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Last Updated: December 12, 2025

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.11% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.11% In Plastic Container is a drug marketed by B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

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Summary for DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.11% 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% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-006 Feb 24, 1988 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% and Sodium Chloride 0.11% in Plastic Container

Last updated: July 29, 2025

Introduction

The combined formulation of Dextrose 5% and Sodium Chloride 0.11% in plastic containers forms an integral part of the intravenous (IV) fluid therapy domain. As a balanced electrolyte solution, it caters to a broad spectrum of medical needs, including hydration, electrolyte replenishment, and nutritional support. The current industry landscape reflects steady growth propelled by medical advancements, increasing healthcare expenditure, and expanding hospital infrastructure globally. This report dissects the market dynamics, forecasted financial trajectory, and key factors affecting the growth of this pharmaceutical segment.

Market Overview

Product Description and Uses

Dextrose 5% and Sodium Chloride 0.11% solution—commonly known as a hypotonic IV fluid—is utilized predominantly for parenteral nutrition, fluid resuscitation, electrolyte balance, and volume replacement. The formulation’s plastic container packaging enhances safety, convenience, and shelf stability. Its versatility in clinical settings across hospitals, clinics, and ambulatory care centers underpins consistent demand.

Regulatory Landscape

The formulation is regulated under strict pharmaceutical standards, such as the U.S. FDA’s Current Good Manufacturing Practice (cGMP) guidelines, EMA regulations, and equivalent authorities worldwide. Market entry requires significant compliance infrastructure, yet approval processes are streamlined for established formulations, encouraging rapid commercialization.

Market Dynamics

Drivers of Growth

  1. Rising Global Healthcare Expenditure: A surge in healthcare spending—forecasted to reach USD 10.1 trillion globally by 2022 (WHO)—fuels demand for essential IV fluids. As healthcare systems expand, particularly in emerging markets, the need for standardized, safe infusion solutions intensifies.

  2. Increasing Hospitalization and Surgical Procedures: The growing prevalence of chronic diseases, accidents, and surgical interventions necessitates reliable IV solutions. Hospitals are adopting commercially sterile, ready-to-use plastic container formats to improve clinical efficiency.

  3. Technological Advancements in Packaging: Innovations in plastics, such as low-density polyethylene (LDPE) and polyvinyl chloride (PVC), extend shelf life and reduce contamination risk. These improvements bolster market adoption.

  4. Expanding Use in Critical Care and Pediatric Settings: The formulation’s safety profile and ease of administration make it preferred in intensive care units and pediatric wards, where fluid management is crucial.

Challenges Restraining Growth

  1. Regulatory and Compliance Barriers: Stringent approval processes and variation in international standards can delay product launch and increase costs.

  2. Competition From Alternative Solutions: Availability of other IV fluids—e.g., saline, dextrose solutions of different concentrations—creates substitute options, intensifying competition.

  3. Price Pressure and Reimbursement Issues: Governments and insurers' focus on cost containment subjects the segment to pricing pressures, especially in highly regulated markets like the U.S.

Market Segmentation

  • End-User: Hospitals, clinics, ambulatory surgical centers, home healthcare.
  • Geography: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
  • Application: Hydration therapy, electrolyte replenishment, nutritional support.

Competitive Landscape

Major players include Baxter International Inc., B. Braun Melsungen AG, Pfizer Inc., and Fresenius Kabi AG. These companies leverage extensive distribution networks, brand recognition, and compliance expertise. Market entry by regional manufacturers is challenging but facilitated by niche specialization and pricing strategies.

Financial Trajectory and Market Forecast

Historical Market Size and Growth

According to Frost & Sullivan and other market research reports, the global injectable IV fluids market was valued at approximately USD 13 billion in 2021, with the electrolyte segment representing a significant share. The Dextrose 5% and Sodium Chloride 0.11% segment specifically exhibited a compound annual growth rate (CAGR) of roughly 4.5% between 2016 and 2021.

Projected Market Growth (2023-2030)

The segment is expected to expand at a CAGR of approximately 5-6% over the next seven years, driven by:

  • Emerging Markets: The Asia-Pacific region is forecasted to witness a CAGR of around 7%, fueled by expanding healthcare infrastructure and increased clinical adoption.

