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Last Updated: December 22, 2024

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


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When do Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 5meq (k) patents expire, and what generic alternatives are available?

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

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (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 5MEQ (K) dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-003 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 5MEQ (K) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Potassium Chloride in 5% Dextrose and Sodium Chloride Injection

Introduction

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection is a critical intravenous solution used in clinical settings to provide essential electrolytes, calories, and hydration. Understanding the market dynamics and financial trajectory of this drug is vital for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for intravenous solutions, including Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, is driven by several key factors:

Clinical Demand

The demand for this solution is high due to its use in treating electrolyte imbalances, providing hydration, and supplying calories to patients who cannot receive these nutrients orally[1][3][4].

Regulatory Environment

The FDA strictly regulates the production and use of these solutions, ensuring safety and efficacy. Compliance with FDA guidelines is crucial for manufacturers to maintain market presence[2][4].

Competitive Landscape

The market is competitive, with multiple manufacturers such as ICU Medical, Baxter, and others producing various concentrations of Potassium Chloride in Dextrose and Sodium Chloride solutions. Differentiation often comes through product offerings, pricing, and distribution networks[5].

Product Variations and Concentrations

The market offers a range of concentrations to cater to different clinical needs:

Concentration Variations

  • Solutions are available with varying concentrations of Potassium Chloride (e.g., 10 mEq/L, 20 mEq/L, 30 mEq/L, 40 mEq/L) combined with different percentages of Dextrose and Sodium Chloride (e.g., 5% Dextrose and 0.2%, 0.33%, 0.45%, or 0.9% Sodium Chloride)[2][3][5].

Container Sizes and Types

  • These solutions are available in single-dose containers of 500 mL and 1000 mL, which are flexible and made of PVC/DEHP materials. This variety in packaging caters to different clinical settings and patient needs[2][5].

Financial Trajectory

Revenue Growth

The revenue from Potassium Chloride in 5% Dextrose and Sodium Chloride Injection has been steadily increasing due to the consistent demand from hospitals and healthcare facilities. The global market for intravenous solutions is expected to grow, driven by increasing healthcare expenditures and the need for parenteral nutrition.

Cost Factors

  • The cost of production includes raw materials, manufacturing, and regulatory compliance. The pricing strategy often balances the need to be competitive with the necessity to cover these costs.
  • Distribution and marketing costs also play a significant role in the financial trajectory of these products[5].

Market Size and Share

The global intravenous solutions market is substantial, with Potassium Chloride in 5% Dextrose and Sodium Chloride Injection being a significant segment. Market share is distributed among various manufacturers, with leaders in the market holding a larger share due to their extensive distribution networks and brand recognition.

Clinical and Economic Impact

Clinical Benefits

  • These solutions are crucial in clinical settings for treating electrolyte imbalances, providing hydration, and supplying calories. Their use can significantly improve patient outcomes and reduce the length of hospital stays[1][3][4].

Economic Benefits

  • From an economic perspective, the use of these solutions can help reduce healthcare costs by preventing complications associated with electrolyte imbalances and fluid deficiencies.
  • The market for these solutions also supports employment and economic activity in the pharmaceutical and healthcare sectors.

Safety and Precautions

The financial trajectory of this drug is also influenced by safety and precautionary measures:

Adverse Reactions

  • Adverse reactions such as hypersensitivity, anaphylaxis, and hyperkalemia can impact market perception and regulatory scrutiny. Manufacturers must invest in safety monitoring and reporting to maintain market trust[2][3].

Monitoring and Compliance

  • Regular monitoring of fluid balance, electrolyte concentrations, and acid-base balance is necessary during prolonged parenteral therapy. Non-compliance with these precautions can lead to adverse outcomes and financial liabilities[3].

Pediatric and Special Patient Considerations

The use of these solutions in pediatric patients and those with specific conditions also affects the market dynamics:

Pediatric Use

  • While the safety and effectiveness in pediatric patients have not been fully established, these solutions are used in clinical practice to treat potassium deficiency states when oral therapy is not feasible. This use requires careful dosage selection and monitoring to avoid hyperglycemia/hypoglycemia[3][4].

Special Patient Groups

  • Patients with diabetes, those receiving corticosteroids, and those with thiamine deficiency require special consideration. These factors influence the prescribing patterns and market demand for these solutions[3].

Key Takeaways

  • Market Demand: Driven by clinical need for electrolyte balance, hydration, and calorie supply.
  • Product Variations: Multiple concentrations and container sizes cater to different clinical needs.
  • Financial Growth: Steady revenue growth due to consistent demand and increasing healthcare expenditures.
  • Safety and Compliance: Critical for maintaining market trust and regulatory approval.
  • Special Patient Considerations: Pediatric and special patient groups require careful management and monitoring.

FAQs

Q: What are the common indications for Potassium Chloride in 5% Dextrose and Sodium Chloride Injection?

A: These solutions are indicated for use as sources of electrolytes, calories, and water for hydration in adults and pediatric patients.

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

A: Adverse reactions include hypersensitivity, anaphylaxis, rash, pruritus, and hyperkalemia.

Q: How should these solutions be administered?

A: These solutions should be administered only by intravenous infusion and as directed by a physician, with careful monitoring of the patient's condition.

Q: What precautions should be taken when using these solutions in pediatric patients?

A: The dosage and constant infusion rate must be selected with caution, particularly in neonates and low birth weight infants, to avoid hyperglycemia/hypoglycemia.

Q: What is the shelf life of these solutions?

A: The shelf life of these solutions is typically 18 months from the date of manufacture[5].

Sources

  1. DailyMed: Potassium Chloride in Dextrose and Sodium Chloride Injections USP.
  2. FDA: POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTION, USP.
  3. RxList: KCL in D5NS (Potassium Chloride in 5% Dextrose and Sodium Chloride Injection).
  4. Drugs.com: Potassium Chloride in Dextrose and Sodium Chloride.
  5. ICU Medical: Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP.

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