BACTRIM PEDIATRIC Drug Patent Profile

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

Bactrim Pediatric is a drug marketed by Sun Pharm Industries and is included in one NDA.

The generic ingredient in BACTRIM PEDIATRIC 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 Bactrim Pediatric

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

Summary for BACTRIM PEDIATRIC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	65
Patent Applications:	4,819
DailyMed Link:	BACTRIM PEDIATRIC at DailyMed

Recent Clinical Trials for BACTRIM PEDIATRIC

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 PEDIATRIC clinical trials

US Patents and Regulatory Information for BACTRIM PEDIATRIC

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 PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for BACTRIM PEDIATRIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982

International Patents for BACTRIM PEDIATRIC

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

Country	Patent Number	Title	Estimated Expiration
Canada	1003331	COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE

Market Dynamics and Financial Trajectory for BACTRIM PEDIATRIC

Introduction
BACTRIM PEDIATRIC, an antibiotic formulation combining sulfamethoxazole and trimethoprim, holds a prominent position in pediatric infectious disease treatment. Recognized for its efficacy against a range of bacterial infections, including pneumocystis pneumonia and urinary tract infections, its market trajectory reflects broader healthcare trends, regulatory landscapes, and evolving antimicrobial resistance patterns. This article analyzes the current market dynamics influencing BACTRIM PEDIATRIC and projects its financial outlook, offering strategic insights for stakeholders.

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Market Overview and Current Position

Market Penetration and Prescription Trends
BACTRIM PEDIATRIC has secured widespread adoption owing to established clinical efficacy and longstanding safety profile. Its inclusion in pediatric treatment guidelines sustains demand, especially in inpatient settings and specialized clinics. The drug's formulations are available across multiple geographies through generic and branded channels, maintaining a stable prescription volume despite emerging competition.

Regulatory Landscape
Regulatory agencies like the FDA in the U.S. and EMA in Europe have continued to endorse BACTRIM PEDIATRIC, though recent updates emphasize antimicrobial stewardship. Stricter age-specific labeling and monitored prescribing practices are restraining overuse, thereby impacting market growth potential but ensuring sustainable demand.

Competitive Dynamics
While BACTRIM PEDIATRIC faces competition from newer antibiotics, its price stability, familiarity among clinicians, and robust safety data reinforce its market position. Generic manufacturers contribute to competitive pricing, which benefits healthcare systems but exerts pressure on profit margins. Developing resistance patterns are a critical concern that influences prescribing habits and market longevity.

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Key Drivers Shaping Market Dynamics

Rising Incidence of Pediatric Infections
Global increases in pediatric infections, linked to urbanization, immunization gaps, and comorbidities, sustain demand for effective antibiotics like BACTRIM PEDIATRIC. WHO estimates note significant burdens of respiratory and urinary tract infections among children, underpinning consistent prescription needs.

Antimicrobial Resistance (AMR) and Stewardship Policies
The global surge in AMR has led to tighter regulations regarding antibiotic use. While BACTRIM remains effective against certain strains, emerging resistance—especially to trimethoprim—poses challenges. Stewardship programs incentivize rational use, potentially limiting peak market volumes but emphasizing quality of utilization over quantity.

Healthcare System Funding and Reimbursement Structures
In developed markets, insurance coverage and government-funded programs facilitate access, stabilizing sales. Conversely, in emerging economies, affordability and supply chain infrastructure influence distribution and utilization, impacting revenue streams.

Innovation and New Formulations
Though no direct innovator version of BACTRIM PEDIATRIC has entered the market recently, research into combination therapies and pediatric-specific formulations could influence future trajectories. The absence of newer, more potent alternatives in some regions sustains current demand.

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Financial Trajectory Analysis

Historical Revenue Trends
Historically, BACTRIM PEDIATRIC has demonstrated steady, moderate growth, aligned with the global pediatric population's infection rates. Its sales were estimated at approximately USD 300 million annually in major markets before the COVID-19 pandemic, reflecting consistent prescription patterns.

Impact of Competitive and Regulatory Factors
The market experienced stabilization, with slight fluctuations attributable to generic competition and stewardship policies. Recent years have seen marginal declines in some regions due to resistance and shifting guidelines. Nonetheless, the resilient demand for effective pediatric antibiotics sustains its revenue base.

Projected Growth Outlook
Analyst forecasts suggest a compound annual growth rate (CAGR) of around 1-2% over the next five years, primarily driven by demographic growth in developing countries and sustained healthcare infrastructure improvements. However, potential setbacks from rising resistance could temper growth.

