Last Updated: May 11, 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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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
Patent Applications: 5,868
What excipients (inactive ingredients) are in SULFAMETHOXAZOLE AND TRIMETHOPRIM?SULFAMETHOXAZOLE AND TRIMETHOPRIM excipients list
DailyMed Link:SULFAMETHOXAZOLE AND TRIMETHOPRIM at DailyMed
Recent Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM

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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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SULFAMETHOXAZOLE AND TRIMETHOPRIM: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

Sulfamethoxazole and trimethoprim (SMX-TMP, often marketed as co-trimoxazole) is a long-standing, high-generic-share antibiotic. Market dynamics are dominated by (1) off-patent pricing and extensive generic competition, (2) formulary and stewardship-driven volume stability, (3) periodic guideline-driven demand shifts across UTI and Pneumocystis jirovecii pneumonia (PJP) indications, and (4) supply-chain and raw-material cost pass-through rather than innovation-driven pricing.

Is the product still a meaningful commercial revenue driver?

Yes, but the revenue base is tied to volume, not pricing power. SMX-TMP is widely genericized globally, which compresses price per unit and limits margin expansion.

Revenue architecture in mature antibiotic markets

  • Competitive structure: multiple generic manufacturers in most regulated markets.
  • Price formation: dominated by tendering, reference pricing, and payer formularies.
  • Value proposition: low acquisition cost per course, broad indication coverage (with exceptions by region and resistance patterns).

What this implies for financial trajectory

  • Revenue growth is constrained by unit economics: higher volumes are required to outpace price compression.
  • Growth opportunities come from care-setting mix (outpatient vs hospital), guideline adherence, and formulary inclusion, not from premium pricing.

What drives demand for SMX-TMP?

Demand concentrates in two main lanes: common bacterial infections (where susceptibility supports use) and opportunistic infections in immunocompromised populations.

Core demand channels

  1. Urinary tract infections and other community bacterial infections

    • Uptake depends on local resistance trends to sulfonamides and trimethoprim.
    • Empiric use is sensitive to antibiogram shifts and payer restrictions.
  2. PJP prophylaxis and treatment

    • Oncology, transplant, and HIV-associated care drive recurring prophylaxis demand where used.
    • PJP guideline adherence moves baseline volume more than minor product-line changes.

Payer and stewardship influence

  • Formularies and antibiotic stewardship programs can restrict broad empiric use or require prior authorization.
  • In many systems, SMX-TMP holds a “first-line or preferred” position where resistance allows, which supports volume even when prices fall.

How do pricing and competition shape the market?

SMX-TMP is a classic low-innovation, high-generic-penetration segment where competitive intensity typically forces sustained price pressure.

Competition profile

  • Multiple generic entrants with interchangeable dosing forms (oral and injectable where available).
  • Hospital purchasing via tenders often selects by lowest total cost and supply reliability rather than brand differentiation.

Price behavior typical for off-patent antibiotics

  • Downward pressure from reference pricing and generic erosion.
  • Margin volatility when raw-material costs shift or when supply is constrained.

What does the utilization mix suggest about revenue stability?

Revenue stability tends to track care continuity rather than new prescribing behaviors.

Stability indicators

  • Chronic or recurring use settings: PJP prophylaxis is often ongoing in at-risk cohorts.
  • Broad-spectrum but resistance-aware positioning: even when use is restricted by resistance, SMX-TMP often remains an option rather than disappearing.

Downside risks to volume

  • Rising resistance can reduce prescribing for UTIs and other community infections.
  • Stewardship restrictions can shift patients to alternative agents even if SMX-TMP remains clinically viable.

Which regulatory and safety signals affect commercial demand?

Regulatory actions for antibiotics often influence labeling, contraindications, and risk management. For SMX-TMP, commercial effects generally materialize through prescriber behavior and payer coverage.

Key safety-relevant considerations that affect adoption

  • Hypersensitivity reactions and severe adverse events can lead to more conservative prescribing in certain populations.
  • Renal impairment dosing adjustments and drug interaction considerations can narrow use in frail or polypharmacy-heavy patients.

These dynamics typically affect who is prescribed SMX-TMP, not whether it is broadly available.

How does manufacturing and supply impact the trajectory?

In mature antibiotics, supply reliability can cause short-term price and volume swings, especially in hospital systems.

Operational drivers

  • API and intermediate availability for sulfonamide and trimethoprim production.
  • Regulatory batch release cadence and quality-system performance.
  • Transport and storage constraints for different dosage forms.

When supply is tight, hospitals may switch to alternatives; when supply normalizes, utilization can partially rebound, but not always to prior levels if resistance or stewardship thresholds have moved.

