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Last Updated: December 12, 2025

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% Drug Patent Profile


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Which patents cover Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.45%, and what generic alternatives are available?

Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.45% is a drug marketed by Fresenius Kabi Usa, Baxter Hlthcare, and Otsuka Icu Medcl. and is included in three NDAs.

The generic ingredient in POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% 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 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Drug patent expirations by year for POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Pharmacology for POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

US Patents and Regulatory Information for POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

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 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 213523-001 Mar 9, 2021 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008-006 Apr 28, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 213523-005 Oct 11, 2022 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008-005 Apr 28, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018362-005 Mar 28, 1988 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018362-009 Jul 5, 1983 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 Potassium Chloride 10mEq in Dextrose 5% and Sodium Chloride 0.45%

Last updated: August 2, 2025


Introduction

The pharmaceutical segment centered on electrolyte and fluid replacement formulations, such as Potassium Chloride 10mEq in Dextrose 5% and Sodium Chloride 0.45%, holds a significant position within hospitals, clinics, and home-care settings. These formulations are critical in managing electrolyte imbalances, dehydration, and as adjuncts in parenteral nutrition. Understanding their market dynamics and financial trajectories is essential for stakeholders—manufacturers, investors, and healthcare policymakers—to strategize effectively in this niche.


Market Overview

Potassium Chloride in dextrose solutions, combined with sodium chloride infusions, is a staple in clinical electrolyte therapy. The demand aligns strongly with broader trends in healthcare, notably aging populations, rising prevalence of chronic diseases, and increasing use of intravenous therapies.

The global electrolyte solutions market was valued at approximately USD 2.3 billion in 2022, with a compound annual growth rate (CAGR) forecast at around 6% from 2023 to 2030 [1]. While this encompasses various formulations, potassium and sodium chloride solutions form a substantial component, driven by their widespread application.


Market Drivers

1. Rising Incidence of Chronic Diseases

Chronic kidney disease, congestive heart failure, and gastrointestinal disorders are increasingly prevalent globally. These conditions often necessitate electrolyte correction via intravenous modalities [2].

2. Aging Population

The demographic shift toward older populations, particularly in North America and Europe, escalates the demand for electrolyte replenishment solutions due to age-related renal and cardiovascular vulnerabilities [3].

3. Growth of Healthcare Infrastructure and Surgical Procedures

Expanding healthcare infrastructure, coupled with a surge in surgical interventions requiring perioperative fluid management, bolsters market demand [4].

4. Increasing Adoption in Home-Care and Outpatient Settings

Advances in portable infusion devices and home healthcare services stimulate demand for stable, ready-to-use electrolyte solutions outside hospital environments [5].


Market Challenges

1. Price Competition and Generics

With the expiration of patents and subsequent generic entry, market commoditization pressures profit margins [6].

2. Supply Chain Disruptions

Global supply chain issues, notably during the COVID-19 pandemic, impacted raw material availability and manufacturing continuity, affecting market stability [7].

3. Regulatory Stringency

Stringent quality standards and regulatory oversight can raise compliance costs, impacting revenue projections [8].


Financial Trajectory

1. Revenue Trends and Profitability

Large pharmaceutical firms and generic manufacturers dominate this sector. Due to high manufacturing volumes and minimal differentiation, profit margins are often narrow. Nonetheless, consistent demand supports stable revenue streams. As per recent financial disclosures, major players like Baxter International and Fresenius SE & Co. KGaA reported steady sales growth in infusion solutions, including electrolyte formulations, at a CAGR of 4-6% over the past five years [9].

2. Cost Structure and Pricing

Raw material costs (potassium chloride, sodium chloride, dextrose, stabilizers) constitute a major expense. While input costs have fluctuated due to supply chain issues, economies of scale and process optimization have kept prices relatively stable. The market favors volume-driven strategies, emphasizing manufacturing efficiency.

3. Market Penetration and Geographic Variability

In developed regions, the offerings are mature, with moderate growth driven by replacement and expansion. In developing markets, increased healthcare access and infrastructural investments present growth opportunities, with projected CAGR exceeding 8% in some Asian markets [10].

4. Innovation and Product Differentiation

Currently, minimal innovation exists; however, emerging trends in sterile manufacturing techniques and formulation stability may open ancillary revenue streams.

5. Regulatory and Reimbursement Factors

Favorable reimbursement policies in North America and Europe support steady demand. Conversely, pricing pressures and reimbursement cuts, particularly in government-funded healthcare systems, could compress margins [11].


