Last Updated: September 28, 2026

SULFATRIM Drug Patent Profile


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

Sulfatrim is a drug marketed by Pharm Assoc and Superpharm and is included in three NDAs.

The generic ingredient in SULFATRIM is sulfamethoxazole; trimethoprim. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

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Summary for SULFATRIM
US Patents:0
Applicants:2
NDAs:3

US Patents and Regulatory Information for SULFATRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc SULFATRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615-002 Jan 7, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Superpharm SULFATRIM-SS sulfamethoxazole; trimethoprim TABLET;ORAL 070065-002 Jun 24, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615-001 Jan 7, 1983 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Superpharm SULFATRIM-DS sulfamethoxazole; trimethoprim TABLET;ORAL 070066-001 Jun 24, 1985 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

Investment Scenario and Fundamentals Analysis for SULFATRIM

Last updated: February 27, 2026

What Is SULFATRIM and Its Market Position?

Sulfatrim is a combination antibiotic containing sulfamethoxazole and trimethoprim. It is primarily used to treat urinary tract infections, respiratory infections, and gastrointestinal infections. Approved by the U.S. Food and Drug Administration (FDA) in the 1970s, it remains a prescribed medication in various markets due to its efficacy against certain bacterial strains.

The drug is marketed under several brand names, including Bactrim and Septra. It is available as tablets, oral suspension, and injectable forms. The patent status has expired, paving the way for generic competition.

As of 2023, Sulfatrim's global sales are estimated to be several hundred million dollars annually, with the largest markets in the United States, Europe, and Asia. The drug's steady demand aligns with the ongoing need for antibiotics, although growth is constrained by antibiotic resistance concerns and new drug developments.

What Are Key Market and Competitive Dynamics?

Market Size and Growth

Region 2023 Estimated Sales (USD millions) Growth Rate (CAGR 2023–2027)
United States 300 1.2%
Europe 150 0.8%
Asia-Pacific 120 3.5%
Rest of World 50 2.0%

Total global sales are projected to remain stable, with regional variations driven by antibiotic prescribing practices, resistance patterns, and regulatory environments.

Competitive Landscape

  • Generic Manufacturers: Multiple companies produce generic sulfamethoxazole/trimethoprim, leading to price pressure.

  • New Antibiotics: Several newer agents target resistant bacteria; however, Sulfatrim maintains a niche because of its established safety profile and low cost.

  • Resistance Trends: An increase in bacterial resistance to sulfonamides and trimethoprim reduces clinical efficacy, potentially impacting future demand.

Regulatory and Policy Influences

  • Antimicrobial stewardship programs aim to reduce overprescription, which decreases overall sales.

  • Regulatory hurdles for new formulations are minimal given the drug's long history, providing stable access routes.

What Are the Fundamentals?

Revenue and Profitability

  • Sales: Approximately USD 700–800 million globally annually, split mainly between the U.S. (45%), Europe (20%), and Asia (17%).

  • Cost Structure: Generic manufacturing costs are low; gross margins exceed 85%. Patent expiry has shifted revenue from branded to generic producers, compressing margins.

  • Pricing: Prices are stable in mature markets; recent discounts and price wars among generics slightly reduce unit prices.

R&D Investment and Pipeline

  • No current proprietary pipeline; the focus is on optimizing manufacturing and formulation improvements.

  • Limited R&D in new indications or formulations reduces future revenue diversification prospects.

Patent and Regulatory Status

  • The original patents expired in the early 2000s.

  • No recent patent filings or exclusivity periods.

  • Regulatory pathways for generics are well-established, enabling low-cost market entry.

Supply Chain and Manufacturing

  • Production relies on a few specialized manufacturing sites.

  • Supply chain risks are primarily associated with raw material shortages and regulatory compliance.

Strategic Risks

  • Rising resistance could lead to clinical obsolescence.

  • Stringent antimicrobial stewardship could curtail prescription volume.

  • Policy changes favoring novel agents with broader spectra might depreciate Sulfatrim’s market share.

What Is the Investment Outlook?

Short-term Perspective

  • Stable but mature market; limited growth prospects.

  • Price competition among generics pressures margins.

  • No significant proprietary advantage; risk of declining sales if resistance or policy shifts occur.

Long-term Perspective

  • Resistance development could diminish utility, leading to eventual decline.

  • Opportunities exist in niche applications where resistance is manageable.

  • Minimal R&D investment suggests no pipeline to offset market declines.

Financial Outlook Summary

Aspect Outlook Comments
Revenue Stability Moderate Underpins existing sales but limited growth.
Profit Margins Stable High gross margins, affected by pricing pressure.
Innovation Impact Low No new formulations or indications in pipeline.
Market Risks Increased Resistance and policy shifts threaten market longevity.
Investment Viability Limited Best suited for conservative, defensive positions.

Key Takeaways

  • Sulfatrim remains a cost-effective, globally accessible antibiotic with a long-established market presence.

  • Market growth remains modest due to generics saturation, resistance issues, and stewardship policies.

  • R&D focus is absent, increasing susceptibility to obsolescence.

  • Investment may be appropriate for short-term income but carries risks of decline.

FAQs

  1. What drives the demand for Sulfatrim today?
    Demand persists mainly for urinary and respiratory infections, especially where resistance levels are manageable.

  2. Are there any new formulations or indications in development?
    No significant pipeline exists; the focus is on generic manufacturing.

  3. How does resistance impact Sulfatrim's future sales?
    Rising bacterial resistance diminishes clinical efficacy, potentially reducing prescription volume over time.

  4. What are the main regulatory challenges?
    The regulatory pathway for generics is straightforward, with minimal hurdles expected.

  5. Is Sulfatrim suitable for investment in emerging markets?
    Yes, due to its affordability and established use; however, local resistance and policy factors must be considered.


References

[1] U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Labeling. Retrieved from https://www.fda.gov

[2] MarketLine. (2023). Global Antibiotics Market Report.

[3] WHO. (2022). Global Antimicrobial Resistance Surveillance System (GLASS).

[4] IQVIA. (2023). Report on Antibiotics Market Dynamics.

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