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Last Updated: March 23, 2025

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER Drug Patent Profile


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When do Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container patents expire, and what generic alternatives are available?

Clinimix E 4.25/25 Sulfite Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER is amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.

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Summary for CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
Drug patent expirations by year for CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

US Patents and Regulatory Information for CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Baxter Hlthcare CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020678-012 Mar 26, 1997 RX Yes Yes ⤷  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 1 of 1 entries

Market Dynamics and Financial Trajectory for CLINIMIX E 4.25/25 Sulfite-Free with Electrolytes in Dextrose 25% with Calcium in Plastic Container

Introduction

CLINIMIX E 4.25/25 is a parenteral nutrition solution indicated for patients requiring intravenous nutrition when oral or enteral nutrition is not feasible. This product, manufactured by Baxter, combines amino acids, electrolytes, and dextrose in a sulfite-free formulation, making it a critical component in the care of critically ill patients.

Market Overview

The parenteral nutrition market is driven by the increasing demand for intravenous nutrition solutions, particularly in hospitals and long-term care facilities. This demand is fueled by the growing number of patients with malnutrition or those who are unable to receive nutrition through the gastrointestinal tract due to various medical conditions.

Key Market Drivers

  • Increasing Prevalence of Malnutrition: The rising incidence of malnutrition among hospitalized patients and those in long-term care facilities is a significant driver for the parenteral nutrition market[5].
  • Advancements in Formulation: The development of sulfite-free formulations like CLINIMIX E 4.25/25 addresses the need for safer and more tolerable parenteral nutrition solutions, enhancing market appeal.
  • Regulatory Approvals: Continuous regulatory approvals and updates, such as those from the FDA, ensure that products like CLINIMIX E meet stringent safety and efficacy standards, bolstering market confidence[1].

Product Specifications

CLINIMIX E 4.25/25 is characterized by its specific composition:

  • Amino Acid Concentration: 4.25% amino acids (Blend B) per 100 mL.
  • Dextrose Concentration: 25% dextrose.
  • Electrolytes and Calcium: Includes essential electrolytes and calcium, making it a comprehensive nutritional solution[4].

Clinical Indications

This product is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition. It is particularly useful in scenarios where oral or enteral nutrition is not possible or sufficient[5].

Market Segmentation

The market for parenteral nutrition solutions like CLINIMIX E 4.25/25 can be segmented based on several factors:

By Patient Type

  • Pediatric Patients: Specialized formulations are required for pediatric patients, and CLINIMIX E offers various strengths to cater to different age groups.
  • Adult Patients: The product is widely used in adult populations, especially in critical care settings.

By Setting

  • Hospitals: The primary market for CLINIMIX E, given the high demand for parenteral nutrition in acute care settings.
  • Long-Term Care Facilities: Increasingly important as the population ages and requires more prolonged nutritional support.

Competitive Landscape

The parenteral nutrition market is competitive, with several key players:

  • Baxter: The manufacturer of CLINIMIX E, known for its extensive range of parenteral nutrition solutions.
  • Other Manufacturers: Companies like Fresenius Kabi and B. Braun also offer similar products, contributing to market competition[3].

Market Share

Baxter holds a significant market share in the parenteral nutrition segment due to its comprehensive product portfolio and strong distribution network.

Financial Trajectory

The financial performance of CLINIMIX E 4.25/25 is closely tied to the overall parenteral nutrition market trends.

Revenue Growth

  • The parenteral nutrition market has seen steady growth over the past few years, driven by increasing demand and advancements in product formulations.
  • CLINIMIX E, being a premium product with a sulfite-free formulation, contributes significantly to Baxter's revenue in this segment.

Pricing Strategy

The pricing of CLINIMIX E 4.25/25 is influenced by several factors, including production costs, regulatory approvals, and market competition. The product is generally priced higher than its sulfite-containing counterparts due to its enhanced safety profile.

Cost-Benefit Analysis

For healthcare providers, the cost-benefit analysis of using CLINIMIX E 4.25/25 includes:

  • Reduced Complications: The sulfite-free formulation reduces the risk of adverse reactions, potentially lowering overall healthcare costs.
  • Improved Patient Outcomes: Enhanced nutritional support can lead to better patient recovery rates and shorter hospital stays[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of CLINIMIX E 4.25/25.

FDA Approvals

CLINIMIX E has undergone rigorous FDA approval processes, ensuring compliance with safety and efficacy standards. This regulatory backing enhances market confidence and adoption rates[1].

Compliance and Safety

Continuous monitoring and updates by regulatory bodies ensure that the product meets the highest safety standards, which is critical for maintaining market trust.

Future Outlook

The future outlook for CLINIMIX E 4.25/25 is promising, driven by several factors:

Increasing Demand

The growing need for parenteral nutrition solutions, especially in developing countries, is expected to drive market growth.

Technological Advancements

Ongoing research and development in parenteral nutrition formulations are likely to introduce new and improved products, potentially expanding the market further.

Expanding Distribution

Baxter's efforts to expand its distribution network globally will likely increase the availability and adoption of CLINIMIX E 4.25/25.

Key Takeaways

  • Market Growth: The parenteral nutrition market is expected to grow due to increasing demand and advancements in product formulations.
  • Product Differentiation: The sulfite-free formulation of CLINIMIX E 4.25/25 offers a significant advantage in terms of safety and tolerability.
  • Regulatory Compliance: Continuous regulatory approvals and updates are crucial for maintaining market confidence.
  • Financial Performance: CLINIMIX E 4.25/25 contributes significantly to Baxter's revenue in the parenteral nutrition segment.

FAQs

Q: What is the primary indication for CLINIMIX E 4.25/25?

A: CLINIMIX E 4.25/25 is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not feasible.

Q: What makes CLINIMIX E 4.25/25 unique?

A: The product is unique due to its sulfite-free formulation, which reduces the risk of adverse reactions compared to sulfite-containing products.

Q: Who are the key players in the parenteral nutrition market?

A: Key players include Baxter, Fresenius Kabi, and B. Braun, among others.

Q: What are the main drivers of the parenteral nutrition market?

A: The main drivers include the increasing prevalence of malnutrition, advancements in product formulations, and regulatory approvals.

Q: What is the expected future outlook for CLINIMIX E 4.25/25?

A: The future outlook is promising, driven by increasing demand, technological advancements, and expanding distribution networks.

Sources

  1. CENTER FOR DRUG EVALUATION AND RESEARCH - "Clinimixm E (sulfite free Amino Acid with Electrolytes in Dextrose with Calcium) Injections"[1]
  2. Baxter - "CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E (amino acids with electrolytes in dextrose with calcium) Injections"[2]
  3. Pharmacompass - "CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER-2"[3]
  4. Baxter Canada - "CLINIMIX E Product Monograph"[4]
  5. FDA.report - "CLINIMIX E"[5]

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