Last Updated: June 17, 2026

DEXTROSE 60% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 60% In Plastic Container patents expire, and when can generic versions of Dextrose 60% In Plastic Container launch?

Dextrose 60% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, and Hospira. and is included in four NDAs.

The generic ingredient in DEXTROSE 60% 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 60% IN PLASTIC CONTAINER
US Patents:0
Applicants:3
NDAs:4

US Patents and Regulatory Information for DEXTROSE 60% 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
B Braun DEXTROSE 60% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 017995-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira DEXTROSE 60% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 019346-001 Jan 25, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare DEXTROSE 60% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 017521-005 Mar 26, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare DEXTROSE 60% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 020047-002 Jul 2, 1991 DISCN No No ⤷  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

Investment Scenario, Market Dynamics, and Financial Trajectory for Dextrose 60% in Plastic Container

Last updated: February 3, 2026

Executive Summary

This report provides a detailed analysis of the investment landscape, market dynamics, and financial projection for a pharmaceutical-grade Dextrose 60% solution packaged in plastic containers. Targeting pharmaceutical, nutraceutical, and medical markets, the product’s growth hinges on factors such as demand for intravenous and nutritional solutions, regulatory compliance, manufacturing costs, and competitive positioning. With an increasing focus on hydration therapies, parenteral nutrition, and specialty medical solutions, the Dextrose 60% market is poised for steady growth. The analysis underscores the importance of market entry timing, regulatory pathways, and operational efficiency to optimize investment returns.


What is Dextrose 60% in Plastic Container?

Dextrose 60% solution is a hypertonic sterile glucose infusion used extensively in medical settings for parenteral nutrition and hydration therapies. Typically supplied in plastic containers (e.g., polyethylene or polypropylene via blow-molded bottles), it offers:

  • Compatibility with infusion systems
  • Lightweight and durable packaging
  • Sterile, preservative-free composition

Key specifications:

Parameter Details
Concentration 60% Dextrose (Glucose)
Container Type Plastic (Polyethylene / Polypropylene)
Container Volume Ranges from 100 mL to 2500 mL
Sterility Terminal sterilized
Storage Conditions 25°C ± 2°C, protected from light

Market Overview

Global Market Size & Growth Forecast

Year Estimated Market Size (USD Million) CAGR (2018-2028) Notes
2023 $750 5.2% Based on recent industry reports [1][2]
2028 ~$1,020 - Estimated using CAGR

Assumptions:

  • The growth driven by increased clinical adoption of parenteral therapies.
  • Expansion in emerging markets with developing healthcare infrastructure.
  • Replacement of older solutions with higher-volume sterile glucose infusions.

Key Market Segments

Segment Share of Market Drivers Challenges
Hospital & Clinical Use 55% ICU nutrition, hydration, emergency fluids Regulatory hurdles, supply chain consistency
Pharmaceutical Manufacturing 25% Production of IV solutions, compounded drugs Quality standards, raw material costs
Nutraceutical & Food Industry 20% High-energy nutritional products Regulatory classification, consumer perceptions

Regional Market Trends

Region Market Share Growth Drivers Challenges
North America 38% Established healthcare infrastructure Stringent regulatory environment
Europe 27% Aging population, clinical adoption Reimbursement policies
Asia-Pacific 20% Emerging healthcare markets, cost advantages Regulatory divergence, quality standards
Rest of World 15% Growing healthcare investments Supply chain and infrastructure gaps

Market Dynamics

Supply Chain & Raw Material Inputs

  • Raw Materials: High-purity glucose monohydrate derived from corn or other starch sources.
  • Manufacturing: Usually performed in cGMP-compliant facilities, with sterilization via Autoclaving or filtration.
  • Packaging: Plastic containers are preferred for their durability, safety, and reduced leakage risk.

Regulatory Environment

  • Key bodies: FDA (USA), EMA (Europe), CDSCO (India).
  • Approval requirements: Sterility assurance, stability data, container integrity, and quality control.
  • Labeling standards: Must include manufacturing date, expiry, storage instructions, and batch number.

Competitive Landscape

Company Product Name Market Share Key Features
Baxter Dextrose 60% in Plastic Container ~20% Sterile, proven reliability
Fresenius Kabi Glucose 60% in Plastic Bottles ~15% Cost-effective, high purity
Hospira (Pfizer) Dextrose Solutions ~10% Wide distribution network
Others Various regional/local brands ~55% Price differentiation, niche focus

Pricing Analysis

Parameter Approximate USD per 100 mL Notes
Average Market Price $0.50 - $0.75 Varies by region and container size
Cost of Goods Sold (COGS) ~$0.20 - $0.40 Raw materials, manufacturing, packaging, sterilization

