Last Updated: May 11, 2026

SULFATRIM Drug Patent Profile


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When do Sulfatrim patents expire, and what generic alternatives are available?

Sulfatrim is a drug marketed by Pharm Assoc and Superpharm and is included in three NDAs.

The generic ingredient in SULFATRIM 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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Recent Clinical Trials for SULFATRIM

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SponsorPhase
Roswell Park Cancer InstitutePhase 4
National Cancer Institute (NCI)Phase 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 3

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US Patents and Regulatory Information for SULFATRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc SULFATRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615-002 Jan 7, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Superpharm SULFATRIM-SS sulfamethoxazole; trimethoprim TABLET;ORAL 070065-002 Jun 24, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615-001 Jan 7, 1983 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Superpharm SULFATRIM-DS sulfamethoxazole; trimethoprim TABLET;ORAL 070066-001 Jun 24, 1985 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

SULFATRIM: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is SULFATRIM in commercial terms?

SULFATRIM is a brand for the fixed-dose antibacterial combination trimethoprim + sulfamethoxazole (TMP-SMX), typically marketed as an oral formulation (tablets/suspension) for bacterial infections. In most markets, TMP-SMX is an established, off-patent antimicrobial class with extensive generic competition.

How do market dynamics shape pricing and demand?

1) Class-level demand is steady, branded share is not

TMP-SMX has long-standing clinician acceptance for common bacterial indications (for example, urinary tract infections and certain skin or respiratory infections) and is widely stocked in formularies. For brand holders, the market dynamic is dominated by:

  • Generic substitution: once branded exclusivity ends, pricing pressure drives share into lower-cost generics.
  • Low differentiation: efficacy is class-defined; formulation tweaks matter less than price and availability.
  • Payer-driven switching: formularies and pharmacy benefit rules favor least-cost TMP-SMX options.

2) Safety and resistance constraints limit upside

TMP-SMX demand does not grow freely because it faces:

  • Adverse event scrutiny (for example, hypersensitivity and renal effects in susceptible patients), which can shift prescribing toward alternatives.
  • Resistance dynamics in certain pathogens and geographies, which can steer empiric therapy away from TMP-SMX in specific resistance settings. The net effect is a mature-market ceiling: volume tends to be stable or modestly declining as stewardship and alternative antibiotics expand.

3) Supply chain and manufacturing capacity are meaningful

TMP-SMX is produced by many manufacturers globally. In mature markets, financial outcomes correlate with:

  • Generic supply stability (risk of shortages lifts pricing temporarily; stability compresses margins).
  • Regulatory lot release and quality performance, which affects tenders and hospital contracting.

4) Distribution structure drives realized revenue

SULFATRIM’s revenue trajectory typically depends less on brand marketing and more on:

  • Institutional tender outcomes (hospital procurement is price-led),
  • National procurement cycles (quarterly timing can create step-changes in revenue),
  • Channel mix (retail vs institutional).

How has the financial trajectory typically evolved for TMP-SMX brands like SULFATRIM?

1) Branded phase transitions into generic-led economics

For TMP-SMX brand portfolios, a common trajectory is:

  • Early branded growth after launch, built on clinical recognition and payor coverage.
  • Midlife stagnation as competing brands enter.
  • Post-exclusivity decline in both:
    • Volume share (switching to generics)
    • Gross margin (continued price compression, higher promotional pressure for remaining differentiation)

Given TMP-SMX’s long history and broad generic availability, SULFATRIM is best viewed as a mature brand with limited growth headroom rather than a high-growth specialty product.

2) Revenue becomes volume-sensitive and margin-light

As branded share declines, realized revenue becomes a function of:

  • Contracted volumes (often at lower net prices),
  • Loss of premium pricing versus generics,
  • Higher selling costs to defend remaining share.

For investors and R&D planners, the financial model is typically:

  • low to flat top-line growth
  • declining operating margins unless the brand holder maintains manufacturing cost advantages or niche channel access

3) Conversion to “defend-and-license” economics

In many mature antibiotic markets, brand holders pivot from growth investment to:

  • Defending formulary position via price and service
  • Contract manufacturing or licensing models where brand revenue is stabilized but upside is capped

What does this mean for near- to mid-term financial outlook?

Base case: stable demand, erosion of unit economics

For a TMP-SMX brand, the near-term outlook typically has three steady forces:

  1. Demand stability from continuing clinical use and broad guideline inclusion in certain settings.
  2. Ongoing generic price competition that limits net price growth.
  3. Formulary and stewardship-driven shifts that can move some prescribing to alternatives.

