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Last Updated: December 19, 2025

Dextrose; potassium chloride - Generic Drug Details


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What are the generic sources for dextrose; potassium chloride and what is the scope of patent protection?

Dextrose; potassium chloride is the generic ingredient in one hundred and thirty-two branded drugs marketed by Fresenius Kabi Usa, Baxter Hlthcare, B Braun, Otsuka Icu Medcl, Hospira, and Icu Medical Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for dextrose; potassium chloride
US Patents:0
Tradenames:132
Applicants:6
NDAs:22
Finished Product Suppliers / Packagers: 4
DailyMed Link:dextrose; potassium chloride at DailyMed
Pharmacology for dextrose; potassium chloride

US Patents and Regulatory Information for dextrose; potassium chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Icu Medcl POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019691-005 Mar 24, 1988 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-022 Feb 17, 1988 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 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-002 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019308-001 Apr 5, 1985 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018365-005 Mar 28, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-004 Feb 17, 1988 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 and Potassium Chloride in Pharmaceutical Applications

Last updated: July 27, 2025

Introduction

Dextrose (D-glucose) and potassium chloride (KCl) are critical pharmaceuticals widely utilized for medical therapies and intravenous (IV) solutions. Their market dynamics, driven by clinical demand, regulatory environments, and manufacturing capacities, significantly influence their financial trajectories. This analysis dissects current market conditions, key drivers, challenges, and forecasted financial performance to guide stakeholders’ strategic decisions.

Market Overview

Dextrose: Ubiquitous in Medical and Food Industries

Dextrose, a monosaccharide derived from starch, serves dual roles in nutrition and pharmacotherapy. Its medical applications include energy replenishment, hydration, and as a component in IV fluids. The global dextrose market was valued at approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) of ~5.2% projected through 2030 (Grand View Research)[1].

Dextrose's medical-grade segment is characterized by intense regulatory scrutiny, emphasizing purity and manufacturing standards conforming to pharmacopeial standards (e.g., USP, EP). The increasing incidence of chronic diseases like diabetes and malnutrition amplifies demand for IV solutions containing dextrose.

Potassium Chloride: Essential Electrolyte Therapy

KCl functions primarily to correct hypokalemia and maintain electrolyte balance, fundamental for cardiac, muscular, and nerve functions. The global potassium chloride market was valued at USD 2.8 billion in 2022, with projected CAGR exceeding 4.8% until 2030[2].

In pharmaceuticals, KCl is predominantly supplied as oral tablets, injectable solutions, and as a component in total parenteral nutrition (TPN). Its use in emergency medicine and chronic illness management underscores its market stability.

Market Drivers

Rising Healthcare Expenditure and Chronic Disease Burden

An aging global population and escalating healthcare spending bolster demand for IV fluids and electrolyte therapies. The World Health Organization reports a rise in diabetes globally, increasing the need for dextrose-based solutions, while electrolyte imbalances associated with chronic kidney disease and gastrointestinal disorders amplify KCl demand.

Regulatory Standardization and Manufacturing Advances

Stringent quality standards ensure pharmaceutical-grade dextrose and KCl meet safety and efficacy benchmarks. Innovations in fermentation and purification processes enhance yield and purity, reducing costs and increasing supply reliability.

Demand for Ready-to-Use Injectable Solutions

The convenience and safety profile of pre-mixed IV solutions elevate the consumption of dextrose and KCl formulations, driving market expansion.

Supply Chain Stabilization Post-Pandemic

COVID-19 underscored the importance of supply chain resilience. Investments in manufacturing capacity and inventory stocking have mitigated shortages, reinforcing market stability.

Market Challenges

Pricing Pressures and Market Competition

Price erosion due to generic competition and commoditization risk erodes profit margins. Key manufacturers face intense price competition, especially in emerging markets.

Regulatory Barriers and Quality Assurance

Strict compliance costs and evolving regulations pose barriers, demanding continuous quality improvement and validation efforts.

Raw Material Volatility

Fluctuations in starch, salt, and mineral feedstock prices can impact production costs, affecting overall profitability.

Environmental and Ethical Concerns

Sustainability in sourcing raw materials and waste management influence reputation and operational costs, especially under increasingly rigorous environmental standards.

