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Last Updated: December 19, 2025

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5% And Potassium Chloride 0.075% In Plastic Container, and what generic alternatives are available?

Dextrose 5% And Potassium Chloride 0.075% In Plastic Container is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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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  • What is the 5 year forecast for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER?
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Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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
Baxter Hlthcare DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-004 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-011 Jan 18, 1986 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

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for Dextrose 5% and Potassium Chloride 0.075% in Plastic Container


Introduction

The pharmaceutical market for intravenous (IV) solutions remains a cornerstone of global healthcare, driven by the critical need for timely, effective fluid and electrolyte replacement therapies. Among these, the combination of dextrose 5% and potassium chloride 0.075% in plastic containers addresses electrolyte balance and caloric needs in various clinical settings. Understanding the market dynamics and forecasted financial trajectory of this product involves analyzing factors such as clinical demand, regulatory landscape, manufacturing trends, competitive forces, and technological innovations.


Market Overview

Dextrose 5% and potassium chloride 0.075% in plastic containers serve primarily as parenteral nutritional solutions and electrolyte replenishers. These solutions are essential in hospitals, clinics, and emergency care settings, especially for patients unable to consume food orally or intravenously due to surgical procedures, critical illness, or dehydration. The global hospital supplies and IV solutions market has exhibited steady growth, influenced by an aging population, rising incidences of chronic diseases, and expanding healthcare infrastructure across emerging markets.

The increasing prevalence of electrolyte imbalance disorders, such as hypokalemia, coupled with the expanding scope of critical care, propels demand for this formulation. Manufacturers have shifted toward prefilled plastic containers over traditional glass bottles, driven by safety, convenience, and regulatory incentives for single-use, tamper-evident packaging.


Market Drivers

1. Clinical Demand and Population Trends
Rising incidence of conditions like cardiovascular diseases, chronic kidney disease, and gastrointestinal disorders drives the need for IV electrolyte solutions. An aging global population increases the demand for hospitalized care and intensive therapy, directly impacting sales of dextrose and potassium chloride solutions.

2. Compliance with Safety Regulations
Regulatory agencies worldwide, including the FDA and EMA, encourage the adoption of plastic containers over glass for their safety profile, reducing needlestick injuries and contamination risk. These regulatory shifts favor manufacturers investing in plastic container formulations.

3. Technological Innovations and Product Development
Advances in plastic container manufacturing, such as lightweight, tamper-evident, and compatibility with infusion pumps, enhance product appeal. Ultra-pure, prefilled solutions minimize contamination risks and streamline hospital workflows.

4. Market Expansion in Emerging Economies
Growing healthcare infrastructure, increased healthcare expenditure, and government initiatives in countries like India, China, and Brazil contribute to market penetration. These markets present substantial growth opportunities owing to the expanding middle class and rising healthcare awareness.

5. Strategic Mergers and Acquisitions
Leading pharmaceutical and biotech companies are consolidating their positions through M&A activities, research collaborations, and licensing deals. This consolidates supply chains, broadens product portfolios, and facilitates market penetration.


Market Restraints and Challenges

1. Pricing Pressures and Reimbursement Policies
Price sensitivity, coupled with strict reimbursement and hospital procurement policies, could constrain profit margins. Pricing regulations in some countries impose limitations, affecting revenue streams.

2. Stringent Regulatory and Quality Standards
Developing formulations compliant with Good Manufacturing Practices (GMP) and achieving approvals across multiple jurisdictions involve high costs and lengthy timelines, potentially delaying market entry.

3. Competition from Generics and Biosimilars
The presence of multiple generic manufacturers offering comparable formulations exerts downward pressure on prices and margins, challenging profitability for branded formulations.

4. Supply Chain Complexities
Disruptions caused by geopolitical tensions, pandemics, or raw material shortages affect manufacturing and distribution. Ensuring consistent quality and supply amidst such challenges is vital.


Competitive Landscape

Several key players dominate the market, including Baxter International, Pfizer, Hospira (a Pfizer subsidiary), and Fresenius Kabi. These companies leverage their manufacturing scale, extensive distribution networks, and robust R&D pipelines to maintain competitive positioning. Private label options by hospital procurement agencies and regional players also influence market shares, especially in emerging markets.