The combined effect usually creates:

  • flat to declining net revenue
  • stable or slightly declining volumes
  • margin compression after brand share erosion

Upside scenarios that actually move numbers

Financial upside for SULFATRIM would most plausibly come from:

  • temporary supply disruptions among generics that lift pricing and stabilize gross margin
  • new formulary wins (tender cycles with price advantages)
  • regulatory or quality events that reduce effective generic supply in specific countries

Downside scenarios

Downside usually comes from:

  • renewed generic entry or aggressive pricing by dominant generic suppliers
  • shifts in clinical guidance in key indications
  • safety communication impacts that reduce prescribing intensity

How should business teams model financial trajectory for SULFATRIM?

Modeling framework for a mature TMP-SMX brand

Use a 3-part model rather than a single growth curve:

1) Net price path

  • Start with current net price to payer/channel
  • Apply expected annual generic undercutting (model as a declining price trend)
  • Include tender-driven discontinuities

2) Volume and share path

  • Link volume to category-level utilization (stable with stewardship variability)
  • Apply brand share drift toward generics
  • Capture channel mix effects (hospital tends to switch faster than retail)

3) Gross margin and operating costs

  • Include margin step-down from price erosion
  • Model promotional/sales intensity as defensive spend
  • Incorporate manufacturing cost trends and regulatory lot costs

Key KPI set

  • Brand net revenue (by channel: retail vs institutional)
  • Brand unit volume and market share vs generics
  • Average net price (after rebates, discounts, tender terms)
  • Gross margin after manufacturing and compliance cost loads
  • Formulary status metrics (institutional contracting coverage)

Competitive landscape and its direct financial implications

Generic saturation is the primary competitor

For TMP-SMX, the dominant competitive factor is not new clinical entrants but multi-supplier generic availability that:

  • reduces brand pricing power
  • increases substitution rates at pharmacy and institution levels
  • compresses expected ROIC for incremental marketing investment

Therapeutic alternatives cap pricing latitude

Even if TMP-SMX remains clinically relevant, alternatives compete in many settings:

  • other oral antibiotics
  • different treatment pathways in guidelines That dynamic constrains price increases and creates variability in seasonal or indication-specific demand.

Where are the volatility points?

SULFATRIM financial outcomes typically become lumpy around:

  • tender award timing and contract renewals
  • regional supply changes
  • regulatory actions that affect specific manufacturers’ ability to ship product

For budgeting, treat these as event-driven changes rather than smooth quarterly trends.

Key Takeaways

  • SULFATRIM is a mature TMP-SMX brand operating in a generic-saturated antimicrobial market with pricing dominated by substitution and tenders.
  • Demand is generally stable to modestly declining, while net price and margins erode as branded share shifts to lower-cost generics.
  • Financial trajectory is best modeled as net price decline + brand share drift, with volatility tied to institutional contracting and supply disruptions.
  • Near- to mid-term upside is limited and most likely event-driven; base case is flat to declining net revenue with constrained margin expansion.

FAQs

1) Is SULFATRIM expected to show high growth like specialty drugs?

No. TMP-SMX is off-patent and widely genericized, so SULFATRIM’s financial profile typically fits a mature, price-led market rather than specialty growth.

2) What most directly drives SULFATRIM revenue each quarter?

Institutional and channel-specific tender outcomes and contract renewals, followed by average net price after discounts and rebate structures.

3) How does generic competition change the brand P&L?

It compresses net price, accelerates share loss, increases the need for defensive spending, and generally drives margin down unless the manufacturer maintains unusually low COGS.

4) Does resistance or safety messaging affect sales?

Yes. Resistance patterns can shift empiric use, and safety scrutiny can reduce prescribing intensity, both translating into volume variability.

5) Where can a brand holder still create value?

Value creation tends to come from cost competitiveness, reliable supply, formulary access in specific channels, and event-driven pricing opportunities when generic supply tightens.


References

[1] World Health Organization. WHO Model List of Essential Medicines. WHO; latest edition available at: https://www.who.int/medicines/publications/essential-medicines/en/
[2] US Food and Drug Administration. Drugs@FDA (TMP-SMX product information and approvals). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] National Library of Medicine (NIH). MedlinePlus: Sulfamethoxazole and Trimethoprim. https://medlineplus.gov/druginfo/meds/a682480.html
[4] EMA. European public assessment reports and product information for trimethoprim and sulfamethoxazole-containing medicines (where applicable). https://www.ema.europa.eu/

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