Last Updated: June 24, 2026

BACTRIM PEDIATRIC Drug Patent Profile


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Which patents cover Bactrim Pediatric, and when can generic versions of Bactrim Pediatric launch?

Bactrim Pediatric is a drug marketed by Sun Pharm Industries and is included in one NDA.

The generic ingredient in BACTRIM PEDIATRIC 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bactrim Pediatric

A generic version of BACTRIM PEDIATRIC was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25th, 1986.

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Questions you can ask:
  • What is the 5 year forecast for BACTRIM PEDIATRIC?
  • What are the global sales for BACTRIM PEDIATRIC?
  • What is Average Wholesale Price for BACTRIM PEDIATRIC?
Summary for BACTRIM PEDIATRIC
Recent Clinical Trials for BACTRIM PEDIATRIC

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

SponsorPhase
Hospital Civil de GuadalajaraPHASE2
Ohio State UniversityPHASE4
Johns Hopkins UniversityEarly Phase 1

See all BACTRIM PEDIATRIC clinical trials

US Patents and Regulatory Information for BACTRIM PEDIATRIC

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

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

Country Patent Number Title Estimated Expiration
Canada 1003331 COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for BACTRIM PEDIATRIC

Last updated: April 25, 2026

What is BACTRIM Pediatric and how is it typically marketed?

BACTRIM Pediatric is the pediatric formulation of trimethoprim-sulfamethoxazole (TMP-SMX), a fixed-dose oral antibiotic. In commercial use, BACTRIM Pediatric is positioned for pediatric infections where TMP-SMX is appropriate, with prescribing guided by local resistance patterns, formulary status, and payer preferences for oral antibiotic options.

Core product attributes that drive market acceptance

  • Drug class: TMP-SMX (antibacterial)
  • Route: Oral (pediatric liquid formulation)
  • Common role in care: Empiric and targeted treatment of susceptible infections where TMP-SMX is standard-of-care in relevant guidelines
  • Buying behavior: Pediatric-specific dosing convenience and formulary fit; procurement often competes against alternative oral generics in the same therapeutic space

How does the antibiotic market’s structure shape BACTRIM Pediatric demand?

TMP-SMX sits in a mature, highly competitive antibiotic segment. Market dynamics are dominated by three forces: generic penetration, stewardship restrictions, and resistance-driven switching.

1) Generic dominance compresses pricing

TMP-SMX is widely generic in most markets. Even where “BACTRIM” branding retains share, pricing pressure typically comes from:

  • Generic oral antibiotic alternatives across common pediatric indications
  • Pharmacy benefit manager (PBM) preference steering toward lowest net cost
  • Competitive substitution at the point of dispensing

Implication for revenue trajectory: Unit demand may remain stable, but net revenue per prescription trends toward erosion unless brand differentiation offsets substitution.

2) Stewardship and guideline updates can reduce “default” use

Antibiotic stewardship has narrowed empiric use patterns for many older antibiotics, including TMP-SMX, depending on:

  • Local resistance rates
  • Guideline thresholds for empiric selection
  • Use restrictions for certain indications (varies by country and time)

Implication for volume: Demand becomes more elastic to guideline shifts than it is for niche, high-barrier products.

3) Resistance patterns drive substitution between antibiotic classes

TMP-SMX use depends on susceptibility rates for relevant pathogens. When resistance rises, clinicians shift toward alternatives (beta-lactams, macrolides, clindamycin, or other options depending on infection type and geography).

Implication for mix: Even if total pediatric antibiotic prescriptions do not collapse, the share of TMP-SMX can move across time and regions.

What demand signals typically determine pediatric TMP-SMX sales velocity?

For pediatric TMP-SMX, quarterly performance is usually correlated with a small set of observable drivers:

  • Seasonality in respiratory and skin infections (higher patient presentations can increase antibiotic starts)
  • Pediatric outpatient prescribing rates (urgent care and primary care volume)
  • Formulary placement and prior authorization behavior
  • Adverse event and safety labeling scrutiny affecting clinician comfort (notably in certain risk groups)
  • Substitution rates against equivalent-strength TMP-SMX liquids or tablets where available

How do pricing and payer mechanics affect financial trajectory?

The financial trajectory of BACTRIM Pediatric in a generic-dense environment usually follows a predictable pattern.

Revenue math that matters in this category

For a pediatric antibiotic, total revenue is driven by:

  • Prescription volume
  • Wholesale acquisition cost (WAC) vs net price
  • Rebate intensity (PBM contracting)
  • Channel mix (retail vs mail order, though pediatric liquids are more retail-heavy)
  • Substitution and switching at the pharmacy counter

What “brand” pricing can realistically do

Brand assets generally help on:

  • Patient/parent familiarity
  • Pediatric dosing convenience and packaging
  • Stable supply and consistent formulation experience
  • Tender or health-system contracts that name brand rather than active ingredient

But net pricing is typically constrained by:

  • The availability of therapeutically equivalent generics
  • PBM preference for lower net-cost alternatives
  • Periodic price resets as formularies update

Implication for trajectory: Revenue typically trends flat to down in real terms after each competitive pricing cycle, while volume may hold up if the product remains formulary-locked in key accounts.

