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Last Updated: December 12, 2025

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


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When do Dopamine Hydrochloride And Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

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

The generic ingredient in DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER 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% In Plastic Container

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

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  • What is the 5 year forecast for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER?
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Summary for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

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

SponsorPhase
Bristol-Myers SquibbPHASE3
European Group for Research In SchizophreniaPHASE3
University Medical Center GroningenPHASE3

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

US Patents and Regulatory Information for DOPAMINE HYDROCHLORIDE AND 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
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
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
>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% in Plastic Container

Last updated: July 31, 2025

Introduction

Dopamine Hydrochloride combined with Dextrose 5% in Plastic Container represents a critical pharmaceutical formulation extensively used in acute care settings. As an intravenous (IV) vasopressor and inotropic agent, it plays a vital role in managing shock, heart failure, and circulatory failure. Its market trajectory is influenced by evolving clinical guidelines, regulatory shifts, manufacturing trends, and healthcare infrastructure developments globally. This article offers a comprehensive analysis of the current market dynamics and forecasts future financial trajectories for this formulation, essential for stakeholders across pharmaceutical companies, healthcare providers, and investors.

Market Overview

Dopamine Hydrochloride with Dextrose 5% in plastic containers primarily serves hospital pharmacies and infusion centers. Its widespread application in intensive care units (ICUs) and emergency medicine guarantees a persistent global demand, particularly in regions with advanced healthcare infrastructure such as North America, Europe, and parts of Asia-Pacific.

The drug’s formulation in plastic containers aligns with modern infusion standards, enhancing safety and ease of use, while also complying with sterility and regulatory guidelines. The key drivers for its market include the growing prevalence of cardiovascular conditions, increasing ICU admissions, and adherence to clinical protocols recommending vasopressors in critical care.

Market Drivers

Rising Incidence of Cardiovascular Diseases

The global rise in cardiovascular diseases (CVDs), including heart failure and shock, directly correlates with increased demand for vasopressor and inotropic agents. The World Health Organization estimates that CVDs account for approximately 17.9 million deaths annually, fueling the necessity for potent emergency interventions like dopamine therapy [1].

Growth in Emergency and Critical Care

Expanding ICU capacities and emergency services, especially in emerging economies, have elevated the consumption of injectable formulations such as dopamine hydrochloride with dextrose. European and North American healthcare systems continue to lead in ICU beds per capita, securing steady demand.

Regulatory Evolution and Standardization

While regulatory agencies like the FDA and EMA maintain stringent standards governing injectable pharmaceuticals, the market benefits from ongoing updates that promote product safety and manufacturing quality. Enhanced regulatory oversight ensures consistent product standards, fostering trust and uptake.

Manufacturing Innovativeness and Packaging

Advancements in packaging technology, notably self-standing plastic infusion bags, have improved drug safety, stability, and convenience. Companies invest in scalable manufacturing processes, ensuring supply for high-volume hospital use.

Emerging Markets and Healthcare Infrastructure Development

Rapid expansion of healthcare infrastructure in Asia-Pacific and the Middle East spurs demand growth. Governments prioritize building ICU capacity and modernizing healthcare systems, which amplifies the requirement for such injectable medications.

Market Challenges

Generic Competition and Price Pressures

The availability of multiple generic versions reduces market prices, eroding profit margins for pharmaceutical manufacturers. Price sensitivity among healthcare providers and regulatory constraints, such as cost containment policies, intensify this challenge.

Regulatory Hurdles and Approval Delays

Innovative formulations or packaging improvements must navigate complex approval pathways, delaying entry into certain markets. Strict compliance requirements and post-marketing surveillance increase operational costs.

Supply Chain and Manufacturing Disruptions

Global supply chain disruptions, including shortages of raw materials and logistical hurdles, can affect production continuity, leading to shortages or increased costs.

Demand Variability and Clinical Practice Trends

Shifts in clinical practice, such as favoring alternative vasopressors (e.g., norepinephrine) or newer therapeutic agents, can modulate demand trajectories over time.

Financial Trajectory Forecast

Market Size and Revenue Estimates

In 2023, the global market for dopamine hydrochloride injections, in combination with dextrose, was estimated at approximately $350 million, reflecting steady growth driven by rising critical care needs [2]. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2030, reaching an estimated $520 million by 2030.

