Last Updated: May 12, 2026

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Sulfamethoxazole And Trimethoprim Single Strength patents expire, and what generic alternatives are available?

Sulfamethoxazole And Trimethoprim Single Strength is a drug marketed by Heritage Pharma Avet and is included in one NDA.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sulfamethoxazole And Trimethoprim Single Strength

A generic version of SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25th, 1986.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH?
  • What are the global sales for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH?
  • What is Average Wholesale Price for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH?
Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
Recent Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San FranciscoPHASE4
McGill University Health Centre/Research Institute of the McGill University Health CentrePHASE4
Boston Children's HospitalPHASE4

See all SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH clinical trials

US Patents and Regulatory Information for SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heritage Pharma Avet SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 070030-001 Jun 2, 1987 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 Sulfamethoxazole and Trimethoprim Single Strength

Last updated: March 27, 2026

What Are the Key Market Drivers?

The global market for sulfamethoxazole and trimethoprim single strength (SMX-TMP SS) is driven primarily by its approval and use in bacterial infections, particularly urinary tract infections (UTIs). The growth is influenced by increasing antibiotic resistance, expanding indications, and the rise of healthcare infrastructure in emerging economies.

Market Drivers:

  • Antibiotic Resistance: Growing antimicrobial resistance fuels demand for established antibiotics like SMX-TMP SS.
  • Prescription Trends: Stable prescribing patterns for urinary tract infections and respiratory infections sustain demand.
  • Regulatory Approvals: Several countries have approved SMX-TMP SS as a first-line treatment, improving market availability.
  • Healthcare Infrastructure Development: Expanding facilities in Asia-Pacific and Latin America increase patient access.

Market Restraints:

  • Competitor Drugs: The availability of newer antibiotics with broader spectrums reduces SMX-TMP SS's market share.
  • Safety Concerns: Known adverse effects restrict usage in specific patient populations.
  • Generic Market Entry: Price erosion occurs due to increased generic competition.

What Is the Current Market Size?

The global market value for sulfamethoxazole and trimethoprim single strength was estimated at approximately \$150 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4-6% over the next five years, reaching about \$200-250 million by 2027.

Regional Distribution:

Region Market Share (2022) Estimated Market Size (2022) Predicted CAGR (2023–2027)
North America 40% \$60 million 3-5%
Europe 25% \$37.5 million 4-6%
Asia-Pacific 20% \$30 million 6-8%
Rest of World (RoW) 15% \$22.5 million 4-7%

Revenue Channels:

  • Hospital Supplies: Bulk hospital orders account for approximately 70% of sales.
  • Retail Pharmacies: Accounts for around 25%, with online sales remaining negligible.
  • Government Contracts: Contribute an estimated 5%, mainly in public healthcare systems.

How Do Patent and Regulatory Factors Influence Market Trajectory?

Sulfamethoxazole and trimethoprim single strength are primarily off-patent worldwide. Patent expiries in the late 1990s and early 2000s resulted in widespread generic manufacturing, causing price reductions and market saturation.

Regulatory Landscape:

  • United States: Approved by the FDA for urinary tract infections, pneumonia, and certain skin infections.
  • European Union: EMA-approved for similar indications; clinical guidelines favor its use as a first-line agent.
  • Emerging Markets: Often authorized through local regulatory agencies; less stringent controls can lead to increased generic entry and market expansion.

Regulatory approvals generally bolster market penetration, but off-patent status limits potential for high-margin branded sales.

What Are the Financial Trends?

Pricing Trends:

  • Branded vs. Generic: Branded formulations historically sold at \$1–\$3 per tablet; generics trade as low as \$0.10–\$0.50 per tablet.
  • Market Penetration: High penetration of generics exerts downward pressure on prices.

Revenue Projections:

  • 2022: Estimated global sales of \$150 million.
  • 2023–2027 Forecast: Compound growth of 4-6%, reaching approximately \$200–\$250 million by 2027.

Cost Factors:

  • Manufacturing costs average \$0.05–\$0.10 per tablet.
  • Marketing budgets focus on hospital contracts and distribution channels.

Profitability:

Margins on generic products shift between 10-15%, with branded formulations achieving slightly higher margins but less market share due to price competition.

How Will Competitive Dynamics Evolve?

The market will experience intensified competition from:

  • New Antibiotics: Agents like ceftaroline or omadacycline that target resistant bacteria.
  • Combination Drugs: Emerging formulations combining SMX-TMP with other agents for broader coverage.
  • Digital and Supply Chain Innovations: Streamlined distribution improves access in remote regions.

Market entrants focus on differentiation through formulating enhancements or combination therapies. Off-patent status constrains pricing power but sustains volume sales.

What Are the Impacts of Global Health Policies?

Antimicrobial stewardship programs aim to reduce unnecessary antibiotic use, impacting sales volumes. Regulations restricting over-the-counter access in certain jurisdictions further influence market size and growth.

Summary

Sulfamethoxazole and trimethoprim single strength remains a staple antibiotic for specific bacterial infections, especially in hospital and outpatient settings. The global market is steady, with moderate growth driven by demand resilience and expanding access in developing countries. Price erosion from generics and competition from newer antibiotics pose ongoing challenges. Regulatory environments and health policy shifts will continue to influence sales trajectories.


Key Takeaways

  • The global market for SMX-TMP SS is valued at \$150 million in 2022, with a CAGR of 4-6%.
  • Market growth is driven by antibiotic resistance, prescription stability, and expanding healthcare access.
  • Off-patent status leads to high generic competition, reducing profit margins.
  • Regional markets exhibit different growth dynamics, with Asia-Pacific showing the fastest growth.
  • Competition from newer drugs and antimicrobial stewardship efforts may temper future sales growth.

FAQs

1. What are the main indications for sulfamethoxazole and trimethoprim single strength?
Primarily used for urinary tract infections, respiratory infections like pneumonia, and certain skin infections.

2. How does off-patent status affect the market?
It encourages generic manufacturing, lowering prices and margins but allowing wider access and volume sales.

3. What regions are seeing the fastest growth?
Asia-Pacific leads with a predicted CAGR of 6-8%, driven by healthcare infrastructure expansion.

4. Are there any emerging formulations or combinations?
Yes, combination therapies with other antibiotics or newer formulations aim to expand utility.

5. How might antimicrobial stewardship impact future sales?
Programs to reduce unnecessary antibiotic use could slow volume growth but promote more targeted use of SMX-TMP SS.


References

[1] MarketWatch. (2023). "Sulfamethoxazole and Trimethoprim Single Strength Market Size, Share & Trends." MarketWatch Reports.

[2] GlobalData. (2022). "Antibiotics Market Overview." GlobalData Reports.

[3] U.S. Food & Drug Administration. (2022). "Approved Drugs Database." FDA.

[4] European Medicines Agency. (2022). "Authorized Medicinal Products." EMA.

[5] World Health Organization. (2022). "Antibiotic Resistance and Global Action Plan." WHO.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.