What is the financial trajectory likely to look like over time for BACTRIM Pediatric?

BACTRIM Pediatric is a long-standing antibiotic product. In mature oral generic classes, the pattern is usually:

  1. Early brand maturity phase (higher net pricing, strong differentiation)
  2. Mid-life consolidation (generic competition intensifies; net price compresses)
  3. Late-life pressure (share shifts to lowest-cost alternatives; volume stabilizes or declines modestly)

Given the generic landscape, a high-growth financial trajectory is unlikely unless:

  • A new pediatric-specific dosing advantage locks in formulary preference, or
  • External contracting protects net price, or
  • A safety or supply disruption in competitors temporarily improves relative share

How do manufacturing and supply conditions impact results?

For pediatric liquid antibiotics, supply continuity and acceptable shelf-life are operational drivers.

Typical financial impacts come from:

  • Temporary shortages that allow brief share gains
  • Lot failures or distribution constraints that force switching
  • Storage and logistics costs that can change channel profitability

Even in stable demand environments, supply shocks can shift dispensing patterns, creating quarter-to-quarter volatility in net sales.

What external events can shift TMP-SMX pediatric share quickly?

Key exogenous triggers that can materially change performance include:

  • Labeling changes or safety communications that alter prescribing thresholds
  • Resistance surveillance updates that shift empiric recommendations
  • New competitor launches (even generics) that improve net pricing leverage with PBMs
  • Formulary contracting renewals that re-rank preferred options
  • Outbreak-driven prescribing tied to specific pathogens sensitive or resistant to TMP-SMX

What are the likely competitive set dynamics for pediatric TMP-SMX?

BACTRIM Pediatric competes across multiple axes:

  • Same active ingredient: TMP-SMX liquids and equivalents
  • Same therapeutic space: other oral antibiotics used in pediatric outpatient settings depending on infection type

A typical competition outcome is:

  • Pure generic TMP-SMX tends to win on cost where formulary allows substitution
  • Brand retention depends on formulary language, contract naming, or patient-specific dosing preference

Implication for net sales: The brand’s financial trajectory is mostly governed by relative net price and formulary stickiness rather than clinical superiority.


Market and Financial Outlook Snapshot (Category-Driven)

What direction do key KPIs usually take for mature TMP-SMX pediatric products?

KPI Typical direction in mature TMP-SMX liquids What drives it
Net price Down or flat Generic price competition and PBM rebate pressure
Volume Flat to slight decline Guideline and stewardship effects; substitution
Share within therapeutic class Volatile Resistance patterns and formulary changes
Quarter-to-quarter variability Moderate Seasonality, supply events, contracting timing
Profitability per unit Compresses Higher rebate intensity; margin pressure from competition

What financial outcomes follow from those KPI trends?

  • Net sales: Generally flat-to-declining in nominal terms over multi-year horizons.
  • Gross margin: Pressure from pricing resets and rebate intensity.
  • Operating income: Usually constrained unless cost controls offset pricing pressure.

Key Takeaways

  • BACTRIM Pediatric is a mature pediatric TMP-SMX product in a generic-dense antibiotic market where net price compression is the dominant revenue risk.
  • Demand depends on seasonality, outpatient prescribing rates, stewardship-guideline alignment, and local resistance patterns.
  • The likely financial trajectory is flat to declining in net sales over time, with quarterly volatility from contracting cycles, PBM preferences, and supply stability.
  • Share retention for BACTRIM Pediatric is typically determined by formulary stickiness and pediatric dosing convenience, not by unique clinical differentiation.

FAQs

1) Is BACTRIM Pediatric expected to grow faster than pediatric oral antibiotic peers?

No. Mature TMP-SMX is constrained by generic substitution and payer net-cost contracting, which usually makes growth slower than or comparable to the broader pediatric oral antibiotic category.

2) What most affects quarterly sales for pediatric TMP-SMX products?

Seasonal outpatient infection presentations, formulary and PBM contracting timing, and supply continuity for the pediatric liquid.

3) How do resistance changes influence BACTRIM Pediatric performance?

Higher resistance for key pathogens reduces TMP-SMX suitability, shifting prescribing to alternative antibiotics and lowering TMP-SMX share.

4) Why does branding matter when generics exist?

Branding can protect dispensing share when contracts name brand, when caregivers prefer consistent pediatric liquid performance, or when payer rules limit substitution.

5) What is the core financial lever for manufacturers of mature oral antibiotics?

Net price management and rebate strategy, supported by supply reliability and contract retention, since volume growth is structurally limited by stewardship and generic competition.


References

[1] U.S. Food and Drug Administration. Drug labeling information for trimethoprim-sulfamethoxazole products (BACTRIM and pediatric formulations). APA format source: FDA access data and labeling database.

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