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Last Updated: December 22, 2024

SULFATRIM PEDIATRIC Drug Patent Profile


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

Sulfatrim Pediatric is a drug marketed by Pharm Assoc and is included in one NDA.

The generic ingredient in SULFATRIM PEDIATRIC is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sulfatrim Pediatric

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

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Drug patent expirations by year for SULFATRIM PEDIATRIC
Recent Clinical Trials for SULFATRIM PEDIATRIC

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

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

See all SULFATRIM PEDIATRIC clinical trials

US Patents and Regulatory Information for SULFATRIM PEDIATRIC

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 PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615-001 Jan 7, 1983 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SULFATRIM PEDIATRIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SULFATRIM PEDIATRIC

Introduction to SULFATRIM PEDIATRIC

SULFATRIM PEDIATRIC is a formulation of the antibiotic combination sulfamethoxazole and trimethoprim, specifically designed for pediatric use. This medication is crucial in treating various bacterial infections in children.

Market Context: Pediatric Drugs

The pediatric drugs market is experiencing significant growth, driven by increasing healthcare needs and advancements in medical technology. The global pediatric drugs market was valued at USD 28.8 billion in 2023 and is projected to reach USD 95.4 billion by 2033, growing at a CAGR of 12.7% during the forecast period from 2024 to 2033[4].

Demand Drivers

Increasing Infectious Diseases

The rising incidence of infectious diseases such as diarrhea, malaria, and pneumonia among children under the age of five is a major driver for the pediatric drugs market. According to UNICEF, approximately 5.2 million children under the age of five were anticipated to die in 2020, highlighting the urgent need for effective treatments[4].

Growing Preterm Births and Intrapartum Complications

Preterm births and intrapartum complications are significant factors contributing to the demand for pediatric medications. These conditions often require immediate and effective medical interventions, including antibiotics like SULFATRIM PEDIATRIC[4].

Market Segmentation

Type Analysis

While respiratory disorder drugs dominate the pediatric market with a 39.4% market share, antibiotics like SULFATRIM PEDIATRIC play a critical role in treating bacterial infections, which are a significant portion of pediatric healthcare needs[4].

Route of Administration

The oral route of administration, which includes SULFATRIM PEDIATRIC tablets and suspensions, dominates the market with a 48.7% share. This preference is due to the ease of administration and compliance in pediatric patients[4].

Distribution Channels

Hospital pharmacies lead the distribution of pediatric drugs, capturing a valuable market share of 52.7% in 2023. This indicates that SULFATRIM PEDIATRIC is likely to be widely available and prescribed through hospital settings[4].

Regional Analysis

North America

North America holds a significant market share of 34.9% in the pediatric drugs market. The region's advanced healthcare infrastructure and high demand for pediatric medications contribute to the financial trajectory of SULFATRIM PEDIATRIC[4].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest CAGR during the forecast period, driven by an increasing pediatric population, improving healthcare access, and rising approvals of pediatric drugs by regulatory authorities[4].

Regulatory Environment

FDA Approvals and Guidelines

SULFATRIM PEDIATRIC has been approved by the FDA, and its continued use is subject to regulatory guidelines that ensure safety and efficacy. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) have expedited research and development activities for pediatric drugs, including SULFATRIM PEDIATRIC[4].

Financial Trajectory

Market Size and Growth

Given the overall growth of the pediatric drugs market, SULFATRIM PEDIATRIC is likely to see an increase in sales. The market's projected growth from USD 28.8 billion in 2023 to USD 95.4 billion by 2033 indicates a robust financial trajectory for pediatric antibiotics like SULFATRIM PEDIATRIC[4].

Competitive Landscape

The market for pediatric drugs is competitive, with companies like Horizon Therapeutics Plc., Jazz Pharmaceuticals, Inc., and Gilead Sciences, Inc. actively involved in developing and marketing pediatric medications. Strategic acquisitions and mergers are common, aiming to expand pediatric drug portfolios and enhance capabilities in developing new treatments[4].

Challenges and Opportunities

Adverse Reactions and Safety Concerns

SULFATRIM PEDIATRIC, like other sulfamethoxazole and trimethoprim combinations, carries risks of severe adverse reactions, including skin reactions, hepatic changes, and hematologic effects. These safety concerns necessitate careful monitoring and adherence to contraindications, particularly in pregnant patients, nursing mothers, and infants under two months of age[1][2].

Innovative Treatments and Formulations

There is a surge in the development of innovative pediatric treatments, including new formulations of existing drugs. This trend presents opportunities for SULFATRIM PEDIATRIC to be reformulated or combined with other medications to improve compliance and outcomes in pediatric patients[4].

Key Takeaways

  • The pediatric drugs market is growing rapidly, driven by increasing healthcare needs and advancements in medical technology.
  • SULFATRIM PEDIATRIC benefits from the dominance of oral route administration and hospital pharmacy distribution channels.
  • Regulatory approvals and guidelines play a crucial role in the market dynamics of SULFATRIM PEDIATRIC.
  • Despite safety concerns, the financial trajectory for SULFATRIM PEDIATRIC is positive due to the overall growth of the pediatric drugs market.

FAQs

1. What is SULFATRIM PEDIATRIC used for?

SULFATRIM PEDIATRIC is used to treat various bacterial infections in children, including urinary tract infections, respiratory infections, and other infections caused by susceptible bacteria.

2. What are the common side effects of SULFATRIM PEDIATRIC?

Common side effects include skin reactions, fever, body aches, and in severe cases, conditions like Steven-Johnson syndrome and toxic epidermal necrolysis. Hepatic changes and hematologic effects are also possible[1][2].

3. Is SULFATRIM PEDIATRIC safe for all pediatric patients?

No, SULFATRIM PEDIATRIC is contraindicated in infants under two months of age, pregnant patients, and nursing mothers due to the risk of kernicterus and other adverse effects[1][2].

4. How is SULFATRIM PEDIATRIC administered?

SULFATRIM PEDIATRIC is available in tablet and suspension forms, administered orally. The dosage varies based on the patient's age and weight[1][5].

5. What is the projected market growth for pediatric antibiotics like SULFATRIM PEDIATRIC?

The pediatric drugs market, including antibiotics like SULFATRIM PEDIATRIC, is expected to grow from USD 28.8 billion in 2023 to USD 95.4 billion by 2033, at a CAGR of 12.7%[4].

Cited Sources

  1. AA Pharma, Product Monograph - SULFATRIM, 2023.
  2. APO-SULFATRIM, sulfamethoxazole and trimethoprim tablets, 2017.
  3. Drugs.com, Generic Sulfatrim Pediatric Availability, 2024.
  4. Market.us, Pediatric Drugs Market Growth Analysis, 2024.
  5. Health Canada, Details for: SULFATRIM, 2023.

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