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Last Updated: March 26, 2026

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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Questions you can ask:
  • What is the 5 year forecast for SULFAMETHOXAZOLE AND TRIMETHOPRIM?
  • What are the global sales for SULFAMETHOXAZOLE AND TRIMETHOPRIM?
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Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM
US Patents:0
Applicants:31
NDAs:46
Finished Product Suppliers / Packagers: 43
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 163
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
McGill University Health Centre/Research Institute of the McGill University Health CentrePHASE4
Hospital Civil de GuadalajaraPHASE2

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Interpharm SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 071299-001 Oct 27, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Watson Labs SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 070000-001 Nov 7, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vista Pharms SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 076817-001 Oct 7, 2005 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Able SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim TABLET;ORAL 021105-001 Jun 26, 2001 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roxane SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH sulfamethoxazole; trimethoprim TABLET;ORAL 072769-001 Aug 30, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glenmark Pharms Ltd SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 090828-002 Dec 22, 2010 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: March 1, 2026

What is the current market landscape for sulfamethoxazole and trimethoprim?

The combination drug, commonly marketed as Bactrim or Septra, remains a key antibiotic for treating bacterial infections such as urinary tract infections, Pneumocystis pneumonia, and certain gastrointestinal infections. Production is predominantly handled by Pfizer, although generic versions are available from multiple manufacturers. The global market for this combination was valued at approximately $280 million in 2022, with a compound annual growth rate (CAGR) of 3.2% projected through 2027 (Fortune Business Insights, 2023).

The drug's patent protections expired over a decade ago, leading to widespread generic availability. This diminished patent exclusivity has resulted in price erosion, pressuring revenue streams for branded manufacturers.

How do current market influences impact revenue and pricing?

Patent expiry and generic competition

The loss of exclusivity in the early 2010s prompted significant price declines. Despite this, demand stabilizes because of clinical reliance on the drug's efficacy and affordability, especially in developing markets.

Regulatory approvals and importation policies

Regulatory bodies, including the FDA and EMA, have maintained the drug’s status as an essential medicine. Governments in emerging markets often regulate pricing to keep medication affordable, which caps profit margins.

Clinical guidelines and antimicrobial stewardship

Stringent guidelines to combat antibiotic resistance influence prescribing patterns. The CDC and WHO advocate cautious use of sulfamethoxazole-trimethoprim to prolong effectiveness, potentially reducing volume growth in high-resistance areas.

Emerging resistance and treatment efficacy

Increasing resistance, particularly in urinary pathogens, threatens future demand. Resistance rates have risen from less than 5% in the early 2000s to approximately 20% in some regions (CDC, 2022). This trend may lead to reduced prescribing and increased reliance on alternative antibiotics.

Supply chain considerations

Raw material shortages, especially of active pharmaceutical ingredients (APIs), have intermittently disrupted supply. Environmental concerns connected to chemical manufacturing have prompted stricter regulations, influencing production costs.

What financial projections derive from current trends?

Revenue forecasts

Based on market stability and demand continuity, the global revenue for sulfamethoxazole and trimethoprim is projected to reach $310 million by 2027. The CAGR of 3.2% is driven by steady demand in mature markets and growth in developing nations, where access to affordable antibiotics remains critical.

Price trends

Prices have declined by an average of 2-4% annually since patent expiration. Future price reductions may slow but could accelerate if resistance prompts the development and adoption of new combinations or formulations.

R&D investment and pipeline status

No recent approvals of new formulations or combination variants are under regulatory review. Limited R&D activity suggests ongoing reliance on established molecules.

Competitive landscape

The market is fragmented primarily among generics producers. No dominant brand has re-entered patent protection or introduced a significantly improved formulation in recent years.

How does the broader antimicrobial market influence this drug’s trajectory?

The global antimicrobial market was valued at approximately $44 billion in 2022, with a projected CAGR of 3.8% through 2027 (Fortune Business Insights, 2023). Sulfamethoxazole and trimethoprim occupy a niche within broad-spectrum antibiotics but face competition from newer agents active against resistant strains, such as carbapenems and novel beta-lactam/beta-lactamase inhibitor combinations.

What are the key market risks and opportunities?

Risks

  • Rising antimicrobial resistance reduces efficacy.
  • Supply chain disruptions inflate costs.
  • Regulatory policies favoring antimicrobial stewardship could restrict use.
  • Emerging resistance may accelerate shifts toward newer drugs, diminishing demand.

Opportunities

  • Expanding access in low-income countries, where affordability remains critical.
  • Developing combination formulations to combat resistance.
  • Incorporating diagnostics to optimize prescribing and extend drug utility.

Summary table: Market Snapshot (2022–2027)

Aspect 2022 Projection Notes
Market value $280 million $310 million CAGR 3.2%
Price decline 2–4% annually Continuous Due to generic competition
Resistance rates <5% in early 2000s ~20% in some regions Affects demand
R&D activity Limited No significant new filings Reliance on existing formulations

Key Takeaways

  • The sulfamethoxazole–trimethoprim market remains stable but slow-growing, primarily driven by generics and affordability.
  • Resistance development poses long-term risks to demand.
  • Price erosion continues, but demand persists in emerging markets.
  • No significant recent R&D has occurred, indicating reliance on established pharmaceuticals.
  • Supply chain issues and stewardship policies influence future market dynamics.

FAQs

Q1: How much revenue does sulfamethoxazole and trimethoprim generate annually?
Approximately $280 million globally in 2022, with a projection reaching $310 million by 2027.

Q2: What is the primary factor driving price declines?
Patent expirations and generic competition have led to annual price drops averaging 2–4%.

Q3: How has antimicrobial resistance affected the drug’s market?
Resistance rates have increased from under 5% to about 20% in some regions, potentially limiting prescribing and reducing future sales.

Q4: Are there new formulations or combination drugs in development?
No significant R&D activity is reported; the market continues to rely on existing formulations.

Q5: What are the main risks facing the market?
Resistance, supply chain disruptions, and policy restrictions on antibiotic use.


References

  1. Fortune Business Insights. (2023). Global Antimicrobial Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com/industry-reports/antimicrobial-market
  2. Centers for Disease Control and Prevention (CDC). (2022). Antimicrobial Resistance Threats Report.
  3. World Health Organization (WHO). (2019). Global Priority List of Antibiotic-Resistant Bacteria.

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