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Last Updated: December 22, 2024

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 10% And Sodium Chloride 0.33% In Plastic Container patents expire, and when can generic versions of Dextrose 10% And Sodium Chloride 0.33% In Plastic Container launch?

Dextrose 10% And Sodium Chloride 0.33% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER is dextrose; 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; sodium chloride profile page.

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Summary for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% 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 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-013 Feb 24, 1988 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 10% and Sodium Chloride 0.33% in Plastic Containers

Introduction

Dextrose and Sodium Chloride injections are widely used in medical settings for fluid and electrolyte replenishment, as well as for providing caloric supply. The specific formulation of 10% Dextrose and 0.33% Sodium Chloride in plastic containers is a critical product in this category. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Overview

The market for intravenous solutions, including Dextrose and Sodium Chloride injections, is driven by the increasing demand for fluid and electrolyte replacement therapies. These solutions are essential in various clinical settings, including hospitals, clinics, and emergency services[3].

Product Specifications

  • Composition: The 10% Dextrose and 0.33% Sodium Chloride Injection, USP, is a sterile, nonpyrogenic solution containing 10 grams of dextrose and 0.33 grams of sodium chloride per 100 mL. It is available in flexible plastic containers of various volumes, such as 250 mL, 500 mL, and 1000 mL[5].
  • Osmolarity and pH: The solution has an osmolarity of approximately 365 mOsmol/L and a pH range of 3.5 to 6.5[5].

Market Demand

The demand for Dextrose and Sodium Chloride injections is steady due to their broad clinical applications. These solutions are used in:

  • Fluid Resuscitation: To treat dehydration and fluid loss.
  • Electrolyte Replenishment: To maintain electrolyte balance.
  • Caloric Supply: To provide calories, especially in patients who are unable to take food orally[3].

Competitive Landscape

The market for intravenous solutions is competitive, with several major players such as Baxter International Inc., Hospira Inc. (a Pfizer company), and B. Braun Medical Inc. These companies offer a range of formulations, including the 10% Dextrose and 0.33% Sodium Chloride solution[1][5].

Pricing and Revenue

The pricing of Dextrose and Sodium Chloride injections can vary based on the volume of the solution, the concentration of the ingredients, and the region. Generally, these solutions are priced competitively, with the cost per unit influenced by production costs, regulatory approvals, and market demand.

  • Revenue Trends: The revenue from Dextrose and Sodium Chloride injections has been stable, driven by consistent demand. However, fluctuations can occur due to supply chain disruptions, changes in regulatory policies, or shifts in market demand.
  • Cost Factors: The cost of production includes raw materials, manufacturing processes, and regulatory compliance. The use of plastic containers, such as VIAFLEX, also impacts the overall cost due to material and manufacturing expenses[1].

Supply Chain and Availability

The supply chain for Dextrose and Sodium Chloride injections is critical to ensuring continuous availability. Recent reports indicate that supply availability can be affected by manufacturing delays and demand increases, which may lead to temporary shortages or allocations[2].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Dextrose and Sodium Chloride injections. Regulatory bodies such as the FDA monitor the safety, efficacy, and stability of these solutions. For instance, the FDA has extended expiration dates for certain lots based on stability data, which can impact inventory management and supply chain planning[4].

Financial Performance

The financial performance of companies producing Dextrose and Sodium Chloride injections is influenced by several factors:

  • Sales Volume: Consistent demand for these solutions contributes to stable sales volumes.
  • Market Share: Companies with a strong market presence and diverse product portfolios tend to perform better financially.
  • Operational Efficiency: Efficient manufacturing processes and effective supply chain management can reduce costs and improve profitability.

Future Outlook

The future outlook for the market of Dextrose 10% and Sodium Chloride 0.33% in plastic containers is positive, driven by:

  • Increasing Healthcare Needs: Growing healthcare needs, especially in emerging markets, will continue to drive demand.
  • Technological Advancements: Improvements in manufacturing and packaging technologies can enhance product safety and reduce costs.
  • Regulatory Support: Continued regulatory support and stability in the regulatory environment will help maintain market stability.

Risks and Challenges

Despite the positive outlook, there are several risks and challenges to consider:

  • Supply Chain Disruptions: Manufacturing delays or raw material shortages can impact supply.
  • Regulatory Changes: Changes in regulatory policies can affect production and distribution.
  • Market Competition: Increasing competition from new entrants or generic products can pressure pricing and market share.

Key Takeaways

  • Stable Demand: The demand for Dextrose and Sodium Chloride injections remains stable due to their essential role in clinical settings.
  • Competitive Market: The market is competitive with several major players, influencing pricing and revenue.
  • Regulatory Compliance: Adherence to regulatory standards is crucial for maintaining market presence.
  • Supply Chain Management: Effective supply chain management is vital to ensure continuous availability.
  • Future Growth: The market is expected to grow driven by increasing healthcare needs and technological advancements.

FAQs

Q: What are the primary uses of Dextrose 10% and Sodium Chloride 0.33% injections? A: These injections are used for fluid and electrolyte replenishment, as well as for providing caloric supply in clinical settings.

Q: Who are the major players in the market for Dextrose and Sodium Chloride injections? A: Major players include Baxter International Inc., Hospira Inc. (a Pfizer company), and B. Braun Medical Inc.

Q: What are the potential risks associated with the use of Dextrose and Sodium Chloride injections? A: Risks include hyperosmolality, hypoosmolality, electrolyte disturbances, and overhydration, depending on the patient's clinical condition and the rate of infusion[1].

Q: How does the regulatory environment impact the market for these injections? A: Regulatory bodies like the FDA monitor safety, efficacy, and stability, and their decisions can affect supply chain planning and inventory management[4].

Q: What is the outlook for the future market of Dextrose 10% and Sodium Chloride 0.33% injections? A: The outlook is positive, driven by increasing healthcare needs, technological advancements, and stable regulatory environments.

Sources

  1. Baxter Corporation. Dextrose and Sodium Chloride Injection, USP.
  2. Baxter. USHP Supply Availability Report - April 23rd, 2024.
  3. DailyMed. Dextrose and Sodium Chloride injection, solution.
  4. FDA. Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection and 10% LMD in 5% Dextrose Injection.
  5. FDA. Dextrose and Sodium Chloride Injections USP.

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