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Last Updated: December 19, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.15% In Plastic Container, and when can generic versions of Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.15% In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.15% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.

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Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% 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 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-012 Jan 18, 1986 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 Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 0.15% in Plastic Containers

Last updated: July 28, 2025


Introduction

The intravenous (IV) fluid segment is a vital component within the global pharmaceutical landscape, supporting critical care, surgery, and hydration therapies. Among IV solutions, combination therapies such as Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 0.15% represent a nuanced niche that caters to specific electrolyte and energy management needs in clinical settings. Manufactured predominantly in plastic containers, these solutions are characterized by evolving market dynamics driven by technological innovation, demographic shifts, and healthcare infrastructure expansion.

This analysis examines the current market landscape, key drivers, challenges, and the anticipated financial growth trajectory for this specialized IV therapy segment.


Market Overview and Segmentation

Product Profile

The formulation comprising Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 0.15% offers a balanced electrolyte and glucose remedy suitable for fluid and electrolyte replacement. It is utilized extensively in hospitals, clinics, and emergency care units to replenish fluids while maintaining electrolyte balance, addressing conditions like dehydration, electrolyte imbalance, and metabolic acidosis.

Packaging and Delivery Medium

Plastic containers—commonly polyvinyl chloride (PVC), polyethylene, or polypropylene—are preferred in the industry due to their cost-effectiveness, lightweight nature, and compatibility with IV formulations. Innovations in container design, such as infusion bags with improved safety and permeability features, bolster market demand.

Therapeutic Applications

The primary applications encompass:

  • Acute dehydration management
  • Maintenance fluid therapy
  • Electrolyte imbalance correction
  • Surgical and postoperative care

Market Dynamics

Key Growth Drivers

1. Rising Global Disease Burden

The prevalence of chronic diseases like gastrointestinal disorders, renal dysfunctions, and metabolic disorders necessitates frequent electrolyte and glucose replenishment (WHO reports highlight rising diabetes and kidney-related health concerns), fueling demand for customized IV solutions [1].

2. Increasing Hospitalization and Healthcare Infrastructure

Developing economies are witnessing a surge in healthcare investments, expansion of hospital infrastructure, and an increase in ICU capacity. This growth directly correlates with higher utilization of IV therapies, including the studied formulation.

3. Technological Advances in Packaging and Formulation

Innovation in plastic container materials (e.g., non-PVC, inert plastics) ensures better stability, reduced leaching of harmful substances, and compliance with regulatory standards such as USP and EP. These advancements expand the scope for specialized IV solutions.

4. Growing Focus on Patient Safety and Regulatory Compliance

Stringent regulations on manufacturing practices and contamination prevention motivate industry players to innovate in packaging and formulation, reinforcing market growth.

5. Impact of COVID-19 Pandemic

The pandemic accentuated the need for reliable hydration solutions for severe cases, bolstering demand for IV therapies with electrolyte and glucose components. The global emphasis on hospital preparedness has increased preferences for ready-to-use, sterile plastic containers [2].

Market Challenges

1. Regulatory Complexity and Compliance

Differing international standards complicate manufacturing, delaying product approvals and restricting market penetration.

2. Competition and Pricing

The presence of generic manufacturers and intense price competition exert downward pressure, particularly in price-sensitive markets.

3. Supply Chain Disruptions

Global logistics issues, notably during the COVID-19 pandemic, have impacted raw material availability, influencing production schedules.

4. Safety Concerns in Plastic Packaging

Risks related to leaching, endotoxin contamination, and plastic particulate generation necessitate vigilant quality controls, increasing manufacturing costs.


Financial Trajectory and Forecast

Market Size and Segment Analysis

The global IV fluids market was valued at approximately USD 8.5 billion in 2022, projected to grow at a CAGR of 6.2% through 2030 (Grand View Research). Within this, electrolyte solutions like the Dextrose with electrolytes segment constitute a significant share, driven by increased clinical application and healthcare expenditure.

Regional Outlook

  • North America: Dominates due to advanced healthcare infrastructure, regulatory clarity, and high disease prevalence, especially in the US.
  • Europe: Benefits from aging populations and stringent healthcare policies supporting sterile and safe IV solutions.
  • Asia-Pacific: Expected to witness the fastest growth (CAGR ~8%) owing to expanding healthcare infrastructure, rising per capita health spending, and increasing adoption in emerging economies such as India and China.

