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Last Updated: December 16, 2025

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH Drug Patent Profile


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Which patents cover Sulfamethoxazole And Trimethoprim Double Strength, and when can generic versions of Sulfamethoxazole And Trimethoprim Double Strength launch?

Sulfamethoxazole And Trimethoprim Double Strength is a drug marketed by Fosun Pharma, Heritage Pharma Avet, Martec Usa Llc, Mutual Pharm, Roxane, and Watson Labs. and is included in six NDAs.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-eight 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 Double Strength

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

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Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Drug patent expirations by year for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Recent Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

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SponsorPhase
University of California, San FranciscoPHASE4
Hospital Civil de GuadalajaraPHASE2
Boston Children's HospitalPHASE4

See all SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH clinical trials

US Patents and Regulatory Information for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fosun Pharma SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 018598-004 May 19, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mutual Pharm SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 070007-001 Nov 14, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Heritage Pharma Avet SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 070037-001 Jun 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Martec Usa Llc SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 072417-001 Dec 7, 1988 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 Sulfamethoxazole and Trimethoprim Double Strength

Last updated: July 28, 2025

Introduction

Sulfamethoxazole and Trimethoprim, commercially known as Bactrim or Septra, constitute a combination antibiotic integral to treating bacterial infections. The double-strength formulation amplifies efficacy against resistant strains, positioning it as a preferred option for specific indications. This analysis delineates current market dynamics, growth drivers, market constraints, and future financial forecast trajectories for this combination drug.

Market Overview

The sulfamethoxazole and trimethoprim double-strength formulation is predominantly used for urinary tract infections (UTIs), respiratory infections, and sinusitis. As of 2022, the drug maintained a significant market share within the antibiotics segment, valued globally at approximately $1.3 billion and projected to grow at a compound annual growth rate (CAGR) of 3-4% over the next five years [1].

This growth trajectory reflects persistent demand in both developed and emerging markets driven by antibiotic resistance concerns and expanding indications. The drug's inclusion in the WHO's List of Essential Medicines underscores its medical significance and supports ongoing market demand.

Market Dynamics

Drivers

a. Rising Incidence of Bacterial Infections

The global escalation of bacterial infections, reinforced by urbanization, aging populations, and immunocompromised states (e.g., HIV/AIDS, diabetes), sustains a high demand for broad-spectrum antibiotics like sulfamethoxazole-trimethoprim. The increased prevalence of urinary tract infections, particularly in women and elderly populations, sustains steady sales.

b. Antibiotic Resistance and Therapeutic Demand

Despite rising resistance, sulfamethoxazole-trimethoprim remains effective against certain resistant strains, such as Staphylococcus aureus including MRSA, fostering its continued relevance in both outpatient and inpatient settings [2].

c. Expanding Indications and Formulation Innovations

Researchers and clinicians are exploring additional therapeutic uses, including pneumocystis pneumonia prophylaxis and certain protozoal infections, broadening its application base. The development of double-strength formulations caters to more severe infections requiring higher doses, supporting revenue growth.

d. Favorable Cost-Effectiveness Profile

The drug's affordability and oral bioavailability ensure continued use in low- and middle-income countries, which is critical given the global burden of bacterial infections.

Constraints

a. Antibiotic Resistance Trends

The emergence of resistant pathogens diminishes the drug's effectiveness, leading to regulatory advisories against empiric use in some regions. This trend necessitates combination therapy adjustments and may dampen sales growth.

b. Regulatory and Supply Chain Challenges

Variations in regulatory approvals across jurisdictions and concerns over manufacturing quality impact market access. The supply chain disruptions, notably during the COVID-19 pandemic, temporarily constrained availability.

c. Safety Profile and Side Effects

Potential adverse effects, including hypersensitivity reactions and hematologic toxicities, challenge its continued widespread use. Such side effects, especially in vulnerable populations, can limit prescribing.

Competitive Landscape

The antibiotic space features numerous alternatives—fluoroquinolones, cephalosporins, and other combination antibiotics—creating intense competitive pressure. The rise of generic versions reduces prices but limits profit margins for branded formulations.

Financial Trajectory

Historical Performance

The drug has demonstrated stable sales, with incremental annual growth largely driven by emerging markets. Patented formulations transitioned to generic availability in 2000s, leading to price declines but expanded access.

Future Projections

The forecast anticipates a CAGR of 3-4% over five years, driven by expanding infection burdens and increased adoption of double-strength formulations in hospital and outpatient settings [1]. Revenue growth will likely be moderated by the accelerated generic penetration, regulatory scrutiny, and resistance challenges.

Key Investment Drivers

  • Market Penetration in Emerging Economies: Enhanced access increases sales volume.
  • Expansion of Indications: Ongoing research into novel uses can open new revenue streams.
  • Formulation Enhancements: Development of more convenient formulations, including fixed-dose combinations, enhances patient compliance and adherence, potentially increasing market share.
  • Strategic Partnerships: Collaborations with local manufacturers can facilitate market entry in highly regulated regions.

Risks and Mitigation Strategies

  • Resistance Evolution: Continuous surveillance and stewardship programs can help maintain efficacy levels.
  • Regulatory Hurdles: Proactive engagement and compliance adaptations can streamline approvals.
  • Pricing Pressures: Cost management and value-based pricing strategies are essential in sustaining profitability.

Conclusion

Sulfamethoxazole and trimethoprim double strength are positioned as enduring components within the antibacterial market. Despite headwinds from resistance, regulatory scrutiny, and pricing pressures, sustained demand driven by infection prevalence and broad utility underpin a positive financial trajectory. Strategic focus on innovation, expanding indications, and market penetration can further bolster its market value.

Key Takeaways

  • The global sulfamethoxazole-trimethoprim double-strength market is valued at over $1.3 billion with a projected CAGR of 3-4%.
  • Key growth drivers include rising bacterial infection burdens, resistant pathogen prevalence, and expanding therapeutic indications.
  • Market constraints predominantly involve resistance development, regulatory challenges, and competition from generic and alternative antibiotics.
  • Revenue stability relies on continuous market access, formulation innovations, and targeted penetration into emerging economies.
  • Stakeholders should focus on antimicrobial stewardship, strategic collaborations, and innovative formulations to optimize the drug’s financial trajectory.

FAQs

1. What are the primary indications for sulfamethoxazole-trimethoprim double strength?
It is mainly indicated for urinary tract infections, respiratory infections, sinusitis, and prophylaxis against pneumocystis pneumonia in immunocompromised patients.

2. How does antibiotic resistance impact the market prospects?
Resistance reduces the drug’s efficacy, leading to decreased prescribing and necessitating alternative therapies, which can dampen sales growth.

3. Are there significant regional differences in the drug’s market?
Yes. Emerging markets benefit from affordability and higher infectious disease burdens, whereas regulatory and resistance issues influence developed markets differently.

4. What innovation opportunities exist for this drug?
Development of new formulations, fixed-dose combinations, and expanding indications through clinical research are key innovation opportunities.

5. How do regulatory changes influence market dynamics?
Regulatory policies aimed at antimicrobial stewardship and safety monitoring can restrict usage, impacting sales and profitability.

References

[1] MarketResearch.com, "Global Antibiotics Market," 2022.
[2] World Health Organization, "Antimicrobial Resistance Global Report," 2019.

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