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Last Updated: December 18, 2025

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


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When do Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 5meq In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ 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 5MEQ IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ 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
Baxter Hlthcare DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018629-001 Mar 23, 1982 AP RX 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 5mEq in Plastic Containers

Last updated: July 30, 2025


Introduction

The pharmaceutical sector’s landscape is increasingly influenced by advancements in intravenous (IV) therapy solutions. Among these, the formulation comprising Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 5mEq in plastic containers signifies a critical segment, primarily used for fluid and electrolyte balance in clinical settings. This analysis explores the market dynamics and projected financial trajectory of this specific formulation, considering factors such as demand drivers, regulatory influences, technological trends, and competitive landscape.


Market Overview

The combination of Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 5mEq serves as a balanced electrolyte replenishment solution, typically employed for hydration therapy, metabolic support, and correction of electrolyte imbalances. The global IV fluid market was valued at approximately USD 8.2 billion in 2022[1], with demand driven by expanding healthcare infrastructures, increasing prevalence of chronic diseases, and rising geriatric populations. The segment containing electrolyte solutions like the one under discussion is a significant component, fueled by both hospital and outpatient care settings globally.


Key Market Drivers

1. Growing Healthcare Expenditure and Infrastructure Development

Increasing healthcare investments, especially in emerging economies, bolster the adoption of IV therapies. Governments and private entities are expanding hospital capacities, leading to greater procurement of electrolyte solutions.

2. Rising Prevalence of Chronic Diseases and Electrolyte Imbalances

Conditions such as dehydration, metabolic acidosis, and electrolyte disturbances necessitate IV therapy, directly increasing demand for formulated solutions like Dextrose and electrolyte mixes.

3. Surge in Surgical Procedures and Trauma Cases

Electrolyte solutions are vital intraoperative and postoperative care components. The rising surgical volume worldwide augments the requirement for standardized IV fluids.

4. Technological Improvements and Standardization

Advances in container manufacturing—favoring plastic over glass—improve safety, reduce costs, and enhance shelf life, encouraging market penetration.

5. Regulatory Approvals and Reimbursement Policies

Supportive regulatory frameworks and reimbursement schemes accelerate adoption, especially in mature markets like North America and Europe.


Market Challenges

1. Regulatory Hurdles and Quality Standards

Strict regulatory evaluations, especially regarding container materials and solution sterility, prolong approval processes, and could impose compliance costs.

2. Competition from Alternative Formulations and Packaging

The surge in pre-mixed or customizable formulations may challenge standardized solutions. Additionally, increasing preference for portable infusion devices influences container formats.

3. Price Pressures and Cost Containment

Pooling purchasing power, especially in hospital networks, exerts downward pressure on pricing, affecting profit margins.

4. Supply Chain Disruptions

Global shortages of raw materials, logistical interruptions, and geopolitical factors impact production and distribution.


Market Segmentation and Competitive Landscape

Product Segmentation

The formulation of Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 5mEq in plastic containers predominantly targets hospital and clinic settings. Within this, disposable plastic bags are the preferred container format, favored for their durability, lighter weight, and disposability.

Regional Outlook

  • North America: The most mature market with high adoption rates driven by advanced healthcare infrastructure and regulatory support.
  • Europe: Similar maturity, with a focus on safety standards and technological innovations.
  • Asia-Pacific: Fastest-growing due to expanding healthcare infrastructure, rising awareness, and large patient populations. Countries like China, India, and Southeast Asian nations are key growth engines.
  • Latin America and Middle East: Rising healthcare investments complement market growth.

Competitive Players

Major manufacturers include Baxter International, B. Braun Melsungen AG, Hospira (a Pfizer company), and Fresenius Kabi. These companies are investing in manufacturing capacity expansions, quality enhancements, and regional distribution networks.


Financial Trajectory and Market Forecast

Short-term Outlook (2023-2025)

Given the ongoing global recovery from pandemic disruptions and rising healthcare needs, the market for electrolyte solutions in plastic containers is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8%[2]. Increasing demand from hospitals, clinics, and outpatient settings sustains this trajectory.

