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Last Updated: March 25, 2025

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container launch?

Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, and Hospira. and is included in four NDAs.

The generic ingredient in GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

A generic version of GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as gentamicin sulfate by SANDOZ on December 31st, 1969.

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Summary for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Recent Clinical Trials for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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SponsorPhase
Oslo University HospitalPhase 1/Phase 2
Kaiser PermanentePhase 2
University of California, San DiegoPhase 2

See all GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

Pharmacology for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062414-003 Aug 15, 1983 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062414-005 Aug 15, 1983 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062414-009 Aug 15, 1983 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062588-002 Jan 6, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062588-004 Jan 6, 1986 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
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for Gentamicin Sulfate in 0.9% Sodium Chloride

Introduction

Gentamicin Sulfate in 0.9% Sodium Chloride is a widely used antibiotic for treating serious bacterial infections. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Demand and Usage

Gentamicin Sulfate is indicated for the treatment of serious infections caused by susceptible strains of various microorganisms, including Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus species. Its effectiveness in treating bacterial neonatal sepsis, septicemia, and infections of the central nervous system, urinary tract, respiratory tract, and other areas drives a consistent demand[2][3][4].

Clinical Indications and Restrictions

The drug is used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria. This targeted use helps in maintaining its effectiveness and reducing the development of drug-resistant bacteria. It is not recommended for uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to gentamicin and not to less toxic antibiotics[2][3][4].

Price Trends

The pricing of Gentamicin Sulfate can be influenced by several factors, including production costs, market demand, and regulatory changes. As of recent reports, the price of Gentamicin Sulfate has shown significant fluctuations. For instance, in the third quarter of 2022, the price was assessed at USD 107,060 per metric ton (FOB Shanghai, Europe)[5].

Recent Price Increases

In the pharmaceutical market, price increases are often driven by factors such as increased marketing expenses and changes in industry dynamics. For example, other pharmaceutical products have seen a 40% increase in price over the last three calendar years due to similar factors[1].

Production and Supply Chain

The production of Gentamicin Sulfate involves several key players, including Baxter Healthcare Corporation. The drug is manufactured as a sterile, nonpyrogenic solution in 0.9% sodium chloride for intravenous use. Any disruptions in the supply chain or changes in manufacturing costs can impact the financial trajectory of the drug[3][4].

Regulatory Environment

Regulatory bodies play a crucial role in the market dynamics of Gentamicin Sulfate. The FDA sets standards for susceptibility testing and quality control, which must be adhered to by manufacturers. Compliance with these regulations can affect production costs and, subsequently, the pricing of the drug[3][4].

Competitive Landscape

The antibiotic market is competitive, with various drugs available for treating bacterial infections. Gentamicin Sulfate competes with other aminoglycosides and antibiotics that may have less potential for toxicity. The competitive landscape influences pricing strategies and market share[2][3][4].

Adverse Reactions and Safety Concerns

The potential toxicity of Gentamicin Sulfate, including nephrotoxicity and neurotoxicity, is a significant factor in its market dynamics. Patients with impaired renal function or those receiving high doses or prolonged therapy are at greater risk. These safety concerns can impact prescribing patterns and, consequently, the financial performance of the drug[2][3].

Economic Impact on Healthcare Systems

The cost of Gentamicin Sulfate can have a substantial economic impact on healthcare systems. Given its use in treating serious infections, any price increases can strain hospital budgets and healthcare resources. This economic impact is particularly significant in regions with limited healthcare funding[5].

Forecast and Future Outlook

The future outlook for Gentamicin Sulfate involves continued monitoring of price trends, regulatory changes, and advancements in antibiotic resistance. As the global demand for effective antibiotics remains high, the financial trajectory of Gentamicin Sulfate is likely to be influenced by these factors. Real-time pricing data and market analytics will be essential for stakeholders to navigate the market dynamics effectively[5].

Key Takeaways

  • Consistent Demand: Gentamicin Sulfate has a steady demand due to its effectiveness in treating serious bacterial infections.
  • Price Fluctuations: Prices are influenced by production costs, market demand, and regulatory changes.
  • Regulatory Compliance: Adherence to FDA standards is crucial for maintaining market presence.
  • Safety Concerns: Potential toxicity affects prescribing patterns and market dynamics.
  • Economic Impact: Price changes significantly affect healthcare system budgets.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for Gentamicin Sulfate in 0.9% Sodium Chloride? A: It is used to treat serious infections caused by susceptible strains of microorganisms such as Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus species[2][3][4].

Q: Why is Gentamicin Sulfate not recommended for uncomplicated urinary tract infections? A: It is not recommended unless the causative organisms are susceptible to gentamicin and not to less toxic antibiotics to avoid unnecessary toxicity[2][3][4].

Q: What are the potential adverse reactions associated with Gentamicin Sulfate? A: The drug can cause nephrotoxicity, neurotoxicity, and other adverse effects, particularly in patients with renal impairment or those receiving high doses or prolonged therapy[2][3].

Q: How does the regulatory environment impact the market dynamics of Gentamicin Sulfate? A: Regulatory bodies set standards for susceptibility testing and quality control, which can affect production costs and pricing[3][4].

Q: What factors influence the pricing of Gentamicin Sulfate? A: Pricing is influenced by production costs, market demand, regulatory changes, and industry dynamics such as increased marketing expenses[1][5].

Sources:

  1. 2024 Price Increase Report - Texas Department of State Health Services
  2. Gentamicin Sulfate: Package Insert / Prescribing Info - Drugs.com
  3. Gentamicin Sulfate in 0.9% Sodium Chloride Injection - DailyMed
  4. Gentamicin Sodium Chloride: Package Insert / Prescribing Info - Drugs.com
  5. Gentamicin Sulphate Price Trend and Forecast - ChemAnalyst

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