Last Updated: June 25, 2026

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.22% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.22% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% 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 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% 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 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-013 Jan 18, 1986 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
Last updated: February 4, 2026

Market Dynamics and Financial Trajectory for DEXTROSE 5%, SODIUM CHLORIDE 0.33%, AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINERS

Market Overview

The injectable electrolyte solution containing dextrose 5%, sodium chloride 0.33%, and potassium chloride 0.22% in plastic containers primarily targets hospital, outpatient, and emergency medical settings. The solution is used for rehydration, electrolyte replacement, and as an osmotic agent in intravenous therapy.

Market Size and Growth Trends

  • The global intravenous fluid market was valued at approximately USD 8.4 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6% through 2028[1].
  • Electrolyte solutions constitute a significant segment, accounting for roughly 30% of the market, or approximately USD 2.5 billion in 2021.
  • The electrolyte-injectable solution segment's growth is driven by increasing hospital admissions, rising prevalence of dehydration, and electrolyte imbalance.

Key Drivers

  1. Aging Population: Increased cases of dehydration and electrolyte imbalance among elderly patients boost demand.
  2. Chronic Disease Incidence: Conditions such as diabetes and chronic kidney disease elevate electrolyte therapy usage.
  3. Hospitalization Rates: Growing numbers of surgeries and critical care cases require IV electrolyte therapy.
  4. Regulatory Approvals & Expanding Use Cases: Continuous approval for broader indications fuels market penetration.

Competitive Landscape

The market comprises multinational pharmaceutical companies with established brands and regional producers. Key players include Baxter International, B. Braun Melsungen, ICU Medical, and Fresenius Kabi.

  • These firms focus on product quality, sterile manufacturing, and supply chain reliability.
  • Expansion into emerging markets occurs via local partnerships and registration leveraging global standards.

Pricing and Reimbursement

  • Prices vary globally, influenced by healthcare infrastructure, regulatory frameworks, and tender systems.
  • Median wholesale price for a 100 mL single dose ranges between USD 0.50 and USD 2.00.
  • Reimbursement policies in developed countries typically support intravenous electrolyte solutions, sustaining market profitability.

Regulatory Environment

  • Approval processes governed by agencies like the FDA (U.S.) and EMA (EU) require demonstrating safety, quality, and efficacy.
  • Post-marketing surveillance and compliance with Good Manufacturing Practices (GMP) are mandatory.

Financial Trajectory

  • Revenue for generic electrolyte solutions is stabilizing, with margins squeezed by price competition.
  • Innovation is limited due to the mature, commoditized nature but opportunities exist in formulation improvements and branding.
  • Market expansion hinges on hospital capacity growth, especially in Asia-Pacific, Latin America, and Africa.

Challenges

  • Price pressure from generics and biosimilars.
  • Supply chain disruptions impacting sterile manufacturing and distribution.
  • Regulatory hurdles in emerging markets.

Opportunities

  • Developing ready-to-use formulations with extended shelf life.
  • Targeting niche markets such as pediatric or critically ill patient segments.
  • Incorporating digital tracking and compliance solutions to differentiate products.

Key Takeaways

  • The market for electrolyte solutions like Dextrose 5%, Sodium Chloride 0.33%, and Potassium Chloride 0.22% in plastic containers is closely tied to hospital utilization, critical care needs, and chronic disease management.
  • Growth depends on expanding healthcare infrastructure, especially in emerging economies, but faces challenges from pricing pressures and regulatory pathways.
  • Competitive advantage centers on manufacturing quality, product reliability, and supply chain agility.
  • Innovation favors formulation stability, ease of use, and logistical advantages rather than novel therapeutics.

FAQs

1. What factors most influence pricing for electrolyte solutions?
Regulatory requirements, manufacturing costs, and regional procurement practices impact pricing. Tender systems and reimbursement policies also significantly influence market prices.

2. How does market growth differ across regions?
Developed markets exhibit slow growth due to mature markets and pricing pressures. Asian and Latin American markets show higher growth potential driven by expanding healthcare access.

3. Are there major regulatory barriers for new entrants?
Yes, obtaining approvals involves compliance with GMP, safety, and efficacy standards, with regional variations in approval timelines and requirements.

4. What innovations are emerging in electrolyte solutions?
Focus areas include pre-mixed, ready-to-use formats with longer shelf life, and integrated dosing or tracking integrations for better patient management.

5. How do supply chain issues affect the market?
Disruptions in sterile manufacturing supplies, raw material shortages, and logistical delays impair product availability and can lead to price instability.


References

  1. MarketsandMarkets. "Intravenous (IV) Fluid Market." 2022.

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