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Last Updated: March 30, 2025

TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Travasol 8.5% Sulfite Free W/ Electrolytes In Plastic Container, and when can generic versions of Travasol 8.5% Sulfite Free W/ Electrolytes In Plastic Container launch?

Travasol 8.5% Sulfite Free W/ Electrolytes In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER is amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.

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Summary for TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
Drug patent expirations by year for TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

US Patents and Regulatory Information for TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Baxter Hlthcare TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020173-002 Oct 27, 1995 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 TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

Introduction

TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER is a parenteral nutrition solution used to provide essential and nonessential amino acids, along with electrolytes, to patients who require intravenous nutrition. Here, we will delve into the market dynamics and financial trajectory of this product.

Market Overview

The parenteral nutrition market is driven by the increasing demand for intravenous nutrition solutions, particularly in hospitals and intensive care units. TRAVASOL, as a key player in this market, benefits from this trend.

Competitive Landscape

TRAVASOL competes with other amino acid solutions such as FreAmine II. A clinical comparison study showed that both TRAVASOL and FreAmine II can promote positive nitrogen balance in patients with normal renal and hepatic function, indicating a competitive parity in terms of efficacy[4].

Regulatory Environment

The production and distribution of TRAVASOL are regulated by stringent FDA guidelines. The product must be prepared using careful aseptic techniques to avoid contamination, and it must be diluted and used as an admixture with other components before administration[1].

Demand and Usage

Patient Population

TRAVASOL is used in a variety of patient populations, including stable patients and critically ill patients. The dosage varies based on the patient's condition, with critically ill patients requiring higher doses (1.5 to 2.0 mL/kg/day) compared to stable patients (0.8 to 1.0 mL/kg/day)[1].

Clinical Indications

The solution is indicated for patients who require parenteral nutrition due to various conditions such as organ failure, sepsis, or postoperative major surgery. It is essential for maintaining nitrogen balance and providing the necessary amino acids for protein synthesis[1].

Financial Aspects

Pricing

The pricing of TRAVASOL can vary depending on the supplier and the specific formulation. For instance, the price list from Adena Health System shows that TRAVASOL 3.5% W/ELEC can range from $57.00, though this may not reflect the exact pricing for the 8.5% formulation[2].

Market Size and Growth

The parenteral nutrition market is expected to grow due to increasing healthcare expenditures and the rising need for intravenous nutrition solutions. While specific financial data for TRAVASOL 8.5% is not readily available, the overall market growth indicates a positive financial trajectory for such products.

Supplier Landscape

Multiple companies offer TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, which suggests a competitive supplier market. This competition can influence pricing and availability[3].

Challenges and Opportunities

Safety and Efficacy

One of the significant challenges is the risk of pulmonary vascular precipitates and pulmonary distress associated with the use of TRAVASOL. Monitoring and careful administration are crucial to mitigate these risks[1].

Regulatory Compliance

Ensuring compliance with FDA regulations is essential. Any non-compliance can lead to significant financial and reputational consequences.

Market Expansion

Opportunities exist in expanding the use of TRAVASOL into new patient populations and geographic markets. Increasing awareness among healthcare providers about the benefits of parenteral nutrition can also drive demand.

Key Takeaways

  • Competitive Market: TRAVASOL operates in a competitive market with other amino acid solutions.
  • Regulatory Compliance: Strict adherence to FDA guidelines is crucial.
  • Growing Demand: The parenteral nutrition market is expected to grow, driven by increasing healthcare needs.
  • Safety Monitoring: Continuous monitoring for potential complications such as pulmonary vascular precipitates is necessary.
  • Supplier Competition: Multiple suppliers offer TRAVASOL, influencing pricing and availability.

FAQs

What is TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER used for?

TRAVASOL 8.5% is used as a parenteral nutrition solution to provide essential and nonessential amino acids, along with electrolytes, to patients who require intravenous nutrition.

How is TRAVASOL administered?

TRAVASOL must be transferred to a separate parenteral nutrition container, diluted, and used as an admixture with or without dextrose, electrolytes, and/or lipid emulsion before administration[1].

What are the potential risks associated with TRAVASOL?

Potential risks include pulmonary vascular precipitates causing pulmonary distress and the need for careful monitoring of serum potassium levels and other electrolytes[1].

How does TRAVASOL compare to other amino acid solutions?

TRAVASOL has been shown to be as effective as FreAmine II in promoting positive nitrogen balance in patients with normal renal and hepatic function[4].

What is the typical dosage of TRAVASOL for adult patients?

The recommended daily dosage for stable adult patients is 0.8 to 1.0 mL/kg/day, while critically ill patients may require 1.5 to 2.0 mL/kg/day[1].

Sources

  1. FDA Label: TRAVASOL (amino acids) injection, for intravenous use[1].
  2. Adena Health System: Chg Master for Jean - Adena Health System[2].
  3. Pharmacompass: TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER-5[3].
  4. PubMed: Clinical comparison of two 8.5% amino acid injection products[4].

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