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Last Updated: April 1, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% In Plastic Container, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% 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 0.3% 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 0.3% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-003 Approved Prior to Jan 1, 1982 DISCN 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
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Market Dynamics and Financial Trajectory for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% in Plastic Containers

Introduction

The intravenous solution containing Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% is a critical product in the healthcare industry, particularly for patients requiring parenteral administration of electrolytes, calories, and hydration. This article delves into the market dynamics and financial trajectory of this specific formulation.

Market Demand and Indications

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 patients requiring potassium chloride with minimal carbohydrate calories and sodium chloride[1][3].

Patient Population

The demand for this solution is driven by the need for electrolyte and fluid replacement in various clinical settings, including hospitals, clinics, and home healthcare. Patients undergoing surgery, those with severe dehydration, or those with electrolyte imbalances are key beneficiaries.

Market Segmentation

By End-User

  • Hospitals: The primary consumers, given the frequent need for intravenous solutions in inpatient care.
  • Clinics: Outpatient facilities also utilize these solutions for patient treatment.
  • Home Healthcare: Increasingly, home healthcare services are using these solutions for patient care.

By Geography

  • North America: A significant market due to advanced healthcare infrastructure and high demand.
  • Europe: Another major market with a strong healthcare system.
  • Asia-Pacific: Growing rapidly due to increasing healthcare expenditure and infrastructure development.

Competitive Landscape

Key Players

  • Baxter Corporation: A major player in the market, known for its extensive range of intravenous solutions, including the formulation in question[5].
  • Other Manufacturers: Several other pharmaceutical and medical device companies also produce similar formulations, contributing to a competitive market.

Market Share

The market share is distributed among several key players, with Baxter Corporation holding a significant portion due to its long-standing presence and reputation in the healthcare industry.

Financial Trajectory

Revenue Growth

The market for intravenous solutions, including Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3%, has seen steady revenue growth. This is driven by increasing healthcare expenditure, an aging population, and the rising incidence of conditions requiring electrolyte and fluid replacement.

Pricing Strategies

  • Cost-Based Pricing: Manufacturers often use cost-based pricing, considering the production costs, regulatory approvals, and distribution expenses.
  • Value-Based Pricing: Some companies adopt value-based pricing, reflecting the clinical value and patient outcomes associated with the product.

Cost Structure

  • Raw Materials: The cost of dextrose, sodium chloride, and potassium chloride.
  • Manufacturing: Expenses related to production, including labor, equipment, and facility costs.
  • Regulatory Compliance: Costs associated with obtaining and maintaining regulatory approvals.
  • Distribution and Marketing: Expenses for distributing the product and marketing efforts.

Regulatory Environment

FDA Approvals

The FDA plays a crucial role in regulating these solutions. Manufacturers must comply with strict guidelines and obtain necessary approvals before marketing their products[2].

Storage and Handling

Regulations also dictate the storage and handling conditions, such as maintaining a temperature range of 20 to 25°C (68 to 77°F) and protecting from freezing and excessive heat[1].

Supply Chain Dynamics

Production

Manufacturers produce these solutions in various strengths and volumes, often in single-dose, flexible containers to ensure sterility and ease of use[2][3].

Distribution

The distribution network includes wholesalers, distributors, and direct sales to healthcare facilities. Efficient logistics are crucial to ensure timely delivery and maintain product integrity.

Challenges and Opportunities

Challenges

  • Hyperkalemia Risk: One of the significant challenges is the risk of hyperkalemia, which can lead to cardiac arrhythmias. This necessitates careful patient monitoring and dosage adjustments[2].
  • Competition: The market is highly competitive, with multiple manufacturers offering similar products.
  • Regulatory Compliance: Adhering to stringent regulatory requirements can be challenging and costly.

Opportunities

  • Growing Demand: The increasing need for intravenous solutions in emerging markets presents a significant growth opportunity.
  • Innovation: Developing new formulations or improving existing ones can help companies differentiate themselves and capture more market share.
  • Home Healthcare: The expanding home healthcare sector offers a new avenue for sales and growth.

Key Takeaways

  • The market for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% is driven by clinical needs and supported by a robust supply chain.
  • Regulatory compliance and careful patient monitoring are critical.
  • The market is competitive, but there are opportunities for growth, especially in emerging markets and the home healthcare sector.

FAQs

What are the primary indications for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3%?

This solution is indicated for patients requiring parenteral administration of electrolytes, calories, and hydration, particularly those with electrolyte imbalances or severe dehydration.

How should this solution be administered?

It should be administered only by intravenous infusion and as directed by a physician, with careful monitoring of serum potassium levels to avoid hyperkalemia[1].

What are the contraindications for this solution?

It is contraindicated in patients with known hypersensitivity to potassium chloride and those at risk for hyperkalemia[2].

How is the solution stored and handled?

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

What are the potential side effects of this solution?

Potential side effects include hyperkalemia, cardiac arrhythmias, and other electrolyte imbalances. Careful monitoring is essential to mitigate these risks[2].

Sources

  1. Drugs.com: Potassium Chloride in Dextrose and Sodium Chloride - Drugs.com
  2. FDA: POTASSIUM CHLORIDE IN DEXTROSE AND ... - accessdata.fda.gov
  3. DailyMed: Potassium Chloride in Dextrose and Sodium Chloride Injections USP
  4. Science.gov: injection solution significantly: Topics by Science.gov
  5. Health Canada: (40MMOL/L) POTASSIUM CHLORIDE IN 3.3% DEXTROSE AND 0.3% SODIUM CHLORIDE INJECTION USP

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