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Last Updated: December 15, 2025

CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cefotaxime And Dextrose 2.4% In Plastic Container, and what generic alternatives are available?

Cefotaxime And Dextrose 2.4% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in CEFOTAXIME AND DEXTROSE 2.4% 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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  • What is the 5 year forecast for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER?
  • What are the global sales for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER?
Summary for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Drug patent expirations by year for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Recent Clinical Trials for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

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

SponsorPhase
University Hospital, AkershusPHASE4
Ullevaal University HospitalPHASE4
Asan Medical CenterNA

See all CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEFOTAXIME AND DEXTROSE 2.4% 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
B Braun CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050792-001 Jul 29, 2004 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 Cefotaxime and Dextrose 2.4% in Plastic Container

Last updated: July 29, 2025


Introduction

The pharmaceutical landscape surrounding Cefotaxime combined with Dextrose 2.4% in plastic containers reflects evolving clinical needs and regulatory frameworks. As a broad-spectrum cephalosporin antibiotic utilized predominantly in hospital settings for severe bacterial infections, Cefotaxime's formulation with Dextrose ensures rapid intravenous delivery, offering crucial advantages for critically ill patients. This analysis explores current market drivers, competitive pressures, regulatory environment, and financial prospects shaping the trajectory of this pharmaceutical formulation.


Market Overview

Market Size and Growth Trends

Globally, the antibiotic market is projected to reach approximately USD 55 billion by 2026, with the cephalosporins segment contributing significantly due to their efficacy in combating resistant bacterial strains [1]. Cefotaxime holds a substantial share within this class given its widespread use in respiratory, urinary, and meningitis infections. The infusion of Dextrose facilitates prolonged stability and compatibility, expanding application scope.

The demand for Cefotaxime and Dextrose 2.4% in plastic containers notably aligns with hospital procurement patterns and IV infusion protocols. The increasing incidence of healthcare-associated infections (HAIs) and antibiotic resistance intensifies the need for potent, readily administrable formulations.

Forecasting suggests a compound annual growth rate (CAGR) of approximately 4-6% globally for cefotaxime-based formulations, driven by expanding hospital infrastructure in emerging economies and rising antimicrobial resistance [2].

Key Market Drivers

  • Rising Incidence of Severe Bacterial Infections: Growing cases of pneumonia, meningitis, and intra-abdominal infections bolster demand.
  • Hospital Infrastructure Expansion: Especially in Asia-Pacific and Latin America, enhances access to hospital-based antibiotics.
  • Advancements in IV Formulation Stability: Plastic containers improve portability, shelf-life, and ease of administration, fostering market adoption.
  • Regulatory Approvals and Standardization: Stringent standards from bodies like the FDA and EMA validate product safety and efficacy, paving the way for broader market penetration.

Competitive Landscape

The competitive environment features multinational pharmaceutical giants and regional players. Major manufacturers include Pfizer, GlaxoSmithKline, Sandoz, and local drug makers in emerging markets. Competitive differentiation revolves around:

  • Formulation Stability and Compatibility: Innovations in plastic container design mitigate issues like drug adsorption and sterilization integrity.
  • Pricing Strategies: Region-specific pricing influences market share, especially in price-sensitive economies.
  • Regulatory Approvals: WHO prequalification and adherence to Good Manufacturing Practices (GMP) elevate product credibility.
  • Formulation Variants: Presence of generic versions compresses prices, impacting profit margins.

Patent landscapes for cefotaxime formulations are approaching saturation, with many patents expiring, encouraging generic entry and price competition. However, formulation-specific patents for Dextrose-combined products remain influential.


Regulatory Environment

Regulatory approval and compliance significantly impact product availability and market growth:

  • FDA/EMA Approvals: Certify safety, efficacy, and quality standards.
  • Hospitals and Procurement Policies: Favor products that meet institutional and national regulatory requirements.
  • Environmental and Safety Standards: Emphasize plastic packaging safety, sterility, and disposal protocols.
  • Pricing and Reimbursement Policies: Influence hospital procurement and adoption rates, especially under government health schemes.

Emerging markets often face regulatory hurdles but also offer opportunities due to increasing healthcare spending and infrastructure upgrade programs.


Pricing and Financial Trajectory

Pricing Dynamics

Pricing varies by geography, manufacturing scale, and competitive landscape. In developed markets, unit costs hover around USD 10-20 per vial, with bulk procurement discounts. In emerging markets, prices may range from USD 2-8 per vial, driven by local economic factors and higher generic competition.

