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Last Updated: December 12, 2025

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. Eleven 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: 1
Patent Applications: 1,288
DailyMed Link:SULFAIR 10 at DailyMed
Drug patent expirations by year for SULFAIR 10

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmafair SULFAIR 10 sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 087949-001 Dec 13, 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 the Pharmaceutical Drug: SULFAIR 10

Last updated: August 1, 2025


Introduction

The pharmaceutical landscape is characterized by rapid innovation, intense competition, and evolving regulatory standards. SULFAIR 10—a sulfonamide-based pharmaceutical commonly used for its antimicrobial properties—stands at a pivotal juncture. Understanding its market dynamics and financial trajectory offers key insights for stakeholders, investors, and healthcare providers seeking strategic positioning amid shifting industry parameters.


Market Overview of Sulfa Drugs and SULFAIR 10

Sulfa drugs, including SULFAIR 10, historically revolutionized antimicrobial therapy during the mid-20th century. Although their prominence has declined with the advent of antibiotics like penicillin and cephalosporins, sulfonamides retain niche applications, especially in resource-limited settings and specific infections.

SULFAIR 10, a formulation consisting of 10% sulfadiazine or a similar sulfonamide derivative, remains relevant, primarily due to its efficacy in treating urinary tract infections, ocular infections, and certain dermatological conditions. Its affordability and broad-spectrum activity underpin sustained demand in various regions, particularly emerging markets.


Market Drivers Influencing SULFAIR 10

Global Antibiotic Resistance Crisis:
Emerging resistance to conventional antibiotics, including sulfonamides, prompts renewed interest in existing drugs like SULFAIR 10. Resistance patterns vary; in some regions, sulfa drugs face minimal resistance, bolstering their market appeal.

Regulatory Environment:
Regulatory agencies such as the FDA and EMA maintain stringent standards for antimicrobial drugs, but approved formulations like SULFAIR 10 benefit from established safety and efficacy profiles. Recent regulatory relaxations in low-resource countries further expand their deployment.

Pricing and Accessibility:
In markets with limited healthcare budgets, low-cost therapeutics like SULFAIR 10 are critical. Government procurement policies, insurance coverage, and inclusion in essential medicines lists significantly influence volume sales.

Market Competition:
While less dominant than newer antibiotics, SULFAIR 10 faces competition from other sulfa drugs and alternative antimicrobials. The advent of combination therapies and newer agents narrows the usage scope but also creates opportunities for formulation innovations.

Public Health Initiatives:
Global efforts to control infectious diseases—such as WHO campaigns—favor the continued use of affordable antibiotics, including sulfonamides, especially in endemic regions.


Financial Trajectory and Market Forecast

Historical Revenue Trends:
SULFAIR 10 has experienced stable revenues in developing regions, driven by cost-effectiveness and existing distribution channels. In contrast, developed markets exhibit limited growth due to drug aging, competition, and shifting prescriber preferences.

Projected Market Growth:
Analysts forecast a compounded annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily rooted in emerging economies. Factors influencing this trajectory include increased healthcare access, targeted public health initiatives, and the ongoing need for affordable antimicrobials.

Revenue Segmentation:

  • Emerging Markets: The dominant segment, accounting for up to 70% of global SULFAIR 10 sales, driven by government procurement and endemic infections.
  • Developed Markets: A declining or plateauing segment due to alternative therapies and stringent regulations.
  • Contract Manufacturing & Export: A significant revenue stream stemming from licensing deals and multi-national procurement contracts.

Profitability Considerations:
Due to its low manufacturing costs and high volume, SULFAIR 10 maintains attractive profit margins in high-demand regions. However, patent expiration, generic manufacturer competition, and regulatory challenges may erode margins over time.

Potential Market Risks:

  • Resistance development reduces clinical utility.
  • Regulatory restrictions based on safety profiles.
  • Competition from newer, more targeted antimicrobial agents.

Market Challenges and Opportunities

Challenges

  • Antimicrobial Resistance (AMR): Resistance diminishes efficacy, leading to reduced prescribing and sales. Continuous monitoring and stewardship programs are vital to sustain market viability.
  • Regulatory Hurdles: Variability in approval standards across countries complicates market access.
  • Market Saturation: Saturation in certain regions limits growth; reliance on emerging markets becomes critical.

