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Last Updated: December 12, 2025

DEXTROSE - Generic Drug Details


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What are the generic drug sources for dextrose and what is the scope of freedom to operate?

Dextrose is the generic ingredient in one hundred and eighty-five branded drugs marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Miles, Otsuka Icu Medcl, Hospira, Abbott, Am Regent, DHL, Icu Medical Inc, and Intl Medication Sys, and is included in ninety-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for dextrose. Fifteen suppliers are listed for this compound.

Summary for DEXTROSE
US Patents:0
Tradenames:185
Applicants:11
NDAs:98
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 15
Raw Ingredient (Bulk) Api Vendors: 37
Drug Prices: Drug price trends for DEXTROSE
What excipients (inactive ingredients) are in DEXTROSE?DEXTROSE excipients list
DailyMed Link:DEXTROSE at DailyMed
Drug Prices for DEXTROSE

See drug prices for DEXTROSE

US Patents and Regulatory Information for DEXTROSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-003 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate INJECTABLE;INJECTION 019025-001 Dec 27, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-015 Feb 24, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019691-009 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 0.11% 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 in the Pharmaceutical Sector

Last updated: August 2, 2025

Introduction

Dextrose, a crystalline form of glucose derived primarily from cornstarch, plays a vital role in the pharmaceutical industry. Its applications span from intravenous (IV) solutions to nutrition therapy, making it a staple ingredient in inpatient care and clinical settings. The evolving landscape of healthcare, advancements in drug formulation, and increasing global demand underpin the commercial trajectory of dextrose. Understanding these market dynamics and the financial outlook is essential for stakeholders, including drug manufacturers, investors, and healthcare providers.

Market Overview and Key Drivers

Global Market Size and Growth Trends

The global pharmaceutical dextrose market is forecast to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, reaching an estimated valuation of USD 1.2 billion by 2028 (source: industry reports[1]). Factors contributing to this growth include rising prevalence of chronic diseases requiring nutritional support and expanding healthcare infrastructure in emerging markets.

Application-Driven Demand

Dextrose’s primary application remains in intravenous solutions, notably in parenteral nutrition (PN), which covers a significant share of the total market. The increasing incidence of malnutrition, especially among hospitalized and critically ill patients, bolsters demand for sterile, high-purity dextrose solutions (source: Global Market Insights[2]).

Regulatory and Safety Standards

Stringent regulations surrounding pharmaceutical excipients influence market supply and innovation. The necessity for pharmacopeial compliance, such as USP and EP standards, encourages manufacturers to enhance purity and sterilization processes, which, while increasing production costs, improve product safety and efficacy.

Innovations and Product Development

Recent developments include the production of dextrose monohydrate and specific formulations tailored for injectable or enteral use. Innovations in fermentation technology and extraction processes optimize yield and purity, supporting diversification and premium pricing strategies.

Market Challenges and Constraints

Supply Chain Disruptions

The COVID-19 pandemic exposed vulnerabilities in global supply chains, impacting raw material availability and manufacturing schedules. The dependency on regional corn starch supplies can lead to volatility in prices and availability.

Price Fluctuations and Raw Material Costs

Corn starch prices are affected by agricultural yields, climate conditions, and geopolitical factors. Such volatility influences the manufacturing costs of dextrose, affecting profit margins and pricing strategies.

Environmental and Sustainability Concerns

Growing focus on sustainable sourcing practices adds pressure on manufacturers to adopt eco-friendly operations. Investments in greener extraction and purification processes may initially elevate costs but are increasingly viewed as essential for long-term competitiveness.

Competitive Landscape

Major players in the dextrose pharmaceutical market include Archer Daniels Midland Company, Cargill, Ingredion Incorporated, and Roquette Frères. These companies focus on capacity expansion, R&D investments, and strategic partnerships to maintain market dominance.

Emerging regional manufacturers are progressively capturing market share through cost advantages and localized supply chains, especially in Asia-Pacific, which currently accounts for over 40% of the global dextrose demand (source: MarketWatch[3]).

