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Last Updated: December 11, 2025

SULFAMETHOXAZOLE AND TRIMETHOPRIM Drug Patent Profile


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

Sulfamethoxazole And Trimethoprim is a drug marketed by Abraxis Pharm, Bedford, Hikma, Hospira, Pharmobedient, Somerset, Teva Pharms Usa, Watson Labs, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Aiping Pharm Inc, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Heritage Pharma Avet. and is included in forty-six NDAs.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM is phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim profile page.

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Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM
US Patents:0
Applicants:31
NDAs:46
Finished Product Suppliers / Packagers: 44
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 160
What excipients (inactive ingredients) are in SULFAMETHOXAZOLE AND TRIMETHOPRIM?SULFAMETHOXAZOLE AND TRIMETHOPRIM excipients list
DailyMed Link:SULFAMETHOXAZOLE AND TRIMETHOPRIM at DailyMed
Drug patent expirations by year for SULFAMETHOXAZOLE AND TRIMETHOPRIM
Recent Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM

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

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

See all SULFAMETHOXAZOLE AND TRIMETHOPRIM clinical trials

US Patents and Regulatory Information for SULFAMETHOXAZOLE AND TRIMETHOPRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 018242-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Interpharm SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 071299-001 Oct 27, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 070000-001 Nov 7, 1984 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

Last updated: July 28, 2025

Introduction

Sulfamethoxazole and trimethoprim, marketed collectively as co-trimoxazole, form a cornerstone in antimicrobial therapy. Widely prescribed for bacterial infections, their combined efficacy, affordability, and longstanding clinical use underpin substantial market presence. This analysis dissects the evolving market dynamics, financial trajectories, and strategic opportunities shaping the future landscape of this antibiotic duo.

Market Overview

Sulfamethoxazole and trimethoprim are synergistic antibiotics primarily targeted at urinary tract infections (UTIs), respiratory infections, and certain opportunistic infections. Their global market is driven by factors including the sustained prevalence of bacterial infections, rising antibiotic resistance, and expanding use cases in both developed and emerging markets.

According to Grand View Research, the global co-trimoxazole market was valued at approximately USD 600 million in 2021 and projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2030[1]. The expansion is primarily attributed to increased antimicrobial demand, especially in countries battling rising infectious disease burdens.

Market Drivers

1. Clinical Dependence and Broad-Spectrum Efficacy

Co-trimoxazole's proven effectiveness against a wide range of pathogens—including Escherichia coli, Pneumocystis jirovecii, and Shigella—cements its position in antibiotics portfolios worldwide. Its high efficacy and low cost sustain its popularity in resource-limited settings.

2. Growing Incidence of Infectious Diseases

The World Health Organization reports persistent high rates of urinary tract infections and pneumonia across global populations, especially in low- and middle-income countries[2]. These conditions directly sustain demand.

3. Use in HIV/AIDS and Opportunistic Infections

Prophylactic use in immunocompromised patients, particularly those with HIV/AIDS for Pneumocystis pneumonia prevention, enhances market stability. The UNAIDS reports over 38 million people living with HIV worldwide, many of whom rely on co-trimoxazole for prophylaxis[3].

4. Threat of Antibiotic Resistance and Innovation

Evolving resistance patterns threaten the longevity of traditional antibiotics. This has spurred research into new formulations, combination therapies, and innovative delivery mechanisms, potentially expanding or constraining the market depending on efficacy and regulatory approval.

Market Challenges

1. Antibiotic Resistance

The emergence of resistant strains, notably against sulfonamides, diminishes clinical utility[4]. Resistance mechanisms, such as dihydrofolate reductase mutations, threaten treatment efficacy, prompting a shift toward newer agents.

2. Regulatory and Patent Factors

While the original formulations are off-patent, regulatory hurdles and the emergence of generic competition influence pricing strategies and profitability. Some jurisdictions enforce strict guidelines, impacting sales volume and margins.

3. Safety and Side Effect Profile

Adverse effects, including Stevens-Johnson syndrome and hypersensitivity reactions, have led to restricted use in certain populations, influencing prescribing patterns[5].

4. Competition from Newer Antibiotics

Advances in antimicrobial development introduce alternatives with better safety profiles, e.g., doxycycline, cephalosporins, potentially supplanting co-trimoxazole in certain indications.

Financial Trajectory

Revenue Trends

The co-trimoxazole market has demonstrated steady revenues reflective of its essential role. In 2021, global sales topped USD 600 million, with projections indicating a CAGR of approximately 4.2% until 2030[1]. Developed markets, particularly the U.S. and Europe, exhibit mature markets with stable sales driven by prophylactic use in immunocompromised populations.

