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Last Updated: December 19, 2025

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.3% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.3% In Plastic Container is a drug marketed by Abbott, Fresenius Kabi Usa, Miles, Otsuka Icu Medcl, and B Braun. and is included in six NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.3% 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 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% 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
Abbott DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019486-001 Oct 4, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017799-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 211194-001 Aug 26, 2020 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Miles DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018501-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-008 Feb 24, 1988 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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% and Sodium Chloride 0.3% in Plastic Containers

Last updated: July 29, 2025

Introduction

Dextrose 5% combined with Sodium Chloride 0.3% in plastic containers represents a critical segment within intravenous (IV) fluid therapy. These solutions support a broad spectrum of clinical needs, including hydration, electrolyte balance, and nutritional support. As the global healthcare landscape evolves—with technological advancements, regulatory shifts, and increasing demand for infusion therapies—analyzing the market dynamics and financial trajectory of this drug combination provides essential insights for stakeholders ranging from pharmaceutical manufacturers to investors.

Market Overview

Product Profile

Dextrose 5%/Sodium Chloride 0.3% solutions are isotonic or hypertonic fluids used primarily in hospitals, clinics, and home healthcare. Packaged predominantly in plastic containers—such as polyethylene or polypropylene bottles—these solutions are favored for their convenience, safety, and compliance with modern dispensing standards. The plastic packaging ensures lightweight handling, reduced breakage risk, and compatibility with automated infusion systems.

Market Size and Growth Trends

The global market for IV fluids, including Dextrose and Sodium Chloride solutions, was valued at approximately USD 9 billion in 2021 and is projected to reach USD 12 billion by 2027, growing at a CAGR of about 5.2% (1). This growth reflects expanding healthcare infrastructure, rising prevalence of dehydration, electrolyte imbalances, and parenteral nutrition needs, especially in developing economies.

The segment featuring Dextrose 5% with Sodium Chloride 0.3% specifically accounts for roughly 15–20% of this market, driven by its use in pediatric care, perioperative hydration, and emergency medicine (2). The plastic container format dominates sales owing to safety, ease of use, and the industry’s shift from glass to polypropylene or polyethylene bottles.

Market Drivers

Increasing Healthcare Expenditure

Growing healthcare spending worldwide, notably in Asia-Pacific and Latin America, escalates demand for hospital-grade infusion solutions. Governments and private sectors invest heavily in expanding healthcare capacities, which directly lift the consumption of IV fluids like Dextrose and Sodium Chloride solutions.

Rising Incidence of Chronic Diseases and Acute Conditions

The prevalence of diabetes, gastrointestinal disorders, and surgical procedures creates sustained demand for solutions that restore electrolyte balance and provide caloric intake. For instance, the global diabetes population surpassed 537 million in 2021, a figure expected to escalate, fueling the need for nutritional IV therapies (3).

Regulatory Environment and Standardization

Regulatory frameworks emphasizing safety, sterility, and packaging standards favor the adoption of plastic containers for IV solutions. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to tighten requirements, promoting innovation in container materials and manufacturing processes.

Technological Innovations and Packaging Advances

Advancements in container manufacturing—such as antimicrobial plastic containers and prefilled, ready-to-use systems—improve safety and reduce storage costs. These innovations catalyze further market expansion.

Market Restraints

Price Competition and Cost Pressures

Intense competition among manufacturers, especially in price-sensitive markets, constrains profit margins. Generic manufacturers often produce equivalent solutions at lower costs, intensifying price competition.

Regulatory Barriers and Quality Standards

Stringent regulatory compliance, especially regarding sterility and container safety, can impose high barriers to entry and escalate manufacturing costs. Non-compliance risks include recalls, reputational damage, and legal liabilities.

Environmental Concerns

Environmental impact of plastic waste from packaging contributes to regulatory and societal pressures. Eco-friendly packaging solutions are under development but may introduce initial cost challenges.

Competitive Landscape

Major pharmaceutical players such as Baxter International, B. Braun Melsungen AG, and Hospira (a Pfizer subsidiary) dominate the IV fluids sector. These companies invest in R&D for container innovation, manufacturing efficiencies, and portfolio diversification.

Meanwhile, regional players in emerging markets (e.g., India’s Cipla and Sun Pharma) are rapidly expanding their production capacities, leveraging lower manufacturing costs to compete on price.

Market entry is facilitated by collaborations with hospitals, global distribution networks, and adherence to regulatory standards. Mergers and acquisitions are prevalent as companies seek to consolidate market share.

