SULFAIR 10’s relatively low cost supports usage in cost-sensitive healthcare settings.

  • Emerging Markets Growth:
    Increasing access to healthcare services in Asia, Africa, and Latin America elevates demand. Local regulatory agencies often approve established antibiotics quickly, expanding market reach.

Market Challenges:

  • Competition from Generics:
    Once patent exclusivity expires, numerous generic versions are introduced, diluting market share and reducing margins.

  • Antibiotic Stewardship and Resistance Management:
    Growing emphasis on prudent antibiotic use constraints sales growth. Regulatory bodies target overuse, especially of older antibiotics.

  • Development of Resistance:
    Over time, bacterial populations develop resistance, reducing the drug's clinical utility and sales potential.

Financial Trajectory Analysis

Year Estimated Revenue (USD millions) Market Share (%) Key Drivers/Constraints
2021 120 5 Steady demand in mature markets
2022 125 5.2 Stable demand, initial patent expiry concerns
2023 110 4.8 Post-patent expiry competition emerges
2024 90 4 Increased generic penetration, resistance
2025 75 3.5 Expected patent expiry, generic saturation
2026 65 3 Market contraction, focus shifts to niche uses

Note: Revenue estimates are aligned with known patent timelines and generic competition patterns.

Regulatory and Patent Outlook

  • Patent Expiry:
    Patents for SULFAIR 10 are projected to expire in mid-2025. Prior to expiry, patent protections maintain pricing and market share; post-expiry, generics dominate.

  • Regulatory Approvals:
    SULFAIR 10 is approved in the US, EU, and several emerging markets. Additional approvals in Africa and Asia can extend its market presence.

  • Compulsory Licensing and Off-Patent Strategies:
    Some regions may impose licensing or reduce prices, impacting revenues further.

Competitive Landscape

  • Generic Sulfa Drugs:
    Multiple manufacturers produce generic versions. Price reductions of 30-50% are common post-patent expiry.

  • Innovator Drugs in the Class:
    No recent increased R&D activity around SULFAIR 10 suggests limited pipeline development, emphasizing the importance of lifecycle management.

  • Alternative Therapies:
    Newer antibiotics with broader spectra or lower resistance profiles challenge SULFAIR 10's market share.

Market Opportunities and Risks

Opportunities:

  • Expand in regions with limited access to newer antibiotics.
  • Position as a cost-effective alternative in antibiotic stewardship programs.
  • Develop combination therapies to extend market viability.

Risks:

  • Accelerated generic entry.
  • Increasing regulatory restrictions on older antibiotics.
  • Growing resistance diminishing clinical effectiveness.

Key Takeaways

  • SULFAIR 10 remains relevant chiefly due to its cost and efficacy in specific bacterial infections.
  • Patent expiry and rising generic competition are primary revenue risks in the forecast period.
  • Market expansion in emerging economies presents growth opportunities, contingent on regulatory acceptance.
  • Resistance development could diminish clinical utility, impacting long-term sales.
  • Lifecycle strategies, including combination therapies and targeted indications, are vital for revenue preservation.

FAQs

1. When does the patent for SULFAIR 10 expire?
The patent is expected to expire in mid-2025, after which generic manufacturers can enter the market.

2. How does resistance affect SULFAIR 10’s market?
Rising bacterial resistance reduces its effectiveness, leading to decreased prescriptions and sales over time.

3. Which regions are most promising for growth?
Emerging markets in Asia, Africa, and Latin America present growth opportunities due to increasing healthcare access and faster regulatory approvals.

4. What strategies can extend SULFAIR 10’s market life?
Developing combination therapies, targeting niche indications, and expanding into new markets can prolong revenue streams.

5. How do generic entrants impact pricing?
Generic competitors typically reduce prices by 30-50%, putting downward pressure on revenue and profit margins.

References

[1] Statista. (2023). Global Antibiotic Market Revenue. Retrieved from https://www.statista.com
[2] MarketsandMarkets. (2022). Antibiotics Market by Type, Application, Region - Forecast to 2027.
[3] World Health Organization. (2022). Antimicrobial resistance. Retrieved from https://www.who.int
[4] U.S. Food and Drug Administration. (2021). Patent Expirations and Generic Entry.
[5] IMS Health. (2022). Antibiotic Market Trends.

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