Medium to Long-term Outlook (2026-2030)

Analogous to global healthcare expansion trends, the market is expected to maintain a CAGR of around 7-9%, driven by technological innovations such as smart infusion devices and biodegradable container materials, alongside increased adoption in emerging economies.

Revenue Projections

Based on current market size estimations, the segment could generate revenues exceeding USD 1.5 billion by 2030, with Asia-Pacific accounting for a burgeoning share due to rapid infrastructure development and population growth.

Pricing and Cost Dynamics

Manufacturers are optimizing production costs through automation and economies of scale, while pricing strategies remain sensitive to hospital procurement policies and reimbursement models. Plastic containers, while cost-effective, must meet strict safety standards to avoid liability issues—potentially influencing profit margins.


Technological Trends and Innovation Trajectories

Container Innovations

Transition from glass to plastic containers has improved safety, handling, and logistics. Innovations include resealable bags, integrated filters, and smart labels that enhance traceability and safety.

Formulation Developments

R&D efforts are focused on optimizing electrolyte concentrations for personalized therapy, including customized blends and stability enhancements.

Automation and Data Integration

Connected infusion technologies enable real-time monitoring and dose adjustments, impacting market growth and offering value-added features.


Regulatory and Policy Impact

Stringent regulatory frameworks by agencies such as the FDA, EMA, and other regional authorities impose standards on sterility, stability, and container safety. Compliance incurs costs but ensures market access. Advances in regulatory science, with harmonization efforts like the ICH guidelines, facilitate broader market reach.


Key Market Players' Strategic Moves

  • Capacity Expansion: Companies like Baxter and B. Braun expand manufacturing units to meet rising demand.
  • Technological Collaborations: Strategic partnerships aim to develop smart infusion devices and innovative container materials.
  • Market Penetration Strategies: Focused on gaining share in emerging markets through local partnerships and distribution networks.
  • Regulatory Optimization: Investing in compliance capabilities to accelerate approvals and reduce time-to-market.

Conclusion

The market for Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 5mEq in plastic containers stands at a favorable juncture, with steady growth prospects underpinned by healthcare infrastructure expansion, technological innovation, and increasing global healthcare needs. While regulatory hurdles and competitive pressures persist, the overall trajectory indicates a robust outlook, with significant revenue potential across emerging and developed markets.


Key Takeaways

  • Sustained Demand Drivers: Rising chronic illness prevalence and procedural volumes underpin consistent demand.
  • Regional Growth Opportunities: Asia-Pacific represents the most dynamic growth environment due to infrastructure upgrades.
  • Competitive Landscape: Dominated by established players investing in capacity and innovation.
  • Innovation Focus: Container safety and smart infusion technologies are transforming the market.
  • Regulatory Environment: Stringent standards necessitate compliance investments but promote product safety and market trust.

FAQs

1. What are the primary clinical applications of Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 5mEq in plastic containers?
These solutions are mainly used for fluid replacement, electrolyte balance correction, and metabolic support in hospitals, clinics, and outpatient settings.

2. How does the shift from glass to plastic containers influence market growth?
Plastic containers improve safety, reduce breakage, and lower costs, thereby boosting adoption rates and expanding market reach.

3. Which regions are expected to witness the highest growth in this market segment?
Asia-Pacific and Latin America are projected to experience the highest CAGR due to expanding healthcare infrastructure and rising demand.

4. What technological innovations are shaping the future of electrolyte IV solutions?
Smart infusion devices, biodegradable containers, and connected monitoring systems are key innovations driving efficiency and safety.

5. What are the main challenges facing manufacturers in this market?
Regulatory compliance costs, price pressures, raw material shortages, and competition from alternative formulations pose significant challenges.


References

[1] MarketsandMarkets. (2022). IV Fluid Market.
[2] Grand View Research. (2023). Electrolyte Solutions Market Analysis.

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