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Last Updated: December 22, 2024

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dopamine Hydrochloride In Dextrose 5% In Plastic Container, and when can generic versions of Dopamine Hydrochloride In Dextrose 5% In Plastic Container launch?

Dopamine Hydrochloride In Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare and Hospira and is included in two NDAs.

The generic ingredient in DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER is dopamine hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dopamine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

A generic version of DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as dopamine hydrochloride by HOSPIRA on February 4th, 1982.

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Summary for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

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

SponsorPhase
Stephen RuedrichPhase 4
Neurocrine BiosciencesPhase 4
ChimerixPhase 1

See all DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug ClassCatecholamine

US Patents and Regulatory Information for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-001 Mar 27, 1987 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 018826-003 Sep 30, 1983 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-004 Mar 27, 1987 RX Yes Yes ⤷  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

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dopamine Hydrochloride in 5% Dextrose Injection

Introduction

Dopamine Hydrochloride in 5% Dextrose Injection is a critical medication used to improve the hemodynamic status of patients, particularly those in distributive shock or with reduced cardiac output. The market dynamics and financial trajectory of this drug are influenced by several factors, including supply and demand, manufacturing challenges, and regulatory environments.

Clinical Significance

Dopamine Hydrochloride is a natural catecholamine that exhibits inotropic effects and increases cardiac output, making it essential for patients who are hemodynamically unstable, such as those experiencing cardiogenic shock[1].

Market Demand

The demand for Dopamine Hydrochloride in 5% Dextrose Injection is steady due to its critical role in intensive care and emergency medicine. Hospitals and healthcare facilities consistently require this medication to manage acute cardiovascular conditions.

Supply Chain and Shortages

The supply chain for Dopamine Hydrochloride has faced significant challenges. Manufacturing delays have led to shortages, particularly with major manufacturers like Pfizer. For instance, Pfizer has dopamine 800 mg/500 mL premixed bags on back order with an estimated release date of October 2025[1].

Impact of Shortages

These shortages have significant implications for patient care. Alternative products from other manufacturers, such as Baxter, may be used, but the availability and consistency of these alternatives can vary. This instability in supply can lead to increased costs and logistical challenges for healthcare providers.

Manufacturing and Production

The production of Dopamine Hydrochloride in 5% Dextrose Injection involves several key players, including Pfizer, Hikma, and Baxter. Each manufacturer has its own production lines and distribution networks, but manufacturing delays and quality control issues can disrupt the supply chain.

Production Capacities

Manufacturers like Baxter have maintained a more stable supply of dopamine products, offering various concentrations and container sizes. For example, Baxter provides Dopamine Hydrochloride in 5% Dextrose injection in several strengths, including 200 mg/250 mL, 400 mg/250 mL, and 800 mg/500 mL[1].

Financial Implications

The financial trajectory of Dopamine Hydrochloride in 5% Dextrose Injection is complex and influenced by several factors:

Pricing Dynamics

Shortages can drive up prices due to increased demand and reduced supply. This can lead to higher costs for healthcare providers and potentially affect patient care due to budget constraints.

Revenue Streams

Manufacturers generate significant revenue from the sale of Dopamine Hydrochloride products. However, shortages and manufacturing delays can disrupt revenue streams and impact the financial performance of these companies.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Dopamine Hydrochloride. The FDA oversees the production and distribution of this medication, ensuring compliance with safety and efficacy standards.

Compliance and Quality Control

Manufacturers must adhere to strict quality control measures to avoid recalls and ensure the safety of patients. Non-compliance can result in financial penalties and damage to the company's reputation.

Competitive Landscape

The market for Dopamine Hydrochloride in 5% Dextrose Injection is competitive, with several major pharmaceutical companies involved:

Key Players

  • Pfizer: One of the largest manufacturers, currently facing manufacturing delays.
  • Hikma: Another significant player, with products on back order.
  • Baxter: Maintains a stable supply of various dopamine products[1].

Market Trends

Several trends are shaping the market for Dopamine Hydrochloride:

Increasing Demand

The demand for critical care medications is increasing due to the growing need for intensive care services, driven by factors such as aging populations and the prevalence of cardiovascular diseases.

Technological Advancements

Advancements in manufacturing technology and supply chain management could help mitigate future shortages and improve the consistency of supply.

Economic Impact

The economic impact of Dopamine Hydrochloride shortages extends beyond the pharmaceutical industry:

Healthcare Costs

Shortages can lead to increased healthcare costs due to the need for alternative treatments or the use of more expensive medications.

Patient Outcomes

The availability of Dopamine Hydrochloride directly affects patient outcomes. Shortages can compromise the quality of care, potentially leading to worse health outcomes and increased mortality rates.

Future Outlook

The future outlook for Dopamine Hydrochloride in 5% Dextrose Injection is uncertain due to ongoing supply chain issues:

Resupply Dates

Manufacturers have estimated resupply dates, but these are subject to change. For instance, Pfizer estimates the release of 800 mg/500 mL premixed bags in October 2025[1].

Strategic Initiatives

Companies are likely to invest in strategic initiatives to improve manufacturing capacity and reduce the risk of future shortages.

Key Takeaways

  • Stable Demand: The demand for Dopamine Hydrochloride in 5% Dextrose Injection remains steady due to its critical role in patient care.
  • Supply Chain Challenges: Manufacturing delays and shortages are significant issues affecting the market.
  • Financial Implications: Shortages can drive up prices and disrupt revenue streams.
  • Regulatory Compliance: Adherence to FDA standards is crucial for maintaining market presence.
  • Competitive Landscape: Multiple major pharmaceutical companies are involved, with varying levels of supply stability.

FAQs

Q: What are the primary reasons for the current shortages of Dopamine Hydrochloride in 5% Dextrose Injection?

A: The primary reasons include manufacturing delays, particularly affecting Pfizer's production lines[1].

Q: Which manufacturers currently have a stable supply of Dopamine Hydrochloride products?

A: Baxter is one of the manufacturers that has maintained a stable supply of various dopamine products[1].

Q: How do shortages of Dopamine Hydrochloride affect patient care?

A: Shortages can compromise patient care by limiting the availability of this critical medication, potentially leading to worse health outcomes[1].

Q: What are the estimated resupply dates for Pfizer's Dopamine Hydrochloride products?

A: Pfizer estimates the release of 800 mg/500 mL premixed bags in October 2025[1].

Q: How does the regulatory environment impact the market for Dopamine Hydrochloride in 5% Dextrose Injection?

A: The FDA's oversight ensures compliance with safety and efficacy standards, which is crucial for maintaining market presence and ensuring patient safety[4].

Sources

  1. ASHP: Drug Shortage Detail: Dopamine Hydrochloride Injection.
  2. NCBI: Subsecond dopamine fluctuations in human striatum encode superposed error signals about actual and counterfactual reward.
  3. Eugia US: Milrinone Lactate in 5% Dextrose Injection Premixed Bag.
  4. FDA: Dopamine Hydrochloride and 5% Dextrose Injection, USP.
  5. DailyMed: DOPAMINE HYDROCHLORIDE IN DEXTROSE injection, solution.

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