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Last Updated: December 22, 2024

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 15meq (k), and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 15meq (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 15MEQ (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 15MEQ (K)
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (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 15MEQ (K) dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-004 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 15MEQ (K) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15mEq (K) Injection

Introduction

The intravenous solution composed of Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15mEq (K) is a critical component in medical care, serving as a source of electrolytes, calories, and hydration for patients. This article delves into the market dynamics and financial trajectory of this specific formulation.

Market Overview

The market for intravenous solutions, including those containing dextrose, sodium chloride, and potassium chloride, is driven by several key factors:

Demand for Hydration and Electrolyte Solutions

The demand for IV solutions is consistently high due to their essential role in patient care, particularly in hospitals and clinical settings. These solutions are vital for maintaining hydration, electrolyte balance, and providing necessary nutrients[4].

Regulatory Environment

Regulatory bodies such as the FDA and Health Canada play a crucial role in approving and monitoring the production of these solutions. Compliance with regulatory standards is essential for manufacturers to ensure the safety and efficacy of their products[2][3].

Product Specifications

Concentration and Composition

The solution typically contains 5% dextrose, 0.2% sodium chloride, and 15mEq of potassium chloride per liter. This composition is designed to provide balanced hydration and electrolyte replenishment[4].

Container and Shelf Life

These solutions are often packaged in flexible PVC/DEHP containers with a shelf life of up to 18 months, depending on the manufacturer and storage conditions[5].

Market Segmentation

End-Users

The primary end-users of these IV solutions are hospitals, clinics, and other healthcare facilities. The demand can be segmented based on the type of care provided, such as intensive care units (ICUs), surgical departments, and general patient care.

Geographical Distribution

The market is global, with significant demand in regions with well-developed healthcare systems as well as in areas where access to healthcare is limited but growing.

Competitive Landscape

Key Players

Companies like B. Braun Medical Inc., Baxter Corporation, and ICU Medical are major players in the IV solution market. These companies compete based on product quality, pricing, and distribution networks[1][3][5].

Product Differentiation

Manufacturers differentiate their products through variations in concentration, packaging, and additional ingredients. For instance, some solutions may include additional electrolytes or nutrients tailored to specific patient needs.

Financial Trajectory

Revenue Trends

The revenue for IV solutions, including those with the specified composition, has been steadily increasing due to the consistent demand from healthcare facilities. The global market for IV solutions is projected to continue growing, driven by advancements in healthcare and an increasing patient population.

Price Dynamics

Prices for these solutions can fluctuate based on several factors, including raw material costs, manufacturing processes, and regulatory changes. Recent data shows that price increases have been observed in some formulations due to updates in test methods related to expiration dating[1].

Cost Structure

The cost structure for these solutions includes raw material costs, manufacturing expenses, regulatory compliance costs, and distribution fees. Manufacturers often face pressure to balance profitability with the need to maintain competitive pricing.

Challenges and Opportunities

Supply Chain Disruptions

Supply chain disruptions, such as those caused by global health crises or raw material shortages, can impact the availability and pricing of IV solutions. Manufacturers must navigate these challenges to ensure consistent supply.

Innovation and R&D

Investments in research and development can lead to new formulations and improved manufacturing processes, offering opportunities for market differentiation and growth.

Adverse Reactions and Safety Considerations

Hypersensitivity Reactions

The use of Potassium Chloride in Dextrose and Sodium Chloride solutions can lead to hypersensitivity reactions, including anaphylaxis, which must be carefully monitored and managed by healthcare professionals[2].

Metabolic Complications

Patients, especially those who are severely undernourished, may experience metabolic complications such as hyperkalemia or fluid retention. Slowly increasing nutrient intake and monitoring patient conditions are crucial to prevent these complications[2].

Market Forecast

The market for IV solutions, including the specified formulation, is expected to grow steadily. Factors such as an aging population, increasing healthcare expenditure, and advancements in medical technology will drive this growth.

Key Takeaways

  • Consistent Demand: The demand for IV solutions is consistent and driven by essential medical needs.
  • Regulatory Compliance: Manufacturers must adhere to strict regulatory standards.
  • Competitive Landscape: The market is competitive with key players differentiating through product quality and distribution.
  • Financial Growth: The market is expected to grow, driven by healthcare advancements and increasing patient populations.
  • Safety Considerations: Healthcare professionals must be aware of potential adverse reactions and take necessary precautions.

FAQs

Q: What are the primary components of the Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15mEq (K) injection?

A: The primary components are 5% dextrose, 0.2% sodium chloride, and 15mEq of potassium chloride per liter.

Q: Who are the major manufacturers of this IV solution?

A: Major manufacturers include B. Braun Medical Inc., Baxter Corporation, and ICU Medical.

Q: What are the potential adverse reactions associated with this solution?

A: Potential adverse reactions include hypersensitivity reactions such as anaphylaxis and metabolic complications like hyperkalemia.

Q: What is the typical shelf life of these IV solutions?

A: The typical shelf life is up to 18 months, depending on the manufacturer and storage conditions.

Q: How is the market for IV solutions expected to grow in the future?

A: The market is expected to grow steadily driven by an aging population, increasing healthcare expenditure, and advancements in medical technology.

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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