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Last Updated: December 12, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 5meq (k) patents expire, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 5meq (k) is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) 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%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)?
  • What are the global sales for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)?
  • What is Average Wholesale Price for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)?
Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)

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%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-003 Approved Prior to Jan 1, 1982 AP RX 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 0.2%, and Potassium Chloride 5mEq (K)

Last updated: August 1, 2025

Introduction

The combination of Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 5mEq (K) forms a crucial component in parenteral nutrition and hydration therapies. As a pivotal intravenous (IV) fluid formulation, this compound addresses critical medical needs across hospitals, clinics, and emergency settings. Its market performance is shaped by factors such as clinical demand, regulatory landscape, technological innovation, and geopolitical influences. This report elucidates the current market dynamics and forecasts the financial trajectory for this IV solution over the coming years.

Market Overview

This compounded IV solution is integral for correcting electrolyte imbalances, providing caloric intake, and maintaining fluid balance in critically ill patients. Its utility spans multiple clinical indications including dehydration, surgical recovery, and electrolyte replacement. As a standard component in hospital pharmacy inventories globally, its overall market size remains substantial, driven by aging populations, increasing prevalence of chronic disorders, and expanding healthcare infrastructure, particularly in emerging economies.

According to market estimates, the global infusion therapy market, valued at approximately USD 19 billion in 2021, is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2022 to 2028. A significant determinant of this growth is the demand for electrolyte solutions like Dextrose 5% with electrolytes, fueling both branded and generic segments.

Market Drivers

Growing Clinical and Demographic Demand

An aging population predisposes to chronic illnesses such as cardiovascular disease, diabetes, and renal insufficiency, necessitating continuous electrolyte management. The increasing adoption of parenteral nutrition solutions further propels the necessity for electrolyte-administering compounds like Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 5mEq (K).

Rising Hospitalization Rates and Critical Care Needs

The global surge in hospital admissions, especially due to emergent conditions such as COVID-19, has elevated the usage of IV fluids. Hospitals worldwide depend heavily on reliable supply chains for these solutions, ensuring ongoing market demand.

Advancements in Formulation and Packaging

Recent innovations have resulted in more stable, sterilized, and patient-friendly formulations, which facilitate broader usage in outpatient and home healthcare settings. Single-use vials and ready-to-use formulations enhance safety and convenience, driving sales volume.

Regulatory and Reimbursement Policies

Stringent regulatory standards—by bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)—require consistent quality and safety, leading to increased reliance on approved formulations. Favorable reimbursement policies in developed regions bolster market growth, whereas emerging markets are gradually aligning policies to support imported and locally manufactured solutions.

Market Challenges

Price Competition and Generic Entry

The market’s commoditized nature has led to intense price competition, particularly among generic manufacturers. Regulatory approval processes for biosimilars and generics, coupled with increasing manufacturing capacities, exert downward pressure on prices.

Supply Chain Disruptions

Global disruptions, exemplified during the COVID-19 pandemic, affected the procurement of raw materials such as glucose and electrolytes, impacting production and pricing stability.

Stringent Regulatory Environment

While regulations ensure safety and efficacy, procedural delays and costly compliance pose barriers for smaller manufacturers, limiting competition and innovation.

Limited Differentiation

The formulation’s fundamental nature results in limited differentiation, constraining companies' ability to command premium pricing without innovating beyond standard compositions.

Competitive Landscape

Major pharmaceutical companies such as Baxter International, Fresenius Kabi, and B. Braun dominate the IV fluids market. These entities focus on expanding production capacity, enhancing formulation stability, and expanding into emerging markets.

The entry of generic manufacturers has increased availability and pricing competitiveness, but brand loyalty and regulatory approval hurdles maintain market incumbents’ dominance.

Financial Trajectory and Forecast

Historical Trends

Over the past five years, the segment has seen steady growth driven by increasing adoption and healthcare expenditure. The overall revenue for electrolyte IV solutions globally is estimated at USD 3.2 billion in 2022, with Dextrose 5% solutions constituting a significant portion.

Projected Growth

Forecasts anticipate a CAGR of approximately 6.5-7.5% from 2023 to 2030, driven by increased hospital admissions, expanding healthcare infrastructure, and rising prevalence of diseases requiring electrolyte management.