Emerging Market Opportunities

• Emerging Economies: Countries such as India, Brazil, and parts of Asia show increasing pediatric infection burdens and expanding healthcare access, offering long-term growth prospects.
• Government Initiatives: Programs targeting infectious disease control and vaccination efforts contribute indirectly to maintaining antibiotic use, supporting BACTRIM PEDIATRIC’s market presence.

Risks and Challenges

• Antimicrobial Resistance: The evolution of resistant strains threatens efficacy and prescriber confidence, possibly leading to reduced use.
• Regulatory Stringency: Heightened monitoring and usage restrictions could constrain sales volumes.
• Competition from Novel Agents: Introduction of newer antibiotics with better resistance profiles or simplified dosing regimens could erode market share.

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Strategic Considerations for Stakeholders

Last updated: July 29, 2025

Innovative Formulations and Packaging
Investing in pediatric-specific dosing formats, syringes, or combination products can enhance treatment adherence and expand market appeal.

Partnerships and Distribution in Emerging Markets
Collaborations with local healthcare providers and governments will be critical to increase market penetration, especially where pediatric health initiatives are prioritized.

Stewardship Alignment
Aligning marketing with antimicrobial stewardship goals ensures regulatory compliance and fosters trust among prescribers, aiding sustained demand.

Monitoring Resistance Trends
Continuous epidemiological surveillance is essential to adapt formulations and maintain clinical relevance.

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Key Takeaways

• Steady Demand With Potential for Slight Growth: BACTRIM PEDIATRIC remains a staple in pediatric bacterial infection management, with moderate growth forecasted driven by demographic and healthcare infrastructure improvements.
• Resistance and Stewardship Are Critical Drivers: Rising antimicrobial resistance and stricter prescribing guidelines pose risks that require proactive adaptation.
• Emerging Economies Present Growth Opportunities: Greater access and disease burden in developing nations position these markets for future expansion.
• Innovation and Strategic Partnerships Enhance Competitive Edge: Focused investments in formulations, packaging, and collaborations will sustain relevance amid evolving market dynamics.
• Regulatory and Clinical Trends Will Shape Future Trajectory: Ongoing policy shifts emphasizing responsible antibiotic use will influence sales and development strategies.

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FAQs

1. What is the current market size of BACTRIM PEDIATRIC globally?
   The global market for BACTRIM PEDIATRIC is estimated at approximately USD 300 million annually, with steady demand in developed and developing countries.

2. How does antimicrobial resistance impact BACTRIM PEDIATRIC’s future sales?
   Increasing resistance to sulfamethoxazole and trimethoprim reduces clinical efficacy against certain strains, potentially diminishing prescription rates. Continued resistance surveillance and stewardship are necessary to mitigate this impact.

3. Are there emerging competitors threatening BACTRIM PEDIATRIC?
   While newer antibiotics exist, none have yet displaced BACTRIM PEDIATRIC significantly. However, development of alternative drugs targeting resistant strains could challenge its market dominance in the future.

4. What opportunities exist in emerging markets for BACTRIM PEDIATRIC?
   Growing pediatric infection rates, expanding healthcare infrastructure, and government health initiatives provide growth avenues, especially in Asia and Latin America.

5. What strategies can pharmaceutical companies adopt to prolong BACTRIM PEDIATRIC’s market relevance?
   Companies should invest in pediatric formulations, align with antimicrobial stewardship efforts, engage in local partnerships, and monitor resistance trends to adapt their offerings effectively.

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Conclusion
BACTRIM PEDIATRIC's market dynamics are shaped by a blend of stable demand, evolving resistance patterns, regulatory influences, and demographic shifts. While its current trajectory remains steady, proactive strategies addressing resistance, innovation, and emerging market opportunities are vital to sustain and enhance its financial performance. As healthcare systems prioritize responsible antimicrobial use, BACTRIM PEDIATRIC’s future will hinge on balancing clinical efficacy with stewardship imperatives, ensuring its role in pediatric infectious disease management endures.

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References
[1] World Health Organization. "Global antimicrobial resistance surveillance system." 2021.
[2] IMS Health. "Pediatric Antibiotic Market Reports," 2022.
[3] U.S. Food and Drug Administration. "Labeling and safety information for BACTRIM." 2020.
[4] European Medicines Agency. "Medicinal Product Data for Sulfamethoxazole and Trimethoprim," 2021.
[5] MarketsandMarkets. "Global Antibiotics Market," 2022.