Last Updated: June 24, 2026

DEXTROSE 30% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 30% In Plastic Container, and what generic alternatives are available?

Dextrose 30% In Plastic Container is a drug marketed by Baxter Hlthcare and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in DEXTROSE 30% IN PLASTIC CONTAINER is dextrose. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.

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Summary for DEXTROSE 30% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 30% IN PLASTIC CONTAINER

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 30% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 017521-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl DEXTROSE 30% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 019345-001 Jan 26, 1985 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DEXTROSE 30% IN PLASTIC CONTAINER: MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

Dextrose 30% in Plastic Container is a parenteral nutrition solution used for hyperosmolar therapy and as a carbohydrate source in intravenous feeding. The market for this product is driven by the increasing prevalence of malnutrition, gastrointestinal disorders, and the growing demand for home parenteral nutrition. Competitive pressures and regulatory landscapes shape its financial trajectory.

WHAT ARE THE PRIMARY INDICATIONS AND THERAPEUTIC USES?

Dextrose 30% in Plastic Container's primary therapeutic uses are centered around providing a concentrated source of carbohydrate for patients unable to ingest adequate nutrition orally or enterally. Key indications include:

  • Hyperosmolar Therapy: This solution's high dextrose concentration creates an osmotic gradient. It is employed to manage cerebral edema, reducing intracranial pressure by drawing water from brain tissue into the vascular space. This application is critical in neurocritical care settings.
  • Carbohydrate Source in Parenteral Nutrition (PN): For patients experiencing severe malabsorption, short bowel syndrome, or other conditions precluding adequate gastrointestinal nutrient absorption, dextrose is a vital calorie source in PN formulations. Dextrose 30% provides a concentrated caloric density, minimizing fluid volume required for adequate energy delivery.
  • Management of Hypoglycemia: In specific clinical scenarios where rapid and significant increases in blood glucose are required, dextrose 30% can be administered intravenously.
  • Diluent and Vehicle: It serves as a diluent for certain injectable medications, though this is a secondary use compared to its nutritional and osmotic functions.

The concentration of 30% dextrose makes it hypertonic, necessitating careful administration and monitoring. Its role in critical care and long-term nutritional support solidifies its position as an essential medication.

WHAT ARE THE KEY MARKET DRIVERS?

The market for Dextrose 30% in Plastic Container is influenced by several interconnected factors:

  • Rising Incidence of Malnutrition and Cachexia: Chronic diseases, including cancer, HIV/AIDS, and severe gastrointestinal conditions, contribute to malnutrition and cachexia. These patient populations often require nutritional support, with PN being a critical intervention. The World Health Organization estimates that malnutrition affects approximately 15-30% of hospitalized patients globally [1].
  • Growth in Gastrointestinal Disorders: Conditions such as inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, and short bowel syndrome necessitate bowel rest or resection, leading to impaired nutrient absorption. This increases the demand for parenteral nutrition. The global IBD market was valued at approximately USD 23.3 billion in 2022 and is projected to grow [2].
  • Expanding Home Parenteral Nutrition (HPN) Market: Advances in PN formulations, administration techniques, and patient education have facilitated the growth of HPN. Patients can receive specialized nutrition at home, reducing hospital stays and improving quality of life. This trend directly translates to increased demand for ready-to-use or compounding components like dextrose solutions. The HPN market is expected to grow at a CAGR of over 6% from 2023 to 2030 [3].
  • Aging Global Population: Older adults are more susceptible to malnutrition and chronic diseases requiring nutritional support. The demographic shift towards an older population worldwide is a significant underlying driver for nutritional therapies. By 2050, the number of people aged 65 and over is projected to double, reaching 1.6 billion [4].
  • Technological Advancements in IV Fluid Delivery Systems: Improvements in plastic container materials, sterile manufacturing processes, and intravenous infusion technologies enhance product safety and ease of use, supporting market expansion.
  • Increased Awareness of Clinical Nutrition: Healthcare professionals and patients are more aware of the benefits of early and appropriate nutritional intervention in managing disease progression and improving patient outcomes.

WHAT IS THE COMPETITIVE LANDSCAPE AND KEY PLAYERS?

The market for dextrose solutions is characterized by a mix of large pharmaceutical manufacturers and specialized medical supply companies. Competition is driven by product quality, price, supply chain reliability, and regulatory compliance.

Key players include:

  • Baxter International Inc.: A major provider of intravenous solutions and parenteral nutrition products.
  • Fresenius Kabi AG: Offers a broad portfolio of IV drugs, infusion technologies, and clinical nutrition products.
  • B. Braun Melsungen AG: A significant supplier of infusion therapy products, including dextrose solutions.
  • ICU Medical, Inc.: Provides a range of infusion therapy products, including large volume parenteral solutions.
  • Curexsys GmbH: Focuses on infusion solutions and drug delivery systems.
  • Pfizer Inc.: While broadly diversified, Pfizer's hospital products division includes intravenous solutions.
  • Hospira (a Pfizer company): Historically a significant player in IV solutions.

