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Last Updated: December 17, 2025

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.2% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.2% In Plastic Container is a drug marketed by B Braun, Miles, Abbott, and Otsuka Icu Medcl. and is included in five NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.2% 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 0.2% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% 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 0.2% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbott DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019482-001 Oct 4, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-007 Feb 24, 1988 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Miles DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018399-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017606-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 0.2% in Plastic Container

Last updated: August 6, 2025

Introduction

Dextrose 5% combined with Sodium Chloride 0.2% in plastic containers is a widely utilized intravenous (IV) fluid formulation, catering primarily to hospitals, clinics, and healthcare providers for hydration, electrolyte balance, and nutrient delivery. Its widespread application, manufacturing, regulatory status, and evolving market trends significantly influence its commercial prospects. This analysis provides a comprehensive overview of the current market dynamics and the anticipated financial trajectory for this pharmaceutical product.

Market Landscape and Key Drivers

Global Market Size and Regional Outlook

The global IV fluids market, including dextrose and saline solutions, was valued at approximately USD 10 billion in 2022, with projections reaching USD 13–15 billion by 2028, at a compound annual growth rate (CAGR) of around 4% to 6% [1]. The increasing prevalence of chronic diseases, surgical procedures, and hospital admissions are primary growth catalysts. North America dominates with a market share exceeding 40%, led by the United States due to its advanced healthcare infrastructure and high healthcare expenditure. Conversely, Asia-Pacific is experiencing rapid growth, driven by expanding healthcare access, urbanization, and government initiatives.

Product Demand and Clinical Applications

The formulation's core uses include:

  • Hydration therapy for dehydration and electrolyte replenishment.
  • Nutritional support for critically ill or malnourished patients.
  • Drug delivery vehicle for concomitant medication administration.

Its utility in intensive care units (ICUs) and surgical settings sustains robust demand. Technological advancements, like pre-filled plastic containers, enhance ease of use, safety, and shelf life, further favoring market expansion.

Manufacturing and Supply Chain Dynamics

Major pharmaceutical companies and contract manufacturing organizations (CMOs) produce these solutions, with manufacturing costs influenced by raw material prices (notably sodium chloride and dextrose), sterilization protocols, and regulations. Plastic containers, favored over glass, offer advantages such as reduced breakage, ease of handling, and longer shelf life, influencing their market penetration.

Supply chain considerations involve sourcing ingredient purity, sterilization processes, and packaging logistics, all of which can impact operational costs and product pricing.

Market Challenges and Constraints

Regulatory and Safety Concerns

Stringent regulatory standards, especially concerning contamination, stability, and compatibility, necessitate rigorous quality assurance, which increases compliance costs. The risk of IV solution contamination or extraneous particulate matter can result in product recalls or legal liabilities.

Market Saturation and Competition

The presence of multiple generic manufacturers and branded formulations leads to intense price competition. Market entry barriers are moderate, primarily due to regulatory hurdles and manufacturing capital requirements.

Pricing Pressures and Reimbursement

Price sensitivity, especially for publicly funded healthcare systems, exerts downward pressure on margins. Reimbursement policies and generic competition influence profitability margins for manufacturers.

Innovations and Market Trends

Pre-Filled and Ready-to-Use Solutions

The shift toward pre-filled plastic containers and closed-system packaging enhances safety and operational efficiency. These innovations tend to command premium pricing, supporting higher margins.

Sustainability and Packaging

Environmental concerns are prompting manufacturers to adopt biodegradable plastics, recyclable materials, and eco-friendly manufacturing practices, potentially increasing costs but aligning with global sustainability trends.

Regulatory Advances

Regulatory agencies are emphasizing strict quality standards, which catalyze innovation but may slow time-to-market for new formulations.

Financial Trajectory and Market Forecasts

Revenue Growth and Profitability

Given existing market size and growth drivers, revenue for dextrose 5% and sodium chloride 0.2% in plastic containers is projected to grow at a CAGR of 4% to 6% over the next five years. The Asia-Pacific region will likely exhibit the highest growth rate, potentially exceeding 7%, driven by market penetration and healthcare infrastructure development.

Pricing Trends

While generic competition constrains pricing, innovations such as pre-filled containers and premium packaging could support incremental price increases, offsetting costs associated with regulatory compliance and sustainability initiatives.

Investment and Market Opportunities

Investments in manufacturing capacity expansion, research on stability and compatibility, and sustainable packaging solutions are poised to generate competitive advantages. Strategic collaborations and acquisitions may facilitate market share expansion.

Regulatory and Market Entry Considerations

Prospective entrants should prioritize compliance with international standards such as those of the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and local regulatory bodies. Establishing reliable supply chains for raw materials and investing in advanced sterilization technology are vital.

Conclusion

The market for Dextrose 5% and Sodium Chloride 0.2% in Plastic Containers remains resilient and expanding, supported by the global burden of chronic and acute healthcare needs. While challenges exist—mainly regulatory hurdles, pricing pressures, and competition—the evolution toward innovative packaging and sustainable practices offers growth opportunities.


Key Takeaways

  • The global IV fluids market, with key focus on dextrose and saline solutions, is projected to grow at a CAGR of 4–6% through 2028.
  • Regional growth disparities favor Asia-Pacific, driven by healthcare infrastructure expansion and rising demand.
  • Market leaders are increasingly adopting pre-filled, eco-friendly packaging solutions to buffer against pricing pressures and regulatory requirements.
  • Innovation, compliance, and sustainability are crucial growth drivers, with potential for higher margins and market differentiation.
  • Strategic investments in capacity, technology, and supply chain resilience will define competitive success.

FAQs

1. What factors are driving demand for dextrose 5% and sodium chloride 0.2% solutions?
Rising prevalence of dehydration, electrolyte imbalances, and the need for nutritional support in hospitalized patients are primary drivers. Additionally, growth in surgical and critical care services sustains demand.

2. How do regulatory changes impact the market for these IV solutions?
Stringent regulations necessitate rigorous quality control, increasing compliance costs and potentially delaying product launches. However, they also ensure safety, fostering trust and standards in the market.

3. What are the main competitive barriers for new entrants?
High manufacturing capital requirements, compliance with global standards, establishing supply chain stability, and attaining regulatory approval are key barriers.

4. How is sustainability influencing the market for these IV solutions?
Manufacturers are shifting to biodegradable and recyclable plastics, though this entails higher costs—this trend reflects increasing environmental awareness and consumer preferences.

5. What future innovations could impact the market?
Development of smarter, single-dose, eco-friendly pre-filled containers, and enhanced formulations for stability and compatibility, will shape future market dynamics.


Sources

[1] MarketsandMarkets. "IV Fluid Market by Product, Application, and Geography," 2022.

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