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Last Updated: December 19, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq 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 20MEQ 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 20MEQ IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ 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 20MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018629-004 Mar 23, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018629-006 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 20mEq in Plastic Container

Last updated: August 17, 2025


Introduction

The pharmaceutical market for intravenous (IV) infusion solutions remains a critical component of global healthcare, driven by the increasing prevalence of chronic diseases, surgical procedures, and acute illnesses requiring tailor-made electrolyte and nutritional support. Among these, formulations containing Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 20mEq in plastic containers serve vital roles in rehydration therapy, correction of electrolyte imbalances, and nutritional supplementation. This analysis evaluates the current market dynamics and projected financial trajectory of this specific IV solution, considering global demand, manufacturing trends, competitive landscape, regulatory factors, and emerging opportunities.


Market Overview

1. Global Market Size and Growth Trends
The intravenous infusion fluids market was valued at approximately USD 7.5 billion in 2022, with a compound annual growth rate (CAGR) estimated at 6.2% through 2030 [1]. This growth is driven by expanding hospital infrastructure, rising incidences of dehydration, electrolyte disturbances, and increasing adoption of parenteral nutrition solutions. The segment comprising dextrose and electrolyte solutions constitutes a significant share, with particular emphasis on products suitable for rapid rehydration and electrolyte management in both adult and pediatric populations.

2. Specific Product Segment Insights
The formulation of Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 20mEq within plastic containers (typically polyethylene or polypropylene) addresses clinical needs for versatile, ready-to-use infusion solutions. Their applications range from hydration therapy to supportive care in surgeries, trauma, and oncology settings. The shift from glass to plastic containers has enhanced safety profiles, reducing breakage risks and facilitating easier storage and transportation.


Market Dynamics

A. Drivers

  • Rising Disease Burden: Increasing prevalence of dehydration from diarrheal diseases, especially in developing economies, props up demand [2]. Chronic illnesses like diabetes and cardio-renal disorders necessitate electrolyte management via infusion solutions.

  • Expanding Healthcare Infrastructure: Growth in hospital capacities, especially in APAC and Latin America, enhances access to parenteral therapies.

  • Technological Advancements: Development of pre-mixed, ready-to-administer IV solutions enhances safety, compliance, and convenience, fueling market expansion.

  • Regulatory Favorability: Continuous approvals and favorable policy environments support product commercialization, particularly in emerging markets.

B. Challenges

  • Pricing Pressures and Reimbursement Policies: Growing competition and regulatory scrutiny influence pricing strategies.

  • Supply Chain Disruptions: Raw material shortages (notably chloride salts and dextrose) and logistics issues impact manufacturing continuity.

  • Stringent Regulatory Frameworks: Variations in approval pathways across countries prolong time-to-market and increase costs.

C. Competitive Landscape

Major players like Baxter International, B. Braun Melsungen, Pfizer, and Fresenius Kabi dominate the market with extensive product portfolios and manufacturing capabilities. Niche players and regional manufacturers focus on cost-competitive, localized products, often in response to government tenders. Innovative packaging, such as prefilled or smart infusion systems, is gaining traction.


Financial Trajectory

1. Revenue Projections
The specific niche of Dextrose 5% with electrolyte admixtures in plastic containers is projected to grow in alignment with the broader infusion fluids segment [1]. Estimated CAGR for this niche is approximately 5.8% over the next decade, driven by increasing clinical applications and expanding geographic markets, especially in Asia-Pacific.

2. Pricing Dynamics
Pricing remains competitive, with regional variations influenced by manufacturing costs, regulatory costs, and market maturity. In emerging nations, price suppression is common due to tender-based procurement models, impacting margins. Premium formulations, such as sterile, pre-packaged solutions with enhanced safety features, command higher prices and margins.

3. Investment in Manufacturing and R&D
Capital deployment in flexible manufacturing lines for plastic containers, and R&D for product stability and extended shelf life, will be central to future growth. The adoption of single-use, environmentally friendly plastics aligns with regulatory pressure and sustainability initiatives, offering both cost and environmental benefits.

