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Last Updated: April 12, 2025

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% Drug Patent Profile


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When do Dopamine Hydrochloride In Dextrose 5% patents expire, and when can generic versions of Dopamine Hydrochloride In Dextrose 5% launch?

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

The generic ingredient in DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% 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%

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

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

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

SponsorPhase
Neurocrine BiosciencesPhase 4
Stephen RuedrichPhase 4
University of NebraskaPhase 1

See all DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% clinical trials

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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 018826-002 Sep 30, 1983 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 018826-003 Sep 30, 1983 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-001 Mar 27, 1987 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-002 Mar 27, 1987 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-003 Mar 27, 1987 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% dopamine hydrochloride INJECTABLE;INJECTION 020542-001 Aug 30, 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
Showing 1 to 6 of 6 entries

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

Introduction

Dopamine Hydrochloride in 5% Dextrose is a critical medication used to improve hemodynamic status in patients experiencing shock or reduced cardiac output. Understanding the market dynamics and financial trajectory of this drug is essential for pharmaceutical companies, healthcare providers, and investors.

Market Demand and Usage

The demand for Dopamine Hydrochloride in 5% Dextrose is driven by its indications in various critical care scenarios, including distributive shock, cardiogenic shock, and other conditions requiring hemodynamic stabilization. The medication is widely used in intensive care units (ICUs) and emergency departments, making it a staple in acute care settings[3][4][5].

Current Market Challenges

Drug Shortages

One of the significant challenges facing the market is the recurring shortage of Dopamine Hydrochloride in 5% Dextrose. Manufacturers such as Hikma and Pfizer have reported shortages due to manufacturing delays, which can severely impact patient care and hospital operations. For instance, Pfizer's dopamine products are on back order with estimated resupply dates ranging from late 2024 to early 2025[1].

Supply Chain Disruptions

Supply chain disruptions, exacerbated by global events like the COVID-19 pandemic, have further complicated the availability of this critical medication. These disruptions can lead to increased costs and logistical challenges for healthcare providers.

Competitive Landscape

The market for Dopamine Hydrochloride in 5% Dextrose is relatively concentrated, with a few major players such as Pfizer, Hikma, and Baxter. These companies compete based on product availability, pricing, and the quality of their formulations. The competitive landscape is also influenced by the presence of generic versions of the drug, which can impact pricing and market share[1][5].

Pricing and Reimbursement

The pricing of Dopamine Hydrochloride in 5% Dextrose can vary based on the concentration, volume, and manufacturer. The medication is generally covered by healthcare insurance and government programs, but reimbursement rates can fluctuate. In the United States, for example, reimbursement is often tied to Medicare and Medicaid rates, which can influence the financial trajectory of the drug[5].

Financial Performance

Revenue Trends

The revenue generated from Dopamine Hydrochloride in 5% Dextrose is stable due to its essential role in critical care. However, revenue can be impacted by shortages and supply chain issues, which may lead to fluctuations in sales. Pharmaceutical companies that manage to maintain a stable supply chain tend to perform better financially.

Cost Structure

The cost structure for Dopamine Hydrochloride in 5% Dextrose includes manufacturing costs, research and development expenses, marketing expenditures, and distribution costs. Companies that optimize their manufacturing processes and supply chains can reduce costs and improve profitability.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Dopamine Hydrochloride in 5% Dextrose. Regulatory bodies such as the FDA ensure that the drug meets strict safety and efficacy standards. Compliance with these regulations is essential for maintaining market approval and avoiding costly recalls or fines[2][4][5].

Innovation and R&D

While Dopamine Hydrochloride in 5% Dextrose has been on the market since 1974, ongoing research and development focus on improving formulations, delivery systems, and patient outcomes. Innovations in this area can enhance the drug's efficacy and safety profile, potentially increasing market share and revenue.

Patient Care Implications

Clinical Outcomes

The medication's effectiveness in improving hemodynamic status is well-documented. Patients who receive timely and appropriate doses of Dopamine Hydrochloride in 5% Dextrose often have better clinical outcomes, including increased cardiac output, improved blood pressure, and enhanced renal function[2][3][4].

Safety Considerations

Safety is a critical aspect of patient care. Dopamine Hydrochloride in 5% Dextrose has specific contraindications, such as pheochromocytoma, and potential interactions with other medications that must be carefully managed to avoid adverse reactions[3][4][5].

Market Forecast

The market for Dopamine Hydrochloride in 5% Dextrose is expected to remain stable due to its essential role in critical care. However, the forecast can be influenced by several factors, including:

  • Supply Chain Stability: Consistent supply chains will help maintain market stability.
  • Regulatory Changes: Any changes in regulatory requirements could impact the market.
  • Innovations: New formulations or delivery systems could enhance market growth.
  • Global Health Trends: Changes in global health trends, such as the prevalence of conditions requiring critical care, can influence demand.

Key Takeaways

  • Stable Demand: The demand for Dopamine Hydrochloride in 5% Dextrose remains stable due to its critical role in acute care.
  • Supply Chain Challenges: Shortages and supply chain disruptions are significant challenges that can impact market dynamics.
  • Regulatory Compliance: Adherence to regulatory standards is crucial for maintaining market approval.
  • Innovation: Ongoing R&D can improve the drug's efficacy and safety, potentially increasing market share.
  • Financial Stability: Companies that manage to maintain a stable supply chain and optimize costs tend to perform better financially.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for Dopamine Hydrochloride in 5% Dextrose? A: The medication is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output[3][4][5].

Q: Why are there shortages of Dopamine Hydrochloride in 5% Dextrose? A: Shortages are often due to manufacturing delays and supply chain disruptions[1].

Q: How is Dopamine Hydrochloride in 5% Dextrose administered? A: It is administered intravenously, preferably in a large vein with an infusion pump, often in an intensive care setting[3][4][5].

Q: What are the potential contraindications for Dopamine Hydrochloride in 5% Dextrose? A: The medication is contraindicated in patients with pheochromocytoma and uncorrected tachyarrhythmias or ventricular fibrillation[3][4][5].

Q: How does the regulatory environment impact the market for Dopamine Hydrochloride in 5% Dextrose? A: Regulatory compliance is essential for maintaining market approval, and any changes in regulatory requirements can significantly impact the market[2][4][5].

Cited Sources

  1. ASHP: Dopamine Hydrochloride Injection - ASHP
  2. FDA: DOPamine Hydrochloride and 5% Dextrose Injection, USP
  3. Drugs.com: Dopamine and Dextrose: Package Insert / Prescribing Info
  4. FDA: DOPamine HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
  5. DailyMed: DOPAMINE HYDROCHLORIDE IN DEXTROSE injection, solution

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