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Last Updated: December 17, 2025

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.225% In Plastic Container patents expire, and when can generic versions of Dextrose 5% And Sodium Chloride 0.225% In Plastic Container launch?

Dextrose 5% And Sodium Chloride 0.225% In Plastic Container is a drug marketed by Abbott and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.225% 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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  • What is the 5 year forecast for DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER?
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Summary for DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.225% 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 0.225% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019482-001 Oct 4, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017606-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 0.225% in Plastic Containers

Last updated: August 6, 2025


Introduction

The pharmaceutical market for intravenous (IV) solutions, such as Dextrose 5% and Sodium Chloride 0.225%, remains a resilient sector driven by global healthcare demands. These solutions are essential in clinical settings for fluid resuscitation, electrolyte management, and as carriers for medication delivery. Their market trajectory is influenced by various factors, including clinical practices, demographic shifts, regulatory frameworks, and emerging market opportunities.


Market Overview and Composition

Dextrose 5% and Sodium Chloride 0.225% solutions are classified as isotonic IV fluids widely used in hospitals, outpatient clinics, and long-term care settings. They are primarily manufactured in plastic containers—typically polyethylene or polypropylene—designed for safety, ease of use, and stability. These solutions are often combined to create customized electrolyte therapy, expanding the market scope.

Market Size & Growth Trends:
The global IV fluids market was valued at approximately USD 10 billion in 2022, with a compound annual growth rate (CAGR) forecast of 6-8% over the next five years, driven by rising hospital admissions, expanding surgical procedures, and growing prevalence of chronic diseases (Grand View Research). Dextrose and sodium chloride solutions represent a significant share of this market, owing to their versatility and indispensable clinical role.


Market Drivers

1. Rising Global Healthcare Needs
An aging population worldwide increases the demand for injectable therapies, particularly in managing dehydration, electrolyte imbalance, and post-surgical care. The World Health Organization reports demographic shifts as a core driver bolstering IV fluid consumption (WHO, 2021).

2. Expansion in Emerging Markets
Growth in healthcare infrastructure, increased medical tourism, and government investments in healthcare improve access and demand in markets such as China, India, and Southeast Asia. These regions are witnessing rapid adoption of plastic-container IV solutions due to supply chain improvements and local manufacturing.

3. Regulatory Approvals and Quality Standards
Stringent regulatory approvals driven by agencies like the FDA and EMA ensure product quality but also impact manufacturing costs. Improved safety profiles of prefilled plastic containers with tamper-evident features support market expansion.

4. Advances in Packaging and Formulation
The transition from glass to plastic containers enhances safety, reduces breakage, and improves shelf life, encouraging manufacturers to invest in plastic packaging technology. Innovations like prefilled syringes and ready-to-use solutions further stimulate demand.


Market Restraints and Challenges

1. Price Pressures and Cost Sensitivity
Healthcare providers and insurers scrutinize costs, compelling manufacturers to optimize production and logistics without compromising quality. Competitive pricing, especially in price-sensitive markets, constrains profit margins.

2. Supply Chain Disruptions
Global disruptions—such as the COVID-19 pandemic—have impacted raw material availability, manufacturing schedules, and distribution networks (WHO Supply Chain Reports). These factors can hinder consistent product availability.

3. Regulatory Hurdles
Stringent approval processes for new formulations or packaging innovations impose delays and elevate compliance costs, especially in the US and Europe.

4. Environmental Concerns
Growing emphasis on eco-friendly packaging demands adaptation in plastic container materials and waste management protocols, inflating operational costs.


Competitive Landscape

Leading players in this sector include Baxter International, B. Braun Melsungen AG, Hospira (a Pfizer subsidiary), and Fresenius Kabi. These companies leverage advanced manufacturing capabilities, robust distribution channels, and extensive product portfolios to sustain market share growth.

Market Entry Barriers:
High regulatory standards, capital-intensive manufacturing, and established relationships among dominant players create significant barriers for new entrants, favoring incumbents.