Emerging companies are innovating with improved formulations, such as concentrated solutions or dual-chamber containers, to enhance stability, compatibility, and patient safety. Additionally, advances in container materials, like polyethylene and polypropylene, improve durability and reduce extractable leachables, aligning with regulatory expectations.


Financial Trajectory and Market Forecast

The global IV solutions market, valued at approximately USD 8.9 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030 [1]. Specifically, the segment of electrolyte solutions such as dextrose and potassium chloride formulations is expected to follow this trend with slight variations driven by regional factors.

Revenue Growth Drivers:

  • Healthcare Infrastructure Expansion: Investments in hospital infrastructure in APAC regions are anticipated to accelerate demand. Countries like India and China are projected to account for a combined CAGR of over 6% in IV solution consumption [2].
  • Regulatory Incentives and Product Differentiation: Innovations in plastic containers—such as prefilled, sterile, and tamper-evident features—position manufacturers to command premium pricing, improving profit margins.
  • Private and Public Sector Investment: Increased funding for healthcare in underserved markets will enhance procurement volumes.

Challenges to Revenue Growth:

  • Pricing and Reimbursement Pressures: These may moderate revenue growth, especially in price-sensitive regions.
  • Market Saturation: Particularly in developed markets, where most institutional demand is met, growth depends on replacement cycles and new hospital admissions.

Projected Financial Trajectory:

Based on current trends, individual formulations like dextrose 5% with potassium chloride 0.075% are expected to see stable to modest growth, with specific spikes in emerging markets and during global health emergencies. Innovative delivery systems and expanded indications could double revenues over the coming decade, particularly if combined with strategic alliances and geographic expansion.


Regulatory and Market Access Considerations

Navigating diverse regulatory landscapes across jurisdictions remains critical for revenue realization. The US FDA’s approval process for sterile injectable solutions mandates rigorous safety and quality standards, potentially extending time-to-market. Conversely, emerging markets may present faster routes but with differing quality benchmarks.

Market access strategies include local manufacturing, strategic partnerships, and compliance with regional pharmacopoeial standards such as USP, EP, or JP. Ensuring compatibility with infusion pumps and other medical devices also influences adoption rates.


Conclusion

The market for dextrose 5% and potassium chloride 0.075% in plastic containers is poised for steady growth driven by demographic shifts, technological advancements, and expanding healthcare infrastructure worldwide. While regulatory, pricing, and supply chain challenges persist, strategic innovation and regional expansion will be pivotal for stakeholders aiming to capitalize on future opportunities.


Key Takeaways

  • Growing Global Demand: Increasing healthcare needs, especially in emerging markets, support sustained growth of electrolyte IV solutions.
  • Innovation and Packaging: Transitioning to prefilled, plastic containers aligned with safety and convenience trends enhances product value and marketability.
  • Regulatory Environment: Navigating and complying with diverse regulatory standards remains vital; approval timelines and quality benchmarks shape market entry strategies.
  • Competitive Dynamics: Market share consolidation and innovation fuel competitiveness, with major players investing heavily in R&D and distribution expansion.
  • Financial Outlook: Anticipated CAGR of approximately 4.2% reflects resilient demand, with regional variances offering investment opportunities.

FAQs

1. What factors most influence the pricing of dextrose and potassium chloride IV solutions?
Pricing is primarily affected by manufacturing costs, regulatory compliance requirements, competitive landscape, and procurement policies of healthcare providers.

2. How does regulatory approval impact the market trajectory for these solutions?
Regulatory approval ensures safety and quality compliance, facilitates market entry, and influences pricing and reimbursement possibilities, directly impacting financial performance.

3. What innovations are shaping the future of IV electrolyte solutions?
Advancements include prefilled containers, tamper-evident packaging, compatibility with infusion pumps, and formulations with extended shelf life, all enhancing safety and convenience.

4. Which regions are expected to generate the highest growth for these solutions?
Emerging economies in Asia-Pacific, Latin America, and parts of Africa are projected to experience higher CAGR due to healthcare expansion and infrastructure development.

5. How do supply chain disruptions affect the market for these IV solutions?
Disruptions can delay production, increase costs, and limit availability, underscoring the importance of diversified supply networks and local manufacturing capacities.


Sources
[1] Market Research Future, “IV Solutions Market Report,” 2023.
[2] Grand View Research, “Asia-Pacific Healthcare Infrastructure Market Analysis,” 2022.

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