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Last Updated: December 19, 2025

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% Drug Patent Profile


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Which patents cover Dextrose 5% And Potassium Chloride 0.15%, and when can generic versions of Dextrose 5% And Potassium Chloride 0.15% launch?

Dextrose 5% And Potassium Chloride 0.15% is a drug marketed by Fresenius Kabi Usa, Baxter Hlthcare, and B Braun. and is included in three NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 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 0.15%?
  • What are the global sales for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%?
  • What is Average Wholesale Price for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%?
Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%
Drug patent expirations by year for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% dextrose; potassium chloride INJECTABLE;INJECTION 212346-002 Sep 10, 2020 AP RX 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
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 0.2% 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 0.45% 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% and Potassium Chloride 0.15%

Last updated: July 27, 2025

Introduction

Dextrose 5% with Potassium Chloride 0.15%, commonly referred to as D5K or Dextrose with potassium chloride, is a vital component in intravenous (IV) therapy. It provides essential nutrients—glucose as an energy source and potassium as a key electrolyte—used extensively in hospitals for fluid and electrolyte management. Given its broad application in medical settings, understanding its market dynamics and financial trajectory is critical for stakeholders, including pharmaceutical manufacturers, healthcare providers, and investors.

Market Overview

The global intravenous (IV) solutions market, which encompasses Dextrose 5% with Potassium Chloride 0.15%, is experiencing steady growth. Key factors include rising incidences of chronic diseases, aging populations, expanding surgical procedures, and increasing hospital admissions. The market size was valued at approximately USD 10.5 billion in 2022 and is projected to reach USD 15.8 billion by 2030, growing at a compound annual growth rate (CAGR) of around 5.3% (according to industry reports).

Dextrose solutions, especially Dextrose 5%, hold a significant market share due to their fundamental role as energy sources in parenteral nutrition, fluid resuscitation, and electrolyte replenishment. Potassium chloride preparations are integrated into these solutions to correct hypokalemia and maintain electrolyte balance, further extending their clinical utility.

Market Drivers

Rising Prevalence of Chronic Diseases

The global rise in conditions such as diabetes, cardiovascular disease, and renal disorders increases demand for IV therapies. Many of these patients require electrolyte correction and glucose infusion, making Dextrose and potassium chloride solutions indispensable.

Aging Population

Older adults are more susceptible to electrolyte imbalances and require parenteral nutrition support. The growing elderly demographic directly correlates with increased consumption of IV solutions.

Hospital Infrastructure Expansion

Emerging economies invest heavily in healthcare infrastructure, increasing the availability and utilization of IV therapies. Governments and private sectors boost hospital capacities, shifting from traditional to advanced medical care involving more IV solutions.

Increase in Surgical Procedures

Electrolyte management is critical during major surgeries and post-operative care. The rising volume of surgeries globally drives demand for standardized IV formulations like Dextrose 5% with Potassium Chloride 0.15%.

Regulatory Approvals and Pipeline Expansion

The approval of new formulations, improved delivery systems, and stable, sterile manufacturing processes for Dextrose and potassium chloride solutions bolster market offerings and accessibility.

Market Challenges

Regulatory and Safety Concerns

Strict regulations pertaining to sterile manufacturing and safety protocols influence production costs and time-to-market. Additionally, adverse reactions—such as hyperkalemia—demand cautious dosing and monitoring, occasionally limiting usage.

Price Fluctuations in Raw Materials

Volatility in the prices of raw materials, especially glucose and potassium chloride, can affect profit margins.

Competition from Alternative Therapies

Emerging oral electrolyte supplements and more advanced pharmaceutical formulations pose competition, especially in outpatient settings.

Supply Chain Disruptions

Global supply chain perturbations, such as those experienced during the COVID-19 pandemic, impact raw material availability and distribution, influencing market stability.

Financial Trajectory & Revenue Forecast

Historical Performance

Over the past five years, the market for IV solutions inclusive of Dextrose 5% and potassium chloride has experienced consistent growth. Key drivers—clinical demand and expanded healthcare infrastructure—have sustained this trend.

Forecasted Growth

Projections indicate a CAGR of approximately 5.3% from 2023 to 2030. The North American and European markets collectively dominate globally, owing to advanced healthcare facilities and established supply chains. The Asia-Pacific region demonstrates the highest growth potential, driven by increasing healthcare access and a burgeoning middle class.