Economic and Financial Trajectory

Revenue Projections:
Projections indicate a steady CAGR of 6-8% over the next five years, with North America and Europe accounting for more than half of the market share due to their mature healthcare infrastructure. Emerging markets are projected to contribute increasingly as healthcare systems evolve and local manufacturing capacity expands.

Pricing Dynamics:
Pricing strategies vary regionally. In mature markets, premium pricing aligns with quality assurance, while in emerging markets, competitive, cost-effective solutions dominate. Volume growth often offsets narrower margins.

Innovation and Genericization:
The market is witnessing a slow shift toward generic formulations with similar safety profiles, driven by patent expirations and regulatory pathways promoting competition. Concurrently, innovation in plastic container designs enhances safety and user convenience, potentially commanding premium prices.


Regulatory and Policy Impact

Global and regional regulatory bodies—such as the FDA, EMA, and the Pharmaceuticals and Medical Devices Agency (PMDA)—set strict standards for sterility, container integrity, and material safety. Compliance impacts manufacturing costs and timelines but also acts as a barrier against inferior or counterfeit products.

Health policy initiatives promoting widespread access to safe IV solutions further influence market dynamics, including government procurement policies and standardization efforts.


Future Outlook and Strategic Opportunities

1. Market Penetration in Developing Economies
As healthcare infrastructure develops, demand for plastic-container IV fluids is expected to grow substantially. Local production facilities could reduce costs and improve supply chain resilience.

2. Product Innovation
Development of smart infusion devices integrated with IV solutions, environmentally sustainable container materials, and biocompatible, tamper-evident plastic packaging will define future growth avenues.

3. Digital and Supply Chain Optimization
Implementing digital tracking, inventory management, and AI-driven demand forecasting will mitigate supply chain risks and optimize inventory levels.

4. Sustainability Initiatives
Adopting biodegradable plastics and recycling protocols can serve as differentiators, aligning with global sustainability goals and regulatory expectations.


Key Takeaways

  • The global market for Dextrose 5% and Sodium Chloride 0.225% in plastic containers is poised for steady growth, supported by rising healthcare needs and technological advancements.
  • Emerging markets represent significant expansion opportunities, driven by infrastructure improvements and increasing healthcare access.
  • Market challenges include price competition, regulatory hurdles, and environmental concerns, requiring proactive strategy formulation.
  • Innovation in packaging and formulation, coupled with digital transformation, will influence future growth trajectories.
  • Strong competitive positioning remains crucial for market leaders amid regulatory complexities and evolving consumer preferences.

FAQs

1. What are the primary factors driving demand for Dextrose 5% and Sodium Chloride 0.225% solutions?
The primary drivers include increasing global healthcare needs, demographic shifts leading to higher hospitalization rates, technological advances in packaging, and expansion in emerging markets.

2. How are regulatory frameworks impacting the market?
Stringent quality and safety standards from regulatory authorities increase compliance costs but ensure product safety, fostering consumer trust and market stability.

3. What role does packaging innovation play in market growth?
Transitioning from glass to plastic containers enhances safety, convenience, and shelf life, enabling wider adoption and new product formats such as prefilled syringes.

4. Which regions are expected to see the fastest market growth?
Emerging economies in Asia-Pacific, Latin America, and parts of Africa are projected to experience the fastest increases, driven by infrastructure investments and regulatory reforms.

5. What sustainable practices are emerging in this market?
Development of biodegradable plastics, recycling programs, and environmentally friendly manufacturing methods are gaining traction to address environmental concerns.


Sources

  1. Grand View Research, "IV Therapy Market Size, Share & Trends Analysis," 2022.
  2. World Health Organization, "Demographic Changes and Healthcare Demand," 2021.
  3. WHO Supply Chain Report, 2022.
  4. FDA Pharmaceutical Manufacturing Standards, 2022.
  5. Company Annual Reports: Baxter, B. Braun, Fresenius Kabi, Pfizer, 2022.

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