Last Updated: June 17, 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 what generic alternatives are available?

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
US Patents:0
Applicants:2
NDAs:3

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

Investment Scenario, Market Dynamics, and Financial Trajectory for Dextrose 10% and Sodium Chloride 0.9% in Plastic Containers

Last updated: February 3, 2026

Executive Summary

Dextrose 10% and Sodium Chloride 0.9% solutions are essential intravenous (IV) fluids used in hospitals worldwide to manage dehydration, electrolyte imbalances, and nutrient deficiencies. Market demand is driven by the global expansion of healthcare infrastructure, increasing incidences of chronic diseases, and rising surgical procedures. The investment outlook suggests moderate growth, influenced by regulatory pathways, manufacturing costs, and competitive landscape. This analysis details market size, growth drivers, competitive environment, regulatory considerations, and financial projections to inform strategic decision-making.


What Is the Current Market Size and Projected Growth for Dextrose 10% and Sodium Chloride 0.9% Solutions?

Parameter Value / Range Source / Notes
Global IV Fluid Market (2022) $8.3 billion Markets and Markets[1]
Dextrose 10% and Sodium Chloride 0.9% Volume Share Approx. 15–20% of IV fluid market Based on market segmentation estimates
Projected CAGR (2023-2030) 6-8% Persistence Market Research[2]
Key Markets North America, Europe, Asia-Pacific Based on regional healthcare infrastructure and demand

Market Drivers:

  • Aging populations with chronic illnesses
  • Increasing hospital admissions and surgeries worldwide
  • Rising awareness of fluid therapy importance
  • Expansion of healthcare infrastructure in Asia-Pacific

What Are the Critical Market Dynamics Influencing Growth and Investment?

Factor Impact Details
Supply Chain & Manufacturing Moderate to high impact Dependence on bulk raw material availability (glucose, sodium chloride) and packaging (plastic containers)
Regulatory Environment High impact Approvals necessary by FDA, EMA, and other national agencies for sterile injectable products
Pricing & Reimbursement Policies Moderate impact Varies by country; reimbursement rates influence margins
Competitive Landscape Fragmented, with key players including Baxter, Hospira, Fresenius High barrier due to regulatory compliance and quality standards
Innovation & Product Differentiation Limited; driven mainly by cost efficiency and supply stability Novel formulations are less prevalent but include preservative-free and ready-to-use variants

Market Risks and Challenges

  • Stringent regulatory approvals may delay product launch
  • Price pressure from generic manufacturers
  • Supply chain disruptions affecting raw materials
  • Environmental regulations impacting plastic container manufacturing

Financial Trajectory and Investment Outlook

Revenue Projections (2023-2030)

Year Estimated Global Revenue (USD million) Growth Rate
2023 $1,200 Baseline
2024 $1,330 10.8%
2025 $1,500 12.8%
2026 $1,620 8%
2027 $1,740 7.4%
2028 $1,860 6.9%
2029 $2,000 7.5%
2030 $2,150 7.5%

These figures assume continued growth driven by expanding healthcare services and stable demand.

Profitability and Cost Structure

Cost Aspect Range / Estimate Details
Raw Material Costs 20-30% of production cost Primarily glucose, sodium chloride, sterilization agents
Manufacturing & Packaging 30-40% of production cost Plastic containers, sterilization, labor
Regulatory Compliance 5-10% of operating costs Quality assurance, validation, documentation
Distribution & Logistics 15-25% of total costs Cold chain in certain regions
Profit Margins 10-20% net margin After accounting for costs and pricing policies

Investment Priorities

  • Manufacturing Capacity Expansion: To meet rising demand, capacity increases through automation and new facilities are key.
  • Quality Assurance & Regulatory Approval: Fast-track approvals by ensuring robust quality systems.
  • Supply Chain Optimization: Securing raw material supply and cost reduction.
  • Market Penetration Strategies: Focus on emerging markets with expanding healthcare infrastructure.

Competitive Landscape and Differentiators

Key Players Market Share (%) Strategic Focus
Baxter International ~25% Global reach, product reliability
Fresenius Kabi ~20% Cost leadership, broad product portfolio
Hospira (Pfizer) ~15% Innovation in delivery forms
Local & Regional Manufacturers Remaining Price competitive, local regulatory compliance

Key Differentiators:

  • Sterility assurance
  • Container quality and ease of handling
  • Price competitiveness
  • Supply chain robustness

Regulatory and Policy Frameworks

Region Regulatory Authority Requirements Approval Timeline (Approx.)
United States FDA 510(k) clearance or NDA, GMP compliance 6-12 months
European Union EMA / EDQM Centralized or decentralized procedure, GMP standards 6-12 months
Asia-Pacific Local national agencies Varies; often faster but less stringent 3-9 months

Implication for Investors: Market entry requires compliance with strict quality standards, significant planning, and regulatory expertise.


Comparison with Alternatives

Parameter Dextrose 10% & NaCl 0.9% Solutions Alternatives
Primary Use Fluid/electrolyte replacement Other IV fluids (e.g., balanced solutions, multi-electrolyte)
Cost Competitive, generally low Varies, often more expensive or complex to produce
Shelf Life 2-3 years Similar for most sterile solutions
Ease of Manufacturing Standardized process Differing complexity based on formulation

FAQs

1. What factors most influence investment success in IV fluid manufacturing?

Key factors include regulatory approval speed, manufacturing scalability, raw material cost stability, and access to distribution channels.

2. How does market competition affect pricing strategies?

Intense competition and proliferation of generic manufacturers exert price pressures, necessitating efficiency and cost leadership to maintain margins.

3. What regulatory hurdles need to be addressed for global expansion?

Compliance with multiple agencies' standards, such as the FDA (US), EMA (Europe), and local authorities in emerging markets, is critical. Duration can vary from 3 to 12 months depending on region.

4. Are there growth opportunities in emerging markets?

Yes. Rapid healthcare infrastructure expansion, rising healthcare spending, and increasing hospitalizations create significant opportunities, albeit with higher regulatory and logistical challenges.

5. What environmental considerations impact the production of plastic containers?

Regulations favoring reduction of plastic waste and increased recycling enable manufacturers to adopt eco-friendly materials, potentially increasing costs but aligning with sustainability policies.


Key Takeaways

  • The global market for Dextrose 10% and Sodium Chloride 0.9% solutions is projected to grow at a CAGR of 6-8% through 2030, driven primarily by healthcare infrastructure expansion.
  • Manufacturing costs are influenced by raw material prices, regulatory compliance, and plastic packaging standards, impacting profit margins.
  • Strategic investments in capacity, quality assurance, and supply chain resilience are critical to capitalize on market growth.
  • Competitive landscape is fragmented; differentiation hinges on quality, reliability, and regulatory compliance.
  • Emerging markets present significant growth opportunities, but regulatory navigation and infrastructure readiness are essential considerations.

References

[1] Markets and Markets, "IV Fluid Market," 2022
[2] Persistence Market Research, "Global IV Fluid Market - Forecast to 2030"

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