  • Developed Markets: North America and Europe are expected to maintain steady growth (~3-4%), owing to market saturation and focus on clinical optimization.

Revenue Projections

By 2030, the global market value for Dextrose and Sodium Chloride IV solutions in plastic containers may reach USD 18-20 billion, assuming steady adoption, regulatory approvals, and minimally disruptive innovations. Incremental growth will be amplified by the ongoing transition from glass to plastic containers, which reduces breakage risk and enhances patient safety.

Pricing Trends

Pricing is influenced by factors such as raw material costs, manufacturing scale, regulatory compliance, and regional reimbursement policies. A slight downward pressure on prices is expected due to increased competition, but premium pricing may persist in specialized formulations with added features like enhanced preservative systems or improved plastics for stability.

Key Market Drivers and Opportunities

  • Growth in Critical and Emergency Care: Heightened demand for immediate, sterile IV fluids in trauma and emergency settings fuels market expansion.
  • Increased Focus on Patient Safety and Sterility: Innovations that emphasize pre-packaged, tamper-evident plastic containers lead to better clinical outcomes and higher acceptance.
  • Expansion in Hospital Infrastructure: Investments in healthcare facilities, particularly in emerging economies, establish long-term demand sustainment.

Challenges and Risks

  • Regulatory Hurdles: Variability in approval timelines and standards across geographies can delay market penetration.
  • Supply Chain Disruptions: Raw material shortages or political instability can impact manufacturing volumes.
  • Environmental Concerns: Growing scrutiny of plastic waste management affects manufacturing and packaging choices, potentially increasing costs.

Strategic Considerations for Stakeholders

  • Market Entry: Companies should prioritize regions with growing healthcare investments and favorable regulatory climates.
  • Differentiation: Innovation in packaging, stability, and compatibility with advanced infusion devices can carve competitive advantages.
  • Cost Efficiency: Scaling manufacturing and optimizing supply chains will be essential to sustain healthy margins amid pricing pressures.

Conclusion

The market for Dextrose 5% and Sodium Chloride 0.11% solutions in plastic containers exhibits steady growth projected through 2030, driven primarily by expanding healthcare infrastructure and the increasing reliance on IV therapies. While challenges such as regulatory complexity and competition persist, technological innovations and targeted regional expansion strategies present significant opportunities for established and emerging market players. Managing costs, enhancing safety features, and aligning with environmental sustainability trends will be pivotal in capturing enduring market share and ensuring financial robustness.

Key Takeaways

  • The global market for Dextrose 5% and Sodium Chloride 0.11% IV solutions in plastic containers is expected to grow at approximately 5-6% annually through 2030.
  • Market expansion is chiefly driven by increasing healthcare infrastructure, rising chronic and acute care needs, and technological improvements in packaging.
  • Emerging markets, especially in Asia-Pacific, offer high-growth opportunities due to infrastructure development and increasing healthcare access.
  • Competition is intense, with innovation in packaging and formulation quality as differentiators.
  • Price pressures and regulatory hurdles remain challenges; strategic adaptation is essential for sustained profitability.

FAQs

  1. What factors contribute most significantly to the growth of this IV solution market?
    The expansion of healthcare infrastructure, increasing hospital admissions, technological advancements in packaging, and growing demand in critical care environments are primary growth drivers.

  2. How do regulatory challenges influence market entry for new manufacturers?
    Stringent compliance requirements, varying regional standards, and lengthy approval processes can delay product launches and increase costs, necessitating strategic regulatory planning.

  3. What role does innovation in packaging play in market competitiveness?
    Advances such as sterile, tamper-evident plastic containers improve safety, shelf life, and convenience, providing manufacturers with a competitive edge.

  4. Which regions are expected to see the highest growth in demand?
    Asia-Pacific and Latin America are poised for higher CAGR owing to expanding healthcare systems and increasing adoption of IV therapies.

  5. How might environmental concerns impact future development of IV fluid packaging?
    Rising ecological awareness may favor biodegradable and recyclable plastics, influencing material choice and manufacturing practices, possibly impacting costs and supply chains.


Sources:

  1. World Health Organization (WHO). Global health expenditure statistics.
  2. Frost & Sullivan. Global Injectable IV Fluids Market report, 2022.
  3. McKinsey & Company. The future of healthcare infrastructure in emerging markets, 2021.

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