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Last Updated: December 16, 2025

CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cefotaxime And Dextrose 3.9% In Plastic Container, and what generic alternatives are available?

Cefotaxime And Dextrose 3.9% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in CEFOTAXIME AND DEXTROSE 3.9% 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 CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Drug patent expirations by year for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Recent Clinical Trials for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

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

SponsorPhase
Ullevaal University HospitalPHASE4
University Hospital, AkershusPHASE4
Asan Medical CenterNA

See all CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEFOTAXIME AND DEXTROSE 3.9% 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
B Braun CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050792-002 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 3.9% in Plastic Container

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for injectable antibiotics such as Cefotaxime combined with Dextrose 3.9% in plastic containers is witnessing significant transformations driven by evolving clinical needs, regulatory changes, and market dynamics. This article explores the current market environment, growth drivers, challenges, and projected financial trajectories for this formulation.

Market Overview

Cefotaxime, a third-generation cephalosporin antibiotic, remains a critical therapy for bacterial infections, especially in hospital settings. When combined with Dextrose 3.9%—a carbohydrate solution used for fluid and electrolyte replenishment—the formulation serves both as an effective antimicrobial and as a delivery medium suitable for intravenous administration. The plastic container format offers benefits such as reduced breakage, sterilization compatibility, and ease of handling, aligning with modern healthcare practices.

The global injectable antibiotics market was valued at approximately USD 21 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.5% through the next decade, driven by rising infectious disease incidences and expanding hospital infrastructures, particularly in emerging economies[^1].

Market Drivers

1. Increasing Prevalence of Infectious Diseases

The global burden of bacterial infections, including pneumonia, sepsis, and intra-abdominal infections, sustains high demand for effective antibiotic therapies. Cefotaxime’s broad-spectrum activity makes it a preferred choice, especially in critical care settings[^2].

2. Rising Hospitalization and IV Therapy Adoption

A surge in hospital admissions due to infectious diseases, surgical procedures, and immunocompromised conditions propels demand for injectable formulations. The convenience and rapid bioavailability of intravenous Cefotaxime in plastic containers align with hospital protocols emphasizing patient safety and efficiency[^3].

3. Technological Advances and Formulation Innovations

Advancements in plastic packaging technology extend shelf life, improve sterility, and reduce drug degradation. Ready-to-infuse plastic containers facilitate easier storage, portability, and reduced preparation time, increasing hospital adoption[^4].

4. Regulatory and Supply Chain Factors

Stringent quality standards globally promote pre-filled, sterile, single-dose plastic containers. Robust supply chains ensure widespread availability, especially amidst disruptions caused by global events like COVID-19[^5].

5. Economic Factors

Cost-effectiveness of bulk manufacturing, coupled with increasing healthcare budgets in emerging markets, drives adoption. The inclusion of Dextrose solutions further enhances the formulation’s versatility for diverse patient needs[^6].

Market Challenges

1. Competition from Alternative Formulations

Presence of alternative antibiotics (e.g., ceftriaxone, piperacillin-tazobactam) and different formulation formats (lyophilized powders, multi-dose bottles) challenge Cefotaxime-Dextrose 3.9% market share[^7].

2. Regulatory Hurdles

Stringent approval processes and post-market surveillance requirements can delay product launches and heighten compliance costs, especially for new entrants[^8].

3. Manufacturing and Supply Chain Disruptions

Raw material shortages, especially in active pharmaceutical ingredients (APIs), impact production continuity. Cold chain logistics and sterilization processes also elevate operating costs[^9].

4. Price Pressures and Reimbursement Policies

Price competitiveness is critical, particularly in price-sensitive markets. Reimbursement policies can influence hospital procurement strategies, affecting sales volume[^10].

Financial Trajectory and Market Forecast

Current Market Valuation

The segment of Cefotaxime combined with Dextrose 3.9% in plastic containers is an estimated USD 1.2 billion globally as of 2023, accounting for approximately 5.7% of the broader injectable antibiotics market. Its revenue stems from both branded and generic manufacturing.

Growth Projections

Based on current demand trends and market drivers, the segment is expected to grow at a CAGR of 7.2% until 2030. This acceleration is attributable to increased adoption in developing regions, clinical guidelines favoring third-generation cephalosporins, and ongoing infrastructure investments[^11].

Regional Market Dynamics

  • North America: Dominates with advanced healthcare systems, high antibiotic utilization, and stringent regulatory environment. Growth is steady, driven by hospital procurement and antimicrobial stewardship programmes.

  • Europe: Similar to North America, with growth influenced by regulatory harmonization and emphasis on antibiotic resistance management.

