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Last Updated: December 31, 2025

DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5% In Plastic Container, and when can generic versions of Dextrose 5% In Plastic Container launch?

Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare, Otsuka Icu Medcl, Hospira, B Braun, Miles, Abbott, Fresenius Kabi Usa, DHL, and Icu Medical Inc. and is included in forty-nine NDAs.

The generic ingredient in DEXTROSE 5% 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% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% 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 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DEXTROSE 5% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 016673-003 Oct 30, 1985 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium acetate; sodium chloride INJECTABLE;INJECTION 018258-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018256-001 Approved Prior to Jan 1, 1982 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% in Plastic Container

Last updated: July 28, 2025


Introduction

Dextrose 5% in plastic container, also known as dextrose solution, is a common intravenous (IV) fluid used across hospitals and clinics for nutritional support, hydration, and medical therapy. The formulation contains 5% dextrose in water and is packaged predominantly in plastic containers due to their durability, weight advantages, and ease of handling. Understanding its market dynamics and financial trajectory requires an analysis of regulatory trends, demand drivers, competitive landscape, manufacturing considerations, and emerging market opportunities.


Market Overview

The global IV fluid market is projected to reach approximately USD 12.8 billion by 2027, growing at a compound annual growth rate (CAGR) of around 6.2% from 2020 to 2027 [1]. Dextrose 5% solutions form a significant segment within this industry, driven by their versatility in clinical applications such as providing calories, maintaining blood sugar levels, and serving as carriers for other medications.

The majority of demand originates from developing regions such as Asia-Pacific and Latin America, fueled by expanding healthcare infrastructure, increased hospitalization rates, and rising prevalence of chronic diseases. Developed markets like North America and Europe form the mature base with high-volume consumption driven by outpatient services and specialized care centers.


Regulatory and Policy Factors

Regulatory frameworks underpin manufacturing, safety, and quality standards for dextrose solutions. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce stringent requirements ensuring sterility, stability, and packaging integrity. Recent trends emphasize aseptic manufacturing and single-use plastic containers to minimize contamination risks.

Regulations favor manufacturers adopting advanced quality control measures and environmentally sustainable packaging practices. Policies encouraging local production and imports influence market entries, especially in emerging economies, creating both opportunities and compliance challenges.


Demand Drivers

  • Hospitalization and Critical Care: Dextrose solutions are integral to intravenous therapy for hospitalized patients, especially in intensive care units (ICUs). Rising cases of acute illnesses and surgeries sustain high demand levels.

  • Aging Population: The global increase in geriatric populations intensifies the need for nutritional support, especially in patients with compromised oral intake.

  • Cancer and Chronic Diseases: As prevalence rates climb for diabetes, cancer, and other chronic conditions, IV nutritional support, including dextrose, remains critical.

  • Emergence of Home Healthcare: Growth in outpatient and home healthcare settings expands the use of ready-to-administer dextrose solutions, bolstering sales.


Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and Hikma Pharmaceuticals. These firms dominate through extensive distribution networks, broad product portfolios, and emphasis on innovation, such as incorporation of plastic technology that enhances safety and shelf life.

The market also features regional players emerging due to low-cost manufacturing, especially within China and India. These firms concentrate on price competitiveness and local regulatory access but face stiff quality and safety scrutiny.

Product Differentiation:
Advances in plastic container technology, including barrier properties, ease of disposal, and eco-friendliness, differentiate offerings. Manufacturers are investing in container designs that reduce contamination risk, optimize storage, and ensure compatibility with infusion pumps.


Manufacturing Considerations

The manufacturing of dextrose 5% solutions involves high-precision sterile processes. Plastic container manufacturing depends on materials like polypropylene, polyethylene, or PVC, selected for chemical inertness, clarity, and safety.

Sustainability is increasingly integral, with companies exploring biodegradable plastics or recyclable options to meet environmental regulations and consumer expectations. Moreover, the stability of dextrose in plastic packaging over shelf life influences packaging design and stability testing protocols.