Emerging markets such as China and India present substantial growth opportunities, with investments in hospital infrastructure and domestic manufacturing expected to lower costs and improve access.

Impact of Technological Innovation

Advancements such as smart infusion devices and improved formulation stability are expected to optimize dosing accuracy, reduce adverse events, and promote market expansion. The integration of digital health solutions will further enhance market uptake.

Regulatory and Economic Factors

Regulatory approvals for innovative formulations or pre-mixed IV solutions could enable premium pricing strategies. Conversely, price compression due to competition remains a constraining factor.

Future Opportunities

  • Personalized IV Solutions: Tailoring electrolyte compositions to patient-specific profiles could unlock premium market segments.
  • Home Healthcare Expansion: The growing geriatric population and preference for outpatient care open avenues for outpatient and home-use formulations.
  • Biosimilar Development: Biosimilar electrolyte solutions may reduce costs and expand access, particularly in cost-sensitive markets.
  • Sustainability Initiatives: Eco-friendly packaging and manufacturing processes are increasingly valued, influencing market competitiveness.

Regulatory and Policy Influences

Global regulatory bodies are emphasizing stringent Quality, Safety, and Efficacy standards, which influence manufacturing practices and market entry strategies. Countries with evolving healthcare policies, like India and Brazil, are creating frameworks that facilitate local manufacturing and importation, impacting regional market share distributions.

Furthermore, reimbursement policies that favor outpatient and home-based IV therapies could accelerate market penetration of these solutions.

Conclusion

The market dynamics for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 5mEq (K) are marked by steady growth driven by demographic trends, technological innovations, and expanding healthcare infrastructure. While faced with pricing pressures and regulatory challenges, the increasing global demand—particularly in emerging markets—is projected to sustain a positive financial trajectory over the next decade.

Stakeholders capable of navigating supply chain complexities, investing in formulation innovation, and aligning with evolving regulatory standards will be positioned advantageously. The convergence of technological advancement, policy support, and demographic shifts underscores a resilient growth outlook for this critical IV solution segment.


Key Takeaways

  • The global electrolyte IV solution market is poised for robust growth, with a projected CAGR of approximately 7% through 2030.
  • Hospitalization rates, aging populations, and expanding healthcare infrastructure underpin sustained demand.
  • Price competition and regulatory hurdles remain challenges, but innovation and emerging markets offer growth opportunities.
  • Manufacturers should prioritize formulation stability, supply chain resilience, and compliance strategies to maximize market share.
  • Integration of digital health and personalized solutions will be pivotal to future value creation.

FAQs

1. What factors most significantly influence the pricing of Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride IV solutions?
Pricing is mainly influenced by manufacturing costs, raw material availability, regulatory compliance, competitive dynamics, and regional reimbursement policies. Generic competition exerts downward pressure, while added value through innovation can command premium prices.

2. How do regulatory standards differ across key markets, and what implications does this have?
Regulatory standards vary globally; developed regions like the US and EU enforce strict quality controls, requiring extensive clinical data. Emerging markets may have more streamlined processes but are increasingly aligning with international standards. This influences market entry strategies, costs, and timelines.

3. What role does technological innovation play in the future of electrolyte IV solutions?
Technologies such as smart infusion devices, stability-enhancing formulation methods, and personalized electrolyte compositions will improve safety, efficacy, and customer appeal. These innovations can also create barriers to entry for less advanced competitors.

4. How has the COVID-19 pandemic impacted the market for electrolyte IV solutions?
The pandemic heightened demand due to increased hospitalization and critical care needs, disrupting supply chains and accelerating the adoption of ready-to-use formulations. It also underscored the need for resilient manufacturing and distribution strategies.

5. What are the key growth opportunities in emerging markets?
Emerging markets offer opportunities through expanding healthcare infrastructure, government initiatives to improve healthcare access, and development of local manufacturing facilities, which can reduce costs and increase availability.


Sources:

[1] Market Research Future, "Infusion Therapy Market," 2022.
[2] Grand View Research, "IV Solutions Market Size & Trends," 2022.
[3] GlobalData Healthcare, "Electrolyte Solutions Industry Outlook," 2023.

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