BACTRIM Drug Patent Profile

Which patents cover Bactrim, and when can generic versions of Bactrim launch?

Bactrim is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bactrim

A generic version of BACTRIM was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25^th, 1986.

Summary for BACTRIM

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	65
Drug Prices:	Drug price information for BACTRIM
DailyMed Link:	BACTRIM at DailyMed

See drug prices for BACTRIM

Recent Clinical Trials for BACTRIM

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

Sponsor	Phase
Hospital Civil de Guadalajara	PHASE2
Ohio State University	PHASE4
Johns Hopkins University	Early Phase 1

See all BACTRIM clinical trials

Pharmacology for BACTRIM

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

US Patents and Regulatory Information for BACTRIM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for BACTRIM

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

International Patents for BACTRIM

See the table below for patents covering BACTRIM around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1003331	COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE
Sweden	348112
United Kingdom	1176395
Israel	27876	INJECTABLE COMPOSITIONS CONTAINING A SALT OF A THERAPEUTIC SULFONAMIDE AND A BASICALLY REACTING SULFONAMIDE-POTENTIATOR
Belgium	698102
Japan	S5017524

Market Dynamics and Financial Trajectory for BACTRIM (Trimethoprim-Sulfamethoxazole)

Last updated: July 28, 2025

Introduction

BACTRIM, a combination antibiotic comprising trimethoprim and sulfamethoxazole, remains a cornerstone in antimicrobial therapy since its inception. Approved for the treatment and prevention of various bacterial infections, BACTRIM's market landscape is influenced by evolving microbial resistance, regulatory policies, competitive products, and shifting physician prescribing patterns. Understanding these elements is essential for stakeholders assessing its current market position and future financial outlook.

Historical Market Context and Product Profile

Introduced in the 1960s, BACTRIM quickly became a frontline agent against urinary tract infections (UTIs), Pneumocystis pneumonia, and other bacterial infections. Its broad-spectrum efficacy, oral bioavailability, and cost-effectiveness fostered widespread adoption across healthcare settings. Nonetheless, concerns regarding adverse effects, resistance development, and newer antimicrobial agents have shaped its long-term utilization patterns (1).

Market Dynamics

1. Resistance Trends and Therapeutic Viability

Antimicrobial resistance (AMR) significantly influences BACTRIM's market trajectory. Resistance rates have escalated in pathogens such as E. coli, Klebsiella pneumoniae, and Staphylococcus aureus. Studies indicate that approximately 20-30% of urinary isolates exhibit resistance, particularly in community settings (2). This diminishes the drug’s efficacy and restricts its indications, prompting clinicians to favor alternative agents in resistant scenarios.

2. Regulatory and Safety Considerations

Regulatory agencies, including the FDA and EMA, have issued warnings regarding BACTRIM’s adverse effects such as hypersensitivity, hematologic issues, and renal toxicity (3). These safety concerns lead to cautious prescribing, especially among vulnerable populations like pregnant women and immunocompromised individuals. Regulatory restrictions or revised labeling can impact market volumes.

3. Emergence of Novel Antibiotics

The development pipeline features newer agents like fosfomycin, nitrofurantoin, and advanced cephalosporins capable of countering resistant strains. Market penetration of such alternatives, supported by improved safety profiles and efficacy, positions BACTRIM as a secondary or reserved option, thereby constraining its growth.

4. Prescribing Trends and Usage Patterns

Despite resistance challenges, BACTRIM maintains an essential role in prophylaxis for pneumocystis pneumonia among HIV/AIDS patients and in certain endemic regions. Conversely, declining use for common UTIs due to resistance and safety issues shifts prescribing toward other classes. Empirical data from the CDC suggest a gradual decline in outpatient BACTRIM prescriptions in North America (4).

5. Geographic Variability

Developing countries, with limited access to newer antimicrobials and higher burden of infectious diseases, continue to rely heavily on BACTRIM. This regional disparity influences global market dynamics, with a steady demand in endemic areas versus stagnation or decline in high-income countries.

Financial Trajectory

1. Revenue Trends

Global sales of BACTRIM reached approximately USD 600 million in recent years, with North America accounting for around 50% due to high usage for pneumocystis prophylaxis (5). Market analysts project a compound annual growth rate (CAGR) of approximately -2% over the next five years, mainly driven by declining usage in community-acquired infections.

2. Impact of Patent and Formulation Variations

Biosimilar versions and generic formulations have fragmented the market, increasing accessibility and reducing costs. The expiry of patent protections in key regions has spurred price competition, compressing profit margins for pharmaceutical companies.

3. Potential Growth Opportunities

Despite challenges, niche indications such as multidrug-resistant infection management, combined with rising antibiotic stewardship programs, could stabilize or create niche markets. Additionally, innovative formulations—such as sustained-release variants—may regain clinician interest, supporting incremental revenues.

4. Contractual and Reimbursement Landscape

Reimbursement policies favor cost-effective antibiotics, benefiting generic BACTRIM formulations. Conversely, stricter regulatory controls or formulary restrictions could hinder market expansion.

Future Outlook

Forecasting BACTRIM’s financial trajectory hinges on multiple factors:

• Resistance Dynamics: Rising resistance compels alternative therapies, diminishing BACTRIM's frontline role.
• Regulatory Actions: Safety warnings and label changes refine its prescribing profile.
• Emerging Therapies: New antibiotics, especially in the pipeline targeting resistant pathogens, threaten market share.
• Global Health Strategies: In endemic regions, persistent reliance ensures continued revenue, albeit at moderated levels internationally.
• Patent and Price Erosion: Generic proliferation ensures competitive pricing but limits potential for high-margin sales.

Consolidating these elements, stakeholders anticipate a continued decline in BACTRIM’s global sales, with revenues stabilizing in niche markets.

Key Takeaways

• Resistance and safety issues are primary determinants constraining BACTRIM's market growth.
• Emerging antimicrobial options have replaced BACTRIM in many indications, particularly in high-income regions.
• Generic producers and patent expirations have driven down costs, positively influencing accessibility but pressuring margins.
• Regional disparities persist, with developing nations maintaining consistent demand.
• Innovation and stewardship programs might sustain niche markets, offering incremental revenue opportunities.

FAQs

Q1: How does antimicrobial resistance impact BACTRIM’s market?
A: Resistance diminishes BACTRIM’s efficacy against common pathogens, leading clinicians to favor alternative antibiotics, thereby reducing demand and sales.

Q2: What safety concerns have affected BACTRIM’s usage?
A: Adverse effects such as hypersensitivity reactions, hematologic toxicity, and renal impairment have prompted cautious prescribing and regulatory warnings, influencing its market position.

Q3: Are there regional variations in BACTRIM’s market?
A: Yes. While high-income countries see declining use, developing regions continue to depend heavily on BACTRIM due to limited access to newer antibiotics.

Q4: What role do generics play in BACTRIM’s financial landscape?
A: Generic formulations have increased competition and lowered prices, expanding access but reducing revenue margins for original manufacturers.

Q5: What future opportunities exist for BACTRIM?
A: Niche indications, combination therapies, and formulation innovations, alongside sustained use in endemic regions, offer potential pockets of growth amid overall decline.

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Sources:

1. CDC. Antibiotic resistance threats in the United States, 2019.
2. Li et al. Emerging resistance in urinary pathogens: implications for therapy. Clin Infect Dis. 2020.
3. FDA. Drug safety communications for BACTRIM.
4. IMS Health. Antibiotic prescription trends in North America. 2021.
5. GlobalData. Antibiotic market report, 2022.