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Last Updated: December 19, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.15% In Plastic Container, and when can generic versions of Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.15% In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.15% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% 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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Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% 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 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-001 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%, Sodium Chloride 0.45%, and Potassium Chloride 0.15% in Plastic Containers

Last updated: July 27, 2025


Introduction

The pharmaceutical infusion market has witnessed rapid evolution driven by technological advancements, regulatory shifts, and increasing healthcare demands globally. Among critical infusion solutions, Dextrose 5%, combined with sodium chloride 0.45% and potassium chloride 0.15%, offers essential electrolyte and carbohydrate replenishment, especially in hospitals, clinics, and emergency settings. The market for these solutions packaged in plastic containers continues to expand owing to factors like safety, convenience, and scalability.

This analysis delves into the market dynamics and financial prospects of this specific infusion formulation, providing insights critical for industry stakeholders and investors seeking to understand growth pathways, competitive landscapes, and key challenges.


Market Overview

Product Composition and Clinical Utility

Dextrose 5%, sodium chloride 0.45%, and potassium chloride 0.15% constitute a balanced electrolyte and glucose infusion, crucial for hydration, correcting electrolyte imbalances, and providing energy. Their typical indications include dehydration, diabetics with hyperglycemia, and patients requiring electrolyte management.

Packaging Innovations

Plastic containers—such as polyethylene or polypropylene bottles and blow-molded sterile containers—offer advantages including weight reduction, shatter resistance, and ease of handling. These features align with modern hospital procurement policies emphasizing safety and logistics efficiency.


Market Drivers

Rising Prevalence of Chronic Diseases

The increasing incidence of diabetes, renal disorders, and gastrointestinal diseases amplifies demand for tailored electrolyte solutions. Data indicates diabetes alone affects over 400 million globally, with a significant portion requiring intravenous therapy [1].

Growing Healthcare Infrastructure

Developing countries are expanding healthcare capacity, leading to increased infusion therapy use. For example, Asia-Pacific regions are witnessing infrastructure investments, fostering local production and procurement of infusion solutions.

Shift Toward Plastic Packaging

Sterility, portability, and safety concerns favor sterile plastic containers over traditional glass bottles. Regulatory bodies, including the U.S. FDA and European agencies, promote safer packaging to mitigate breakage hazards.

Regulatory Approvals and Standardization

Stringent standards for infusion solutions support market growth but also necessitate compliance investments. WHO guidelines and country-specific pharmacopoeia standards drive quality improvements and market entry.

Emerging Markets

Growth in outpatient care, home infusion therapy, and emergency medical services in emerging economies bolsters demand.


Market Restraints

High Competitive Intensity

The global market features key players like Baxter, Fresenius Kabi, B. Braun, and local manufacturers, leading to price concessions and margin pressures.

Regulatory Hurdles

Rigorous approval processes for sterile solutions and packaging modifications increase time-to-market and compliance costs.

Supply Chain Disruptions

Global crises, such as the COVID-19 pandemic, disrupted raw material supplies, impacting production and pricing stability.

Cost Pressures

Healthcare systems under financial strain exert pressure on procurement prices, especially in resource-constrained settings.


Market Opportunities

Product Differentiation and Innovation

Introducing pre-mixed solutions with extended shelf-life, smart packaging with stability indicators, or eco-friendly plastics can provide competitive edge.

Strategic Collaborations

Partnering with hospitals, governments, and NGOs facilitates market penetration and procurement contracts.

Expansion in Emerging Markets

Localized manufacturing and regulatory support in these markets will unlock new revenue streams.


Financial Trajectory and Market Size

Global Market Valuation

The infusion solutions market, encompassing various formulations, is projected to reach approximately USD 13-15 billion by 2028, expanding at a CAGR of 4-6% [2]. The segment specific to Dextrose 5% with electrolyte solutions packaged in plastic containers is a significant subset, estimated to grow proportionally with overall market expansion.