4. Regulatory and Reimbursement Impact
Secure regulatory approvals, especially for biosimilar or generic versions, will directly influence market entry timelines and profitability. Favorable reimbursement policies in major markets, such as the U.S., EU, and Japan, amplify revenue potential.


Emerging Opportunities and Future Trends

A. Personalized Infusion Therapies
Advancements in precision medicine are leading toward customized electrolyte formulations, which could open niche markets for tailored solutions, including specific concentrations for pediatric or geriatric populations.

B. Regional Market Expansion
Growing healthcare investments in Africa, Southeast Asia, and South America present lucrative opportunities, often through government tenders and public health initiatives.

C. Innovation in Packaging and Delivery
Smart infusion systems with integrated safety features and environmentally sustainable plastics are expected to boost adoption rates. These innovations enhance patient safety and reduce administration errors.

D. Strategic Collaborations and M&A
Major manufacturers are pursuing mergers, acquisitions, and strategic alliances to expand product portfolios and access new markets, vital for maintaining competitive edge and capturing growth opportunities.


Regulatory Landscape

Worldwide regulation of parenteral solutions hinges on stringent safety, sterility, and stability standards by agencies such as the FDA, EMA, and PMDA. Ensuring compliance with Good Manufacturing Practices (GMP) and quality standards influences time-to-market and product acceptance. The evolving regulatory landscape emphasizes environmental sustainability, urging manufacturers to innovate in eco-friendly packaging.


Market Challenges and Risk Mitigation

  • Supply Chain Resilience: Establishing diversified sourcing channels and maintaining strategic inventories reduce vulnerability to disruptions.
  • Pricing Strategies: Adoption of cost-effective manufacturing and operational efficiencies can sustain margins amidst pricing pressures.
  • Regulatory Compliance: Early engagement with regulatory agencies and adherence to evolving standards mitigate delays and market access issues.

Conclusion

The market for Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 20mEq in plastic containers is poised for steady growth driven by expanding healthcare needs, technological innovations, and strategic market penetration efforts. While competitive pressures and regulatory complexities pose challenges, ongoing investments in manufacturing, innovation, and regional expansion are likely to sustain positive financial trajectories. Stakeholders must prioritize compliance, supply chain robustness, and product differentiation to capitalize on emerging opportunities.


Key Takeaways

  • The infusion solutions segment, especially electrolyte-admixture formulations, is projected to grow at approximately 6% CAGR annually.
  • Increasing global healthcare infrastructure and rising disease burden sustain demand in both developed and emerging markets.
  • Innovation in packaging, delivery systems, and personalized therapies are pivotal to future growth.
  • Manufacturers should focus on regulatory compliance, supply chain resilience, and regional market expansion to enhance profitability.
  • Strategic collaborations and technological advancements will influence pricing dynamics and market share.

FAQs

1. What are the primary clinical applications of Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 20mEq solutions?
These solutions are used for hydration therapy, electrolyte imbalance correction, and nutritional support, especially in surgical, trauma, oncology, and pediatric care.

2. How does the shift from glass to plastic containers impact this market segment?
Plastic containers enhance safety, reduce breakage, and allow for prefilled, user-friendly packaging, thereby improving storage, transportation, and patient safety.

3. What are the main factors influencing the pricing of these infusion solutions?
Pricing is affected by manufacturing costs, regulatory compliance, regional market dynamics, competitive pricing strategies, and tender processes.

4. Which emerging markets present the highest growth opportunities for these solutions?
Regions such as Southeast Asia, Africa, and Latin America offer significant growth potential due to increasing healthcare investments and expanding hospital infrastructure.

5. How do regulatory policies influence the market trajectory of these infusion solutions?
Regulatory standards for safety, sterility, and packaging govern product approval timelines and market access, impacting overall revenue potential and product lifecycle management.


Sources

[1] Market research reports on IV infusion solutions, 2022-2030.
[2] World Health Organization (WHO), Global Disease Burden Reports.

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