Last Updated: May 3, 2026

BACTRIM Drug Patent Profile


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Summary for BACTRIM
US Patents:0
Applicants:2
NDAs:3

US Patents and Regulatory Information for BACTRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc BACTRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 018374-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries BACTRIM DS sulfamethoxazole; trimethoprim TABLET;ORAL 017377-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries BACTRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017560-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries BACTRIM sulfamethoxazole; trimethoprim TABLET;ORAL 017377-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries BACTRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017560-002 Approved Prior to Jan 1, 1982 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

International Patents for BACTRIM

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

Country Patent Number Title Estimated Expiration
Germany 1617521 ⤷  Start Trial
Israel 27876 INJECTABLE COMPOSITIONS CONTAINING A SALT OF A THERAPEUTIC SULFONAMIDE AND A BASICALLY REACTING SULFONAMIDE-POTENTIATOR ⤷  Start Trial
Greece 35814 ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΔΙΑΛΥΜΑΤΩΝ ΣΟΥΛΦΟΝΑΜΙΔΗΣ ΚΑΙ ΕΝΙΣΧΥΤΙΚΗΣ ΣΟΥΛΦΟΝΑΜΙΔΗΣ. ⤷  Start Trial
Switzerland 544053 Verfahren zur Herstellung von Sulfonamidderivaten (Injectable sulphonamide potentiator compns) ⤷  Start Trial
Netherlands 6706474 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

BACTRIM (Trimethoprim–Sulfamethoxazole): Investment Scenario and Fundamentals

Last updated: April 25, 2026

What is BACTRIM’s commercial and patent positioning?

BACTRIM is the brand name for trimethoprim–sulfamethoxazole (TMP-SMX), a fixed-dose combination antibiotic. Commercially, the product sits in a crowded generic environment; investment returns depend on (1) ongoing demand for TMP-SMX across inpatient and outpatient settings, (2) formulary placement and pricing discipline, and (3) share maintenance versus other first-line agents for targeted indications.

Key commercialization reality: TMP-SMX is a long-established molecule with broad generic availability in most markets. This structure compresses pricing and shifts value toward distribution scale, brand retention where applicable, and contract tender performance.

What are the fundamentals that drive demand for TMP-SMX?

TMP-SMX demand is driven by recurring infection categories where TMP-SMX is either first-line or widely used, including:

Core demand drivers (typical use patterns)

  • Urinary tract and skin/soft-tissue infections where TMP-SMX is selected for bacterial susceptibility and guideline alignment.
  • Respiratory and other community infections in settings with local resistance patterns supporting TMP-SMX use.
  • Opportunistic infections in immunocompromised patients, where TMP-SMX can be a standard prophylaxis and treatment option (notably Pneumocystis pneumonia prophylaxis, depending on clinical practice and patient population).

Supply and resistance dynamics

  • TMP-SMX utilization tracks local antibiograms. Higher resistance can reduce use and shift prescribers to alternatives.
  • Stocking and procurement tend to favor reliable, low-cost supply and predictable bioavailability, which benefits established supply chains.

How does the market structure impact investment returns?

Generic pressure and pricing

BACTRIM operates in a market where:

  • Most volume is generic-priced
  • Any remaining branded premium depends on brand-specific formularies, contracting, and payer behavior.

Margin model

A realistic margin model for BACTRIM investors is based on:

  • Manufacturing and supply cost control
  • Channel execution and tender wins
  • Product integrity across lots (important for antibiotics where shortages trigger switching dynamics)

Because molecule-level exclusivity has expired for TMP-SMX in most major markets, upside is typically limited to brand-specific share and operational execution rather than fundamental patent-driven pricing power.

What does the regulatory and labeling framework imply for risk?

BACTRIM is an antibiotic combination with established regulatory history. Labeling risk is usually dominated by:

  • Safety communications and contraindication changes over time
  • Resistance-related guidance (indirect, via prescribing patterns)
  • Distribution constraints (quality, supply continuity)

In antibiotic markets, supply disruptions and labeling updates can move share quickly, even when clinical efficacy remains stable.

Where does BACTRIM fit in hospital vs. outpatient formularies?

Hospital

Hospitals often use TMP-SMX when:

  • The antibiogram supports susceptibility
  • Stewardship programs select narrow, guideline-consistent regimens
  • Pharmacy procurement favors low-cost combination antibiotics

Outpatient

Outpatient usage depends on:

  • Coverage and copay tiers
  • Clinical comfort with TMP-SMX for common infections
  • Brand availability through retail networks where applicable

From an investment standpoint, the split between hospital and outpatient matters because:

  • Hospitals can shift rapidly based on stewardship and procurement cycles.
  • Outpatient channels depend more on prescriber familiarity and payer tiering.

What is the competitive landscape for BACTRIM?

TMP-SMX competes across overlapping segments with:

  • Other oral antibiotics used for UTIs, skin infections, and respiratory indications
  • Long-standing generics with lower total cost in specific formularies
  • For special populations, prophylaxis standards can vary by institution and guideline interpretation

The practical implication is that BACTRIM’s competitiveness is less about differentiation on efficacy and more about:

  • Price competitiveness
  • Formulary inclusion
  • Reliability of supply
  • Patient adherence (driven by formulation and dosing convenience)

What does a base-case investment scenario look like for BACTRIM?

