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Last Updated: December 23, 2024

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.22% In Plastic Container patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.22% In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.22% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 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.

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Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% 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 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-002 Approved Prior to Jan 1, 1982 DISCN 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 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.22% in Plastic Containers

Introduction

The intravenous solution comprising Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.22% is a critical component in medical care, particularly for patients requiring electrolyte and calorie replenishment. This article delves into the market dynamics and financial trajectory of this specific formulation.

Market Demand and Usage

Clinical Indications

This solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories, and water for hydration. It is particularly useful in scenarios where patients require parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride[1][3].

Patient Segments

The demand for this solution is driven by various patient segments, including those with severe potassium deficiency, patients undergoing surgery, and those in intensive care units. The versatility of the solution in addressing multiple clinical needs contributes to its consistent demand.

Market Size and Growth

Current Market Size

The market for intravenous solutions, including those with Dextrose, Sodium Chloride, and Potassium Chloride, is substantial and growing. The increasing need for hydration and electrolyte balance in hospital settings, coupled with the rising number of surgical procedures, drives the demand for these solutions.

Growth Projections

The market is expected to grow due to several factors, including an aging population, an increase in chronic diseases, and advancements in healthcare infrastructure. The global intravenous solutions market is projected to see significant growth over the next few years, driven by these demographic and healthcare trends.

Competitive Landscape

Key Players

The market for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.22% solutions is dominated by several major pharmaceutical and medical supply companies, such as Baxter Corporation and other manufacturers. These companies compete based on factors such as product quality, pricing, and distribution networks[2][5].

Product Differentiation

While the core formulation remains consistent, companies differentiate their products through variations in concentration, container size, and material (e.g., PVC/DEHP flexible containers). This differentiation helps in targeting specific market segments and clinical needs.

Financial Trajectory

Revenue Streams

The revenue for these solutions comes primarily from hospital purchases and healthcare institutions. The pricing is influenced by factors such as production costs, regulatory approvals, and market competition.

Cost Structure

The cost structure includes raw material costs, manufacturing expenses, regulatory compliance costs, and distribution fees. Companies often face challenges in managing these costs, especially during periods of raw material shortages or supply chain disruptions[4].

Profit Margins

Profit margins in this industry can be moderate to high, depending on the efficiency of the manufacturing process and the company's ability to negotiate favorable prices with suppliers and distributors. However, the margins can be squeezed during times of high competition or regulatory pressures.

Supply Chain Dynamics

Production and Distribution

The production of these solutions involves strict adherence to aseptic techniques and regulatory standards. Distribution is typically managed through a network of wholesalers and direct shipments to hospitals and healthcare facilities. Supply chain disruptions, such as those seen during the COVID-19 pandemic, can significantly impact the availability and pricing of these solutions[4].

Storage and Shelf Life

These solutions have specific storage requirements, such as protection from excessive heat and freezing, and they typically have a shelf life of 18 to 24 months. Proper storage and handling are crucial to maintaining the product's efficacy and safety[1][2].

Regulatory Environment

FDA and Health Canada Regulations

The production and distribution of these solutions are heavily regulated by bodies such as the FDA in the United States and Health Canada. Compliance with these regulations is essential for maintaining market approval and avoiding recalls or other regulatory actions[3][5].

Market Challenges

Raw Material Shortages

Shortages of key raw materials, such as dextrose or potassium chloride, can impact production and lead to supply chain disruptions. This can result in increased costs and reduced availability of the solution.

Competitive Pressures

The market is competitive, with multiple manufacturers offering similar products. This competition can drive down prices and reduce profit margins for companies.

Market Opportunities

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure in developing countries presents a significant opportunity for growth. Increasing access to healthcare services in these regions can drive up demand for intravenous solutions.

Technological Advancements

Advancements in manufacturing technology and packaging materials can improve product quality, reduce costs, and enhance patient safety. Companies that invest in these technologies can gain a competitive edge.

Key Takeaways

  • Consistent Demand: The solution is essential for various clinical needs, ensuring consistent demand.
  • Growth Potential: The market is expected to grow driven by demographic and healthcare trends.
  • Competitive Landscape: Key players compete on product quality, pricing, and distribution.
  • Regulatory Compliance: Strict adherence to regulatory standards is crucial.
  • Supply Chain Management: Proper storage and handling are vital to maintaining product efficacy.

FAQs

What are the clinical indications for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.22% solutions?

These solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories, and water for hydration, particularly in scenarios requiring parenteral administration of potassium chloride.

How are these solutions administered?

These solutions should be administered only by intravenous infusion and as directed by a physician. The dose and rate of injection depend on the patient's age, weight, and clinical condition[1].

What are the storage requirements for these solutions?

These solutions should be stored at 20 to 25°C (68 to 77°F), protected from freezing, and avoided from excessive heat[1][2].

Who are the key players in the market for these solutions?

Key players include companies like Baxter Corporation and other major pharmaceutical and medical supply companies.

What are the potential growth drivers for this market?

The market is expected to grow due to an aging population, an increase in chronic diseases, and advancements in healthcare infrastructure.

Sources

  1. Drugs.com: Potassium Chloride in Dextrose and Sodium Chloride.
  2. ICU Medical: Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride.
  3. DailyMed: Potassium Chloride in Dextrose and Sodium Chloride Injections USP.
  4. U.S. Hospital Product Availability Report: Baxter.
  5. Health Products and Food Branch Inspectorate: (40MMOL/L) Potassium Chloride in 3.3% Dextrose and 0.3% Sodium Chloride Injection USP.

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