SULFAMETHOXAZOLE; TRIMETHOPRIM - Generic Drug Details

What are the generic sources for sulfamethoxazole; trimethoprim and what is the scope of freedom to operate?

Sulfamethoxazole; trimethoprim is the generic ingredient in twenty-two branded drugs marketed by Sun Pharm Inds Inc, Monarch Pharms, Abraxis Pharm, Bedford, Hikma, Hospira, Pharmobedient, Somerset, Teva Pharms Usa, Watson Labs, Sun Pharm Industries, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Pharm Assoc, Usl Pharma, Alpharma Us Pharms, Naska, Novel Labs Inc, Aiping Pharm Inc, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Vista Pharms, Heritage Pharma Avet, Superpharm, and Shionogi, and is included in sixty-five NDAs. Additional information is available in the individual branded drug profile pages.

Forty-seven suppliers are listed for this compound.

Summary for SULFAMETHOXAZOLE; TRIMETHOPRIM

US Patents:	0
Tradenames:	22
Applicants:	38
NDAs:	65
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	159
DailyMed Link:	SULFAMETHOXAZOLE; TRIMETHOPRIM at DailyMed

Recent Clinical Trials for SULFAMETHOXAZOLE; TRIMETHOPRIM

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

Sponsor	Phase
University of California, San Francisco	PHASE4
Boston Children's Hospital	PHASE4
Ohio State University	PHASE4

See all SULFAMETHOXAZOLE; TRIMETHOPRIM clinical trials

Pharmacology for SULFAMETHOXAZOLE; TRIMETHOPRIM

Drug Class	Dihydrofolate Reductase Inhibitor Antibacterial Sulfonamide Antimicrobial
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SULFAMETHOXAZOLE; TRIMETHOPRIM

J01EA	Trimethoprim and derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01EE	Combinations of sulfonamides and trimethoprim, incl. derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SULFAMETHOXAZOLE; TRIMETHOPRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Vista Pharms	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	076817-002	Oct 7, 2005	AB	RX	No	No
Aurobindo Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	091348-001	Jun 8, 2010	AB	RX	No	Yes
Chartwell Molecular	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	077785-001	Jan 24, 2007	AB	RX	No	No
Teva	COTRIM D.S.	sulfamethoxazole; trimethoprim	TABLET;ORAL	070048-001	Mar 18, 1985		DISCN	No	No

Expired US Patents for SULFAMETHOXAZOLE; TRIMETHOPRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	4,209,513
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982	3,551,564
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	4,209,513
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	RE28636
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982	RE28636

Market Dynamics and Financial Trajectory for Sulfamethoxazole; Trimethoprim

Last updated: July 29, 2025

Introduction

Sulfamethoxazole and Trimethoprim (SMX-TMP) is a well-established combination antibiotic widely prescribed for bacterial infections such as urinary tract infections, respiratory infections, and gastroenteritis. Market dynamics surrounding this pharmaceutical duo are shaped by evolving clinical practices, patent landscapes, generics proliferation, and emerging resistance issues. This report provides a comprehensive analysis of the current market environment and forecasts the financial trajectory of Sulfamethoxazole; Trimethoprim, informing stakeholders on future opportunities and risks.

Market Overview

Historical Context and Market Penetration

Since its introduction in the 1960s, Sulfamethoxazole combined with Trimethoprim has been a cornerstone in antibacterial therapy. The combination’s high efficacy, low cost, and minimal side effects contributed to widespread adoption. Its patent expired in many regions by the late 1980s, leading to the proliferation of generic versions that dominate supply chains globally. The global market was valued at approximately USD 1.2 billion in 2020[1], with steady growth driven by high prescription volumes.

Current Market Landscape

The antibiotic market faces complexities linked to antimicrobial resistance (AMR), regulatory scrutiny, and shifting prescribing practices. Despite the introduction of newer agents, SMX-TMP remains relevant due to its affordability and broad-spectrum activity. Key market players include generic manufacturers such as Teva, Mylan, and Sandoz, accounting for the majority of supply.

Regulatory Environment

Regulatory agencies like the FDA and EMA have maintained stringent oversight to encourage responsible use amidst rising resistance. Recent guidelines emphasize stewardship programs to curb unnecessary prescriptions, potentially impacting volumetric sales growth.

Market Drivers

Clinical Efficacy and Cost-Effectiveness

SMX-TMP's proven clinical efficacy in treating validated bacterial infections ensures consistent demand. Its low manufacturing cost boosts accessibility in low-to-middle-income countries, expanding market reach.

Prevalence of Bacterial Infections

Infection incidences such as urinary tract infections (UTIs), pneumonia, and gastrointestinal infections sustain demand. The World Health Organization (WHO) reports high global UTI prevalence, particularly in developing regions where access to advanced antibiotics remains limited.

