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Last Updated: December 19, 2025

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


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When do Dextrose 5% And Potassium Chloride 0.15% In Plastic Container patents expire, and when can generic versions of Dextrose 5% And Potassium Chloride 0.15% In Plastic Container launch?

Dextrose 5% And Potassium Chloride 0.15% 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 0.15% 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% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% 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
Baxter Hlthcare DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-001 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 0.45% 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
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-012 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

Market Dynamics and Financial Trajectory for Dextrose 5% and Potassium Chloride 0.15% in Plastic Containers

Last updated: July 27, 2025

Introduction

The pharmaceutical segment comprising Dextrose 5% combined with Potassium Chloride 0.15% in plastic containers represents a crucial component in intravenous (IV) fluid therapy. This hypertonic solution effectively manages fluid and electrolyte imbalances, making it indispensable in hospitals, clinics, and emergency settings. As healthcare infrastructure expands globally and the demand for intravenous therapies surges, understanding the market dynamics and projected financial trajectory of this formulation becomes vital for pharmaceutical companies, investors, and healthcare providers.


Market Overview and Composition

Dextrose 5%, a glucose-based intravenous solution, serves as a primary energy source for critically ill patients, including those undergoing surgery, suffering from dehydration, or experiencing electrolyte disturbances. When combined with Potassium Chloride 0.15%, it addresses hypokalemia, a common electrolyte deficiency resulting from various medical conditions or treatments.

The formulations are typically packaged in plastic bottles or bags—most notably polyethylene or polypropylene containers—that are sterile, safe, and convenient for intravenous administration. The plastic container format ensures ease of storage, transport, and patient safety compliance.


Market Drivers

1. Growing Global Healthcare Infrastructure

Expansion of healthcare facilities, especially in emerging markets such as Asia-Pacific, Latin America, and Africa, drives demand for hospital-grade IV fluids like Dextrose 5% with Potassium Chloride. Increased government investments, urbanization, and rising healthcare awareness bolster hospitalization rates, further propelling market growth [1].

2. Rising Incidence of Electrolyte Imbalances and Critical Illnesses

Electrolyte disorders—particularly hypokalemia—are prevalent among hospitalized and critically ill patients, necessitating effective IV solutions. Conditions such as cardiac arrhythmias, renal disorders, and gastrointestinal losses amplify the need for replenishment therapies with precise electrolyte compositions [2].

3. Growth of Oncology and Surgical Procedures

The surge in surgical interventions, chemotherapy treatments, and organ transplants necessitates consistent electrolyte management. The demand for ready-to-use, sterile, plastic-packaged solutions like Dextrose 5% with Potassium Chloride aligns with clinical needs for rapid and safe administration.

4. Preference for Plastic Packaging Solutions

Plastic containers offer advantages over glass—reduced breakage risk, lightweight nature, ease of handling, and long shelf life. These qualities improve supply chain efficiency and patient safety, making plastic-container formulations increasingly desirable [3].

5. Regulatory Environment and Market Approvals

Global regulatory agencies such as the FDA, EMA, and regional health authorities facilitate the approval and adoption of IV solutions if manufacturing standards are maintained. Stringent quality and safety standards, although challenging, act as barriers to entry for unqualified producers, resulting in a relatively consolidated market structure.


Market Challenges

1. High Competition and Pricing Pressures

The market is characterized by intense competition among multinational and regional players, driving price erosion. Generic manufacturers offer lower-cost alternatives, often impacting profit margins for innovator companies.

2. Manufacturing and Quality Control Complexities

Maintaining sterile conditions, ensuring compatibility of plastic materials, avoiding leaching of plasticizers, and adhering to quality standards entail substantial investment. Any lapse can result in recalls, legal liabilities, or loss of market trust.

3. Supply Chain Disruptions

Global shortages of raw materials such as plastic resins and electrolytes, along with logistical hurdles, particularly during pandemics or geopolitical tensions, can disrupt supply chains, affecting delivery timelines and sales.

4. Stringent Regulatory Compliance

Compliance with evolving regulations—such as US Pharmacopoeia standards, European Pharmacopoeia, and ISO certifications—requires continual updates and validation, increasing operational costs.


Market Segmentation and Regional Dynamics

By End-User

  • Hospitals and clinics: Major consumers due to inpatient and emergency use.
  • Ambulatory surgical centers: Growing contribution owing to minimally invasive procedures.
  • Pharmaceutical and research laboratories: Use for research and formulation development.

