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Last Updated: December 12, 2025

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 10% And Sodium Chloride 0.45% In Plastic Container patents expire, and when can generic versions of Dextrose 10% And Sodium Chloride 0.45% In Plastic Container launch?

Dextrose 10% And Sodium Chloride 0.45% In Plastic Container is a drug marketed by B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.45% 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 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.45% 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 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018229-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-014 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 10% and Sodium Chloride 0.45% in Plastic Containers

Last updated: August 2, 2025


Introduction

The intravenous (IV) fluids market, pivotal within the global pharmaceutical landscape, continues to evolve, driven by expanding healthcare needs, technological advancements, and regulatory shifts. Among key formulations, Dextrose 10% combined with Sodium Chloride 0.45% in plastic containers occupies a specialized segment. This combination, primarily used for hydration, nutrition support, and electrolyte replenishment, has experienced sustained demand amidst global healthcare challenges. This analysis explores the market dynamics governing this segment and forecasts its financial trajectory, underpinning strategic business and investment decisions.


Market Overview and Composition

Product Profile

Dextrose 10% and Sodium Chloride 0.45%, packaged primarily in polypropylene or polyvinyl chloride (PVC) plastic containers, serve as isotonic or slightly hypotonic solutions. They are integral in clinical settings for fluid therapy, especially in hospitals, ambulatory clinics, and emergency scenarios.

Market Segments

The market can be segmented by:

  • Application: Hospitals, clinics, emergency services
  • End-use: Critical care, nutrition therapy, electrolyte management
  • Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa

Manufacturers

Major players include Baxter International, B. Braun Melsungen, Hospira (Pfizer), and Fresenius Kabi, leveraging their extensive distribution networks and R&D capacities.


Market Dynamics

Driving Forces

1. Expanding Healthcare Infrastructure

Globally, rising investments in healthcare infrastructure — especially in emerging markets — underpin increased consumption of IV fluids. In countries like India, China, and Brazil, healthcare reforms aim to improve patient care, escalating demand.

2. Aging Population and Chronic Diseases

An aging demographic amplifies the need for hydration and electrolyte management. Chronic illnesses such as cardiovascular and renal diseases frequently require IV solutions, including Dextrose and Sodium Chloride formulations.

3. Growing Hospitalization Rates

The COVID-19 pandemic accentuated the significance of IV therapy, with hospitals deploying large volumes of fluids to manage critically ill patients, thus stimulating market growth.

4. Advances in Packaging Technologies

Transition from glass to plastic containers offers benefits such as reduced breakage, convenience, and extended shelf-life, fueling market expansion.

Restraints

1. Regulatory Challenges

Stringent approval processes by agencies like the FDA and EMA lengthen product commercialization timelines, impacting time-to-market and profitability.

2. Price Sensitivity and Reimbursement Policies

Cost containment measures and reimbursement constraints, particularly in public healthcare systems and emerging economies, restrict price premiums and profit margins.

3. Competition from Biosimilars and Generics

The commoditized nature of IV fluids leads to intense price competition, limiting revenue growth.

Opportunities

1. Innovation in Formulation and Packaging

Enhanced formulations with added benefits, such as sterile filtration and stability, or eco-friendly packaging, could create differentiation.

2. Regional Market Penetration

Expanding presence in Asia-Pacific and African markets presents considerable growth potential owing to expanding healthcare infrastructure and population size.

3. Strategic Partnerships

Collaborations among manufacturers, healthcare providers, and policymakers can streamline supply chains and accelerate adoption.


Financial Trajectory Analysis

Market Size and Growth Forecasts

The global IV fluids market, valued at approximately USD 9 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 5.0% over the next five years [1]. The segment comprising Dextrose 10% and Sodium Chloride 0.45%, representing a substantial proportion of this market, is expected to reflect similar growth trends.

