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Last Updated: December 22, 2024

CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Claforan In Sodium Chloride 0.9% In Plastic Container patents expire, and what generic alternatives are available?

Claforan In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Sterimax and is included in one NDA.

The generic ingredient in CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.

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Summary for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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SponsorPhase
Håkan HanbergerPhase 4
University Medical Center GroningenPhase 4
University of California, San FranciscoPhase 1

See all CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sterimax CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-001 May 20, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sterimax CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-003 May 20, 1985 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

CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLAFORAN (Cefotaxime) in Sodium Chloride 0.9% in Plastic Containers

Introduction

CLAFORAN, the brand name for cefotaxime sodium, is a semisynthetic, broad-spectrum cephalosporin antibiotic used for parenteral administration. This article delves into the market dynamics and financial trajectory of CLAFORAN, particularly when formulated in sodium chloride 0.9% in plastic containers.

Market Overview of Cephalosporin Antibiotics

Cephalosporin antibiotics, including cefotaxime, are a crucial segment of the broader antibiotic market. These drugs are widely used to treat various bacterial infections due to their broad spectrum of activity and stability against many types of bacterial enzymes[3].

Demand and Usage Patterns

The demand for cefotaxime and other cephalosporins is driven by the need to treat bacterial infections effectively. The antibiotic's efficacy against a wide range of gram-negative and gram-positive bacteria makes it a preferred choice in clinical settings. For instance, cefotaxime is highly stable against many types of β-lactamases, which are enzymes produced by bacteria to resist antibiotics[3].

Market Competition

The antibiotic market is highly competitive, with numerous generic and branded products available. The entry of generic versions of cefotaxime has increased competition, affecting the pricing and market share of branded products like CLAFORAN. However, the stability and broad-spectrum activity of cefotaxime help it maintain a significant market presence[4].

Pricing Dynamics

Pricing in the pharmaceutical industry, especially for antibiotics, is influenced by various factors including regulatory policies, competition from generics, and the overall healthcare landscape. Price controls can significantly impact the profitability of pharmaceutical research and development. For example, only 3 out of every 10 pharmaceutical products generate after-tax returns in excess of average R&D costs, highlighting the economic challenges faced by the industry[5].

Impact of Mergers and Acquisitions

Mergers and acquisitions in the pharmaceutical industry can also affect the market dynamics of specific drugs. These deals often lead to increased prices due to reduced competition, but they can also result in reduced advertising efforts, which may counteract some of the price increases. For instance, the merger between Pfizer and Wyeth led to a smaller price increase than expected due to reduced advertising[4].

Financial Support and Investment

Financial support from institutions like the European Bank for Reconstruction and Development (EBRD) can significantly impact the development and production of pharmaceuticals. For example, the EBRD's financial package to Polpharma, a leading pharmaceutical group in Poland, supports the expansion of production and research and development activities, including the development of generic and biosimilar medicines. Such investments can enhance the financial trajectory of pharmaceutical companies and their products[2].

Production and Distribution

CLAFORAN is supplied in various forms, including dry powder in vials and frozen, premixed, iso-osmotic injections in plastic containers. The production process involves strict quality control to ensure the stability and efficacy of the drug. The use of specially designed multilayer plastic containers, for instance, is crucial to prevent leaching of chemical components from the container into the solution[3].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of pharmaceuticals. CLAFORAN must be used only to treat or prevent infections proven or strongly suspected to be caused by bacteria, as per FDA guidelines. Regulatory approvals and compliance with safety and efficacy standards are essential for maintaining market presence[3].

Clinical Pharmacology and Efficacy

Cefotaxime's clinical pharmacology, including its serum concentrations, elimination half-life, and metabolic pathways, is well-documented. The drug's high affinity for penicillin-binding proteins and its stability against β-lactamases contribute to its efficacy. These factors are crucial in maintaining its position in the market[3].

Patient Access and Healthcare Impact

The availability and accessibility of CLAFORAN can significantly impact patient outcomes. Financial support and investments in pharmaceutical research and development, such as those provided by the EBRD, contribute to improving access to healthcare and medical services. This is particularly important in regions where access to advanced medical treatments is limited[2].

Market Trends and Future Outlook

The pharmaceutical market is continuously evolving, with trends towards generic and biosimilar medicines gaining traction. The development of new medical products, supported by financial investments and regulatory frameworks, will continue to shape the market dynamics of drugs like CLAFORAN. The focus on affordability, innovation, and access to healthcare will remain key drivers in the future[2].

Challenges and Opportunities

Despite the challenges posed by regulatory environments, competition from generics, and the high costs of R&D, there are opportunities for growth. The increasing demand for effective antibiotics, coupled with advancements in biotechnology and biosimilars, presents a promising future for pharmaceutical companies. Strategic partnerships, financial support, and innovative production methods will be essential in navigating these challenges and capitalizing on opportunities[2][5].

Key Takeaways

  • Market Demand: Driven by the need for effective bacterial infection treatments.
  • Competition: Influenced by generic entries and mergers and acquisitions.
  • Pricing: Affected by regulatory policies, competition, and healthcare landscape.
  • Financial Support: Crucial for R&D and production expansion.
  • Regulatory Compliance: Essential for maintaining market presence.
  • Clinical Efficacy: Supported by its pharmacological properties.
  • Patient Access: Improved through investments in pharmaceutical development.

FAQs

What is CLAFORAN used for?

CLAFORAN (cefotaxime sodium) is used to treat or prevent infections proven or strongly suspected to be caused by bacteria.

How is CLAFORAN administered?

CLAFORAN is administered parenterally, either through intramuscular (IM) or intravenous (IV) injection, and is available in various forms including dry powder and premixed solutions in plastic containers.

What are the key factors influencing the market dynamics of CLAFORAN?

The market dynamics of CLAFORAN are influenced by factors such as competition from generics, mergers and acquisitions, regulatory policies, and financial support for R&D.

How does financial support impact the production and development of CLAFORAN?

Financial support from institutions like the EBRD can significantly enhance the production and R&D activities of pharmaceutical companies, improving the availability and accessibility of drugs like CLAFORAN.

What are the future trends in the market for antibiotics like CLAFORAN?

Future trends include a focus on generic and biosimilar medicines, advancements in biotechnology, and an emphasis on affordability and access to healthcare.

Sources

  1. Switching From Ceftriaxone to Cefotaxime Significantly Contributes to Reduced Clostridioides difficile Infection Rates - Oxford University Press.
  2. EBRD supports development of Poland's pharmaceutical sector - European Bank for Reconstruction and Development.
  3. CLAFORAN® Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP) - FDA.
  4. Mergers and Advertising in the Pharmaceutical Industry - TSE.
  5. The Effect of Price Controls on Pharmaceutical Research - National Bureau of Economic Research.

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