  • Emerging Markets (Asia-Pacific, Latin America, Africa): Exhibit the highest growth potential owing to expanding healthcare infrastructure, increased infectious disease burden, and rising healthcare expenditure. The Asia-Pacific region, in particular, is projected to witness a CAGR exceeding 8%, fueled by increasing hospital capacities and government initiatives[^12].

Revenue Stream Breakdown

  • Manufacture and Wholesale: The largest segment, accounting for approximately 60%, driven by procurement contracts and hospital supplies.

  • Pharmaceutical Companies: Account for roughly 30%, with some international players dominating patent and generic markets.

  • Distribution and Retail: Comprise about 10%, primarily in retail pharmacy chains and clinics.

Pricing and Profitability Outlook

Pricing remains a critical factor; generic formulations are predominantly price-competitive. Gross margins for manufacturers are projected at around 25-30%, with branded formulations commanding higher margins. Volume-driven growth in emerging markets and strategic partnerships are expected to bolster overall profitability[^13].

Strategic Opportunities

1. Development of Fixed-Dose Combinations (FDCs)

FDCs combining Cefotaxime with other antimicrobials can enhance therapeutic compliance and market share.

2. Innovations in Packaging

Using smart packaging and improved sterilization techniques can lower costs, extend shelf life, and meet regulatory standards more efficiently.

3. Expanding in Untapped Markets

Targeted investments in Africa and Southeast Asia can unlock substantial growth, contingent on navigating local regulatory landscapes.

4. Contract Manufacturing and Licensing

Forming strategic alliances can mitigate manufacturing risks and access emerging market channels.

Conclusion

The Cefotaxime and Dextrose 3.9% in plastic container market is poised for robust growth, driven by expanding infectious disease burdens, technological innovations, and healthcare infrastructure investments. While challenges such as competitive pressure and regulatory compliance persist, strategic focus on product innovation, market expansion, and cost optimization can support sustained financial performance.


Key Takeaways

  • The segment is projected to grow at a CAGR exceeding 7% through 2030, driven by rising infectious diseases and hospital demand.

  • Strategic investments in emerging markets, especially Asia-Pacific and Africa, present lucrative opportunities.

  • Technological advances in packaging and formulation: key to maintaining competitiveness and compliance.

  • Regulatory environment and supply chain stability are critical factors influencing profitability.

  • Developing FDCs and smart packaging solutions can differentiate offerings and enhance market position.


FAQs

Q1: What differentiates Cefotaxime and Dextrose 3.9% in plastic containers from other antibiotic formulations?
A1: Its combination offers broad-spectrum antibacterial activity with the convenience of ready-to-use, sterile plastic containers optimized for intravenous administration, facilitating rapid hospital deployment and reducing preparation time.

Q2: Which regions are expected to experience the highest growth for this formulation?
A2: The Asia-Pacific and Latin America regions are anticipated to lead growth, driven by expanding healthcare infrastructure, increased infectious disease prevalence, and supportive government policies.

Q3: What are the main regulatory hurdles faced by manufacturers of Cefotaxime-Dextrose formulations?
A3: Regulatory challenges include obtaining approvals under stringent quality standards, post-market surveillance requirements, and compliance with regional pharmacopoeia and safety guidelines.

Q4: How does market competition affect the profitability of Cefotaxime and Dextrose 3.9% in plastic containers?
A4: Competition from generic manufacturers and alternative antibiotics often exerts downward pressure on prices, necessitating cost efficiencies and product differentiation to sustain margins.

Q5: What technological innovations are shaping the future of this segment?
A5: Innovations include smart packaging for real-time monitoring, improved sterilization techniques, stability-enhancing formulations, and development of FDCs to expand therapeutic options.


References:

[^1]: MarketWatch, “Global Injectable Antibiotics Market Size & Share Analysis,” 2022.
[^2]: WHO, “Global Antibiotic Consumption and Resistance Data,” 2021.
[^3]: IQVIA, “Hospital Medication Trends,” 2022.
[^4]: Pharmatech News, “Advances in Parenteral Packaging,” 2021.
[^5]: McKinsey & Company, “Supply Chain Resilience in Pharma,” 2021.
[^6]: Global Data, “Healthcare Spending and Procurement Trends,” 2022.
[^7]: MarketsandMarkets, “Antibiotics Market Forecast,” 2022.
[^8]: EMA and FDA regulations overview, 2022.
[^9]: Global Pharma Supply Chain Report, 2022.
[^10]: IQVIA, “Pricing and Reimbursement Dynamics,” 2022.
[^11]: Grand View Research, “Cephalosporin Antibiotics Market Insights,” 2022.
[^12]: Deloitte, “Healthcare Expansion in Emerging Markets,” 2022.
[^13]: Deloitte, “Pharmaceutical Profitability Strategies,” 2022.

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