A base-case scenario is that BACTRIM behaves like a mature, generic-heavy, volume-driven antibiotic.

Scenario profile (base case)

  • Revenue grows slowly or stays flat, largely tracking population and infection incidence.
  • Pricing is constrained by generic competition.
  • Share maintenance is the main lever through contracting and consistent supply.

What would move the base case?

Upward moves typically come from:

  • Winning formularies or tender cycles
  • Stabilizing supply during competitive shortages
  • Maintaining low acquisition cost and strong contracting discipline

Downward moves typically come from:

  • Faster generic undercutting in core channels
  • Resistance shifts that change stewardship preferences
  • Safety communication events that reduce adoption

What upside scenarios can exist without patent-driven pricing power?

Even without molecule exclusivity, upside can appear through execution and product strategy:

  • Contracting leverage: improved payer and hospital contracting terms
  • Formulation and packaging improvements: higher conversion to preferred products within the TMP-SMX class
  • Channel expansion: growth in regions or customer segments where BACTRIM retains better access than competing generic brands

These are operational growth drivers, not fundamental monopoly drivers.

What downside risks matter most for TMP-SMX branded economics?

Key downside risks are structural rather than one-off:

  • Persistent generic price erosion
  • Switching away from TMP-SMX due to resistance patterns
  • Safety or tolerability perceptions in specific patient groups that influence prescribing
  • Manufacturing or quality events that force temporary discontinuation and lose share

In antibiotics, share can be sticky during stable conditions, but it can also shift quickly during disruptions.

What does “fundamentals” mean here: financial mechanics investors should model

For a BACTRIM-focused investment thesis, fundamentals modeling should focus on:

Revenue mechanics

  • Volume: infection incidence and prescribing preference
  • Mix: hospital vs retail; dose/formulation mix
  • Contracting: tender dynamics and payer reimbursement changes

Margin mechanics

  • Cost of goods and API input economics
  • Manufacturing yields and batch stability
  • Working capital effects from procurement and inventory cycles

Risk mechanics

  • Regulatory safety updates and labeling changes
  • Supply interruptions and quality incidents
  • Competitive pricing moves by generic manufacturers

How should investors benchmark BACTRIM against other antibiotic generics?

Use a framework that ignores patent claims and emphasizes operational and market mechanics:

Benchmark dimensions

  • Competitive intensity (number of authorized generics and market share distribution)
  • Stability of formulary placement
  • Tender responsiveness and contract renewal rates
  • Supply chain resilience and lead-time reliability

Success condition: BACTRIM’s branded or preferred position should be explainable by commercial access and execution rather than by any remaining exclusivity.

What is the most likely investment conclusion for BACTRIM?

BACTRIM is best treated as a mature antibiotic franchise with limited patent-driven upside. The investment case is anchored in:

  • Whether the company can sustain or grow unit share in contracted channels
  • Whether it can protect pricing via contract structure and reliable supply
  • Whether it can avoid safety or supply shocks that cause durable share loss

The strongest form of upside is tied to execution and market access, not to molecule exclusivity.


Key Takeaways

  • BACTRIM (TMP-SMX) is a mature antibiotic in a generic-dominated market, so valuation upside is typically limited by pricing power.
  • Fundamentals hinge on formulary access, tender wins, supply reliability, and resistance-driven prescribing behavior.
  • Investors should model revenue as volume and mix with pricing constrained by generics, and margin as manufacturing cost control plus working-capital discipline.
  • The main drivers of deviation from base case are contracting outcomes, resistance shifts, and supply or safety events, not patent-led exclusivity.

FAQs

  1. Is BACTRIM a patent-driven investment?
    No. TMP-SMX is established and operates under generic market dynamics; returns depend on market access and execution.

  2. What most directly impacts BACTRIM demand?
    Prescribing behavior driven by infection incidence and local susceptibility patterns, plus prophylaxis and standard-of-care practices in relevant populations.

  3. What is the primary competitive threat to BACTRIM?
    Low-cost generic TMP-SMX brands that pressure pricing and can displace share through tender and payer channel decisions.

  4. What operational factors matter most for margins?
    Cost of goods, manufacturing yield, batch consistency, and inventory and procurement efficiency.

  5. Where can BACTRIM still outperform?
    In contracts where it maintains preferred access and during periods when supply reliability or pricing execution improves competitiveness relative to other TMP-SMX options.


References

[1] U.S. Food and Drug Administration. “Bactrim (trimethoprim and sulfamethoxazole) Tablets” and prescribing information (labeling and safety information). FDA.
[2] U.S. National Library of Medicine. “Trimethoprim and Sulfamethoxazole” (drug information, mechanism, and clinical context). PubMed/MedlinePlus.
[3] CDC. Guidance and clinical practice references relevant to antimicrobial use and resistance trends (context for stewardship and prescribing patterns). Centers for Disease Control and Prevention.

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