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Last Updated: December 23, 2024

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 20meq (k), and when can generic versions of Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 20meq (k) launch?

Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 20meq (k) is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) 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 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)

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 20MEQ (K) dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-001 Approved Prior to Jan 1, 1982 AP 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 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20mEq (K) Injection

Introduction

The intravenous solution composed of Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20mEq (K) is a critical component in medical care, serving as a source of electrolytes, calories, and hydration. This article delves into the market dynamics and financial trajectory of this specific formulation.

Market Overview

The market for intravenous solutions is driven by the increasing demand for hydration and electrolyte balance in both acute and chronic care settings. The global IV solutions market is expected to grow significantly due to factors such as an aging population, rising incidence of chronic diseases, and advancements in healthcare infrastructure[5].

Product Indications and Uses

This formulation is indicated for use in adults and pediatric patients as a source of electrolytes, calories, and water for hydration. It is particularly useful in treating or preventing fluid and electrolyte imbalances, which can occur due to various medical conditions or surgical procedures[4].

Composition and Variations

The solution typically contains 5% Dextrose, 0.2% Sodium Chloride, and 20mEq/L Potassium Chloride. Variations in concentration, such as different levels of Potassium Chloride (e.g., 10mEq/L, 30mEq/L, 40mEq/L) and Sodium Chloride (e.g., 0.45%, 0.9%), are available to cater to different clinical needs[2][4].

Manufacturers and Market Players

Several pharmaceutical companies, including B. Braun Medical Inc., Baxter Corporation, and ICU Medical, manufacture and distribute these IV solutions. These companies play a significant role in the market by ensuring a steady supply of high-quality products and innovating packaging and delivery systems[1][3][5].

Pricing and Cost Dynamics

The pricing of these IV solutions can vary based on factors such as the concentration of the components, container size, and the manufacturer. For instance, a 500 mL or 1000 mL flexible container of Potassium Chloride in Dextrose and Sodium Chloride Injection can have different price points depending on the specific formulation and the region it is sold in. Recent reports indicate that price increases have been observed in some formulations due to updates in test methods related to expiration dating[1].

Regulatory Environment

The production and distribution of these IV solutions are heavily regulated by health authorities such as the FDA and Health Canada. Manufacturers must comply with strict guidelines regarding the composition, labeling, and safety of these products. Adverse reactions and contraindications are closely monitored and reported to ensure patient safety[2][3].

Supply Chain and Distribution

The supply chain for IV solutions involves a complex network of manufacturers, distributors, and healthcare providers. Ensuring a stable supply is crucial, especially during times of high demand or supply chain disruptions. Companies often maintain large inventories and have contingency plans to mitigate any potential shortages[5].

Financial Performance

The financial performance of companies manufacturing these IV solutions is influenced by several factors, including market demand, competition, and regulatory compliance costs. The market is generally stable, with steady revenue streams due to the essential nature of these products in healthcare settings. However, fluctuations in raw material costs and changes in regulatory requirements can impact profitability.

Revenue Trends

The revenue generated from the sale of these IV solutions has been steadily increasing due to the growing demand for hydration and electrolyte balance therapies. Companies like B. Braun Medical Inc. and Baxter Corporation report significant revenues from their IV solution product lines.

Profit Margins

Profit margins can vary based on the specific formulation, production costs, and market competition. Companies that innovate in packaging, reduce production costs, and maintain high-quality standards tend to have better profit margins.

Market Challenges and Opportunities

Challenges

  • Supply Chain Disruptions: Recent global events have highlighted the vulnerability of supply chains, which can impact the availability of these critical products.
  • Regulatory Changes: Changes in regulatory requirements can increase compliance costs and affect production timelines.
  • Competition: The market is competitive, with multiple manufacturers offering similar products, which can drive down prices and reduce profit margins.

Opportunities

  • Innovation in Packaging: Developing more convenient and safe packaging solutions can enhance market share.
  • Emerging Markets: Expanding into emerging markets where healthcare infrastructure is improving can provide new revenue streams.
  • Customized Formulations: Offering customized formulations to meet specific clinical needs can differentiate a company from its competitors.

Key Takeaways

  • The market for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20mEq (K) Injection is driven by increasing healthcare demands.
  • Manufacturers must comply with strict regulatory guidelines to ensure product safety.
  • The financial performance of companies in this sector is influenced by market demand, competition, and regulatory compliance costs.
  • Innovations in packaging and customized formulations present opportunities for growth.

FAQs

What are the primary indications for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20mEq (K) Injection?

This formulation is used as a source of electrolytes, calories, and hydration in both adults and pediatric patients, particularly for treating or preventing fluid and electrolyte imbalances.

Which companies are major manufacturers of this IV solution?

B. Braun Medical Inc., Baxter Corporation, and ICU Medical are among the major manufacturers of this IV solution.

What are the common variations in the concentration of this IV solution?

Variations include different levels of Potassium Chloride (e.g., 10mEq/L, 30mEq/L, 40mEq/L) and Sodium Chloride (e.g., 0.45%, 0.9%).

How does the regulatory environment impact the production of these IV solutions?

The production is heavily regulated by health authorities such as the FDA and Health Canada, with strict guidelines on composition, labeling, and safety.

What are the key challenges facing the market for these IV solutions?

Supply chain disruptions, regulatory changes, and market competition are significant challenges.

Sources

  1. New York State Department of Financial Services. Drug Price Increases Report - October 2024.
  2. FDA. POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTION USP.
  3. Health Canada. BAXTER CORPORATION - Drug and Health Products Portal.
  4. DailyMed. Potassium Chloride in Dextrose and Sodium Chloride Injections USP.
  5. ICU Medical. Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP.

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