Growth Drivers

  • CAGR Factors: Strong growth driven by increased healthcare spending, aging populations, and technological advances.
  • Pricing Trends: Premium pricing for high-quality, regulatory-compliant solutions; however, competitive pressures could compress margins.
  • Regional Variations: North America and Europe currently lead in demand, but Asia-Pacific and Latin America are expected to exhibit the fastest growth rates (>7%), owing to infrastructure investments and disease burden.

Cost Considerations

Manufacturing costs, including raw materials like glucose, salts, and plastics, are influenced by global commodity markets, regulatory compliance costs, and manufacturing efficiencies. Economies of scale significantly affect profitability.

Pricing Strategy

Premium segments command higher margins, while commoditized solutions compete on volume. Contract manufacturing and private-label arrangements also influence revenue streams.


Competitive Landscape

Market players invest heavily in R&D, quality assurance, and supply chain optimization. Differentiation hinges on product safety, packaging innovations, and regulatory compliance. Companies like Baxter and Fresenius Kabi lead with diversified portfolios and extensive global distribution networks.


Regulatory and Quality Standards

Adherence to USP, EP, and FDA standards is mandatory. Evolving regulations favor innovations in sterilization methods, container materials, and traceability systems, creating opportunities for early adopters.


Supply Chain and Logistics

Efficient cold chain logistics, inventory management, and regional manufacturing hubs are essential to meet demand fluctuations, especially amidst global supply chain disruptions experienced during recent crises.


Forecasting and Investment Outlook

Short-Term (1–3 years)

  • Steady growth driven by hospital procurement cycles.
  • Focus on compliance, quality assurance, and cost optimization.
  • Adoption of new plastic container technologies increases.

Medium to Long-Term (3–10 years)

  • Accelerated growth in emerging markets.
  • Diversification into pre-mixed and tailored electrolyte solutions.
  • Focus on sustainable packaging solutions.

Investment Suggestion

Stakeholders should monitor regulatory developments, invest in manufacturing efficiencies, and capitalize on emerging-market growth. Strategic partnerships with healthcare providers will be pivotal.


Key Takeaways

  • The infusion market for Dextrose 5%, sodium chloride 0.45%, and potassium chloride 0.15% in plastic containers is poised for stable growth, driven by rising disease prevalence, healthcare infrastructure expansion, and safety-focused packaging innovations.
  • Competitive landscape remains intense; differentiation through quality, safety, and innovation is vital.
  • Regulatory compliance, supply chain robustness, and regional market adaptation define success.
  • Emerging markets offer significant growth potential, requiring tailored strategies to navigate local regulatory and procurement landscapes.
  • Financial performance hinges on balancing production costs, pricing strategies, and market expansion efforts.

FAQs

Q1: What factors most influence the adoption of plastic containers for infusion solutions?
A1: Safety, durability, weight, ease of handling, and regulatory support for sterile packaging drive adoption of plastic containers over glass.

Q2: How do regulation changes impact the market for electrolyte infusion solutions?
A2: Stricter quality and safety standards increase compliance costs but also create opportunities for companies with advanced manufacturing processes and quality assurance protocols.

Q3: What regional markets offer the highest growth potential?
A3: Asia-Pacific and Latin America are projected to experience the fastest growth due to expanding healthcare infrastructure and rising disease burdens.

Q4: What are the main challenges faced by manufacturers in this segment?
A4: High competition, regulatory hurdles, supply chain disruptions, and pricing pressures are primary challenges.

Q5: How can companies differentiate their infusion solutions in a saturated market?
A5: Through innovations in packaging safety, formulation stability, pre-mixed solutions, eco-friendly plastics, and strategic partnerships.


References

  1. International Diabetes Federation. "IDF Diabetes Atlas," 9th ed., 2019.
  2. MarketsandMarkets. "Infusion Therapy Market," 2022.

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