By Geography

  • North America: Largest market share, driven by advanced healthcare infrastructure and high prescription rates.
  • Europe: Steady growth, adhering to strict regulatory standards.
  • Asia-Pacific: Rapid expansion due to healthcare infrastructure development, rising income levels, and increased disease burden.
  • Latin America and Middle East Africa: Emerging markets with increasing healthcare access are poised for future growth.

Financial Trajectory and Market Forecast

Market Size and Growth Projections

Global demand for IV solutions, including Dextrose and Potassium Chloride formulations, is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6-8% from 2023 to 2030. The increasing prevalence of chronic diseases, surgical procedures, and critical care requirements underpin this growth [4].

Revenue Estimates

By 2030, the market value could surpass USD 2.5 billion, driven mainly by increased adoption in developing regions, regulatory approvals of new formulations, and technological advancements in packaging. The Asia-Pacific region alone might constitute a significant fraction of this growth, owing to low-cost manufacturing and expanding healthcare access.

Profitability Trends

Margins in this sector are influenced by raw material costs, manufacturing efficiency, and regulatory compliance. Innovation in plastics—such as bio-based resins and improved barrier properties—may reduce material costs, while economies of scale will boost profitability. Strategic partnerships, licensing, and generic manufacturing will remain dominant within the value chain.

Impact of Technological Innovations

Development of pre-filled, ready-to-use plastic containers with enhanced safety features (e.g., tamper-evident seals, dose indicators) is expected to add value, streamline logistics, and command premium pricing. Additionally, advances in container materials to reduce leaching and improve shelf life will favorably impact financial trajectories.


Regulatory and Market Entry Considerations

Entering this market requires substantial investment in quality assurance, regulatory compliance, and manufacturing capacity. Companies must obtain necessary approvals aligned with regional standards and demonstrate safety and efficacy. Strategic localization and partnerships can mitigate entry barriers in emerging markets.


Key Drivers for Investment and Growth

  • Expanding healthcare infrastructure in emerging markets.
  • Rising awareness of electrolyte and hydration therapy.
  • Technological advances in plastic container manufacturing.
  • Regulatory landscape favoring safety innovations.
  • Strategic mergers and acquisitions enhancing market share.

Key Takeaways

  • The market for Dextrose 5% combined with Potassium Chloride 0.15% in plastic containers is poised for steady growth, driven by increasing healthcare needs globally.
  • Innovations in packaging, coupled with rising hospitalizations and surgical procedures, underpin future revenue expansion.
  • Competitive pressures and regulatory compliance represent significant hurdles; effective cost management and quality assurance are vital.
  • The Asia-Pacific region offers fertile ground for market penetration due to demographic and economic factors.
  • Stakeholders should capitalize on technological advancements and regional expansion opportunities to maximize profitability.

FAQs

1. What are the primary factors influencing the demand for Dextrose and Potassium Chloride solutions?
Rising rates of electrolyte imbalances, increasing hospitalizations, surgical procedures, and critical care needs globally drive demand.

2. How does plastic container packaging impact the market?
Plastic containers offer safety, convenience, and cost advantages, facilitating higher adoption and supporting market growth.

3. What are major regulatory considerations for manufacturers?
Regulatory bodies require rigorous quality control, demonstration of safety, and compliance with standards such as USP, EMA, and regional health authority approvals.

4. Which regions are expected to exhibit the fastest market growth?
The Asia-Pacific region is projected to lead growth due to expanding healthcare infrastructure and increasing disease burden.

5. How might technological innovations influence market profitability?
Innovations in container materials, safety features, and formulation stability can enhance product value, reduce costs, and provide competitive differentiation.


Sources

[1] Global Healthcare Infrastructure Report, WHO, 2022.
[2] Electrolyte Imbalance Statistics, National Institutes of Health, 2021.
[3] Packaging Industry Trends, Packaging Digest, 2020.
[4] MarketForecast: Intravenous Solutions, MarketsandMarkets, 2023.


In summary, the market for Dextrose 5% and Potassium Chloride 0.15% in plastic containers presents robust opportunities rooted in healthcare expansion, clinical demand, and technological progress. Strategic positioning, quality focus, and regional considerations are critical for capitalizing on this trajectory.

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