Revenue Streams

Revenue streams derive from wholesale procurement by hospitals, clinics, and governmental agencies. The average sales volume correlates with prevalence of infections requiring IV antibiotics and hospital capacities.

Profitability Outlook

  • Margins: Gross margins typically range between 30-45%, influenced by raw material costs, regulatory compliance, and competition.
  • Cost Considerations: Raw materials (antibiotics, Dextrose), manufacturing expenses, sterilization, and packaging constitute significant costs.
  • Market Penetration Strategies: Licensing, strategic partnerships, and localized manufacturing optimize margins and expand reach.

Financial Projections

Market analysis predicts steady revenue growth driven by increased hospital demand, generics entry, and expanding healthcare infrastructure. The shift towards pre-filled, ready-to-use plastic containers enhances applicability and reduces preparation time, further amplifying sales prospects.


Distribution Channels and Supply Chain

  • Hospital Procurement: Primary channel, emphasizing reliability and compliance.
  • Pharmaceutical Distributors: Facilitate regional reach, especially in remote areas.
  • Direct Sales to Institutional Buyers: Ensures inventory control and tailored contracts.

Efficient supply chain management mitigates risks of stockouts and counterfeiting, critical in the antibiotic market.


Market Challenges and Risks

  • Antimicrobial Resistance (AMR): Promotes prescription restrictions and stewardship programs that may constrain volume.
  • Regulatory Delays: Potential pipeline stagnation due to evolving standards.
  • Price Pressures: Increased generic competition limits pricing power.
  • Environmental Concerns: Plastic packaging's environmental footprint prompts regulatory scrutiny and supply chain adjustments.

Technological and Innovation Outlook

Innovations in formulation stability, co-formulations, and container designs secure the competitive edge:

  • Smart Infusion Devices: Integration with technology for controlled delivery.
  • Biodegradable Packaging: Addressing environmental concerns.
  • Extended Shelf Life Formulations: Facilitating storage and distribution in resource-limited settings.

Investments in R&D are anticipated to yield formulations with improved stability, efficacy, and safety profiles, thereby enhancing market dynamics.


Key Takeaways

  • Growing Hospital Demand: The increasing burden of bacterial infections and hospital infrastructure expansion underpin market growth.
  • Generic Competition Convergence: Patent expirations foster price competition, favoring affordability and accessibility.
  • Regulatory Stringency: Compliance is vital for market entry and expansion; maintaining safety and quality standards drives trust.
  • Innovation Drives Differentiation: Formulation improvements and packaging innovations bolster market positioning.
  • Regional Opportunities: Emerging markets offer substantial growth potential owing to healthcare investments and unmet needs.

Conclusion

The market outlook for Cefotaxime and Dextrose 2.4% in plastic containers remains favorable amid increasing healthcare needs, regulatory support, and technological advancements. Manufacturers leveraging innovation, strategic partnerships, and adaptive pricing will be well-positioned to capitalize on burgeoning opportunities, despite challenges from regulatory complexities and competitive pressures.


FAQs

  1. What factors influence the pricing of Cefotaxime and Dextrose in plastic containers?
    Pricing is affected by manufacturing costs, competition, regional economic conditions, regulatory approvals, and healthcare procurement policies.

  2. How does antimicrobial resistance impact the market for Cefotaxime formulations?
    AMR can limit antibiotic efficacy, prompting stricter stewardship and reducing volume growth. However, it also increases demand for potent, broad-spectrum agents like Cefotaxime.

  3. What role does packaging innovation play in market competitiveness?
    Innovative plastic containers improve stability, ease of use, and safety, helping firms differentiate and meet regulatory requirements, thus enhancing market share.

  4. Are there specific regional trends influencing demand for this formulation?
    Emerging markets in Asia and Latin America show increased adoption due to expanding hospital infrastructure, while developed regions focus on stewardship and resistance management.

  5. What are the future technological developments expected in Cefotaxime formulations?
    Upcoming innovations include biodegradable packaging, smart infusion devices, extended shelf-life formulations, and combination therapies to improve efficacy and safety.


References

[1] Market Research Future, "Antibiotics Market," 2021.
[2] Grand View Research, "Cephalosporins Market Size, Share & Trends," 2022.

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