In absolute terms, the demand for these formulations is estimated to increase from an estimated USD 1.5 billion in 2022 to approximately USD 2 billion by 2027. This growth trajectory reflects the convergence of increasing healthcare infrastructure, aging populations, and rising chronic disease prevalence.

Revenue Drivers

  • Volume Expansion: Increased hospital admissions and outpatient treatments.
  • Pricing Dynamics: Despite competitive pricing, premium formulations or value-added packaging can support higher margins.
  • Geographic Expansion: Entry into untapped markets enhances revenue streams.

Profit Margin Considerations

Average gross profit margins for IV fluids range between 20% and 30%, influenced by manufacturing costs, raw material prices, and regulatory compliance expenses. Cost optimization through automation and supply chain efficiencies can improve profitability, particularly in high-volume markets.

Risk Factors Affecting Financial Trajectory

  • Raw Material Price Volatility: Fluctuations in glucose and salt commodity prices directly impact production costs.
  • Regulatory Delays: Lengthy approval and post-market surveillance increase operational costs.
  • Market Saturation: In mature markets, growth may plateau, necessitating innovation or diversification.

Regulatory and Market Entry Considerations

Compliance with global standards (e.g., USP, Pharmacopoeia of China, Indian Pharmacopoeia) remains critical. Recent regulatory trends favoring stricter safety standards and environmental considerations for plastic packaging could influence formulation choices and costs.

Market entry strategies should include rigorous quality assurance, establishing local manufacturing where feasible, and fostering relationships with healthcare institutions.


Strategic Recommendations

  • Invest in R&D to develop formulations with enhanced stability, safety, and eco-friendly packaging.
  • Focus on emerging markets through strategic partnerships, localized manufacturing, and tailored marketing efforts.
  • Leverage technological advancements such as smart packaging for traceability and expiry tracking, adding value for healthcare providers.
  • Monitor regulatory developments to adapt compliance strategies swiftly, avoiding delays and penalties.
  • Optimize supply chains to mitigate raw material risks and consumer pricing pressures.

Key Market Trends

  • The push for environmentally sustainable packaging solutions.
  • Integration of digital health tools for inventory and usage tracking.
  • Increasing adoption of ready-to-use formulations driven by operational efficiencies.
  • Growing importance of regulatory harmonization across regions for seamless distribution.

Key Takeaways

  • The Dextrose 10% and Sodium Chloride 0.45% segment is poised for steady growth, driven by expanding healthcare infrastructure, aging populations, and rising chronic disease rates.
  • Market players must navigate regulatory landscapes, raw material volatility, and stiff price competition to capitalize on growth opportunities.
  • Innovation in formulation and packaging, strategic regional expansion, and supply chain optimization are vital to enhancing profitability.
  • Evolving environmental concerns necessitate adoption of eco-friendly packaging options, presenting both challenges and opportunities.
  • Strategic collaborations and compliance agility will serve as crucial differentiators in an increasingly competitive landscape.

FAQs

1. What are the main applications of Dextrose 10% and Sodium Chloride 0.45% in clinical settings?
They are primarily used for hydration therapy, electrolyte replenishment, and nutritional support in hospitalized and outpatient patients.

2. How does packaging in plastic containers influence market growth?
Plastic containers offer improved safety, convenience, and longer shelf life, making them preferable in healthcare settings, thus supporting market expansion.

3. What are the major regional markets for these IV solutions?
North America and Europe currently lead due to mature healthcare systems, but Asia-Pacific is emerging rapidly owing to infrastructure development and population growth.

4. How do regulatory policies impact the market?
Stringent approval processes and evolving safety standards can delay product launches and increase compliance costs, affecting market timing and profitability.

5. What future innovations could influence this segment?
Developments include eco-friendly packaging, smart monitoring systems integrated with IV solutions, and formulations with enhanced stability or additional therapeutic benefits.


References

[1] MarketsandMarkets, “IV Fluids Market – Global Forecast to 2027,” 2022.

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