You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 31, 2025

DEXTROSE 5% Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Dextrose 5% patents expire, and what generic alternatives are available?

Dextrose 5% is a drug marketed by Am Regent, Baxter Hlthcare, Fresenius Kabi Usa, Otsuka Icu Medcl, Hospira, B Braun, Miles, Abbott, DHL, Icu Medical Inc, and Intl Medication Sys. and is included in fifty-eight NDAs.

The generic ingredient in DEXTROSE 5% 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DEXTROSE 5%?
  • What are the global sales for DEXTROSE 5%?
  • What is Average Wholesale Price for DEXTROSE 5%?
Summary for DEXTROSE 5%
US Patents:0
Applicants:11
NDAs:58
Finished Product Suppliers / Packagers: 15
DailyMed Link:DEXTROSE 5% at DailyMed
Drug patent expirations by year for DEXTROSE 5%

US Patents and Regulatory Information for DEXTROSE 5%

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 30MEQ dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-005 Apr 13, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl DEXTROSE 50% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 018563-001 Mar 23, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate INJECTABLE;INJECTION 019634-003 Feb 24, 1988 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017607-001 Approved Prior to Jan 1, 1982 AP RX Yes 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%

Last updated: July 30, 2025

Introduction

Dextrose 5% (Dextrose in 0.9% Sodium Chloride or Water) remains a cornerstone in intravenous (IV) fluid therapy, primarily deployed for hydration, carbohydrate supplementation, and as a diluent for other medications. As a sterile, isotonic glucose solution, Dextrose 5% enjoys widespread utilization within hospitals, clinics, and outpatient care settings globally. Its commercial viability hinges on complex dynamics such as technological advances, regulatory pathways, market demand, and competitive landscape. This analysis explores the current market environment, key drivers, barriers, regulatory considerations, and projected financial trends impacting Dextrose 5% over the coming decade.

Market Overview and Size

The global IV fluids market, including Dextrose 5%, was valued at approximately USD 8 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 6-8% through 2030 [1]. The increasing prevalence of dehydration, electrolyte disturbances, and chronic diseases, plus expanding healthcare infrastructure in emerging economies, sustains robust demand. Dextrose 5% accounted for a significant proportion of this market, particularly in hospital settings for fluid resuscitation and nutritional support.

In terms of geographical distribution, North America dominates the market, driven by high healthcare expenditure and a well-developed pharmaceutical distribution network. However, Asia-Pacific offers rapidly growing opportunities, fueled by expanding healthcare access and increasing disease burden in countries such as China and India.

Market Dynamics

Drivers of Market Growth

1. Rising Prevalence of Dehydration and Chronic Conditions

Increased incidences of dehydration due to infectious diseases, heatwaves, and aging populations contribute directly to higher demand for IV glucose solutions. Patients receiving chemotherapy, undergoing surgery, or managing metabolic disorders benefit from Dextrose 5% as part of their treatment regimen [2].

2. Growing Adoption in Critical Care and Emergency Medicine

In intensive care units (ICUs), Dextrose 5% serves as a primary energy source and diluent for medication administration. As critical care practices expand, especially amid global health crises like COVID-19, utilization intensifies [3].

3. Advances in Hospital Infrastructure and Supply Chain

The expansion of healthcare infrastructure in emerging markets, coupled with higher procurement capacities, enhances accessibility and deployment of Dextrose 5%. Centralized supply chains streamline procurement, reducing costs and improving market penetration.

4. Increased Focus on Nutritional Support

The role of Dextrose 5% in total parenteral nutrition (TPN) regimes elevates its importance amid rising nutritional deficiency awareness. This intensifies the demand for sterile, ready-to-use IV solutions.

Barriers and Challenges

1. Regulatory and Reimbursement Complexities

Stringent manufacturing standards, quality control measures, and regional regulatory requirements (e.g., FDA, EMA, CDSCO) pose hurdles, potentially delaying time-to-market or increasing compliance costs. Additionally, reimbursement policies influence market penetration, especially in cost-sensitive regions.

2. Competition from Alternative Formulations

The introduction of higher-concentration dextrose solutions (e.g., Dextrose 10%, 50%) and specialized nutritional formulations offers alternatives, possibly cannibalizing demand for Dextrose 5%.

3. Price Sensitivity and Market Saturation

Hospitals often seek cost-effective procurement strategies, pressuring manufacturers to optimize production costs. Market saturation, especially in developed healthcare systems, limits growth prospects.

