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Last Updated: March 29, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container launch?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 20meq In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ 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 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Baxter Hlthcare DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018629-004 Mar 23, 1982 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018629-006 Mar 23, 1982 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection

Introduction

Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection is a critical medical solution used for fluid and electrolyte replenishment, as well as providing caloric supply. This article delves into the market dynamics and financial trajectory of this specific formulation, highlighting its indications, market demand, pricing trends, and future outlook.

Indications and Uses

This solution is indicated for patients requiring parenteral administration of potassium chloride, along with minimal carbohydrate calories and sodium chloride. It serves as a source of water, electrolytes, and calories, making it essential for various clinical scenarios, including post-operative care, severe dehydration, and electrolyte imbalances[3][5].

Market Demand

The demand for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection is driven by several factors:

  • Clinical Need: The solution addresses critical electrolyte and fluid imbalances, which are common in hospital settings.
  • Versatility: It is available in various concentrations and volumes, making it adaptable to different patient needs[1][3][5].
  • Regulatory Approval: The solution is approved by regulatory bodies such as the FDA and Health Canada, ensuring its safety and efficacy[2][5].

Market Segmentation

The market for this solution can be segmented based on:

  • Concentration: Different concentrations of potassium chloride, dextrose, and sodium chloride cater to various clinical requirements.
  • Volume: Solutions are available in 500 mL and 1000 mL containers, suitable for different treatment durations and patient needs[1][3][5].
  • Geography: Demand varies across regions due to differences in healthcare infrastructure, patient population, and regulatory environments.

Pricing Trends

Pricing for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection can be influenced by several factors:

  • Raw Material Costs: Fluctuations in the cost of dextrose, sodium chloride, and potassium chloride can impact the final product price.
  • Manufacturing Costs: Changes in production costs, including labor and facility expenses, can also affect pricing.
  • Regulatory Changes: Updates in regulatory requirements, such as changes in expiration dating methods, can lead to price adjustments[4].

Recent Price Adjustments

As of recent reports, there have been price increases due to updated test methods related to expiration dating. For example, B. Braun Medical Inc. adjusted the prices for their formulations in October 2024, reflecting these changes[4].

Financial Trajectory

The financial trajectory of this drug is influenced by several key factors:

  • Sales Volume: The consistent demand from healthcare institutions drives sales volume.
  • Pricing Strategies: Manufacturers adjust prices based on market conditions, regulatory changes, and production costs.
  • Competitive Landscape: The presence of multiple manufacturers, such as Baxter Corporation and B. Braun Medical Inc., influences pricing and market share[2][4].

Revenue Projections

Given the stable demand and essential nature of the solution, revenue projections are generally positive. However, fluctuations in raw material costs and regulatory changes can impact profitability.

Competitive Landscape

The market for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection is competitive, with several major players:

  • Baxter Corporation: Known for its wide range of medical solutions, including various formulations of potassium chloride injections[2].
  • B. Braun Medical Inc.: Offers a variety of intravenous solutions, including this specific formulation[4].
  • Other Manufacturers: Several other companies also produce similar solutions, contributing to market competition.

Regulatory Environment

Regulatory bodies play a crucial role in the market dynamics of this drug:

  • Approval Process: Strict approval processes ensure the safety and efficacy of the solution.
  • Quality Standards: Manufacturers must adhere to stringent quality standards, which can impact production costs and pricing[2][5].

Future Outlook

The future outlook for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection is promising due to:

  • Continuous Demand: The ongoing need for fluid and electrolyte replenishment in clinical settings ensures a steady demand.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and increasing awareness of electrolyte balance will likely drive further demand.
  • Innovations in Formulations: Potential innovations in formulation concentrations and delivery methods could expand market opportunities[1][3][5].

Challenges and Opportunities

While the market is generally stable, there are challenges and opportunities to consider:

  • Challenges: Fluctuations in raw material costs, regulatory changes, and intense competition can pose challenges.
  • Opportunities: Expanding into new markets, developing new formulations, and improving manufacturing efficiency can provide growth opportunities.

Key Takeaways

  • Essential Clinical Use: The solution is critical for fluid and electrolyte replenishment.
  • Stable Demand: The demand is driven by consistent clinical needs.
  • Competitive Market: Multiple manufacturers compete in the market.
  • Regulatory Influence: Regulatory changes can impact pricing and production.
  • Positive Future Outlook: Continuous demand and potential innovations ensure a positive future outlook.

FAQs

What is the primary indication for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection?

The primary indication is for patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.

How is the solution supplied?

The solution is supplied in single-dose, flexible containers of 500 mL and 1000 mL.

What are the key components of the solution?

The key components are potassium chloride, dextrose, and sodium chloride.

How does the pricing of the solution change?

Pricing can change due to raw material costs, manufacturing costs, and regulatory changes.

Who are the major manufacturers of this solution?

Major manufacturers include Baxter Corporation and B. Braun Medical Inc.

Sources

  1. Drugs.com: Potassium Chloride in Dextrose and Sodium Chloride - Drugs.com
  2. Drug and Health Products Portal: BAXTER CORPORATION - Drug and Health Products Portal
  3. RxList: KCL in D5NS (Potassium Chloride in 5% Dextrose and Sodium Chloride Injection) - RxList
  4. New York State Department of Financial Services: Drug Price Increases Report - October 2024
  5. DailyMed: Potassium Chloride, Dextrose Monohydrate and Sodium Chloride Injection - DailyMed

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