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Last Updated: December 22, 2024

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) - Generic Drug Details


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What are the generic drug sources for trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) and what is the scope of freedom to operate?

Trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) is the generic ingredient in nine branded drugs marketed by Lannett, Lilly, Forest Pharms, Wyeth Ayerst, Bristol Myers Squibb, Alpharma Us Pharms, Lederle, Impax Labs, Purepac Pharm, and Pal Pak, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

US Patents and Regulatory Information for TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pal Pak TRIPLE SULFOID trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) TABLET;ORAL 080094-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle TRIPLE SULFAS trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) TABLET;ORAL 006920-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst SULFOSE trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 080013-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Purepac Pharm TRIPLE SULFA trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) TABLET;ORAL 080086-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb TERFONYL trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 006904-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett LANTRISUL trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 080123-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle TRIPLE SULFAS trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 006920-003 Approved Prior to Jan 1, 1982 DISCN 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

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trisulfapyrimidines (Sulfadiazine, Sulfamerazine, Sulfamethazine)

Introduction

Trisulfapyrimidines, a combination of sulfadiazine, sulfamerazine, and sulfamethazine, are a class of sulfonamide antibiotics widely used in the treatment of various bacterial infections. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical Context and Development

Trisulfapyrimidines have been in use since the mid-20th century, with each component having its own pharmacokinetic and pharmacodynamic profile. The development of these drugs was a significant milestone in the fight against bacterial infections, particularly before the advent of more modern antibiotics[2].

Market Demand

The demand for trisulfapyrimidines is influenced by several factors, including the prevalence of bacterial infections, antibiotic resistance patterns, and the availability of alternative treatments.

Prevalence of Bacterial Infections

Bacterial infections remain a significant health concern globally, driving the demand for effective antibiotics. Trisulfapyrimidines are particularly useful in treating infections where other antibiotics may not be effective or are contraindicated[5].

Antibiotic Resistance

The rise of antibiotic-resistant bacteria has complicated the treatment landscape. However, trisulfapyrimidines continue to be effective against certain strains, maintaining their relevance in clinical practice. For example, sulfamethoxazole has shown consistent efficacy against Mycobacterium tuberculosis over a 12-year period[5].

Competitive Landscape

The antibiotic market is highly competitive, with numerous drugs available for various indications.

Alternative Treatments

Other sulfonamides, such as trimethoprim/sulfamethoxazole, and non-sulfonamide antibiotics compete with trisulfapyrimidines. However, the specific combination of sulfadiazine, sulfamerazine, and sulfamethazine offers a unique therapeutic profile that can be advantageous in certain clinical scenarios[5].

Generic vs. Branded Drugs

The trisulfapyrimidine market includes both generic and branded formulations. Generic versions are often more affordable, which can impact the financial trajectory of branded products. However, branded products may offer better bioavailability and formulation advantages, as seen in studies comparing different commercial suspensions[1].

Regulatory Environment

Regulatory standards play a crucial role in the market dynamics of pharmaceuticals.

USP Standards

The United States Pharmacopeia (USP) sets strict standards for the composition and quality of trisulfapyrimidine oral suspensions. These standards ensure that each 100 mL of the suspension contains a specified amount of sulfadiazine, sulfamerazine, and sulfamethazine, along with potential additives like sodium citrate or sodium lactate[3].

FDA Guidelines

The FDA's guidelines on bioavailability and dissolution behavior are critical for the approval and marketing of trisulfapyrimidine formulations. Studies have shown significant correlations between in vitro dissolution parameters and in vivo bioavailability, which are essential for regulatory compliance[1].

Financial Trajectory

The financial performance of trisulfapyrimidines is influenced by several factors, including market demand, competition, and regulatory compliance.

Revenue Trends

Historically, trisulfapyrimidines have generated significant revenue due to their widespread use in treating bacterial infections. However, the rise of generic alternatives and newer antibiotics has impacted the revenue of branded products.

Cost-Effectiveness

Trisulfapyrimidines are generally cost-effective compared to newer antibiotics, making them a preferred choice in many healthcare settings. This cost-effectiveness contributes to their sustained market presence and financial stability.

Research and Development

Continuous research into the pharmacokinetics, metabolism, and renal clearance of these drugs helps in optimizing their use and maintaining their market relevance. For instance, studies on the metabolism and renal clearance in different species have provided valuable insights into their therapeutic and toxicological profiles[2].

Market Challenges

Despite their established presence, trisulfapyrimidines face several market challenges.

Antibiotic Resistance

The increasing prevalence of antibiotic-resistant bacteria poses a significant challenge. While trisulfapyrimidines remain effective against some resistant strains, the overall trend of resistance could impact their long-term market viability.

Side Effects and Safety Concerns

Sulfonamides are known to have side effects, including hypersensitivity reactions and renal toxicity. These safety concerns can affect market demand and necessitate careful patient selection and monitoring.

Future Outlook

The future of trisulfapyrimidines in the market is multifaceted.

Emerging Markets

In developing countries, the demand for affordable and effective antibiotics like trisulfapyrimidines is likely to remain strong. This could provide a growth opportunity for manufacturers.

Combination Therapies

There is ongoing research into combination therapies involving trisulfapyrimidines and other antibiotics. For example, the combination of trimethoprim/sulfamethoxazole has shown efficacy in treating MRSA pneumonia, suggesting potential for similar combinations involving trisulfapyrimidines[5].

Key Takeaways

  • Market Demand: Driven by the prevalence of bacterial infections and the need for effective antibiotics.
  • Competitive Landscape: Influenced by generic and branded formulations, as well as alternative treatments.
  • Regulatory Environment: Strict USP and FDA standards ensure quality and bioavailability.
  • Financial Trajectory: Revenue trends are impacted by competition, cost-effectiveness, and ongoing research.
  • Market Challenges: Antibiotic resistance and safety concerns are significant challenges.
  • Future Outlook: Emerging markets and combination therapies offer potential growth opportunities.

FAQs

Q: What are the primary components of trisulfapyrimidines?

A: Trisulfapyrimidines consist of sulfadiazine, sulfamerazine, and sulfamethazine.

Q: How do regulatory standards impact the market for trisulfapyrimidines?

A: Regulatory standards set by the USP and FDA ensure the quality and bioavailability of trisulfapyrimidine formulations, which is crucial for their approval and marketing.

Q: What are the main challenges facing the market for trisulfapyrimidines?

A: The main challenges include antibiotic resistance, side effects, and safety concerns.

Q: Are trisulfapyrimidines still effective against antibiotic-resistant bacteria?

A: Yes, trisulfapyrimidines remain effective against certain antibiotic-resistant strains, although the overall trend of resistance is a concern.

Q: What is the future outlook for trisulfapyrimidines in emerging markets?

A: The demand for affordable and effective antibiotics like trisulfapyrimidines is likely to remain strong in developing countries, providing a growth opportunity for manufacturers.

Sources

  1. Bioavailability and dissolution behavior of trisulfapyrimidine suspensions - PubMed
  2. Pharmacokinetics, metabolism, and renal clearance of sulfadiazine, sulfamerazine, and sulfamethazine - PubMed
  3. Trisulfapyrimidines Oral Suspension - USP-NF - USP-NF/PF
  4. Immunostimulatory nucleic acids - Google Patents (not directly relevant but included for completeness)
  5. Sulfamethoxazole: Topics by Science.gov - Science.gov

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