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Last Updated: December 19, 2025

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% Drug Patent Profile


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

Dopamine Hydrochloride And Dextrose 5% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% is dopamine hydrochloride. There are nine drug master file entries for this compound. Eight 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 And Dextrose 5%

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

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

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SponsorPhase
Krzysztof BankiewiczPHASE1
University Medical Center GroningenPHASE3
University of ArkansasPHASE1

See all DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% dopamine hydrochloride INJECTABLE;INJECTION 019099-002 Oct 15, 1986 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019099-003 Oct 15, 1986 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% dopamine hydrochloride INJECTABLE;INJECTION 019099-004 Oct 15, 1986 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019099-001 Oct 15, 1986 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Last updated: August 3, 2025

Introduction

Dopamine Hydrochloride combined with Dextrose 5% is a critical formulation used primarily in the management of cardiovascular shock, heart failure, and certain inotropic support scenarios in clinical settings. As a medical asset, this combination commands interest due to its essential role in acute patient care, especially in intensive care units (ICUs). The pharmaceutical market surrounding this drug, however, is shaped by a complex interplay of regulatory, technological, and economic factors influencing its future trajectory.

This analysis explores the current market dynamics, key drivers, constraints, and financial outlook associated with Dopamine Hydrochloride and Dextrose 5%, providing strategic insights for stakeholders.

Market Overview

Dopamine Hydrochloride and Dextrose 5% are often supplied as a premixed infusion solution or as separate components requiring compounding. The drug's pivotal role in adrenergic and catecholaminergic therapy has preserved its status as a core medication within intensive care, anesthesia, and emergency medicine.

The global market for inotropic agents, which include dopamine, is projected to grow steadily, driven by increased incidence of cardiovascular diseases (CVD), expanding ICU populations, and advanced healthcare infrastructure in emerging markets. The global inotropic agents market was valued at approximately USD 4.6 billion in 2022, with dopamine accounting for a significant share owing to its widespread clinical acceptance.

Market Drivers

Rising Incidence of Cardiovascular Diseases

An aging global population correlates with an increase in conditions such as congestive heart failure, myocardial infarction, and septic shock—conditions that necessitate inotropic support with dopamine. According to the World Health Organization (WHO), CVD accounts for over 17.9 million deaths annually, a figure that is expected to perpetuate the demand for supporting drugs like dopamine [1].

Growth in ICU and Emergency Care Infrastructure

Expanding ICU facilities and advancements in emergency medical responses heighten the clinical utilization of dopamine. Particularly in emerging economies, improved healthcare access catalyzes increased drug use, contributing to a higher market volume.

Regulatory Approvals and Clinical Guidelines

Leading health authorities, including the FDA and EMA, recognize dopamine as a standard treatment for shock and cardiac failure. Updated clinical guidelines reinforce its role, fueling ongoing demand. Furthermore, approvals for expanded indications in certain jurisdictions bolster market stability.

Cost-Effectiveness and Ease of Use

Dopamine is relatively inexpensive, has a straightforward administration route, and well-understood pharmacodynamics, making it an attractive choice, especially in low- and middle-income countries (LMICs). Its compatibility with Dextrose 5% as a carrier solution simplifies preparation logistics.

Manufacturing Consolidation and Supply Chain Stability

A consolidation trend among manufacturers, particularly in Asia-Pacific and North America, aims to ensure supply stability and meet rising demand. Innovations in manufacturing and sterilization processes enhance product availability and reduce costs.

Market Constraints and Challenges

Regulatory and Safety Concerns

Dopamine use carries notable safety concerns, including arrhythmias and tachycardia, leading regulatory scrutiny. Recent guidelines emphasize precise dosing and monitoring, potentially restricting use and influencing manufacturing standards.

Generic Competition and Pricing Pressures

The availability of multiple generic manufacturers increases competition and pressures profit margins. Price erosion impacts revenue, notably for established formulations.

Supply Chain Disruptions

Global supply chains for raw materials, particularly for active pharmaceutical ingredients (APIs), are vulnerable to geopolitical, environmental, and pandemic-related disruptions, affecting production and distribution.

