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Last Updated: December 15, 2025

COTRIM D.S. Drug Patent Profile


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When do Cotrim D.s. patents expire, and what generic alternatives are available?

Cotrim D.s. is a drug marketed by Teva and is included in one NDA.

The generic ingredient in COTRIM D.S. 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.

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Summary for COTRIM D.S.
Drug patent expirations by year for COTRIM D.S.
Recent Clinical Trials for COTRIM D.S.

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

SponsorPhase
Roswell Park Cancer InstitutePhase 4
National Cancer Institute (NCI)Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4

See all COTRIM D.S. clinical trials

US Patents and Regulatory Information for COTRIM D.S.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva COTRIM D.S. sulfamethoxazole; trimethoprim TABLET;ORAL 070048-001 Mar 18, 1985 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 COTRIM D.S.

Last updated: August 9, 2025


Overview of COTRIM D.S.

COTRIM D.S., a fixed-dose combination medicine, primarily contains sulfamethoxazole and trimethoprim. Its indication spans bacterial infections, notably urinary tract infections, respiratory infections, and gastrointestinal infections. Its popularity stems from broad-spectrum efficacy, affordability, and established clinical use, making it a staple in many therapeutic areas.


Market Landscape

Global Market Size & Growth

The global antibacterial drugs market, which encompasses COTRIM D.S., was valued at approximately USD 30 billion in 2022 and is projected to reach USD 45 billion by 2030, growing at a compound annual growth rate (CAGR) of roughly 5.2% [1]. This growth driven by increasing antibiotic use, rising bacterial resistance, and expanding healthcare infrastructure in emerging economies.

Geographic Dynamics

  • North America: Holds the largest share due to high healthcare expenditure, established pharmaceutical manufacturing; characterized by mature markets with steady demand.

  • Europe: Significant market presence, driven by aging populations and antibiotic consumption.

  • Asia-Pacific: Fastest-growing segment with a CAGR surpassing 7%, fueled by increasing infectious disease prevalence, expanding healthcare access, and affordability.

  • Latin America and Africa: Growing markets with increasing demand, but impacted by regulatory challenges and supply chain issues.

Market Drivers

  • Antibiotic Resistance: Growing bacterial resistance pushes for sustained use of existing antibiotics like COTRIM D.S., though also risking diminished efficacy over time.

  • Infectious Disease Burden: Rising cases globally, especially in developing nations, bolsters demand.

  • Regulatory Approvals & Off-label Uses: Expanding approvals for new indications or markets extend commercial potential.

Market Challenges

  • Antimicrobial Stewardship: Efforts to curb misuse and overuse threaten sales volume.

  • Regulatory Scrutiny: Stringent approval processes and ongoing safety monitoring may slow market expansion.

  • Generic Competition: Multiple generics reduce prices, compress margins for branded or patent-holding entities.

  • Resistance Development: Rising resistance reduces drug effectiveness, necessitating combination therapies or new formulations.


Competitive & Patent Landscape

COTRIM D.S. is a generic medication with widespread formulation patents expired in many jurisdictions. Competition is intense, with numerous pharmaceutical companies manufacturing similar formulations. Efforts for novel delivery systems or combination enhancements are underway to distinguish offerings [2].

Emerging alliances with local distributors and collaborations in emerging markets foster wider reach. However, patent expiries and regulatory challenges threaten market exclusivity.


Regulatory & Patent Trajectory

COTRIM D.S. faces minimal patent protection due to its age, with most formulations classified as off-patent. Regulatory pathways differ across regions, with some jurisdictions requiring local clinical data to obtain approval for domestic manufacturing or distribution.

Patent expiries in several markets have triggered a surge in generic manufacturing, intensifying price competition [3].


Financial Trajectory & Revenue Outlook

Historical Performance

COTRIM D.S., owing to its established generic status, has experienced stable revenue streams in major markets, with margins dictated by manufacturing costs and pricing pressures. In developed markets, revenue growth remains steady but slow due to market saturation and stewardship programs.

Projected Revenue Trends

  • Short-Term (1-3 years): Stable revenues driven by existing formulations; slight growth in emerging markets as infectious diseases proliferate.

  • Medium to Long-Term (3-7 years): Potential decline in mature markets due to antimicrobial resistance and stewardship measures; however, increased penetration in underserved regions could offset this.

  • Innovation and Formulation Enhancements: Introduction of fixed-dose combinations or new delivery methods may create niche growth opportunities.

Pricing & Profitability

Prices are under downward pressure globally [4]. Cost reductions via optimized manufacturing can maintain margins, while marketing and distribution costs influence profitability.


Future Opportunities and Risks

Opportunities

  • Expansion into New Markets: Developing countries and regions with increasing healthcare infrastructure offer growth avenues.

  • Development of Novel Formulations: Sustained-release or combination therapies can extend product life cycles.

  • Biosimilar & Line Extensions: Potential development of biosimilars or new indications can provide long-term revenue.

Risks

  • Emergence of Resistance: Diminished clinical efficacy threatens market viability.

  • Regulatory Barriers: Changes in approval processes and safety standards.

  • Healthcare Policy Changes: Antibiotic stewardship policies increasingly favor restricted use, constraining sales.

  • Competitive Patent Litigation: Threatening market exclusivity.


Conclusion & Strategic Outlook

COTRIM D.S. remains a resilient product within the antibiotics market landscape, primarily driven by its cost-effectiveness and broad clinical utility. However, its financial trajectory faces headwinds from evolving resistance patterns, regulatory landscapes, and aggressive generic competition. Strategic focus on market expansion, formulation innovation, and adherence to stewardship principles will be critical for maintaining its market position.


Key Takeaways

  • The global antibacterial drugs market is steadily expanding, with emerging markets serving as pivotal growth hubs for COTRIM D.S.

  • Patent expiries and generic manufacturing density compress margins but also facilitate widespread availability and affordability.

  • Rising antimicrobial resistance presents both challenges and opportunities, necessitating innovation and strategic adaptation.

  • Geographic diversification, especially expanding into underserved regions, offers substantial growth potential.

  • Sustainable profitability depends on balancing competitive pricing, regulatory compliance, and product differentiation through formulation improvements.


FAQs

  1. What are the main therapeutic indications for COTRIM D.S.?
    It is primarily used for bacterial infections such as urinary tract infections, respiratory infections, and gastrointestinal infections caused by susceptible organisms.

  2. How does antimicrobial resistance impact COTRIM D.S. market prospects?
    Resistance reduces its clinical efficacy, which can lead to decreased utilization. Nevertheless, resistance patterns also create demand for alternative therapies, keeping COTRIM D.S. relevant where it remains effective.

  3. Are there upcoming regulatory hurdles for COTRIM D.S.?
    Future hurdles include evolving safety standards, approval processes for new formulations, and regulations aimed at antimicrobial stewardship to prevent misuse.

  4. What competitive strategies are effective in the current market?
    Industry players focus on developing novel formulations, expanding into emerging markets, forging local partnerships, and optimizing supply chains to maintain competitiveness.

  5. Can COTRIM D.S. benefit from innovation-driven growth?
    Yes. Innovations like sustained-release formulations, fixed-dose combinations with newer agents, or formulation improvements can create new revenue streams.


Sources

[1] MarketsandMarkets. "Antibiotics Market by Type, Disease, and Region," 2022.

[2] GlobalData Healthcare. "Antibiotics Market Analysis," 2023.

[3] U.S. Patent and Trademark Office. Public records on patent expirations.

[4] IQVIA. "Pharmaceutical Pricing Trends," 2022.

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