What does the financial trajectory look like across time horizons?

Without patent-driven premium pricing, the long-term financial trajectory typically reflects a “volume-maintenance with price compression” pattern.

Short-term (1-2 years)

  • Revenue and profit are primarily influenced by:
    • tender pricing and payer reimbursement cycles
    • localized resistance-driven prescribing shifts
    • supply events (availability of key dosage forms)

Medium-term (3-5 years)

  • Expect continued pressure from:
    • additional generic entries in some geographies
    • increased competition from alternative cheap antibiotics when resistance rises
  • Medium-term growth typically does not come from new claims because the product is mature.

Long-term (5-10 years)

  • The long-term base case is:
    • continued low unit pricing
    • stable demand where guideline-supported indications persist (notably prophylaxis)
  • The principal structural risk is microbiology: sustained resistance changes can materially reduce suitable patient populations.

How should investors and R&D planners interpret the economics?

SMX-TMP commercial value is best evaluated as a distribution and tender execution business rather than as a product innovation story.

Business implications

  • Differentiation is operational: reliable supply, stable manufacturing costs, and fast tender responsiveness.
  • Profit pools are often concentrated among manufacturers with scale advantages and stable input cost structures.
  • Market share changes come from procurement outcomes and supply reliability more than from clinical differentiation.

R&D implications

Given the maturity and genericization, R&D spend typically shifts to:

  • new formulations or dosing optimizations
  • line extensions that improve tolerability or adherence
  • combination strategies or resistance-modulating approaches

What market indicators matter most for monitoring?

For decision-grade monitoring, track indicators that translate into procurement and prescribing behavior.

High-signal indicators

  • Formulary status in major payer systems for UTI and prophylaxis indications.
  • Local antibiogram trends for sulfonamide and trimethoprim susceptibility.
  • Procurement pricing benchmarks (tender price per course, not just per tablet).
  • Hospital inventory availability and distribution fill rates.

How does SMX-TMP compare with alternative therapies in commercial terms?

Alternative antibiotics often compete on:

  • resistance-driven empiric placement
  • safety profile in specific populations
  • cost per treated patient

In off-patent segments, the “winner” is often the lowest total cost option that maintains acceptable outcomes within stewardship constraints.

Competitive positioning summary

  • SMX-TMP tends to win where:
    • susceptibility remains acceptable
    • guideline placement keeps it in preferred tiers
    • procurement costs are competitive
  • SMX-TMP tends to lose where:
    • resistance reduces efficacy enough to shift practice
    • safety constraints drive prescribing away from TMP-SMX
    • formulary restrictions require prior authorization or restrict use

Key Takeaways

  • SMX-TMP is a mature, broadly genericized antibiotic market where pricing power is limited and revenue tracks volume and procurement.
  • Demand centers on PJP prophylaxis/treatment and community bacterial infections, with guideline and resistance trends determining prescribing intensity.
  • The financial trajectory follows “volume stability with price compression,” with short-term volatility driven by tender dynamics and supply constraints.
  • Commercial differentiation is operational (supply reliability, manufacturing cost control, tender execution), while long-term risk is primarily microbiology-driven.

FAQs

1) Is SMX-TMP’s market growth innovation-led or volume-led?

Volume-led. In off-patent antibiotics, revenue growth depends on utilization and formulary position, not new patent-protected innovation.

2) What typically causes SMX-TMP to lose share?

Sustained resistance shifts and stewardship/formulary restrictions that steer empiric therapy toward alternatives, reducing eligible patient populations.

3) What typically causes short-term revenue swings?

Tender price resets, payer reimbursement cycle timing, and supply constraints that disrupt hospital ordering and shift procurement to alternatives.

4) Which indications most strongly anchor baseline demand?

PJP prophylaxis and treatment in immunocompromised populations, plus community infections where susceptibility supports use.

5) How should procurement and pricing be analyzed for SMX-TMP?

Evaluate pricing on a course basis within tender and formulary frameworks, then correlate with antibiogram trends that drive eligible utilization.


References

[1] FDA. “Sulfamethoxazole and Trimethoprim.” Drug Label Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] WHO. WHO Model Formulary for Children: Medicines for Children. World Health Organization. https://apps.who.int/iris/
[3] IDSA. Clinical Practice Guidelines and Antibiotic Stewardship Resources. Infectious Diseases Society of America. https://www.idsociety.org/
[4] National Library of Medicine (NLM). Drugs@FDA / PubChem / Drug Label and Mechanism References for SMX-TMP. https://pubchem.ncbi.nlm.nih.gov/

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