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Last Updated: April 1, 2026

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 2.5% And Sodium Chloride 0.11% In Plastic Container, and what generic alternatives are available?

Dextrose 2.5% And Sodium Chloride 0.11% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% 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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Questions you can ask:
  • What is the 5 year forecast for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER?
Summary for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% 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 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-001 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 Outlook for Dextrose 2.5% and Sodium Chloride 0.11% in Plastic Containers

Last updated: March 1, 2026

What are the key drivers of demand for this product?

The combination of dextrose 2.5% and sodium chloride 0.11% in plastic containers primarily targets intravenous (IV) fluid therapy. The growth of this segment hinges on several factors:

  • Increasing prevalence of dehydration, electrolyte imbalances, and nutritional support needs in hospitals and clinics drives demand for IV fluids.
  • Expanding healthcare infrastructure in emerging markets amplifies access to IV therapies.
  • Aging population in developed regions raises the need for supportive care involving electrolyte management.
  • Shift toward pre-filled, single-use plastic containers enhances safety and convenience, favoring market growth.

How does the competitive landscape look?

The market is characterized by a mix of global pharma firms, regional manufacturers, and contract manufacturing organizations (CMOs). The top players include:

  • Baxter International Inc.
  • B. Braun Melsungen AG
  • Fresenius Kabi
  • ICU Medical
  • Hospira (now part of Pfizer)

These companies have established manufacturing capacities, extensive distribution channels, and regulatory approvals. Competition centers on pricing strategies, product convenience, and supply chain robustness.

What are the regulatory considerations?

Approval protocols depend on regional authorities:

Region Regulatory Agency Requirements
US FDA 510(k) clearance, Good Manufacturing Practice (GMP) adherence
Europe EMA & MDR CE marking, GMP compliance
China NMPA Local registration, GMP standards

Regulatory approval influences entry timelines and market penetration, especially given the sterile, injectable nature of these products.

How do manufacturing and supply chain factors affect market performance?

The manufacturing of IV fluids in plastic containers involves stringent sterile conditions, quality checks, and compliance with regulatory standards. Supply chain stability affects availability:

  • Raw material costs, especially plastics and sterile solutions, impact margins.
  • Production scale influences capacity to meet growing demand.
  • Geopolitical factors, such as trade policies, affect logistics and costs.

What is the projected revenue trajectory?

Global IV fluid market size was valued at approximately $7 billion in 2022, with a compound annual growth rate (CAGR) of about 4.8% from 2023-2028. The segment specific to dextrose and saline solutions is estimated to constitute roughly 40%, equating to $2.8 billion in 2022.

Forecast assumptions:

  • Continued healthcare infrastructure investment in emerging markets.
  • Accelerated adoption of pre-filled plastic containers driven by safety concerns.
  • Increased demand from outpatient and home-care settings.

Based on these factors, revenue for dextrose 2.5% and sodium chloride 0.11% solutions is projected to grow at a CAGR of 4.5% over the next five years, reaching approximately $3.4 billion by 2028.

What are the pricing trends?

Pricing varies by region, container size, and manufacturer. Key points:

  • Unit price in North America and Europe: $0.50–$2.00 per 100 mL, depending on container size.
  • Market pressure for competitive pricing has led to slight reductions over recent years.
  • Promotional strategies include bundling with other IV solutions and offering contract-based discounts to hospital networks.

What are the potential challenges and risks?

Market growth faces hurdles, including:

  • Regulatory delays or additional requirements.
  • Price pressure from generic and regional manufacturers.
  • Supply chain disruptions caused by raw material shortages or geopolitical issues.
  • Product recalls stemming from contamination or manufacturing faults, impacting brand reputation.

Conclusion

The market for dextrose 2.5% and sodium chloride 0.11% in plastic containers reflects steady growth driven by global healthcare needs. Industry competition emphasizes cost management, regulatory compliance, and supply chain resilience. Expected revenue expansion aligns with growth in healthcare infrastructure and safety-driven product adoption practices.


Key Takeaways

  • Demand is driven by increasing healthcare infrastructure, aging populations, and safety preferences.
  • The global market was valued at $2.8 billion in 2022, projected to reach $3.4 billion by 2028 at a CAGR of 4.5%.
  • Market players include Baxter, B. Braun, and Fresenius Kabi, operating under strict regulatory standards.
  • Price competition and supply chain stability are critical to market performance.
  • Regulatory timelines and raw material costs remain key risk factors.

FAQs

1. How does the growth of outpatient care influence this market?
It increases demand for ready-to-use, pre-filled IV solutions, boosting market size.

2. What regional differences impact pricing strategies?
Pricing is typically higher in North America and Europe due to regulatory standards and market maturity.

3. Are there emerging markets with high growth potential?
Yes, regions like Southeast Asia and Africa exhibit expanding healthcare systems and rising demand for IV fluids.

4. What role does regulatory approval play in market entry?
Regulatory approval determines product launch timelines and compliance costs, influencing competitiveness.

5. How does technological innovation affect this sector?
Advances in container materials and sterilization methods improve safety and streamline manufacturing processes.


References

  1. MarketsandMarkets. (2023). IV fluids market forecast.
  2. Investigational New Drug Application (IND), FDA. (2022). Regulatory guidelines for sterile injectable products.
  3. European Medicines Agency. (2022). Clinical and manufacturing standards for IV solutions.
  4. Statista. (2023). Global supply chain disruptions affecting pharmaceutical raw materials.
  5. IMS Health. (2022). IV fluid market insights and sales data.

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