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Last Updated: March 27, 2026

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 10% And Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Dextrose 10% And Sodium Chloride 0.9% In Plastic Container launch?

Dextrose 10% And Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.9% 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 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.9% 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 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018047-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-015 Feb 24, 1988 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 016696-001 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 10% and Sodium Chloride 0.9% in Plastic Container

Last updated: January 18, 2026


Summary

Dextrose 10% combined with Sodium Chloride 0.9%, contained within plastic containers, serves as a critical intravenous (IV) infusion product used primarily for fluid replenishment, electrolyte balance, and metabolic support across hospital and clinical settings. The pharmaceutical market for these solutions is influenced by macroeconomic, regulatory, technological, and competitive factors. Currently valued globally at approximately USD 1.3 billion in 2022, with a compound annual growth rate (CAGR) projected around 4.5% from 2023 to 2028, the market is poised for steady expansion driven by shifts in healthcare infrastructure, increasing prevalence of chronic diseases, and technological innovations in pharmaceutical manufacturing.


Market Overview

Aspect Details
Global Market Size (2022) USD 1.3 billion
Projected CAGR (2023-2028) 4.5%
Key Markets North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Primary End-Users Hospitals, clinics, outpatient infusion centers, home healthcare

Market Drivers

Driver Details
Growing Healthcare Infrastructure Expansion of hospital capacities, especially in emerging markets
Rising Incidence of Chronic Diseases Diabetes, gastrointestinal conditions heighten demand for IV therapy
Aging Population Elderly demographics require more fluid and electrolyte management
Regulatory Approvals and Policies Favorable policies promote product availability and safety standards

Market Restraints

Restraint Details
Stringent Regulatory Approvals Variations across jurisdictions (FDA in US, EMA in Europe) challenge swift market adoption
Raw Material Price Volatility Fluctuations in the costs of pharmaceutical-grade chemicals and plastics
Competition from Alternative Solutions Use of alternative delivery routes or formulations, such as pre-filled syringes

Key Market Players and Competitive Landscape

Company Market Share (Estimate) Notable Products Strategic Moves
Baxter International 25% Dextrose and Saline Injections Focus on sterile manufacturing, innovation in infusion devices
Fresenius Kabi 20% Premixed IV solutions Expansion into emerging markets, supply chain optimization
B. Braun 15% Customized IV solutions Strategic acquisitions, R&D investments
Hikma Pharmaceuticals 10% Generic IV solutions Cost-leadership strategies
Others 30% Various regional brands Entry through local partnerships

(Percentages are estimates based on analyst reports and market surveys, e.g., GlobalData, 2023)


Technological and Regulatory Influences

Factor Impact on Market
Manufacturing Technologies Automation and sterile processing enhance product quality and reduce costs
Packaging Innovations Plastic containers enhance safety, reduce contamination risk
Regulatory Frameworks US FDA CFR Title 21, EU EMA directives, WHO standards dictate compliance requirements
Quality and Safety Standards Stringent testing protocols uphold product efficacy and safety

Financial Trajectory Analysis

Year Forecasted Market Size (USD billion) Growth Rate (%) Comments
2023 USD 1.36 4.5% Moderate growth driven by healthcare infrastructure
2024 USD 1.42 4.4% Continued demand from expanding hospital networks
2025 USD 1.48 4.3% Increasing adoption in emerging markets
2026 USD 1.55 4.2% Product innovation supporting expanded indications
2027 USD 1.62 4.1% Market saturation slows slightly, steady revenue increase
2028 USD 1.70 4.0% Market matures with stable contributions from established players

Pricing and Revenue Models

  • Pricing Range: USD 0.50 to 2.50 per unit, depending on volume, formulation, and packaging
  • Revenue Drivers: Volume sales, product differentiation, contractual supply agreements
  • Profit Margins: Estimated between 15% and 25%, influenced by manufacturing costs and regulation compliance

Regional Analysis

Region Market Size (2022 USD bn) CAGR (2023-2028) Key Characteristics
North America USD 0.55 4.0% Mature with high adoption rates; strict regulatory environment
Europe USD 0.38 4.2% Emphasis on pharmaceutical standards, aging population
Asia-Pacific USD 0.25 6.0% Fast-growing with expanding healthcare infrastructure
Latin America USD 0.08 3.8% Emerging markets, increasing healthcare investment
Middle East & Africa USD 0.04 3.5% Niche market with significant potential

Comparison with Alternative IV Solutions

Aspect Dextrose 10% + Sodium Chloride 0.9% Alternatives
Uses Fluid and electrolyte replacement Colloids, blood products, oral rehydration
Advantages Cost-effective, widely available Some alternatives offer longer shelf life or targeted effects
Limitations Limited to fluid and electrolyte imbalance Higher cost or complex administration

Market Challenges and Opportunities

Challenges Opportunities
Regulatory delays Accelerated approvals via expedited pathways (e.g., Emergency Use Authorization)
Raw material shortages Diversification of supply chain, local sourcing
Price competition Customization, bundling, and service differentiation
Market saturation Diversification into specialized formulations (e.g., glucose with electrolytes)

Forecasting and Strategic Outlook

Key Factors Impact
Digital Transformation Adoption of automation and real-time quality monitoring
Regulatory Harmonization Streamlining approvals for global markets
Emerging Market Penetration Infrastructure development, local manufacturing
Innovation in Packaging Enhanced safety, reduced waste, and extended shelf life

Key Takeaways

  • The global market for Dextrose 10% and Sodium Chloride 0.9% in plastic containers is projected to grow at approximately 4.5% CAGR through 2028.
  • North America and Europe dominate with advanced healthcare infrastructure, while Asia-Pacific presents the highest growth potential.
  • Innovations in manufacturing, packaging, and regulatory processes underpin market expansion.
  • Price sensitivity, raw material costs, and regulatory barriers are key challenges.
  • Strategic focus areas include market diversification, technological integration, and regional expansion.

Frequently Asked Questions (FAQs)

1. What are the main applications of Dextrose 10% combined with Sodium Chloride 0.9%?
Primarily used for IV fluid therapy to correct dehydration, electrolyte imbalances, and provide metabolic support in hospital and outpatient settings.

2. How does regulatory approval impact the market growth for these solutions?
Stringent regulatory processes can delay product launch, increase compliance costs, but ensuring safety and efficacy is critical for market access, especially in highly regulated regions like the US and EU.

3. What drives price competition among manufacturers?
Raw material costs, manufacturing efficiencies, regulatory compliance, and brand positioning influence pricing strategies within the market.

4. Which regions are anticipated to experience the fastest growth?
Asia-Pacific is expected to outpace other regions due to expanding healthcare infrastructure and rising medical tourism.

5. How might technological innovations influence future market dynamics?
Advancements such as automation, smart packaging, and integrated supply chain management can reduce costs, improve safety, and enable product differentiation.


Sources

[1] GlobalData Pharmaceutical Intelligence, 2023
[2] MarketsandMarkets, "Intravenous Solutions Market," 2022
[3] US FDA CFR Title 21, 2023
[4] European Medicines Agency (EMA) Guidelines, 2022
[5] Company Annual Reports and Industry Publications, 2022-2023

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