Emerging Alternatives

Newer inotropic agents, such as levosimendan and milrinone, are gaining favor in particular clinical scenarios due to perceived safety or efficacy advantages, potentially limiting dopamine's future market share.

Technological and Formulation Limitations

Limited innovation in enhancing drug stability, delivery systems, or combination formulations constrains competitiveness and market expansion.

Financial Trajectory and Revenue Projections

Historical Performance

Historically, the market for dopamine formulations has experienced moderate growth, aligning with global cardiovascular disease epidemiology and ICU expansion. Major pharmaceutical firms report consistent sales, often in the hundreds of millions annually, with notable variation based on geographic region.

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of approximately 3-4% for dopamine-based products from 2023 to 2030, reflecting steady demand with potential accelerators from emerging markets. The increasing integration of dopamine into emergency protocols and its continued presence in hospital formularies underpin this trend.

Regional Market Insights

  • North America: Mature but stable owing to widespread ICU infrastructure, regulatory clarity, and steady demand.
  • Europe: Similar to North America, with slight growth influenced by aging populations and healthcare expenditure.
  • Asia-Pacific: Fastest-growing segment driven by rising healthcare infrastructure, expanding ICU capacities, and increased cardiovascular disease prevalence.
  • Latin America and Middle East: Emerging markets offer further growth opportunities, supported by healthcare investment.

Market Share and Competitive Landscape

The market remains dominated by a handful of multinational players—Pfizer, Novartis, and Fresenius Kabi—who supply both branded and generic formulations. The entry of biosimilars or reformulations may alter future market shares.

Pricing Trends and Econonomies

Price stabilization is expected in mature markets, while competition intensifies in emerging regions. Cost-reduction efforts and manufacturing innovations aim to preserve profit margins amidst price pressures.

Strategic Implications for Stakeholders

  • Pharmaceutical Companies: Focus on manufacturing efficiency, expanding in emerging markets, and maintaining rigorous safety standards to retain market share.
  • Healthcare Providers: Prioritize integrating newer inotropic therapies where safety and efficacy advantages suggest potential benefits over dopamine.
  • Investors: Target companies with diversified portfolios, strategic manufacturing hubs, and capacity to adapt to regulatory shifts.

Future Outlook

The pharmaceutical landscape for Dopamine Hydrochloride and Dextrose 5% remains resilient due to its essential role. However, market evolution hinges on technological innovation, regulatory environments, and competitive dynamics. A shift toward precision medicine and improved formulations may unlock new revenue streams, but current projections favor steady, incremental growth aligned with overarching healthcare trends in cardiovascular and critical care.

Key Takeaways

  • The dopamine and dextrose 5% market exhibits resilient, moderate growth driven by rising cardiovascular disease rates and expanding ICU infrastructure.
  • Regulatory scrutiny and safety concerns influence clinical use patterns, with newer inotropic agents emerging as alternatives.
  • Supply chain stability and manufacturing innovation are vital to sustaining market share amidst increasing competition.
  • Emerging markets present significant expansion opportunities, especially in Asia-Pacific and Latin America.
  • Strategic investments in formulation innovation and safety profile enhancement are critical for long-term profitability.

FAQs

1. How does the safety profile of Dopamine influence its market trajectory?
Safety concerns, including arrhythmia risk, necessitate strict monitoring and influence clinical guidelines, potentially restraining growth but also encouraging innovations in safer formulations.

2. What are the main competitive factors impacting Dopamine Hydrochloride sales?
Price competitiveness, supply chain reliability, regulatory compliance, safety profile, and emerging therapeutic alternatives are primary determinants.

3. How significant are emerging markets for the future growth of Dopamine formulations?
Highly significant; expanding healthcare infrastructure and rising disease burden make regions like Asia-Pacific key growth drivers.

4. Could technological advances disrupt the current market?
Yes, advancements such as safer inotropes, novel delivery systems, or biosimilars could modify the competitive landscape substantially.

5. What are the strategic considerations for pharmaceutical firms involved in this market?
Firms should prioritize manufacturing efficiency, regulatory compliance, safety profile improvements, and geographic expansion to capture growth opportunities.


References

[1] World Health Organization. (2022). Cardiovascular Diseases Factsheet.

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