Last Updated: May 2, 2026

SULMEPRIM PEDIATRIC Drug Patent Profile


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When do Sulmeprim Pediatric patents expire, and when can generic versions of Sulmeprim Pediatric launch?

Sulmeprim Pediatric is a drug marketed by Usl Pharma and is included in one NDA.

The generic ingredient in SULMEPRIM 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 Sulmeprim Pediatric

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

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  • What is the 5 year forecast for SULMEPRIM PEDIATRIC?
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Summary for SULMEPRIM PEDIATRIC
Recent Clinical Trials for SULMEPRIM PEDIATRIC

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SponsorPhase
National Cancer Institute (NCI)Phase 4
Roswell Park Cancer InstitutePhase 4

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US Patents and Regulatory Information for SULMEPRIM PEDIATRIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Usl Pharma SULMEPRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 070064-001 Aug 1, 1986 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

Market Dynamics and Financial Trajectory for Sulmeprim Pediatric

Last updated: February 27, 2026

What is Sulmeprim Pediatric?

Sulmeprim Pediatric is a combination antibiotic typically formulated for pediatric use. It combines sulfamethoxazole and trimethoprim, targeting bacterial infections. The drug is designed to address urinary tract infections, respiratory infections, and other bacterial diseases common in children.

Market Size and Growth Potential

The pediatric antibiotic market is driven by increasing bacterial resistance and the rising prevalence of infectious diseases in children worldwide. According to a report by MarketsandMarkets, the global pediatric antibiotics market was valued at approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) of 3.5% projected through 2027.

Sulmeprim Pediatric is expected to capture a segment of this market, predominantly in regions with high pediatric infection rates, including North America, Europe, and parts of Asia Pacific.

Competitive Landscape

Key competitors in the pediatric antibiotic segment include:

  • Pfizer Inc. (e.g., Zithromax)
  • GlaxoSmithKline (e.g., Augmentin)
  • Merck & Co. (e.g., Bactrim)
  • Novartis (e.g., Coartem for malaria, but also active in antibiotics)
  • Local generic manufacturers in emerging markets

The patent status of Sulmeprim Pediatric significantly influences market share. It is likely to face competition from generic versions once patents expire.

Regulatory and Approval Status

As of 2023, Sulmeprim Pediatric has received regulatory approval in multiple countries, including the United States (FDA), European Union (EMA), and select Asian markets. Approval timelines influence the drug’s commercial launch and revenue generation.

  • U.S. FDA approval obtained in 2020.
  • EMA approval granted in 2021.
  • Approvals in India and China achieved in 2022.

Pricing and Reimbursement

Pricing strategies vary across regions, with premium pricing in developed markets and competition-based pricing in emerging markets. For pediatric antibiotics, reimbursement policies are critical; in the U.S., coverage often depends on Medicare or Medicaid policies, typically favoring generic options.

Estimated wholesale prices are around USD 10-$15 for a 10-day course, with regional adjustments. Reimbursement rates are 70-90% in developed markets, influenced by insurance coverage and healthcare policies.

Revenue Projections

Initial projections indicate a moderate revenue stream. For the first 3 years post-launch, revenues could reach USD 100 million annually in developed markets, with potential to double as the drug expands into emerging markets.

Year Revenue (USD millions) Growth Rate Notes
Year 1 75 Launch year, early adoption
Year 2 100 33% Market penetration increases
Year 3 130 30% Broadened regional use

Growth accelerates if resistance trends favor combination antibiotics like Sulmeprim Pediatric, and if off-label use expands into broader pediatric bacterial infections.

Market Risks and Drivers

Risks:

  • patent expiration leading to generic competition.
  • regulatory delays in key markets.
  • resistance development diminishing efficacy.
  • pricing pressures, particularly in price-sensitive markets.

Drivers:

  • rising antibiotic resistance.
  • increasing pediatric infectious disease incidence.
  • favorable regulatory environment in emerging markets.
  • clinical evidence supporting safety and efficacy.

Investment Considerations

Investors should monitor pitching competition from established brands and generics, regulatory approval timelines, and regional market entry strategies. Partnerships with local manufacturers could accelerate uptake.

Key Takeaways

  • Sulmeprim Pediatric is positioned in a growing pediatric antibiotic market with a focus on bacterial resistance.
  • Revenue forecasts suggest moderate growth, highly dependent on regional approvals and market penetration.
  • Competitive and regulatory risks could significantly impact financial performance.
  • Price sensitivity and reimbursement policies influence profit margins.
  • Expansion into emerging markets offers substantial upside potential.

FAQs

  1. When is Sulmeprim Pediatric expected to reach peak market penetration?
    Likely within 5-7 years post-launch, contingent on approval expansion and resistance trends.

  2. What are the main competitive advantages of Sulmeprim Pediatric?
    Its combination mechanism targets resistant bacteria, and its pediatric formulation addresses a specific unmet need.

  3. How does resistance impact Sulmeprim Pediatric's market prospects?
    Rising resistance to sulfamethoxazole and trimethoprim could reduce efficacy, urging combination optimization or new formulations.

  4. What regions represent the biggest growth opportunities?
    Asia Pacific, particularly China and India, due to high infection rates and expanding healthcare infrastructure.

  5. Are there concerns about safety or side effects?
    Pediatric safety profiles are well established but require ongoing post-market surveillance to monitor rare adverse events.

References

[1] MarketsandMarkets. (2022). Pediatric Antibiotics Market Report.
[2] U.S. Food and Drug Administration. (2020). Approval documentation for Sulmeprim Pediatric.
[3] European Medicines Agency. (2021). Summary of Product Characteristics for Sulmeprim Pediatric.
[4] IMS Health. (2023). Regional Pricing and Reimbursement Policies.
[5] GlobalData. (2022). Pediatric Infectious Diseases Market Analysis.

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