Emerging markets, notably India, China, and parts of Africa, drive significant growth due to high infectious disease burdens and cost-sensitive healthcare systems. The increasing adoption of generic formulations ensures affordability, boosting volume sales.

Profitability and Cost Dynamics

The generic manufacturing landscape dominates, maintaining low unit prices. Despite modest profit margins, high volume sales sustain revenue streams. R&D investments are limited given the off-patent status; however, incremental innovations, such as fixed-dose combinations and improved formulations, present incremental revenue opportunities.

Impact of Patent Expiry and Generic Competition

Patents for initial formulations have long expired[6], fostering a competitive environment. This trend sustains low pricing but constrains profit margins for brand-name manufacturers. However, it enhances accessibility and broadens market penetration.

Potential Market Expansion Opportunities

  • Prophylactic extensions: Leveraging prophylactic efficacy in immunocompromised patients can open new pharmaceutical formulations.
  • Combination therapies: Developing novel fixed-dose combinations with other antimicrobials or supportive agents can revitalize demand.
  • Diagnostics integration: Pairing personalized diagnostics with co-trimoxazole therapy aligns with precision medicine trends and can command premium pricing.

Regulatory and Strategic Trends

Global health agencies, including WHO, advocate responsible antimicrobial use to mitigate resistance. Regulatory bodies are emphasizing stewardship programs, which may restrict usage to specific indications, impacting market volume.

Moreover, the COVID-19 pandemic underscored the importance of antimicrobial stewardship, with fluctuations in antibiotic demand observed during pandemic peaks and troughs.

Pharmaceutical companies are exploring partnerships and licensing agreements to sustain revenue streams, especially in emerging markets where local manufacturing reduces costs.

Future Outlook

The trajectory of sulfamethoxazole and trimethoprim hinges on balancing perpetual demand against resistance and regulatory headwinds. Growth is anticipated in regions with high infectious disease burdens, provided that clinicians continue to prioritize stewardship. Technological innovation, including new formulations and combination regimens, offers avenues for market expansion.

Furthermore, the increasing global focus on antimicrobial resistance (AMR) mitigation presents both risks and opportunities. Investments in stewardship and diagnostics can sustain demand while also encouraging the development of next-generation antibacterials.

Key Takeaways

  • The co-trimoxazole market remains vital, especially in low-resource settings and for prophylactic use in immunocompromised patients.
  • Market growth prospects are steady, with a CAGR of approximately 4.2% projected through 2030, driven by high disease prevalence and expanding use in emerging markets.
  • Challenges such as antibiotic resistance, generic competition, and safety concerns demand strategic innovation and stewardship.
  • Revenue streams are primarily volume-driven, with low margins due to generic competition, necessitating cost efficiencies and product differentiation for sustained profitability.
  • Aligning with global AMR policies and integrating diagnostics will be critical to maintaining market relevance.

FAQs

1. How does antibiotic resistance affect the future of sulfamethoxazole and trimethoprim?
Resistance diminishes clinical effectiveness, prompting cautious prescribing and potential restrictions. Continuous surveillance and stewardship are essential to extend the utility of co-trimoxazole.

2. Are there emerging formulations or combinations that can revive market growth?
Yes. Fixed-dose combinations with newer antimicrobials or supportive agents, along with improved delivery methods, could enhance efficacy, safety, and compliance, thus expanding market potential.

3. What role do regulatory agencies play in shaping the market?
Regulators influence prescribing practices through guidelines and restrictions, particularly around safety concerns. They also approve new formulations and biosimilars, affecting competition and pricing.

4. How significant is the impact of generic competition on profitability?
It substantially reduces prices, limiting margins but ensuring high-volume sales. Strategic differentiation, such as novel formulations or indications, can offset this impact.

5. What opportunities exist for pharmaceutical companies in emerging markets?
There is scope for local manufacturing, licensing, and tailored formulations to meet specific regional needs, capitalizing on high infection rates and cost sensitivities.

References

[1] Grand View Research. Co-trimoxazole Market Size & Trends. 2022.
[2] WHO. Antimicrobial resistance global report. 2014.
[3] UNAIDS. Global HIV & AIDS statistics. 2022.
[4] Andersson, D. I., & Hughes, D. (2014). Microbiological effects of sublethal levels of antibiotics. Nature Reviews Microbiology, 12(7), 465–478.
[5] Centers for Disease Control and Prevention. Adverse reactions to sulfonamides. 2020.
[6] FDA. Patent expiration data for co-trimoxazole formulations. 2015.

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