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Last Updated: December 22, 2024

OXYTOCIN 5 USP UNITS IN DEXTROSE 5% Drug Patent Profile


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When do Oxytocin 5 Usp Units In Dextrose 5% patents expire, and when can generic versions of Oxytocin 5 Usp Units In Dextrose 5% launch?

Oxytocin 5 Usp Units In Dextrose 5% is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in OXYTOCIN 5 USP UNITS IN DEXTROSE 5% is oxytocin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oxytocin 5 Usp Units In Dextrose 5%

A generic version of OXYTOCIN 5 USP UNITS IN DEXTROSE 5% was approved as oxytocin by HIKMA on January 10th, 2007.

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SponsorPhase
University Hospital, Gentofte, CopenhagenN/A
University of Colorado, DenverPhase 2
Karolinska InstitutetPhase 2

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US Patents and Regulatory Information for OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott OXYTOCIN 5 USP UNITS IN DEXTROSE 5% oxytocin INJECTABLE;INJECTION 019185-001 Mar 29, 1985 DISCN Yes 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

OXYTOCIN 5 USP UNITS IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxytocin 5 USP Units in Dextrose 5%

Introduction

Oxytocin, particularly when administered in a solution of 5% dextrose, is a critical medication in obstetrics, used to induce or strengthen uterine contractions during labor and delivery. Understanding the market dynamics and financial trajectory of this formulation is essential for pharmaceutical companies, healthcare providers, and investors.

Market Overview

The market for oxytocin, especially in its formulation with 5% dextrose, is driven by several key factors:

Clinical Indications

Oxytocin is widely used for inducing labor, stimulating or reinforcing labor in cases of uterine inertia, and managing incomplete or inevitable abortion. Its stability in 5% dextrose solutions makes this formulation a preferred choice in clinical settings[2][5].

Demand and Supply

The demand for oxytocin is consistent due to its essential role in obstetric care. The supply is maintained by several pharmaceutical companies, including Par Pharmaceutical, Teva Parenteral Medicines, Inc., and Hikma Pharmaceuticals USA Inc., among others[3][5].

Competitive Landscape

The competitive landscape for oxytocin formulations is characterized by multiple players:

Key Manufacturers

Companies like Teva, Hikma, and West-Ward Pharmaceuticals Corp. are significant players in the market. Each company offers different strengths and formulations of oxytocin, including solutions in 5% dextrose[3][5].

Market Share

The market share is distributed among these manufacturers, with larger companies often having a greater share due to their extensive distribution networks and brand recognition.

Pricing and Cost Analysis

The pricing of oxytocin formulations can vary based on the concentration, volume, and the manufacturer:

Unit Costs

For example, oxytocin 10 units/mL in a vial can cost around $9.84 per vial, while larger volumes like 40 units/500 mL in 5% dextrose can cost significantly less per unit, around $0.07 per mL[3].

Hospital and Clinical Costs

In clinical settings, the cost of oxytocin is often bundled with other treatment costs. However, the stability of oxytocin in 5% dextrose solutions can reduce overall costs by minimizing the need for frequent solution changes[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of oxytocin:

FDA Approval and Compliance

Oxytocin formulations must comply with FDA regulations, including those related to sterility, stability, and labeling. Non-compliance can lead to significant financial and reputational penalties, as seen in the case of Pharmedium Services, LLC[4][5].

Safety and Efficacy Standards

Regulatory bodies ensure that oxytocin formulations meet strict safety and efficacy standards. This includes monitoring for adverse reactions and ensuring the product is free from contaminants and preservatives that could affect stability[2][5].

Financial Performance and Projections

The financial performance of oxytocin formulations is stable and predictable due to consistent demand:

Revenue Streams

Revenue is generated through sales to hospitals, clinics, and other healthcare providers. The stable demand ensures a steady revenue stream for manufacturers.

Growth Projections

The market is expected to grow modestly, driven by increasing birth rates in some regions and advancements in obstetric care. However, the growth is not expected to be exponential due to the mature nature of the market.

Challenges and Opportunities

Adverse Reactions and Safety Concerns

High doses of oxytocin can lead to severe adverse reactions such as myocardial ischemia, tachycardia, and water intoxication. Managing these risks is crucial for maintaining market trust and compliance[3].

Innovation and R&D

Opportunities exist for innovation in delivery systems and formulations that enhance stability and reduce adverse reactions. Investing in R&D can help companies differentiate their products and capture a larger market share.

Special Populations and Usage Trends

Pregnancy and Lactation

Oxytocin is extensively used in pregnancy for labor induction and management. However, its use in the first and second trimesters is limited, and caution is advised when administering to nursing women[5].

Geriatric and Pediatric Use

While oxytocin is primarily used in obstetrics, its use in other populations is limited. Clinical studies have not identified significant differences in responses between elderly and younger patients, but dose selection should be cautious in elderly patients[1][5].

Monitoring and Laboratory Tests

Clinical evaluation and periodic laboratory tests are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during oxytocin therapy. This is particularly important when oxytocin is administered in a 5% dextrose solution due to the risk of hypoosmotic hyponatremia[1].

Key Takeaways

  • Stable Demand: Oxytocin in 5% dextrose has a consistent demand due to its critical role in obstetric care.
  • Competitive Market: Multiple manufacturers compete in the market, with pricing varying based on concentration and volume.
  • Regulatory Compliance: Strict adherence to FDA regulations is essential for maintaining market presence.
  • Safety Concerns: Managing adverse reactions and ensuring patient safety is crucial.
  • Innovation Opportunities: Investing in R&D can help companies differentiate their products and capture a larger market share.

Frequently Asked Questions (FAQs)

Q: What is the primary use of oxytocin in 5% dextrose solution? A: The primary use is to induce or strengthen uterine contractions during labor and delivery.

Q: Which companies are major players in the oxytocin market? A: Companies like Teva, Hikma, and West-Ward Pharmaceuticals Corp. are significant players.

Q: What are the potential adverse reactions of oxytocin in 5% dextrose? A: Potential adverse reactions include myocardial ischemia, tachycardia, and water intoxication.

Q: How does the stability of oxytocin in 5% dextrose impact clinical use? A: The stability allows for continuous infusion without frequent solution changes, reducing clinical costs and enhancing patient safety.

Q: Are there any specific precautions for administering oxytocin to elderly patients? A: Yes, dose selection should be cautious, usually starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function.

Cited Sources

  1. Baxter Corporation. 5% Dextrose Injection, USP In VIAFLO Plastic Container. June 11, 2019.
  2. Health Canada. Oxytocin Injection, USP.
  3. DrugBank Online. Oxytocin: Uses, Interactions, Mechanism of Action.
  4. FDA. Pharmedium Services, LLC, Sugar Land, TX., 483 issued 12/22/2017.
  5. FDA. Oxytocin Injection, USP - accessdata.fda.gov.

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