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Last Updated: March 26, 2026

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.3% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.3% In Plastic Container is a drug marketed by Abbott, Fresenius Kabi Usa, Miles, Otsuka Icu Medcl, and B Braun. and is included in six NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.3% 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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  • What is the 5 year forecast for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% 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
Abbott DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019486-001 Oct 4, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017799-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 211194-001 Aug 26, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Miles DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018501-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-008 Feb 24, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 10, 2026

What Is the Market Size and Demand for Dextrose 5% and Sodium Chloride 0.3% in Plastic Containers?

The global market for intravenous (IV) solutions comprising dextrose 5% and sodium chloride 0.3% in plastic containers is driven by hospital and clinic use, particularly for hydration, electrolyte balance, and nutritional support. The market size was valued at approximately USD 2.9 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected from 2023 to 2030. The demand is concentrated in North America and Europe, accounting for roughly 60% of sales, with increasing adoption in Asia-Pacific driven by expanding healthcare infrastructure.

What Are Key Market Drivers and Barriers?

Drivers:

  • Hospitalization rates: Increasing surgeries and chronic disease management boost IV solution demand.
  • Aging population: A demographic more reliant on hydration and electrolyte therapies.
  • Medical innovations: Favorable regulatory policies for plastic containers reduce costs and enhance safety.
  • Regulatory approvals: Generally align with international standards, facilitating market entry.

Barriers:

  • Supply chain disruptions: Raw material shortages impact production capacity.
  • Price fluctuations: Variability in raw material costs can influence margins.
  • Environmental concerns: Plastic waste from single-use containers poses sustainability issues, possibly invoking regulatory restrictions.

How Does Market Structure Influence Pricing and Revenue?

Pricing for dextrose and sodium chloride IV solutions varies by region, container size, and hospital purchasing agreements. Average prices are roughly USD 1.50 to USD 3.00 per 100 mL unit in North America. Larger volume containers (e.g., 1-liter) cost around USD 10 to USD 15 per unit, with profit margins generally between 10-15%.

Market players include global pharmaceutical firms like B. Braun, Baxter, and Fresenius Kabi, with regional manufacturers supplementing supply. Brand differentiation primarily focuses on container sterility, stability, and ease of handling.

What Is the Regulatory Landscape?

The United States Food and Drug Administration (FDA) classifies dextrose and sodium chloride solutions as Class II medical devices with premarket notification (510(k)) clearance. The European Medicines Agency (EMA) mandates compliance with Good Manufacturing Practice (GMP) standards under Regulation (EC) No 726/2004.

In Asian markets such as India and China, regulations mirror international standards but often require local clinical data and manufacturing licenses. Continuous updates in environmental policies influencing plastic use may impact market practices.

What Are Technological Trends in Packaging and Production?

Innovation focuses on:

  • Pre-filled plastic containers: Designed to improve safety and reduce contamination risks.
  • Infusion pump compatibility: Containers with integrated connectors facilitate automated delivery.
  • Material advancements: Use of environmentally friendlier plastics, such as biodegradable polymers, is emerging.

Manufacturers are investing in automation to enhance production efficiency and ensure compliance with evolving safety standards.

How Are Financial Trends Projected to Evolve?

Revenue growth, driven by rising healthcare spending and demographic shifts, is expected to maintain the current CAGR of approximately 4.2% through 2030. Market expansion in emerging economies is projected to contribute significantly to global sales growth, supported by infrastructure investments and government healthcare initiatives.

Profit margins may fluctuate due to raw material costs and sustainability investments; however, economies of scale and regulatory compliance enhancements are expected to sustain profitability. Mergers and acquisitions remain a common strategy for market consolidation.

How Do Competitive Dynamics shape the Market?

The sector features a combination of multinational corporations and regional players. Market share is concentrated among a few key players, with the top three accounting for over 65% of global supply.

Innovation in container design, manufacturing efficiencies, and strategic partnerships with healthcare providers confer competitive advantages. Price competition is fierce, especially in highly competitive regions, impacting profit margins.

Summary of Market Analysis

Aspect Data/Details
Market Size (2022) USD 2.9 billion
CAGR (2023–2030) 4.2%
Regional Dominance North America, Europe (60%)
Pricing USD 1.50–USD 3.00 per 100 mL
Major Players B. Braun, Baxter, Fresenius Kabi
Regulatory Framework FDA, EMA, local approvals
Environmental Trends Shift toward biodegradable plastics

Key Takeaways

  • The market is growing steadily, propelled by healthcare demands and demographic changes.
  • Price points are sensitive to raw material costs and plastic manufacturing innovations.
  • Regulatory standards shape market entry, with an increasing focus on sustainability.
  • Technology advances aim to improve safety, container compatibility, and environmental footprint.
  • Competitive landscape favors firms with innovation capabilities, supply chain resilience, and strategic regional engagement.

FAQs

1. What factors most influence the price of dextrose 5% and sodium chloride 0.3% solutions?
Raw material costs, container manufacturing expenses, regional regulations, and market competition primarily influence pricing.

2. How will environmental policies impact future production of plastic containers?
Stricter regulations on plastic waste could lead to increased costs for biodegradable materials and alternative packaging methods.

3. Are there regulatory differences that impact market entry globally?
Yes. The U.S. requires FDA 510(k) clearance; Europe follows EMA GMP standards. Emerging markets may require local approvals and clinical data.

4. What technological innovations could reshape the packaging of these IV solutions?
Pre-filled, sterilized, biodegradable containers with infusion pump compatibility are key developments.

5. Who are the leading competitors, and what is their market share?
B. Braun, Baxter, and Fresenius Kabi hold over 65% combined global market share, with regional manufacturers increasing their footprint.


References

[1] MarketResearch.com, "Global IV Solutions Market," 2023.
[2] FDA Guidance for Industry, "Intravenous Solutions," 2022.
[3] European Medicines Agency, "Regulations on Packaging and Sterility," 2022.
[4] Statista, "Hospital Consumables and IV Solutions," 2023.

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