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Last Updated: December 16, 2025

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Claforan In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Claforan In Dextrose 5% In Plastic Container is a drug marketed by Sterimax and is included in one NDA.

The generic ingredient in CLAFORAN IN DEXTROSE 5% 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 DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

SponsorPhase
Håkan HanbergerPhase 4
University Medical Center GroningenPhase 4
University of California, San FranciscoPhase 1

See all CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CLAFORAN IN DEXTROSE 5% 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 DEXTROSE 5% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-002 May 20, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sterimax CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-004 May 20, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Claforan in Dextrose 5% in Plastic Container

Last updated: July 30, 2025


Introduction

Claforan, the brand name for cefotaxime sodium, is a third-generation cephalosporin antibiotic administered intravenously for serious bacterial infections. The formulation of Claforan in Dextrose 5% (D5W) in plastic containers caters to clinical settings seeking stable, ready-to-use antibiotics, improving bedside administration efficiency.

This report explores current market dynamics, competitive landscape, manufacturing considerations, regulatory environment, and financial outlook for Claforan in Dextrose 5% in plastic containers, providing strategic insights for stakeholders and investors.


Market Overview

Global Antibiotics Market and Growth Drivers

The global antibiotic market was valued at approximately USD 51 billion in 2022, with a compound annual growth rate (CAGR) of around 2.8% projected through 2030 (1). The demand for intravenous antibiotics like Claforan is driven by increasing bacterial infection incidences, rising hospitalizations, and the need for effective hospital-acquired infection control.

Segment Focus: Cephalosporins and IV Formulations

Cephalosporins constitute a significant share of the antibiotic market, with third-generation agents like cefotaxime positioned as critical options in severe infections. In IV form, the shift toward ready-to-use formulations—including Dextrose 5% solutions in plastic containers—addresses portability, sterility, and convenience, aligning with modern hospital workflows.


Market Drivers for Claforan in Dextrose 5% in Plastic Containers

  1. Rising Prevalence of Bacterial Infections: Increasing cases of pneumonia, sepsis, and complicated urinary tract infections underpin demand for potent antibiotics such as cefotaxime.

  2. Hospital and Healthcare Settings: The shift toward pre-filled, sterile plastic containers enhances infection control and reduces preparation time, bolstering the attractiveness of Claforan in ready-to-use formats.

  3. Antibiotic Stewardship and Resistance Management: While antimicrobial resistance (AMR) remains a concern, targeted use in hospitals and optimized formulations mitigate resistance risks and streamline treatment protocols.

  4. Regulatory Approvals and Stringent Quality Standards: Approved formulations in plastic containers meet hospital and regulatory standards, facilitating widespread adoption.


Market Challenges and Limitations

  • Antimicrobial Resistance (AMR): Rising resistance to cephalosporins can diminish the clinical utility of cefotaxime, affecting sales volume.
  • Pricing Pressures: Government and insurance-driven price regulation in several markets restrict margins.
  • Manufacturing and Supply Chain Complexity: Ensuring sterility and stability in plastic container formulations necessitates advanced manufacturing, increasing costs.
  • Competition: Several third-generation cephalosporins with similar spectrum (e.g., ceftriaxone, ceftazidime) compete directly.

Competitive Landscape

Major players include Sanofi, Pfizer, and Sandoz, with multiple generic manufacturers also active. The market is characterized by several formulations—lyophilized powders, pre-filled syringes, and ready-to-use solutions—each catering to specific clinical needs.

Sanofi's Claforan remains a prominent brand, with ongoing efforts focusing on expanding formulation options, including Dextrose 5% in plastic containers to improve hospital logistics.


Regulatory Environment

Regulatory agencies such as the FDA (United States), EMA (Europe), and regional authorities impose rigorous standards for injectable antibiotics. Approvals for formulations in plastic containers require stability and sterility data, with additional considerations for compatibility with Dextrose 5% solutions.

