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Last Updated: December 22, 2024

OXYTOCIN 10 USP UNITS IN DEXTROSE 5% Drug Patent Profile


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When do Oxytocin 10 Usp Units In Dextrose 5% patents expire, and what generic alternatives are available?

Oxytocin 10 Usp Units In Dextrose 5% is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in OXYTOCIN 10 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 10 Usp Units In Dextrose 5%

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

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Summary for OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
Drug patent expirations by year for OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
Recent Clinical Trials for OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

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

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

See all OXYTOCIN 10 USP UNITS IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for OXYTOCIN 10 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 10 USP UNITS IN DEXTROSE 5% oxytocin INJECTABLE;INJECTION 019185-004 Mar 29, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbott OXYTOCIN 10 USP UNITS IN DEXTROSE 5% oxytocin INJECTABLE;INJECTION 019185-003 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 10 USP UNITS IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxytocin 10 USP Units in Dextrose 5%

Introduction

Oxytocin, a synthetic hormone, is widely used in medical settings to induce or strengthen uterine contractions, particularly during labor and delivery. The formulation of oxytocin in 5% dextrose solution is a common method of administration. Here, we will delve into the market dynamics and financial trajectory of oxytocin 10 USP units in dextrose 5%.

Market Overview

The market for oxytocin is driven by its critical role in obstetric care. Oxytocin is indicated for the medical induction of labor, stimulation or reinforcement of labor, and management of postpartum hemorrhage and incomplete or inevitable abortion[2][3][4].

Demand Drivers

  • Obstetric Needs: The primary demand driver is the constant need for oxytocin in obstetric procedures. With a steady birth rate globally, the demand for oxytocin remains consistent.
  • Medical Indications: Oxytocin is used for medical rather than elective induction of labor, which includes conditions such as pre-eclampsia, maternal diabetes, and premature rupture of membranes[2][3][4].

Market Segmentation

The market can be segmented based on the type of administration (intravenous and intramuscular), the concentration of oxytocin, and the geographical region.

Competitive Landscape

The oxytocin market is competitive, with multiple manufacturers providing various formulations.

Key Players

  • Cantrell Drug Company: Offers oxytocin injection solutions in different concentrations[1].
  • Teva Parenteral Medicines, Inc.: Provides oxytocin injections in various strengths[1].
  • West-Ward Pharmaceuticals Corp.: Manufactures oxytocin injections for intravenous and intramuscular use[1].
  • Pfizer Canada Inc.: Supplies oxytocin injection USP in sterile, nonpyrogenic solutions[4].

Financial Trajectory

Revenue Streams

The revenue for oxytocin 10 USP units in dextrose 5% comes from hospital and clinical settings where it is administered.

Pricing

The pricing of oxytocin varies based on the concentration, volume, and manufacturer. For example, the cost of oxytocin 10 units/mL in a 1 mL vial can range from $1.6 to $9.84 per vial, depending on the labeller and region[1].

Sales Volume

The sales volume is influenced by the number of births and obstetric procedures requiring oxytocin. Given the essential nature of oxytocin in these procedures, the sales volume tends to be stable.

Cost Structure

The cost structure includes manufacturing costs, distribution expenses, and regulatory compliance.

Manufacturing Costs

Manufacturing involves the synthesis of oxytocin, formulation in dextrose solution, and packaging. The costs include raw materials, labor, and facility expenses.

Distribution and Marketing

Distribution costs involve getting the product to hospitals and clinics. Marketing expenses are relatively low since oxytocin is a well-established product with a clear medical indication.

Profit Margins

Profit margins for oxytocin can vary among manufacturers but generally remain moderate due to the competitive nature of the market.

Regulatory Environment

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

FDA Approval and Compliance

Oxytocin injections must comply with FDA regulations, including strict guidelines for manufacturing, labeling, and storage[2][3][5].

Stability and Storage

Oxytocin solutions must be stored between 20°C and 25°C and protected from freezing. The solution must be clear and free of particulate matter before administration[2][4].

Market Trends

Technological Advancements

There are limited technological advancements in the formulation of oxytocin itself, but improvements in delivery systems and monitoring technologies can impact its use.

Global Health Initiatives

Global health initiatives aimed at improving maternal health can increase the demand for oxytocin, especially in regions with high birth rates and limited access to obstetric care.

Challenges and Opportunities

Challenges

  • Competition: The market is highly competitive, which can lead to pricing pressures.
  • Regulatory Compliance: Strict regulatory requirements can increase costs and complexity.
  • Supply Chain Disruptions: Disruptions in the supply chain can affect availability and pricing.

Opportunities

  • Emerging Markets: Expanding into emerging markets where access to obstetric care is improving can increase demand.
  • Innovative Delivery Systems: Developing innovative delivery systems or formulations can differentiate a product in the market.

Key Takeaways

  • Oxytocin 10 USP units in dextrose 5% is a critical product in obstetric care.
  • The market is driven by medical indications and is segmented by administration type and geographical region.
  • The competitive landscape is characterized by multiple manufacturers, and the financial trajectory is influenced by stable demand and moderate profit margins.
  • Regulatory compliance and stability in storage are crucial factors.
  • Emerging markets and innovative delivery systems present opportunities for growth.

FAQs

What are the primary indications for oxytocin 10 USP units in dextrose 5%?

Oxytocin is indicated for the medical induction of labor, stimulation or reinforcement of labor, and management of postpartum hemorrhage and incomplete or inevitable abortion[2][3][4].

How is oxytocin 10 USP units in dextrose 5% administered?

It is administered intravenously or intramuscularly. For intravenous infusion, 10 units of oxytocin are added to 500 mL of physiologic saline solution or 5% dextrose solution and infused at a rate of 20 to 40 drops/minute[2][3][5].

What are the storage requirements for oxytocin 10 USP units in dextrose 5%?

The solution must be stored between 20°C and 25°C, protected from freezing, and used only if the solution is clear and free of particulate matter[2][4].

Who are the key players in the oxytocin market?

Key players include Cantrell Drug Company, Teva Parenteral Medicines, Inc., West-Ward Pharmaceuticals Corp., and Pfizer Canada Inc.[1][4].

What are the potential challenges in the oxytocin market?

Challenges include competition, regulatory compliance, and supply chain disruptions[1][2][4].

What opportunities exist for growth in the oxytocin market?

Opportunities include expanding into emerging markets and developing innovative delivery systems or formulations[1][2][4].

Sources

  1. DrugBank Online: Oxytocin: Uses, Interactions, Mechanism of Action.
  2. DailyMed: OXYTOCIN INJECTION, USP.
  3. FDA: Oxytocin Injection, USP - accessdata.fda.gov.
  4. Pfizer Canada Inc.: PRESCRIBING INFORMATION Oxytocin Injection USP.
  5. FDA: Pitocin® (Oxytocin Injection, USP) Synthetic.

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