Antimicrobial Stewardship and Resistance Trends

Efforts to combat antimicrobial resistance influence drug utilization. While resistance to SMX-TMP has increased in some bacteria (e.g., Staphylococcus aureus), overall, it remains a first-line treatment in many settings, supporting ongoing demand.

Patent Expiry and Generic Competition

Patent expiration led to an ultra-competitive landscape, significantly reducing prices and elevating volume sales. The promise of low-cost generics sustains market access especially in emerging economies.

Emerging Applications and Research

Recent research explores SMX-TMP in preventing Pneumocystis pneumonia in HIV/AIDS patients and prophylactic use against certain parasitic infections, diversifying possible future revenue streams.

Market Challenges

Antimicrobial Resistance (AMR)

Rising resistance threatens the long-term efficacy of SMX-TMP. Surveillance data indicates rising resistance in E. coli and Klebsiella pneumoniae, challenging clinicians' reliance on this combination and potentially constraining future prescriptions.

Regulatory and Political Pressures

Regulatory agencies advocate for prudent use, potentially limiting prescription volumes. While this aims to slow resistance development, it could suppress revenue growth.

Market Saturation

High generic penetration has led to price erosion. Market saturation in developed regions restricts fast growth, although emerging markets continue to offer expansion potential.

Competition from Newer Antibiotics

Newer agents with broader spectra and targeted mechanisms are emerging but often at higher costs, which may limit their adoption where SMX-TMP remains affordable.

Financial Trajectory and Future Outlook

Market Revenue Trends

Projected compound annual growth rate (CAGR) for the global SMX-TMP market is modest at 2-3% between 2023 and 2030[2], driven mainly by volume increases rather than price hikes. The expansion is primarily centered in Africa, Asia-Pacific, and Latin America, where infectious disease burdens remain high and healthcare infrastructure continues to improve.

Impact of Resistance and Stewardship

Resistance trends are likely to influence sales volume. Antimicrobial stewardship efforts might restrict over-prescription, reducing growth but encouraging optimized usage. Therefore, revenue stability rather than significant increases is anticipated.

Emerging Markets and Access Expansion

Growth in regions with historically low access to healthcare and antibiotics is forecasted to be a vital driver. Government initiatives and donor programs aiming to improve infectious disease treatment access could expand market size.

Research and Development

Current R&D focuses on novel combinations and formulations to address resistance. While these innovations may enhance efficacy, regulatory hurdles and high R&D costs suggest limited near-term impact on revenues.

Pricing Trends

Generic competition has led to aggressive price erosion globally. Price stabilization is unlikely without patent protections or formulation innovations offering added value.

Conclusion

The Sulfamethoxazole; Trimethoprim market appears resilient, supported by its established clinical role, affordability, and broad availability, particularly in emerging markets. However, the trajectory toward modest growth reflects constraints imposed by rising antimicrobial resistance, regulatory stewardship, and intense competition. Forward-looking strategies should prioritize resistance management, optimizing use, and exploring new indications to sustain or enhance revenue streams.

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Key Takeaways

• The global SMX-TMP market is characterized by high volume, low margin competition, with an anticipated CAGR of approximately 2-3% through 2030.
• Resistance development remains a significant challenge, potentially limiting future prescribing and revenue.
• Emerging markets present substantial growth opportunities, driven by increasing infectious disease burdens and expanding healthcare access.
• Competition from newer antibiotics and price erosion due to generic proliferation necessitate innovation, such as formulation improvements and new indications.
• Strategic focus on antimicrobial stewardship and global health initiatives can bolster access and demand, safeguarding the drug’s market position.

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FAQs

1. How does antimicrobial resistance impact the long-term market of Sulfamethoxazole; Trimethoprim?
Rising resistance reduces clinical efficacy, limiting prescriptions and constraining revenue growth. Continuous surveillance and stewardship are essential to prolong its utility in therapy.

2. What regions offer the greatest growth potential for SMX-TMP?
Emerging economies in Africa, Asia-Pacific, and Latin America exhibit high infectious disease burdens and increasing healthcare infrastructure, presenting significant growth opportunities.

3. Are there ongoing efforts to develop new formulations or combinations involving SMX-TMP?
Research explores alternative formulations, dosing regimens, and novel combinations to overcome resistance and improve pharmacokinetics, which might influence future markets.

4. How does generic competition influence SMX-TMP’s market?
Generics dominate supply, leading to price reductions and increased accessibility but also squeezing profit margins for manufacturers.

5. Can SMX-TMP be replaced by newer, more effective antibiotics?
While newer agents exist, cost and accessibility often favor SMX-TMP, especially in resource-limited settings. Its role will diminish only if resistance or safety issues impose insurmountable barriers.

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References

[1] MarketWatch. (2021). Sulfamethoxazole and Trimethoprim Drug Market Overview.
[2] GlobalData. (2022). Antibiotic Market Forecasts and Trends.