Competitive Landscape

Major players competing in this segment include Baxter, Fresenius, B. Braun Melsungen AG, and Hikma Pharmaceuticals. These companies focus on scalable manufacturing, regulatory compliance, and distribution efficiency. Entry barriers remain high due to stringent quality standards and capital requirements, although emerging regional manufacturers are gradually gaining market share, especially in emerging economies.


Future Outlook and Growth Opportunities

1. Expansion through Product Line Extensions

Development of balanced electrolyte solutions, customized formulations, and ready-to-use delivery systems can catalyze growth.

2. Strategic Mergers and Acquisitions

Acquiring regional manufacturers or smaller biotech firms specializing in infusion solutions could consolidate market position.

3. Digital Transformation and Supply Chain Optimization

Adoption of advanced manufacturing technologies, AI-driven demand forecasting, and supply chain controls will likely reduce costs and enhance margin stability.

4. Increasing Adoption in Emerging Markets

Expanding healthcare infrastructure and rising demand for essential medicines underpin financially promising opportunities in Asia-Pacific, Latin America, and Africa [12].


Regulatory Landscape and Impact

Regulations in key markets such as the US (FDA), European Union (EMA), and other jurisdictions dictate manufacturing practice, labeling, and drug approval processes. Ensuring compliance entails considerable investment but safeguards market access. Variability in regulatory stringency can influence market entry and expansion costs, consequently affecting profitability.


Conclusion

The market for Potassium Chloride 10mEq in Dextrose 5% and Sodium Chloride 0.45% solutions remains resilient, driven by ongoing healthcare needs and demographic trends. While revenue trajectories suggest stable growth, margin pressures, regulatory challenges, and supply chain vulnerabilities require strategic management. For industry players, focusing on operational efficiencies, product innovation, geographic expansion—especially into emerging markets—and navigating regulatory environments will be crucial for maximizing financial performance amidst evolving market dynamics.


Key Takeaways

  • Demand stability is anchored in the essential role of electrolyte solutions in clinical care, offering predictable revenue streams for manufacturers.
  • Growth is moderate but steady, with higher CAGR observed in emerging markets due to infrastructural investment and increasing healthcare access.
  • Competitive intensity is high, with a predominant focus on cost control and product standardization; innovation remains limited but essential for differentiation.
  • Regulatory compliance influences market entry and operational costs but also acts as a barrier for new entrants.
  • Strategic initiatives, such as product diversification and geographic expansion, will determine long-term financial success amid market pressures.

FAQs

1. What are the primary factors influencing the market price of Potassium Chloride in infusion solutions?
Raw material costs, manufacturing efficiency, regulatory compliance costs, and competitive pricing strategies predominantly influence market prices.

2. How do regulatory standards impact the development and commercialization of electrolyte infusion solutions?
Strictly enforced quality and safety standards require significant investment in manufacturing facilities, quality control, and compliance processes, influencing time-to-market and profitability.

3. What are the key growth regions for this market?
While North America and Europe constitute matured markets, Asia-Pacific and Latin America present high-growth opportunities driven by expanding healthcare infrastructure.

4. How have recent supply chain disruptions affected this segment?
Disruptions have led to raw material shortages, manufacturing delays, and increased costs, impacting supply stability and profitability temporarily.

5. What innovations are emerging in electrolyte infusion solutions?
Emerging trends include sterile manufacturing techniques, stable multi-electrolyte formulations, and ready-to-use pre-filled infusion devices to enhance safety and convenience.


Sources:

[1] MarketsandMarkets. "Electrolyte Solutions Market." 2022.
[2] WHO. "Global Burden of Chronic Kidney Disease." 2021.
[3] UN World Population Prospects. "Aging Trends." 2022.
[4] IBISWorld. "Hospital and Healthcare Facilities Industry." 2023.
[5] Grand View Research. "Home Healthcare Market Analysis." 2022.
[6] Statista. "Generic Pharmaceuticals Market Trends." 2022.
[7] McKinsey & Company. "Supply Chain Resilience in Healthcare." 2021.
[8] EMA & FDA Publications. "Regulatory Guidelines for Intravenous Solutions." 2022.
[9] Financial Reports of Baxter and Fresenius, 2022.
[10] GlobalData. "Emerging Markets in Infusion Solutions." 2022.
[11] Healthcare Financial Management Association. "Reimbursement Trends." 2022.
[12] WHO. "Healthcare Infrastructure Investment Opportunities." 2022.

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