Financial Trajectory and Investment Outlook

Revenue Streams and Profitability

Revenue generation for pharmaceutical-grade dextrose hinges on high-volume procurement by large healthcare institutions and process manufacturing for injectable solutions. Margins are influenced by raw material costs, compliance investments, and technology upgrades.

Pricing Strategies

Premium pricing is achievable through certifications, superior purity levels, and customization for specialized pharmaceutical applications. Conversely, commoditized segments face intense price competition, especially from regional producers.

Investment Opportunities

The sector presents compelling opportunities driven by healthcare spending growth, technological innovations, and expanding healthcare coverage. Capital investments in plant modernization, quality assurance, and R&D underpin sustainable growth.

Risks and Mitigation

Market risks include supply chain disruptions, regulatory uncertainties, and price commoditization. Diversification of supply sources, ongoing compliance, and product differentiation are critical mitigation strategies.

Regional Market Dynamics

North America

Leading market, driven by advanced healthcare infrastructure, high IV therapy adoption, and strict regulatory standards. Growth is steady, with pharmaceutical dextrose used extensively in clinical nutrition.

Europe

Significant demand, with focus on compliance with EU pharmacopoeia standards. Increasing emphasis on sustainable practices influences manufacturing policies.

Asia-Pacific

Fastest-growing segment, fueled by increasing healthcare access, rising prevalence of metabolic disorders, and expanding pharmaceutical manufacturing capacities. China and India are notable hubs for dextrose production and consumption.

Latin America and Middle East & Africa

Emerging markets with expanding healthcare systems. Demand growth is constrained by infrastructure challenges but offers long-term investment potential.

Regulatory Environment and Its Impact

Regulatory agencies like the US FDA, EMA, and WHO enforce strict guidelines on pharmaceutical excipients, including dextrose. Compliance ensures market access but imposes costs related to quality control, documentation, and process validation. Regulatory harmonization efforts aim to streamline approval pathways, thereby positively influencing market trajectory.

Future Outlook

The outlook for pharmaceutical dextrose remains robust, centered on increased global healthcare needs, technological advances, and strategic manufacturing expansions. The integration of automation, ensuring purity, and sustainable sourcing will be pivotal. Price stabilization alongside innovation-driven premium offerings will define financial performance.

Key Takeaways

  • The pharmaceutical dextrose market is projected to grow steadily, driven by demand for nutritional and injectable applications.
  • Supply chain resilience and raw material cost management are critical for maintaining profitability.
  • Innovation and compliance investments provide differentiation opportunities amid intense competition.
  • Asia-Pacific presents high-growth potential, with regional manufacturing and rising healthcare needs.
  • Sustainability and regulatory adaptation are increasingly central to long-term strategic planning.

FAQs

1. What are the primary drivers behind the demand for pharmaceutical-grade dextrose?
The increasing prevalence of malnutrition, growth in parenteral nutrition therapies, and expanding healthcare infrastructure globally are primary demand drivers.

2. How does regulatory compliance impact the pricing of pharmaceutical dextrose?
Strict adherence to quality standards (USP, EP, etc.) incurs costs but enhances safety and allows premium pricing for high-purity products. Non-compliance risks market access and penalties.

3. What regional markets are emerging as key players in dextrose production and consumption?
Asia-Pacific, particularly China and India, are rapidly expanding both manufacturing and consumption, supported by growing healthcare sectors and cost advantages.

4. How have recent supply chain disruptions affected the dextrose market?
Pandemics and geopolitical issues have caused raw material shortages and logistical delays, prompting manufacturers to diversify supply sources and increase inventory buffers.

5. What innovations are shaping the future of pharmaceutical dextrose?
Advancements include optimized fermentation processes, high-purity crystallization techniques, and sustainable extraction methods, all aimed at improving quality and environmental performance.

References

[1] Industry Reports on Pharmaceutical Excipients Market, 2022.
[2] Global Market Insights, "Dextrose Market Outlook," 2022.
[3] MarketWatch, "Regional Trends in Pharmaceutical Ingredients," 2022.

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