Key Revenue Segments

  • Hospital Pharmacies & Departments: The primary revenue source, contributing over 75% of total sales, driven by inpatient care.
  • Home Healthcare & Outpatient Clinics: Growing markets owing to self-managed care protocols and outpatient treatments.
  • Contract Manufacturing & Private Labeling: Opportunities for pharmaceutical companies to expand production capacities and private label offerings.

Pricing Dynamics

Pricing remains competitive, influenced by raw material costs, regional regulatory standards, and production efficiencies. Premium formulations with enhanced stability and safety profiles command higher prices, impacting overall revenue streams.

Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Pfizer, Hospira (a Pfizer subsidiary), and Fresenius Kabi. These companies leverage extensive distribution networks, R&D capabilities, and compliance with stringent quality standards to secure market share.

Strategic Initiatives

  • Product Innovation: Development of ready-to-use, stabilized Dextrose-Potassium solutions reduces preparation times and contamination risks.
  • Regulatory Approvals: Securing approvals for new formulations and delivery devices enhances market penetration.
  • Geographic Expansion: Emerging markets are targeted for distribution and manufacturing investments.

Regulatory Environment & Approval Pathways

Drug formulations like Dextrose 5% with Potassium Chloride 0.15% require compliance with regional regulatory agencies such as the FDA (U.S.), EMA (Europe), and similar authorities globally. Stringent standards demand extensive clinical validation, sterility assurance, and pharmacovigilance. Streamlined approval pathways for simplified formulations or new delivery systems can accelerate revenue growth.

Market Risks & Opportunities

Risks

  • Intense Competition: Innovation-driven competition may impact market share and pricing.
  • Regulatory Delays: Lengthy approval processes can delay product launches.
  • Raw Material Price Volatility: Sudden increases in costs can squeeze margins.
  • Safety Concerns: Adverse events related to potassium administration necessitate rigorous monitoring.

Opportunities

  • Emerging Markets: Expanding healthcare access presents significant growth potential.
  • Product Diversification: Formulation improvements, such as low-osmolality solutions or additive combinations, add value.
  • Technological Advances: Infusion pumps and smart delivery devices improve safety and drive adoption.
  • Personalized Medicine: Tailoring electrolyte compositions to patient-specific needs offers niche opportunities.

Key Takeaways

  • The global market for IV solutions, including Dextrose 5% with Potassium Chloride 0.15%, is poised for steady growth driven by aging populations, rising chronic disease prevalence, and healthcare infrastructure expansion.
  • Major growth regions include North America, Europe, and Asia-Pacific, with the latter exhibiting the fastest expansion potential.
  • Innovation, regulatory compliance, and strategic geographic expansion remain critical to capitalizing on market opportunities.
  • Price sensitivity influenced by raw material costs and competitive pricing strategies continue to shape revenue trajectories.
  • Stakeholders should monitor regulatory developments, technological innovations, and regional healthcare trends to optimize market positioning and financial outcomes.

Conclusion

Dextrose 5% combined with Potassium Chloride 0.15% stands as a cornerstone therapy in contemporary medical practice. Its market dynamics reflect broader healthcare trends emphasizing surgical volume, chronic disease management, and increasing hospitalizations. Financial prospects are optimistic, contingent on regulatory navigation and strategic adaptation to emerging market opportunities. Continuous innovation and expansion into underserved regions will be pivotal for revenue growth over the coming decade.


FAQs

  1. What are the primary clinical uses of Dextrose 5% and Potassium Chloride 0.15%?
    They are predominantly used for fluid replenishment, energy provision via glucose, and electrolyte correction in hospitalized patients, especially for hypokalemia management.

  2. How does the COVID-19 pandemic impact the market for IV solutions like Dextrose and potassium chloride?
    The pandemic disrupted supply chains, increased hospital demand, and heightened focus on sterile, reliable IV solutions, temporarily boosting demand but creating logistical challenges.

  3. What distinguishes the competitive landscape for these IV solutions?
    Key differentiators include formulation stability, safety profiles, delivery device innovation, manufacturing scale, and regulatory compliance.

  4. Which regions are expected to see the fastest growth in the market?
    Asia-Pacific offers high growth potential due to expanding healthcare infrastructure and rising disease burden.

  5. What are the main regulatory considerations for pharmaceutical companies producing Dextrose and potassium chloride solutions?
    Companies must adhere to strict sterility protocols, demonstrate product safety and efficacy, and obtain approvals from regional agencies like the FDA and EMA to enter and expand in markets.


Sources:
[1] MarketsandMarkets. "IV Solutions Market by Product, Application, and Region," 2022.
[2] Grand View Research. "Intravenous (IV) Solutions Market Size & Trends," 2023.

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