Last Updated: May 2, 2026

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.224% In Plastic Container, and when can generic versions of Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.224% In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.224% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% 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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  • What is the 5 year forecast for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% 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 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-005 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

Market Dynamics and Financial Trajectory for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 0.224% in Plastic Containers

Last updated: March 1, 2026

What is the market size and growth forecast for this infusion solution segment?

The global infusion solutions market was valued at approximately $14 billion in 2022. Compound annual growth rate (CAGR) is projected around 7.2% through 2028. The segment comprising Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 0.224% in plastic containers is a subset used primarily for hydration, electrolyte replacement, and nutritional support in clinical settings.

How does this specific formulation compare to traditional IV solutions?

This formulation offers a balanced electrolyte and carbohydrate profile, commonly used in hospital intravenous therapy, especially in the U.S., Europe, and emerging markets. It serves as a standard for rehydration, with advantages over glass containers, including lower breakage risk, lighter weight, and improved shelf stability. The market penetration remains high due to established clinical protocols.

What are key drivers influencing market growth?

Prevalence of Chronic Diseases

The rise in diabetes, renal failure, and dehydration cases drives demand for electrolyte and glucose infusions. Hospitals and clinics increasingly adopt standardized IV formulations.

Healthcare Infrastructure Expansion

Developing countries expand hospital infrastructure and infusion therapy practices, contributing to growing demand for plastic-container solutions.

Product Innovation

Advances include pre-mixed, ready-to-use formulations with enhanced stability and safety profiles. Regulatory approvals for these innovations show a positive impact on sales.

Cost-Effectiveness

Plastic containers reduce manufacturing and distribution costs compared to glass, influencing procurement decisions favorably towards pre-packaged solutions.

What competitive factors influence the market?

Market Players

Major manufacturers include Baxter International, Fresenius Kabi, and Becton Dickinson. These companies offer a wide portfolio of infusion products, including the formulation in question.

Regulatory Landscape

Regulatory bodies like the FDA and EMA enforce standards for container safety and solution sterility. Approval timelines and compliance costs influence market entry.

Pricing Policies

Pricing strategies often focus on standardization and bulk procurement by hospitals. Cost pressures influence the shift towards generics and private-label brands.

Patent and IP Trends

Most formulations are off-patent, allowing for generic competition, which drives down prices but limits profit margins.

What are recent market developments and innovations?

Manufacturing Trends

Automation and quality control advances ensure consistent solution quality and reduce contamination risks.

Packaging Regulation

Updated regulations favor plastic over glass due to safety, which accelerates adoption in hospitals worldwide.

Market Entry Barriers

High regulatory approval costs and the need for Good Manufacturing Practice (GMP) compliance pose barriers for new entrants.

What are the financial outlooks and forecasted revenue streams?

Revenue Projections

For the next five years, the infusion solutions segment, including this specific formulation, could generate approximately $17.8 billion annually, assuming steady growth rates.

Margin Analysis

Gross margins range from 25% to 40%, impacted by raw material costs, manufacturing efficiencies, and competitive pricing. Market competition pressures margins downward.

Regional Variations

North America remains the largest market, accounting for about 40% of global sales, followed by Europe at 30%. Emerging markets in Asia-Pacific and Latin America show high growth potential, with CAGR estimates exceeding 8%.

What risks may impact the financial trajectory?

  • Regulatory delays: Prolonged approval processes can inhibit product launches.
  • Supply chain disruptions: Raw material shortages impact manufacturing.
  • Competitive pricing: Entry of generics leads to eroded profit margins.
  • Market saturation: Mature markets might see slowed growth.

Summary overview table

Parameter Data Points
Market size (2022) $14 billion
CAGR (2023-2028) 7.2%
Leading regions North America (40%), Europe (30%), Asia-Pacific (20%)
Average margins 25-40%
Key competitors Baxter International, Fresenius Kabi, Becton Dickinson

Key Takeaways

  • The infusion solution market, including Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 0.224% in plastic containers, is expanding due to rising healthcare needs.
  • Cost reductions, safety, and regulatory shifts favor plastic container adoption.
  • Growth in emerging markets presents significant upside, countered by pricing pressures and regulatory hurdles.
  • Innovation in packaging and solution stability sustains competitive advantage.
  • Market revenue is projected to increase modestly, with regional variations influencing overall performance.

FAQs

1. What factors influence the pricing of these infusion solutions?
Pricing depends on raw material costs, manufacturing expenses, regulatory compliance, competition, and hospital procurement strategies.

2. Are there new regulations affecting container materials?
Yes. Regulations increasingly favor plastic over glass for safety reasons, influencing container design and production.

3. How do regulatory approvals impact market entry?
Stringent requirements can delay product launches, increase development costs, and influence the competitive landscape.

4. What are the key regions driving future growth?
North America and Europe dominate current sales, but Asia-Pacific and Latin America offer high-growth opportunities due to expanding healthcare infrastructure.

5. What is the typical profit margin for manufacturers of this product?
Gross margins generally range from 25% to 40%, affected by competitive pricing and raw material variability.


References

[1] MarketsandMarkets. (2022). Infusion Therapy Market by Product, Type, Application, and Region – Global Forecast to 2028.

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