Last Updated: September 29, 2026

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container, and when can generic versions of Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container launch?

Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER is dextrose; sodium chloride. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

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  • What is the 5 year forecast for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
Summary for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% 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 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-002 Feb 24, 1988 RX 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 and Fundamentals Analysis for Dextrose 2.5% and Sodium Chloride 0.2% in Plastic Container

Last updated: March 26, 2026

What Is the Market Position of Dextrose 2.5% and Sodium Chloride 0.2%?

The solution, used as an intravenous fluid for hydration and electrolyte balance, remains essential in hospitals worldwide. Its manufacturing is primarily controlled by pharmaceutical companies with sterile production facilities compliant with Good Manufacturing Practice (GMP). The global IV fluids market is projected to reach USD 9.89 billion by 2027, growing at a compound annual growth rate (CAGR) of 6.5% from 2020 [1].

The product’s core market segments include hospitals, clinics, and outpatient care, with steady demand from emerging markets. The standard formulation compliance, ease of manufacturing, and shelf stability make it a steady revenue generator.

How Does the Product Fit into the Pharmaceutical Sector?

The product is classified as a sterile injectable solution. It is classified under hospital and clinical use, with generic status. Its key manufacturers are large pharmaceutical companies such as Baxter, Fresenius Kabi, and Hikma Pharmaceuticals, as well as smaller regional players.

The product’s regulatory environment involves approval by national agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities in emerging markets. Stringent GMP compliance and sterilization validation underpin operational risk mitigation.

What Are the Production and Supply Chain Dynamics?

Manufacturing involves sterile reservoir assembly, solution preparation in closed systems, sterilization (e.g., gamma irradiation or filtration), and aseptic filling. Raw materials include pharmaceutical-grade dextrose and sodium chloride, with supply chain vulnerabilities chiefly tied to raw material sourcing, sterilization capacity, and logistics.

The shelf life typically extends to 24-36 months. Cold chain logistics are not necessary, reducing distribution complexity.

Financial and Investment Considerations

Cost Structure

  • Raw materials: ~10-15% of production cost.
  • Manufacturing: 30-35%, including sterilization and filling.
  • Packaging: 10%.
  • Distribution and logistics: 15-20%.

Pricing and Margins

Average wholesale price per 100 mL unit ranges from USD 0.25 to USD 0.50, depending on regional market dynamics. Gross margins are estimated between 35-50% for producers, given competition and procurement volume.

Revenue and Volume Projections

Global units sold annually approximate 2-3 billion, with hospital demand steady and regional growth driven by healthcare infrastructure improvements.

Regulatory and Patent Risks

The product's status as a generic makes patent risk minimal; however, regulatory approval remains essential for market continuation. Any shifts towards formulation improvements or new delivery systems could introduce patent or proprietary advantages.

Investment Risks

  • Supply chain disruptions affecting raw material or sterility.
  • Price erosion due to increased generic competition.
  • Regulatory changes impacting labeling or approvals.
  • Potential for product reformulation to include additional electrolytes for improved clinical profile.

Competitive Landscape

Company Market Share Key Strengths Notable Initiatives
Baxter 40% Extensive global manufacturing network Expansion into new electrolyte formulations
Fresenius Kabi 25% Strong presence in Europe and Asia Investment in sterile manufacturing facilities
Hikma 10% Focus on emerging markets Cost-competitive supply chain strategies

Strategic Opportunities

  • Entering emerging markets with rising hospital infrastructure.
  • Developing low-cost manufacturing to capture price-sensitive segments.
  • Investing in sterilization process innovations to reduce costs.
  • Diversifying product offerings to include electrolyte-enhanced solutions.

Key Takeaways

  • The product has mature market dynamics, with steady demand driven by global healthcare needs.
  • Cost structure and supply chain robustness are critical for profitability.
  • Regulatory compliance and quality assurance are fundamental to maintaining market access.
  • Competition remains intense but focused on cost reduction and regional expansion.
  • Opportunities persist in emerging markets and through product differentiation.

FAQs

1. What is the typical shelf life of Dextrose 2.5% and Sodium Chloride 0.2% solutions?

Typically, 24 to 36 months, depending on storage conditions and packaging integrity.

2. Are there regulatory barriers to market entry?

Yes; approvals from national health agencies are necessary, especially for new manufacturing sites or formulations.

3. How sensitive is the market to price fluctuations?

Moderately; large-volume hospital procurement often drives pricing, and intense competition can lead to price erosion.

4. What are the primary raw materials?

Pharmaceutical-grade dextrose and sodium chloride, sourced globally with stable supply chains.

5. Are there opportunities to develop alternative formulations?

Yes; electrolyte-enhanced solutions, nutrient additives, or stability-optimized formulations could represent growth avenues.

References

[1] MarketsandMarkets. (2020). Intravenous (IV) fluids market. Retrieved from https://www.marketsandmarkets.com

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