4. Supply Chain Disruptions

Global events such as pandemics, geopolitical tensions, and raw material shortages can disrupt supply chains, affecting availability and pricing stability.

Regulatory Landscape

Dextrose 5% is classified as a sterile, injectable medication requiring rigorous compliance with Good Manufacturing Practices (GMP). Innovation is limited due to its established status, but manufacturing practices must adapt to evolving standards, such as USP and pharmacopeial monographs. Regulatory bodies emphasize product quality, sterility, and stability, influencing R&D investment and manufacturing costs [4].

Approval pathways are generally straightforward, given its status as a generic, but manufacturers must ensure consistent quality to meet global standards, opening opportunities for premium formulations with enhanced safety profiles.

Financial Trajectory and Business Opportunities

Revenue Projections

Forecasting revenues for Dextrose 5% involves considering market growth rates, competitive dynamics, and regional demand. Assuming an annual growth rate of 6-8%, the market could approach USD 15-20 billion globally by 2030. The sterile IV fluids segment is mature, with incremental improvements driven by manufacturing efficiencies and geographic expansion.

Key prospects include market expansion into emerging economies, leveraging rising hospitals and outpatient clinics, and partnering with government health schemes to increase uptake.

Profitability Outlook

Margins are influenced by raw materials, manufacturing costs, regulatory compliance, and distribution. As established products, profit margins may hover around 10-15%, but innovation in formulations or packaging could elevate margins through differentiation.

Strategic investment in manufacturing automation and supply chain optimization could reduce costs and improve competitiveness.

Emerging Business Models

  • Contract Manufacturing & Licensing: Opportunities exist for outsourcing production to meet regional demand efficiently, especially as regional regulations evolve.

  • Private Label and Rebranded Products: Generic manufacturers can capitalize on brand differentiation via quality and safety assurances.

  • Value-Added Formulations: Combining Dextrose 5% with other electrolytes or nutrients to develop specialized formulations for targeted indications.

Risks and Uncertainties

Market volatility linked to regulatory changes, raw material price fluctuations, and geopolitical issues pose inherent risks. The commoditized nature of Dextrose 5% necessitates robust quality assurance and competitive pricing strategies.

Conclusion

Dextrose 5% remains a vital component within IV therapy, with a resilient market outlook driven by expanding healthcare needs worldwide. While growth may taper in mature markets, emerging economies and critical care demands provide fertile ground for expansion. Companies that invest in manufacturing efficiency, regulatory compliance, and strategic regional partnerships can capitalize on these opportunities, ensuring financial sustainability and growth.


Key Takeaways

  • The global market for Dextrose 5% is projected to grow at 6-8% annually, reaching USD 15-20 billion by 2030.
  • Rising clinical demand from dehydration management, critical care, and nutritional support underpins growth.
  • Regulatory compliance and quality standards are critical barriers; efficient supply chains and cost management are key to profitability.
  • Emerging markets represent significant upside due to expanding healthcare infrastructure.
  • Innovation through value-added formulations and strategic manufacturing partnerships can enhance margins and market share.

FAQs

  1. What factors most influence the pricing of Dextrose 5%?
    Pricing is primarily driven by raw material costs, manufacturing expenses, regulatory compliance costs, and regional market competition.

  2. How do regulatory changes impact the commercialization of Dextrose 5%?
    Regulatory updates may necessitate additional validation, quality assurance protocols, or manufacturing adjustments, potentially delaying product launches or increasing costs.

  3. What are the major regional markets for Dextrose 5%?
    North America and Europe are the largest markets, but Asia-Pacific, Latin America, and Africa are rapidly expanding due to healthcare infrastructure growth.

  4. Can biosimilars or novel formulations threaten traditional Dextrose 5% products?
    While biosimilars are less applicable, new formulations offering improved safety, stability, or convenience could challenge traditional options.

  5. What opportunities exist for differentiation within the Dextrose 5% market?
    Investing in sterile packaging, product stability, safety profiles, and developing adjunct formulations can offer competitive advantages.


References

[1] MarketsandMarkets. (2022). IV Fluids Market Size & Share.
[2] World Health Organization. (2020). Dehydration prevalence and management.
[3] Society of Critical Care Medicine. (2021). Trends in IV fluid utilization in critical care settings.
[4] U.S. Pharmacopeia. (2022). General Chapter on IV Solution Manufacturing Standards.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.