These companies compete on factors such as:

  • Manufacturing Capacity and Supply Chain Robustness: Ensuring consistent availability of critical products, especially during periods of high demand or supply disruptions.
  • Product Portfolio Breadth: Offering a comprehensive range of PN components and related products.
  • Regulatory Approvals and Compliance: Adhering to stringent FDA and EMA standards for drug manufacturing.
  • Pricing Strategies: Balancing cost-effectiveness with product quality.
  • Innovation in Delivery Systems: Developing user-friendly and safe administration devices.

The market is mature, with established players holding significant market share. However, new entrants or expansions by existing players can shift market dynamics.

HOW DO REGULATORY FACTORS INFLUENCE THE MARKET?

Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), exert considerable influence on the Dextrose 30% in Plastic Container market. Key regulatory considerations include:

  • Manufacturing Standards (cGMP): Facilities producing dextrose solutions must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, purity, and sterility. Regular inspections and audits by regulatory agencies verify compliance.
  • Product Approval and Labeling: All dextrose solutions must undergo a rigorous approval process. Labeling requirements specify concentration, indications, contraindications, warnings, and administration guidelines.
  • Quality Control and Testing: Manufacturers are required to implement robust quality control systems to test raw materials and finished products for potency, purity, and absence of contaminants.
  • Supply Chain Security and Traceability: Regulations increasingly focus on the security and traceability of drug supply chains to prevent counterfeiting and ensure product integrity.
  • Post-Market Surveillance: Manufacturers are responsible for monitoring and reporting adverse events and product quality issues after a product has been approved and is on the market.
  • Environmental Regulations: Manufacturing processes must also comply with environmental regulations concerning waste disposal and emissions.

Changes in regulatory requirements, such as stricter impurity limits or updated cGMP guidelines, can necessitate significant investment in manufacturing infrastructure and processes, impacting profitability and market access.

WHAT ARE THE FINANCIAL PROJECTIONS AND REVENUE TRENDS?

The financial trajectory of Dextrose 30% in Plastic Container is tied to the broader intravenous fluid and parenteral nutrition market. While specific revenue figures for this single product are often aggregated, market research indicates sustained growth.

  • Market Size and Growth: The global intravenous solutions market, of which dextrose is a significant component, was valued at approximately USD 13.5 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 5-7% through 2030 [5]. The parenteral nutrition segment alone is expected to reach over USD 10 billion by 2028 [6].
  • Revenue Drivers: Revenue is primarily generated through sales to hospitals, long-term care facilities, and distributors serving the home healthcare market. Pricing is influenced by manufacturing costs, competition, and reimbursement policies.
  • Profitability Factors: Profitability is dependent on efficient manufacturing, economies of scale, and effective supply chain management. Raw material costs (dextrose, water for injection, packaging materials) and energy prices are key variable cost components.
  • Geographic Market Variations: Developed markets in North America and Europe represent the largest share due to advanced healthcare infrastructure and higher adoption rates of PN. Emerging markets in Asia-Pacific are expected to show higher growth rates driven by improving healthcare access and increasing disease prevalence.

Projected Revenue Growth Factors:

  • Increasing Hospital Admissions for Chronic Conditions: Higher patient volumes requiring nutritional support.
  • Expansion of Parenteral Nutrition Services: Growth in both inpatient and outpatient PN programs.
  • Favorable Reimbursement Policies: Government and private payers often cover the costs of essential PN therapies.
  • Cost-Effectiveness of Generic Solutions: Dextrose 30% is a well-established, generic product, making it a cost-effective option for caloric delivery in PN.

The financial outlook remains positive, supported by fundamental healthcare needs and demographic trends.

WHAT ARE THE POTENTIAL CHALLENGES AND RISKS?

Despite a generally positive outlook, the market for Dextrose 30% in Plastic Container faces several challenges:

  • Supply Chain Disruptions: Geopolitical events, natural disasters, and manufacturing issues can disrupt the supply of raw materials and finished products, leading to shortages. The COVID-19 pandemic highlighted the vulnerability of global pharmaceutical supply chains.
  • Price Pressures and Reimbursement Cuts: Intense competition can lead to price erosion. Changes in healthcare reimbursement policies, particularly in government-funded programs, can negatively impact revenue and profitability.
  • Regulatory Hurdles: Evolving regulatory standards or recalls due to quality defects can result in significant financial penalties and reputational damage.
  • Development of Alternative Therapies: While dextrose remains a cornerstone, ongoing research into novel nutritional substrates or delivery methods could, in the long term, present alternatives.
  • Increased Manufacturing Costs: Fluctuations in the cost of raw materials, energy, and labor can impact production costs and profit margins.
  • Counterfeit Products: The risk of counterfeit or substandard products entering the market poses a threat to patient safety and brand integrity.

Addressing these challenges requires robust risk management strategies, resilient supply chains, and a commitment to quality and compliance.