Projected Revenue Growth for the Specific Formulation

Given the niche nature of Dextrose 5% with electrolyte admixtures in plastic containers, growth will be influenced by:

  • Market Penetration: Enhanced adoption in hospitals, clinics, and emerging markets.
  • Product Innovation: Development of prefilled, ready-to-administer solutions with improved safety profiles.
  • Regulatory Approvals: Streamlined approval processes in key markets.

Estimates suggest a compounded annual growth rate (CAGR) of approximately 7-9% from 2023 to 2030, with the potential to reach USD 500 million in global revenue by 2030 (industry analysis projections).

Pricing Trends and Cost Dynamics

Price pressures persist due to generic competition and bulk procurement by healthcare systems. However, premium offerings in safer, plastic container-adapted formulations and differentiated packaging could command higher margins.

Raw material costs, particularly for plastics and active ingredients, influence final pricing structures. Innovations reducing manufacturing costs and enhancing shelf life are pivotal for financial sustainability.


Regulatory Landscape

Regulatory standards play a crucial role in market expansion. Agencies such as the FDA (US), EMA (Europe), and PMDA (Japan) enforce strict compliance, especially for intravenous formulations. Innovations in container materials must adhere to biocompatibility standards, such as USP <87> and <88>, and meet environmental regulations to minimize plastic waste impacts.

Emerging trends involve accelerated approval pathways for essential medications, simplified registration procedures in emerging markets facilitated by local regulatory collaborations, and increased focus on environmental sustainability in packaging materials.


Market Opportunities and Strategic Considerations

1. Advancements in Container Technologies

Developing non-PVC, environmentally friendly plastic containers aligns with global sustainability initiatives. Incorporating smart infusion systems integrated with IoT could further enhance safety, usage tracking, and compliance.

2. Expansion in Emerging Markets

Emerging economies are investing heavily in healthcare infrastructure. Local manufacturing, strategic partnerships, and licensing agreements offer growth avenues.

3. Focus on Personalized and Modular Solutions

Customizable electrolyte formulations and modular packaging systems can cater to specific patient demographics, pathogen risks, and hospital protocols.

4. Digital and Data-Driven Approaches

Integrating digital analytics for demand forecasting, inventory management, and traceability will streamline supply chains and reduce wastage.


Conclusion

The market for Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 0.15% in plastic containers embodies a pivotal segment within the broader IV solutions domain. The convergence of technological innovation, demographic shifts, and healthcare infrastructure growth predicates a robust financial trajectory, characterized by steady CAGR and expanding market penetration.

Healthcare providers’ focus on safety, regulatory compliance, and sustainable packaging will shape the competitive landscape. Stakeholders capable of leveraging these dynamics through innovation, strategic regional expansion, and quality excellence stand to gain significantly in this evolving market.


Key Takeaways

  • The IV electrolyte and glucose solution market, especially formulations like Dextrose 5% with electrolytes, is projected to grow at approximately 7-9% CAGR through 2030.
  • Increasing healthcare infrastructure, aging populations, and rising chronic diseases drive demand, particularly in North America, Europe, and Asia-Pacific.
  • Technological innovations in plastic container materials and IoT-enabled infusion systems offer differentiation and safety enhancements.
  • Regulatory compliance and environmental sustainability are critical considerations influencing product development and market accessibility.
  • Strategic expansion into emerging markets, coupled with advancements in packaging and digital integration, present significant growth opportunities.

FAQs

1. What are the primary benefits of using plastic containers for IV solutions like Dextrose and electrolytes?
Plastic containers offer lightweight, cost-effective, and flexible packaging options that improve handling, sterilization, and compatibility with infusion systems, while reducing breakage risks compared to glass.

2. How is the market for combination IV solutions evolving in response to healthcare needs?
The market is shifting toward personalized, flexible formulations that optimize patient safety and therapeutic efficacy, driven by technological innovations in container design and formulation customization.

3. What regulatory challenges exist for manufacturing IV solutions in plastic containers?
Manufacturers must ensure biocompatibility, sterility, and environmental safety standards, with compliance varying across jurisdictions, requiring thorough validation and documentation processes.

4. Which regions are expected to see the fastest growth for these IV solutions?
Asia-Pacific and Latin America are anticipated to experience the highest growth rates due to expanding healthcare infrastructure and increasing healthcare spending.

5. How can manufacturers differentiate their products in this competitive market?
Investment in innovation—such as non-PVC, eco-friendly packaging, integrated safety features, and digital infusion management—along with strategic regional partnerships, can provide competitive advantages.


References:

[1] World Health Organization. Global Health Observatory Data. 2022.
[2] Johns Hopkins Medicine. Impact of COVID-19 on IV Therapy Demand. 2021.

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