Patent expirations, where applicable, allow for generic proliferation but also increase price competition. Continuous post-marketing surveillance is mandated to monitor safety and efficacy.


Manufacturing and Supply Chain Considerations

Manufacturing Claforan in Dextrose 5% in plastic containers involves challenges related to:

  • Sterility Assurance: Ensuring contamination-free production.
  • Container Compatibility: Compatibility of cefotaxime with plastic materials without degradation.
  • Stability Profile: Maintaining efficacy during shelf life under various storage conditions.

These aspects impact production costs and, subsequently, pricing strategies.


Financial Trajectory and Market Potential

Revenue Outlook

Based on historical data and market expansion trends, Claforan in Dextrose 5% in plastic containers is expected to exhibit moderate growth, driven by increased hospital adoption and expanding indications, such as off-label uses in community settings.

Revenue projections for the next five years estimate a compounded annual growth rate (CAGR) of approximately 3-4%. The primary revenue streams include hospital procurement, outpatient infusion services, and regional markets, notably in Europe, Asia-Pacific, and North America.

Pricing and Reimbursement Dynamics

Pricing strategies will depend on regional regulatory environments. In mature markets, negotiated reimbursement rates influence margins; in emerging markets, price controls limit profitability but expand access.

Market Penetration and Expansion

Further adoption hinges on:

  • Educational initiatives: Increasing clinician awareness.
  • Formulation improvements: Enhancing stability and ease-of-use.
  • Partnerships: Collaborations with hospital chains and supply chain optimizations.

Conclusion: Strategic Outlook

Claforan in Dextrose 5% in plastic containers remains a strategically important formulation within the cephalosporin market, combining clinical efficacy with logistical advantages. Its financial trajectory hinges on navigating AMR trends, competitive pressures, and regulatory landscapes. Stakeholders should focus on innovation, portfolio expansion, and market penetration to sustain growth.


Key Takeaways

  • The market for intravenous cephalosporins, including Claforan in Dextrose 5% in plastic containers, is poised for steady growth driven by hospital demand and formulation innovations.

  • Competitive differentiation relies heavily on formulation stability, ease-of-use, and regulatory compliance; ongoing investments in manufacturing quality are vital.

  • Price regulation and antimicrobial resistance pose challenges; strategies should include targeted use and value-based pricing.

  • Expanding geographical presence, especially in emerging markets, offers growth opportunities but requires navigating complex regulatory environments.

  • Continuous innovation in formulation and marketing tactics will be key to maintaining market share and financial stability.


FAQs

1. What advantages does Claforan in Dextrose 5% in plastic containers offer over traditional lyophilized forms?
Ready-to-use plastic containers provide enhanced convenience, reduced preparation time, minimized contamination risk, and improved bedside administration efficiency, aligning with hospital infection control practices.

2. How does antimicrobial resistance impact the market for cefotaxime formulations?
Rising resistance diminishes clinical effectiveness, prompting reduced usage and encouraging development of newer agents or combination therapies, which could threaten long-term sales.

3. What are the key regulatory considerations for manufacturing cefotaxime in plastic containers?
Manufacturers must demonstrate stability, sterility, and container compatibility under various conditions, adhering to stringent standards set by agencies like the FDA and EMA to obtain approvals.

4. How do market dynamics vary between developed and emerging markets?
Developed markets prioritize innovation and brand reputation with higher margins, while emerging markets focus on affordability, regulatory approval, and expanding access, often leading to different pricing and packaging strategies.

5. What strategies can enhance the financial trajectory of Claforan in this formulation?
Investing in formulation stability, expanding regional presence, engaging in strategic partnerships, and adopting flexible pricing models aligned with local reimbursement policies can bolster revenue and market share.


Sources

  1. [1] MarketsandMarkets. "Antibiotics Market by Type, Route of Administration, Application, and Region – Global Forecast to 2030." 2022.

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