Financial Trajectory and Forecasts

Revenue Growth and Market Penetration

The convergence of increasing medical demand and product innovation is projected to sustain a moderate CAGR of approximately 4.5–5% for dextrose and 4–5% for KCl through 2030. Leading companies, such as Baxter, Fresenius, and local generics producers, are expanding manufacturing capacities and diversifying product portfolios, contributing to revenue growth.

Profitability Trends

Margins hinge on production efficiencies, raw material costs, and regulatory compliance. Emphasis on high-quality, sterile, ready-to-use formulations commands premium pricing in mature markets, supporting healthier profit margins.

Investment and Innovation

Continued R&D investment in sourcing sustainable raw materials and advanced manufacturing technologies is expected to bolster supply chain stability and product quality, potentially translating into premium pricing and market share gains.

Emerging Markets and Expansion Opportunities

Growing healthcare infrastructure in Asia-Pacific and Latin America presents lucrative opportunities. Localization of manufacturing and strategic partnerships with regional distributors are key to capturing emerging market share.

Competitive Landscape

Major players include international pharmaceutical companies and regional generic producers. The competitive environment is characterized by:

  • Manufacturing Scale and Capacity: Large-scale facilities with advanced sterilization and purification processes secure supply.
  • Regulatory Approvals: Stringent adherence to international standards enhances market access.
  • Product Differentiation: Value-added formulations, such as concentrated solutions or multi-electrolyte blends, differentiate offerings.

Market consolidation, through mergers and acquisitions, is common to improve bargaining power and expand product portfolios, affecting the financial outlook positively.

Regulatory and Policy Environment

Regulatory handbooks, such as those from the FDA (U.S.) and EMA (Europe), emphasize quality, safety, and environmental sustainability. Policy shifts towards stricter pharmacovigilance and manufacturing transparency can lead to increased compliance costs but also favor reputable industry players.

Conclusion

The market for pharmaceutical-grade dextrose and potassium chloride remains resilient, supported by robust healthcare demands, technological advances, and strategic industry investments. While pricing pressures and regulatory hurdles pose challenges, innovations in manufacturing and expanding healthcare access, especially in emerging markets, create a positive financial trajectory—albeit moderate and steady.

Key Takeaways

  • Steady Growth: Both dextrose and KCl markets are projected to grow at approximately 4.5–5% CAGR through 2030, driven by rising healthcare needs and chronic disease prevalence.
  • Supply Chain and Manufacturing Innovation: Investments in capacity expansion and process improvements are critical to maintaining market share and profitability.
  • Regulatory Compliance: High regulatory standards reinforce market barriers for new entrants but benefit established players with reliable quality systems.
  • Emerging Markets Opportunities: Growth in Asia-Pacific, Latin America, and Africa offers substantial revenue expansion potential through localized manufacturing and partnerships.
  • Market Challenges: Price competition, raw material volatility, and environmental standards require strategic management to sustain profitability.

FAQs

1. How does regulatory compliance impact the financial outlook for dextrose and KCl manufacturers?
Regulatory compliance ensures market access and product safety but increases operational costs. Companies with established compliance credentials can command premium pricing and secure long-term contracts, positively influencing their financial trajectory. Non-compliance risks, including sanctions and recalls, pose significant financial hazards.

2. What are the key growth drivers for the dextrose and KCl markets in the next five years?
Growing prevalence of chronic diseases, increasing global healthcare expenditure, rising demand for IV therapies, and technological manufacturing advancements are primary drivers. The expansion of healthcare infrastructure in emerging markets further reinforces growth prospects.

3. How do raw material costs influence profitability in these markets?
Fluctuations in starch and mineral prices directly affect the cost of goods sold. Companies that effectively hedge against raw material volatility or diversify sourcing can maintain margins and competitive pricing.

4. What role does innovation play in shaping the financial trajectory of these pharmaceutical ingredients?
Innovation in fermentation, purification, and formulation enhances product quality, reduces costs, and enables the development of value-added products. These advancements can lead to premium pricing and expanded market share, positively impacting revenue and profitability.

5. Are there environmental considerations that could influence future market dynamics?
Yes. Increasing environmental regulations necessitate sustainable sourcing, waste management, and energy-efficient manufacturing. Companies investing in green technologies may face higher upfront costs but benefit from reputational enhancements and compliance advantages.

References

[1] Grand View Research. "Dextrose Market Size, Share & Trends Analysis Report." 2022.
[2] Research and Markets. "Global Potassium Chloride Market Forecast 2022-2030." 2022.

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