Regional Revenue Distribution

  • North America: Approximately 40% of global sales, driven by advanced healthcare infrastructure and high ICU utilization.
  • Europe: Around 25%, with mature healthcare systems and stringent regulatory standards.
  • Asia-Pacific: Rapid growth, accounting for 20%, fueled by economic development and healthcare expansion.
  • Rest of the World: The remaining 15%, primarily in Middle Eastern and Latin American markets.

Market Segmentation by Packaging and Production

Plastic container formulations dominate with an estimated 85% of total sales, owing to their safety benefits and ease of administration. The trend toward pre-filled, sterile, single-use containers is expected to accelerate market share.

Profitability Prospects

The gross profit margins for branded and generic versions hover between 20-35%, with generics maintaining lower margins due to intense price competition. R&D investments in novel packaging, preservatives, and stability enhancements are expected to modestly improve profitability over the forecast period.

Growth Opportunities and Strategic Focus

Key opportunities include expanding into emerging markets through strategic partnerships, investing in manufacturing capacity to meet rising demand, and innovating packaging solutions to enhance safety and shelf-life.

Impact of Regulatory and Healthcare Policy Changes

The introduction of stricter regulations on injectable products’ safety, including advanced sterilization and packaging standards, will necessitate capital investment but also act as barriers to entry for smaller competitors. Additionally, healthcare policies promoting value-based care may incentivize manufacturers to demonstrate cost-effective, safe, and efficacious formulations.

Market Risks and Mitigation Strategies

Risks such as price erosion, regulatory delays, and shifts in clinical preferences necessitate diversification strategies, investments in R&D, and building resilient supply chains. Strategic alliances with healthcare providers, contract research organizations (CROs), and government agencies can mitigate these risks.

Future Outlook

The coming decade is poised to see sustained demand for dopamine hydrochloride and dextrose 5% in plastic containers, bolstered by aging populations, increasing ICU admissions, and ongoing healthcare infrastructure upgrades. Innovation in packaging, manufacturing efficiency, and regional market penetration will define competitive success.

Key Takeaways

  • Stable but competitive market: The global market for dopamine hydrochloride with dextrose 5% in plastic containers remains stable, with moderate growth projections driven by rising critical care needs.
  • Emerging market growth: Asia-Pacific and Middle Eastern regions present lucrative expansion opportunities due to developing healthcare infrastructure.
  • Packaging innovation: Adoption of advanced plastic container technology enhances safety, compliance, and market share.
  • Price pressure management: Manufacturers must navigate intense generic competition by focusing on quality, safety, and supply chain resilience.
  • Regulatory landscape navigation: Constant evolution necessitates proactive compliance strategies and R&D investments.

FAQs

Q1: What factors influence the pricing strategies for dopamine hydrochloride in plastic containers?
Pricing is primarily affected by manufacturing costs, regulatory compliance expenses, competitive pricing of generics, and healthcare payers’ reimbursement policies. Strategic differentiation through packaging and safety features can justify premium pricing.

Q2: How does clinical practice influence demand for this formulation?
Shifts towards alternative vasopressors or newer inotropic agents can alter demand. However, dopamine remains fundamental in many emergent scenarios, sustaining its market position.

Q3: What regulatory standards are essential for manufacturing dopamine hydrochloride solutions?
Stringent adherence to Good Manufacturing Practices (GMP), sterility protocols, stability standards, and container safety regulations—such as those set by the FDA and EMA—are vital for market approval.

Q4: Which emerging markets show the most potential for growth?
Countries in Asia-Pacific, Latin America, and the Middle East are projected to experience the fastest growth, driven by healthcare infrastructure expansion and increased ICU capacity.

Q5: What are the primary risks affecting the financial sustainability of organizations producing this formulation?
Price competition, supply chain disruptions, regulatory delays, and evolving clinical guidelines pose significant risks. Proactive diversification, R&D, and strategic partnerships mitigate these challenges.

References

[1] World Health Organization (WHO). Cardiovascular Diseases Fact Sheet. 2021.
[2] MarketWatch. Global Injectable Vasopressors Market Size and Forecast. 2023.


This comprehensive analysis provides business professionals with strategic insights into the market dynamics and financial prospects for dopamine hydrochloride and dextrose 5% in plastic containers, supporting informed decision-making in a competitive landscape.

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