Opportunities

  • Formulation Innovation: Combining SULFAIR 10 with other agents, such as trimethoprim, can enhance efficacy and combat resistance, opening new therapeutic niches.
  • Expanded Indications: Investigating new indications, including topical or ocular applications, broadens market potential.
  • Strategic Partnerships: Collaborations with public health organizations, NGOs, and government agencies facilitate market expansion.
  • Genericization and Price Leadership: As patents expire, aggressive pricing strategies can consolidate market presence, especially in price-sensitive markets.

Regulatory and Industry Trends Impacting SULFAIR 10

The shifting regulatory landscape emphasizes antimicrobial stewardship and safety. Greater scrutiny over older antibiotics has led some markets to restrict sales or require additional safety data. Nonetheless, recognition of SULFAIR 10 as an essential medicine sustains its relevance, especially when aligned with national health priorities.

Industry trends also favor the incremental modernization of existing formulations. Developing combination drugs, improved delivery systems, and stability enhancements can extend Product lifecycle and market relevance.


Strategic Outlook for Stakeholders

Manufacturers should focus on cost-effective production, diversification of formulations, and expansion into underserved markets. Emphasizing stewardship and sustainable use can prevent resistance buildup and safeguard market longevity.

Investors should analyze regional demand trends, resistance landscapes, and patent expiration timelines. Long-term profitability hinges on navigating regulatory environments and maintaining cost leadership.

Healthcare providers must balance the affordability of SULFAIR 10 with emerging resistance challenges, employing judicious prescribing practices in conjunction with antimicrobial stewardship programs.


Conclusion

SULFAIR 10 maintains its place within the antimicrobial formulary, particularly in developing regions where affordability and efficacy remain paramount. The drug’s market dynamics are shaped by resistance patterns, regulatory evolutions, and public health initiatives. While steady growth is projected, particularly in emerging markets, sustainability will depend on strategic adaptation amid the industry's ongoing transformation toward newer, more targeted therapies.


Key Takeaways

  • SULFAIR 10's primary strength lies in its affordability and efficacy, ensuring demand in resource-constrained settings.
  • Market growth is expected at a CAGR of 2-3%, mainly driven by emerging markets' expanding healthcare infrastructure.
  • Resistance development remains a critical challenge, necessitating formulation innovations and responsible use policies.
  • Patent expirations and generic competition emphasize the importance of strategic cost management for sustained profitability.
  • Stakeholders should explore formulation diversification and regional expansion strategies to maximize long-term value.

FAQs

1. What are the main therapeutic applications of SULFAIR 10?
SULFAIR 10 is primarily used for urinary tract infections, skin infections, and ocular infections due to its antimicrobial properties.

2. How does antimicrobial resistance affect the future of SULFAIR 10?
Rising resistance reduces clinical efficacy, prompting the need for formulations with enhanced activity or combination therapies and emphasizing antimicrobial stewardship.

3. What markets offer the greatest growth opportunities for SULFAIR 10?
Emerging economies in Africa, Asia, and Latin America present the most substantial growth prospects due to expanding healthcare access and cost-sensitive demand.

4. How will patent expirations influence SULFAIR 10’s market share?
Patent expirations typically lead to increased generic competition, exerting downward pressure on prices and margins, unless differentiated through formulations or indications.

5. What strategic actions should manufacturers consider to sustain SULFAIR 10’s market position?
Invest in formulation innovation, explore combination therapies, expand into new indications, and strengthen distribution channels in high-demand regions.


Sources:

[1] World Health Organization. “WHO Model List of Essential Medicines.” 2021.
[2] MarketsandMarkets. “Antimicrobial Drugs Market Analysis.” 2022.
[3] Statista. “Global Antibiotic Market Revenue Forecast.” 2023.
[4] Persistence Market Research. “Global Sulfa Drugs Market Outlook.” 2022.
[5] Regulatory Affairs Professionals Society. “Global Trends in Antimicrobial Drug Regulations.” 2023.

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