Financial Trajectory

The financial outlook for dextrose 5% in plastic containers is favorable, shaped by expanding demand and technological innovations. Revenue streams are expected to demonstrate resilient growth despite market saturation in mature regions.

  • Pricing Dynamics: Premium pricing can be maintained through differentiation in safety features, container design, and certified manufacturing processes. Cost efficiencies gained through bulk manufacturing and supply chain optimization also influence profitability.

  • Market Expansion: Entry into emerging markets provides volume growth potential, driven by rising healthcare spending. Local partnerships and licensing agreements are typical pathways.

  • Innovation Investment: R&D investments in container technology, sterile manufacturing processes, and environmentally sustainable solutions will influence both costs and sales growth.

  • Impact of COVID-19: The pandemic underscored the essential nature of IV fluids, including dextrose solutions, with heightened procurement for ICU and emergency care, temporarily boosting revenues. Post-pandemic, steady demand persists due to ongoing healthcare needs.

Data from industry reports suggest that the North American segment maintains solid margins due to high standards and volume sales, while emerging markets offer rapid growth but at lower margins and higher regulatory risks.


Market Challenges and Risks

  • Regulatory Hurdles: Navigating varied approval processes across countries can delay product launches and increase compliance costs.

  • Supply Chain Disruptions: Material shortages, political instability, or logistical issues can impact manufacturing and distribution.

  • Environmental Regulations: Pressure to reduce plastic waste may necessitate redesigns and increased R&D expenditure, potentially impacting profit margins.

  • Competition and Price Erosion: Price wars, especially with regional manufacturers, threaten profitability.


Opportunities for Growth

  • Sustainable Packaging: Adoption of biodegradable plastics and innovative recycling programs can attract environmentally conscious buyers.

  • Product Differentiation: Enhanced safety features, infusion compatibility, and shelf life improvements foster competitive advantages.

  • Market Penetration: Expansion into pediatric and specialized therapy markets, including combination solutions, presents additional revenue streams.

  • Digital Integration: Supply chain optimization through digital tracking and predictive analytics can reduce costs and improve responsiveness.


Key Takeaways

  • The global demand for dextrose 5% in plastic containers is set for steady growth, driven by expanding healthcare infrastructure, aging populations, and increased chronic disease prevalence.

  • Innovation in packaging, stricter regulatory compliance, and environmental sustainability are pivotal in shaping competitive advantages.

  • Major pharmaceutical and medical device firms continue to dominate through quality, innovation, and extensive distribution networks, while regional manufacturers capitalize on cost advantages.

  • Financial prospects remain robust, with potential for increased margins through technological advancements, market expansion, and operational efficiencies.

  • Monitoring regulatory changes, environmental policies, and technological trends will be essential for stakeholders aiming to optimize investment and strategic decisions.


FAQs

1. What are the defining features of dextrose 5% in plastic containers?
Dextrose 5% in plastic containers is an IV infusion solution composed of 5% dextrose in water, packaged in plastic containers designed for sterile administration. Its features include ease of handling, safety, and compatibility with infusion devices, along with formulations optimized for stability and shelf life.

2. How does the regulatory landscape influence the market?
Regulatory standards governing sterility, safety, and quality control directly impact manufacturing practices, approval timelines, and market entry strategies. Stringent regulations can elevate costs but also serve to differentiate high-quality products, underpinning market growth for compliant manufacturers.

3. What are the main growth opportunities for manufacturers?
Key opportunities include expanding into emerging markets, developing environmentally sustainable packaging, integrating safety innovations, and diversifying product portfolios into specialized formulations or combination therapies.

4. How has COVID-19 affected the market trajectory?
The pandemic heightened demand for IV solutions, including dextrose 5%, especially in critical and emergency care settings. This short-term surge has reinforced the essential nature of these solutions and may lead to sustained demand due to ongoing healthcare needs.

5. What role does technological advancement play in future market growth?
Advancements in plastic container technology, sterile manufacturing processes, and digital supply chain management are expected to enhance safety, efficiency, and environmental sustainability, offering competitive edges and driving long-term growth.


Sources
[1] Fortune Business Insights, "IV Fluid Market Size, Share & Industry Analysis," 2022.

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