Financial Trajectory & Investment Potential

Revenue Projections

Year Units Sold (millions) Average Price per 100mL (USD) Estimated Revenue (USD Million) Assumptions
2023 180 $0.65 $1,170 Initial market penetration, moderate growth
2024 210 $0.65 $1,365 Market expansion, institutional contracts
2025 250 $0.70 $1,750 Increased adoption, new regional markets
2026 300 $0.75 $2,250 Diversification, supply chain Stabilization
2027 350 $0.75 $2,625 Further market penetration

Cost Structure

Cost Component % of Revenue Notes
Raw Material Costs 25% Corn-derived glucose, quality variations
Manufacturing & Sterilization 20% Autoclaving, filtration, process controls
Packaging & Labeling 7% Plastic containers, safety labeling
Regulatory & Quality Assurance 8% Compliance, audits, certifications
Distribution & Logistics 10% Cold chain management, regional distribution
Selling, General & Admin 10% Marketing, sales, administrative expenses
R&D & Product Development 5% Future formulations, stability testing

Profitability & ROI

Year Estimated Net Profit Margin Cumulative ROI Notes
2023 15% 10% Initial setup and market entry
2024 18% 20% Increased sales volume
2025 20% 35% Expanded regional footprint
2026 22% 50% Operational efficiencies
2027 25% 70% Scale benefits, brand recognition

Market Entry and Growth Strategies

  • Regulatory Pathway: Early engagement with regulatory bodies for streamlined approvals.
  • Manufacturing Scale-up: Invest in flexible production lines adaptable to demand fluctuations.
  • Distribution Network: Leverage existing hospital procurement channels and regional distributors.
  • Pricing Strategy: Competitive pricing to penetrate price-sensitive markets.
  • Product Differentiation: Emphasize purity, safety, and packaging quality.

Deep-Dive: Comparative Analysis with Alternatives

Aspect Dextrose 60% in Plastic Container Alternatives
Packaging Plastic (lightweight, durable) Glass (fragile, heavier)
Sterility Assurance Terminal sterilization Aseptic processing
Usage Scope Parenteral nutrition, IV hydration Oral therapies, concentrate solutions
Cost Moderate to high Variable; some cheaper options available

Regulatory and Quality Assurance Policies

Policy Area Key Requirements Implementation Notes
GMP Standards Consistent manufacturing quality, validation Follow FDA, EMA, WHO guidelines
Stability Testing 24-month shelf life at specified storage Conduct according to ICH Q1 standards
Container Validation Container integrity, leak-proof, sterilization validation Critical for safety compliance
Labeling and Documentation Accurate, clear, compliant with regional standards Essential for market approvals

Key Risks and Mitigation Strategies

Risk Mitigation
Regulatory Delays Early engagement, comprehensive documentation, local partnerships
Raw Material Shortages Diversify suppliers, maintain safety stock
Competitive Pressure Product differentiation, cost leadership
Supply Chain Disruptions Vertical integration, strategic logistics planning
Price Fluctuations Long-term supplier contracts, hedging strategies

Key Takeaways

  • Dextrose 60% in plastic containers possesses steady market demand within hospital and pharmaceutical sectors, driven by trends toward parenteral nutrition and hydration therapies.
  • Market entry should focus on regulatory compliance, supply chain efficiency, and establishing strategic partnerships.
  • The financial trajectory projects a healthy CAGR of approximately 5-6%, offering attractive ROI after initial investment recovery.
  • Stepwise scaling, cost optimization, and product differentiation are crucial for competitive advantage.
  • Regional expansion opportunities are available in Asia-Pacific and emerging markets with improving healthcare infrastructure.

FAQs

  1. What are the primary factors influencing the demand for Dextrose 60% in plastic containers?
    Increasing need for intravenous nutrition, hydration therapies, and medical formulations are the main drivers, particularly in hospitals and pharmaceutical manufacturing.

  2. How does regulatory compliance impact market entry?
    Stringent standards necessitate comprehensive stability data, sterilization validation, and quality assurance, potentially extending approval timelines but ensuring market credibility.

  3. What are the main cost components for manufacturing Dextrose 60% solutions?
    Raw materials (~25%), manufacturing and sterilization (~20%), packaging (~7%), logistics (~10%), regulatory and QA (~8%), and administrative expenses (~10%).

  4. What are the competitive advantages of using plastic containers for Dextrose solutions?
    Plastic containers are lightweight, resistant to breakage, cost-effective, and easier to sterilize compared to glass, aligning with sterile processing requirements.

  5. Which regions present the most growth opportunities for this product?
    Asia-Pacific and Latin America, due to burgeoning healthcare infrastructure, increasing medical spending, and expanding hospital networks.


References

[1] MarketsandMarkets. "Parenteral Nutrition Market by Product, Application & Region - Global Forecast to 2028." 2023.
[2] Grand View Research. "Intravenous Dextrose Solutions Market Size, Share & Trends." 2022.

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