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Last Updated: April 16, 2026

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  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

Market Dynamics and Financial Trajectory for Dextrose 10% and Sodium Chloride 0.45% in Plastic Containers

Last updated: March 1, 2026

What Is the Current Market Size and Growth Potential?

The global intravenous (IV) fluids market, which includes dextrose 10% and sodium chloride 0.45% solutions, was valued at approximately USD 8.7 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6.8% from 2023 to 2030, driven by increasing cancer prevalence, surgical procedures, and rising geriatric populations.

The segment involving dextrose 10% and sodium chloride 0.45% solutions specifically accounts for about 35% of the total IV fluids market, valued around USD 3 billion in 2022. Growth stems from hospital demand for electrolyte-balanced, hyperosmolar solutions for fluid replacement and nutritional support.

What Are Key Market Drivers and Barriers?

Drivers

  • Surge in chronic and acute illnesses, including dehydration, electrolyte imbalance, and surgeries.
  • Expansion of healthcare infrastructure, especially in emerging economies.
  • Rising prevalence of conditions requiring parenteral nutrition, including cancer and gastrointestinal disorders.

Barriers

  • Stringent regulatory requirements for sterile, injectable products.
  • Competition from larger multinational pharmaceutical companies with established supply chains.
  • Price sensitivity in developing markets, affecting profit margins.

How Is the Supply Chain Structured?

The supply chain involves raw material sourcing, primarily glucose monohydrate and sodium chloride, produced by chemical and pharmaceutical manufacturers. These materials are processed into IV solution precursors, sterilized, and packaged into plastic containers compliant with pharmaceutical standards.

Distribution channels primarily include hospitals, clinics, and pharmacies. Cold chain logistics are usually not required for these solutions but maintaining sterility during transportation remains critical.

What Are Competitive and Regulatory Factors?

Major market players include Baxter International, Pfizer, B. Braun Melsungen, and Fresenius Kabi. Market share is roughly evenly split among these firms, with regional players holding a significant share in local markets.

Regulatory standards in the U.S. (FDA), Europe (EMA), and other regions emphasize pre-market approval, Good Manufacturing Practices (GMP), and batch testing for sterility, pyrogens, and particulate contamination.

Revenue and Profitability Outlook

Given the current market size, the potential revenue for a new entrant or existing manufacturer with a focus on dextrose 10% and sodium chloride 0.45% solutions can be projected based on:

  • Production capacity.
  • Pricing strategies aligned with market norms.
  • Market penetration rates considering regional demand.

If a manufacturer secures a 5% share of the USD 3 billion segment in emerging markets within five years, annual revenues could reach USD 150 million. Profit margins are estimated between 15% and 25%, depending on scale, supply chain efficiencies, and regulatory compliance costs.

Pricing Trends and Economics

Average pricing for a 1000 mL plastic container ranges from USD 2.50 to USD 4.00, influenced by regional economic factors and competitive dynamics. Price pressures are more prominent in low- and middle-income countries, affecting margins.

Raw material costs, primarily glucose and sodium chloride, constitute approximately 40% of total manufacturing costs. Sterilization, packaging, and logistics contribute the rest.

Future Market Outlook

Technological advancements, such as pre-filled, ready-to-use solutions and improved sterilization techniques, will influence product differentiation and cost structures. Regulatory shifts towards more stringent sterilization and quality assurance will increase compliance costs but enhance product safety.

Emerging markets present opportunities for growth, driven by increased healthcare access and infrastructure development. Innovation in formulations to improve stability, shelf life, and patient comfort can expand the product portfolio.

Key Takeaways

  • The IV fluids segment, including dextrose 10% and sodium chloride 0.45%, is growing steadily, driven by healthcare needs.
  • Market players face regulatory hurdles and price competition, especially in emerging markets.
  • Revenue potential hinges on production scale, regional market share, and compliance costs.
  • Pricing remains competitive; raw material costs heavily impact profitability.
  • Technological and regulatory developments will shape future market dynamics.

FAQs

1. What are the main applications for dextrose 10% and sodium chloride 0.45% solutions?

They are used in fluid replacement therapy, electrolyte correction, and parenteral nutrition, especially in hospitals and clinics.

2. How does regional regulation affect market entry?

Regions with strict regulatory standards, like the U.S. and Europe, require comprehensive compliance, increasing time-to-market and costs but ensuring product safety.

3. What is the typical profit margin for manufacturing these solutions?

Profit margins range from 15% to 25%, influenced by production scale, raw materials, and regulatory compliance.

4. Which companies dominate the market?

Baxter International, Pfizer, B. Braun Melsungen, and Fresenius Kabi hold major market shares globally.

5. How will technological advancements impact future pricing?

Innovations such as pre-filled solutions and improved sterilization can reduce costs and create differentiation, potentially stabilizing or reducing prices.


References

[1] Grand View Research. (2023). Intravenous (IV) fluids market size, share & trends analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/intravenous-iv-fluids-market

[2] MarketsandMarkets. (2022). IV fluids market, by type, application & region. Retrieved from https://www.marketsandmarkets.com/ResearchInsight/intravenous-fluids-market.asp

[3] U.S. Food and Drug Administration (FDA). (2022). Regulations for sterile injectable drugs. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-resources/ sterile-drug-products

[4] Statista. (2023). Global healthcare infrastructure development. Retrieved from https://www.statista.com/healthcare-development

[5] Frost & Sullivan. (2022). Strategies in the IV solutions industry. Retrieved from https://ww2.frost.com/services/market-research/pharmaceuticals/

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