Financial Trajectory

Revenue Forecasts

  • Projected CAGR: The Dextrose 5%/Sodium Chloride 0.3% segment in plastic containers is expected to grow at approximately 6% annually through 2028, slightly exceeding the overall IV fluids market.
  • Revenue Drivers: Increased procurement by hospitals, expanding home healthcare markets, and innovations in container technology.

Pricing and Margins

  • Pricing Trends: Prices are increasingly driven by raw material costs (notably plastics), regulatory costs, and competitive dynamics. Standardized solutions often operate under thin margins, with prices generally decreasing over time due to commoditization.
  • Profitability: Larger manufacturers benefit from economies of scale, whereas niche or regional players may operate with higher margins owing to specialization and branding.

Cost Structure Breakdown

  • Raw materials: 40–50%
  • Manufacturing and packaging: 20–25%
  • Regulatory compliance and quality assurance: 10–15%
  • Distribution and logistics: 10%
  • R&D and marketing: 5–10%

Potential Revenue Opportunities

  • Product Differentiation: Formulating solutions with enhanced stability, safety features, or added nutrients.
  • Geographic Expansion: Tapping into emerging markets with rising healthcare infrastructure.
  • Innovation in Packaging: Developing sustainable, cost-effective, and safer container solutions.

Regulatory and Technological Trends Impacting Financial Outlook

Regulatory bodies are increasingly scrutinizing the safety profile of IV solutions, impacting manufacturing costs and investment. Investments in sterile manufacturing environments, validation processes, and container safety are expected to rise, impacting profit margins but ensuring long-term stability.

Simultaneously, technological innovation—such as embedded sensors in containers for real-time monitoring and antimicrobial plastics—may command premium pricing and open new revenue streams.

Key Challenges and Risks

  • Supply Chain Disruptions: Raw material shortages, geopolitical conflicts, or pandemics could hinder production.
  • Regulatory Delays or Non-compliance: Non-adherence can result in product recalls and financial penalties.
  • Environmental Regulations: Stricter waste management laws may increase disposal costs or force redesigns.
  • Market Saturation: Price erosion in mature markets could compress margins further.

Strategic Outlook and Business Implications

Investors and manufacturers should focus on:

  • Enhancing manufacturing efficiencies to combat pricing pressures.
  • Innovation in container materials and designs for safety and environmental sustainability.
  • Expanding in emerging markets where healthcare infrastructure development is rapid.
  • Integrating digital health solutions for infusion monitoring, potentially expanding service and software revenues.

Conclusion

The market for Dextrose 5% and Sodium Chloride 0.3% solutions in plastic containers aligns with the broader trends shaping global IV therapy—growth driven by healthcare expansion, technological advances, and regulatory pressures. While profitability is challenged by fierce competition and price sensitivity, strategic investments in innovation and regional expansion offer substantial upside. The financial trajectory remains optimistic, contingent on navigating regulatory landscapes, environmental considerations, and supply chain resilience.


Key Takeaways

  • The global IV fluids market is projected to grow at over 5% annually, with Dextrose and Sodium Chloride solutions constituting a significant share.
  • Innovations in plastic container technology, regulatory compliance, and geographic expansion are critical growth drivers.
  • Price competition and environmental regulations pose risks, but innovation and efficiency improvements can mitigate margins pressure.
  • Larger players with economies of scale and strategic regional focus are better positioned for sustained profitability.
  • Continuous R&D and digital enhancements in infusion management are emerging opportunities to enhance financial performance.

FAQs

  1. What are the main factors driving demand for Dextrose 5%/Sodium Chloride 0.3% solutions?
    Rising healthcare spending, increased prevalence of chronic diseases, surgical procedures, and advancements in hospital and home healthcare infrastructure primarily drive demand.

  2. How does packaging in plastic containers influence the market?
    Plastic containers offer safety, lightweight handling, and compatibility with automated infusion systems, aligning with regulatory safety standards and facilitating widespread adoption.

  3. What are the key challenges faced by manufacturers of these IV solutions?
    Regulatory compliance costs, price competition, environmental regulations concerning plastics, and supply chain disruptions pose notable challenges.

  4. Which regions present the highest growth opportunities?
    Emerging markets in Asia-Pacific and Latin America offer significant growth potential due to expanding healthcare infrastructure and increasing adoption of IV therapies.

  5. How might technological innovations impact the financial outlook of this market?
    Innovations like antimicrobial plastics, embedded sensors, and eco-friendly packaging can command premium pricing, enhance safety, and open new revenue streams, positively influencing financial trajectories.


Sources

  1. MarketsandMarkets, "Intravenous (IV) Fluids Market," 2022.
  2. Global Data, "IV Solutions Market Analytics," 2021.
  3. International Diabetes Federation, "Diabetes Atlas," 2022.

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