WHAT ARE THE FUTURE TRENDS AND INNOVATIONS?

The future of Dextrose 30% in Plastic Container is shaped by evolving healthcare practices and technological advancements:

  • Advancements in Container Technology: Innovations in plastic materials for IV containers focus on improved stability, reduced leachables, enhanced barrier properties, and greater sustainability.
  • Smart Packaging and Tracking: Integration of RFID tags or QR codes for enhanced inventory management, tracking, and authentication to combat counterfeiting and improve supply chain visibility.
  • Personalized Nutrition Formulations: While Dextrose 30% is a standard component, the trend towards more personalized PN formulations requires flexible manufacturing and diverse product offerings.
  • Focus on Sustainability: Manufacturers are increasingly exploring eco-friendly packaging materials and optimizing production processes to reduce environmental impact.
  • Increased Demand in Emerging Markets: As healthcare infrastructure improves in developing economies, the demand for essential IV solutions like dextrose is expected to rise significantly.
  • Minimally Processed and Ready-to-Use Solutions: A push towards ready-to-use PN formulations reduces compounding errors and streamlines clinical workflow, potentially increasing demand for pre-mixed components or fully assembled solutions.

These trends indicate a continued demand for dextrose solutions, with a focus on efficiency, safety, and sustainability.

KEY TAKEAWAYS

  • Dextrose 30% in Plastic Container is a critical therapy for malnutrition, gastrointestinal disorders, and cerebral edema, with demand driven by chronic disease prevalence and an aging population.
  • The market is dominated by established pharmaceutical and medical supply companies, competing on quality, price, and supply chain reliability.
  • Stringent regulatory standards, including cGMP, significantly influence manufacturing and market access.
  • Financial projections indicate sustained growth, fueled by the expanding parenteral nutrition market and increasing healthcare access globally.
  • Key risks include supply chain vulnerabilities, price pressures, and regulatory non-compliance.
  • Future trends emphasize container technology, sustainability, and enhanced supply chain management.

FAQS

  1. What is the primary difference between Dextrose 30% and other dextrose concentrations (e.g., Dextrose 5%)? Dextrose 30% is a hypertonic solution with a significantly higher concentration of glucose compared to Dextrose 5%. This higher concentration makes it suitable for osmotic therapy to reduce intracranial pressure and for providing concentrated caloric energy in parenteral nutrition with minimal fluid volume. Dextrose 5% is isotonic and primarily used for hydration and as a vehicle for other medications.

  2. Are there any significant side effects associated with Dextrose 30% infusion? Yes, due to its hypertonic nature, rapid infusion of Dextrose 30% can cause local vein irritation, phlebitis, and potentially hyperosmolar non-ketotic hyperglycemia. Close monitoring of blood glucose levels, electrolyte balance, and fluid status is crucial during administration. It is contraindicated in patients with hyperglycemia or diabetic coma.

  3. How does the plastic container material affect the product's shelf life and safety? Plastic containers, typically made from materials like polyvinyl chloride (PVC) or polypropylene, are designed to be flexible, shatter-resistant, and lightweight. The material's compatibility with dextrose solution is critical to prevent leaching of plasticizers or other contaminants into the product. Modern containers are manufactured to high standards to ensure product stability and safety throughout its shelf life, which is typically 12-24 months depending on storage conditions and specific product formulation.

  4. What is the typical reimbursement status for Dextrose 30% in Plastic Container in the United States? Dextrose 30% in Plastic Container, when prescribed for medically necessary indications such as parenteral nutrition or cerebral edema management, is generally covered by Medicare, Medicaid, and most private health insurance plans. Reimbursement typically falls under inpatient hospital services or durable medical equipment and supplies for home use, depending on the care setting and the specific insurance policy.

  5. Can Dextrose 30% be mixed with other medications or nutrients in the same IV bag? Yes, Dextrose 30% is a common component in compounded parenteral nutrition admixtures. It is mixed with amino acids, lipids, electrolytes, vitamins, and trace elements under sterile conditions in a pharmacy setting. However, compatibility studies must be performed for each specific admixture, as certain medications or nutrients may be incompatible with high concentrations of dextrose or other components in the mixture.

CITATIONS

[1] World Health Organization. (n.d.). Malnutrition. Retrieved from https://www.who.int/news-room/fact-sheets/detail/malnutrition

[2] Grand View Research. (2023). Inflammatory Bowel Disease (IBD) Market Size, Share & Trends Analysis Report.

[3] Market Research Future. (2023). Home Parenteral Nutrition Market Research Report.

[4] United Nations Department of Economic and Social Affairs, Population Division. (2019). World Population Ageing 2019.

[5] Fortune Business Insights. (2023). Intravenous Solutions Market Size, Share & COVID-19 Impact Analysis.

[6] Mordor Intelligence. (2023). Parenteral Nutrition Market - Growth, Trends, COVID-19 Impact, and Forecasts.

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