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Last Updated: December 22, 2024

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Normosol-m And Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Normosol-m And Dextrose 5% In Plastic Container is a drug marketed by Icu Medical Inc and is included in one NDA.

The generic ingredient in NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; magnesium acetate; potassium acetate; sodium chloride. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextrose; magnesium acetate; potassium acetate; sodium chloride profile page.

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Summary for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanderbilt University Medical CenterPhase 3
Rainer LenhardtPhase 4
Nationwide Children's HospitalPhase 3

See all NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Icu Medical Inc NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER dextrose; magnesium acetate; potassium acetate; sodium chloride INJECTABLE;INJECTION 017610-001 Approved Prior to Jan 1, 1982 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

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Normosol-M and 5% Dextrose Injection

Introduction

Normosol-M and 5% Dextrose Injection is a sterile, nonpyrogenic solution used for parenteral maintenance of daily fluid and electrolyte requirements, along with minimal carbohydrate calories. This solution is widely used in clinical settings to manage patients who are unable to take fluids and nutrients orally.

Market Demand

The demand for Normosol-M and 5% Dextrose Injection is driven by several factors:

Clinical Need

The solution is essential for maintaining fluid and electrolyte balance in patients, particularly those in intensive care units, surgical patients, and individuals with severe illnesses or injuries that prevent oral intake[2][4][5].

Patient Population

The patient population requiring parenteral nutrition and fluid replacement is significant and includes a broad range of patients, from neonates to adults. This diverse patient base ensures a steady demand for the product.

Hospital and Healthcare Settings

Hospitals, clinics, and other healthcare facilities are the primary consumers of Normosol-M and 5% Dextrose Injection. The solution is often included in standard treatment protocols, ensuring consistent demand.

Competitive Landscape

The market for parenteral fluids and electrolyte solutions is competitive, with several manufacturers offering similar products. However, Normosol-M and 5% Dextrose Injection has a strong presence due to its balanced electrolyte composition and the inclusion of dextrose as a carbohydrate source.

Key Players

Companies like ICU Medical, which manufactures Normosol-M and 5% Dextrose Injection, compete with other pharmaceutical and medical device companies. The competitive landscape is influenced by factors such as product quality, pricing, and distribution networks[1][3][4].

Financial Trajectory

The financial performance of Normosol-M and 5% Dextrose Injection can be analyzed through several key metrics:

Revenue Growth

The revenue generated from the sale of Normosol-M and 5% Dextrose Injection has been steady, driven by the consistent demand from healthcare facilities. The product's inclusion in standard treatment protocols ensures a stable revenue stream.

Market Share

Normosol-M and 5% Dextrose Injection holds a significant market share in the parenteral fluids segment. This is due to its well-established brand reputation and the trust of healthcare professionals in its efficacy and safety[2][4].

Pricing Strategy

The pricing of Normosol-M and 5% Dextrose Injection is competitive and influenced by regulatory environments, production costs, and market dynamics. The solution is available in various container sizes, which helps in catering to different patient needs and hospital budgets[1][3][4].

Cost Structure

The cost structure for Normosol-M and 5% Dextrose Injection includes several components:

Production Costs

These include the costs of raw materials (such as dextrose, sodium chloride, potassium acetate, and magnesium acetate), manufacturing, and packaging. The use of flexible plastic containers, which are fabricated from specially formulated polyvinyl chloride, also contributes to the production costs[2][3].

Distribution and Marketing

The costs associated with distributing the product to hospitals and healthcare facilities, as well as marketing and promotional activities, are significant. These costs help in maintaining the product's visibility and market share.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics and financial trajectory of Normosol-M and 5% Dextrose Injection:

Compliance and Approval

The solution must comply with strict regulatory standards, including those set by the US FDA. Ensuring compliance with these regulations is essential for maintaining market presence and avoiding any financial penalties[3][5].

Labeling and Packaging

Regulations also govern the labeling and packaging of the product. For instance, the solution is supplied in single-dose flexible plastic containers, and the labeling must include detailed information about the product's composition, dosage, and warnings[2][4].

Future Outlook

The future outlook for Normosol-M and 5% Dextrose Injection is positive due to several factors:

Growing Healthcare Needs

The increasing demand for healthcare services, particularly in intensive care and surgical settings, will continue to drive the need for parenteral fluids and electrolyte solutions.

Innovations and Improvements

Continuous innovations in packaging and formulation can help in reducing costs and improving the product's efficacy and safety. For example, advancements in container materials and design can enhance patient safety and reduce the risk of complications.

Expanding Market Reach

Expanding into new markets, especially in regions with growing healthcare infrastructure, can provide new revenue opportunities for the product.

Key Takeaways

  • Stable Demand: Normosol-M and 5% Dextrose Injection benefits from a stable demand driven by clinical needs.
  • Competitive Market: The market is competitive, but the product's balanced electrolyte composition and inclusion of dextrose give it a strong market position.
  • Regulatory Compliance: Adherence to regulatory standards is crucial for maintaining market presence.
  • Future Growth: The product has a positive future outlook due to growing healthcare needs and potential for innovations.

FAQs

Q: What is Normosol-M and 5% Dextrose Injection used for? A: Normosol-M and 5% Dextrose Injection is used for the parenteral maintenance of daily fluid and electrolyte requirements, along with minimal carbohydrate calories.

Q: Who are the primary consumers of Normosol-M and 5% Dextrose Injection? A: Hospitals, clinics, and other healthcare facilities are the primary consumers of this solution.

Q: What are the key components of Normosol-M and 5% Dextrose Injection? A: The solution contains dextrose, sodium chloride, potassium acetate, magnesium acetate, and may include hydrochloric acid for pH adjustment.

Q: How is Normosol-M and 5% Dextrose Injection administered? A: The solution is administered by intravenous infusion, with the dose dependent on the age, weight, and clinical condition of the patient.

Q: What are the potential risks associated with Normosol-M and 5% Dextrose Injection? A: The solution should be used with caution in patients with conditions such as congestive heart failure, severe renal insufficiency, and hyperkalemia. Frequent monitoring of serum glucose concentrations is required, especially in pediatric patients.

Cited Sources

  1. ICU Medical: Normosolâ„¢-M and 5% Dextrose Injection.
  2. Pfizer Labeling: Normosol-M and 5% Dextrose Injection.
  3. DailyMed: Normosolâ„¢-M and 5% Dextrose Injection.
  4. Drugs.com: Normosol-M and Dextrose: Package Insert / Prescribing Info.
  5. DailyMed: dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate.

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