You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 11, 2025

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


✉ Email this page to a colleague

« Back to Dashboard


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. 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 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.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER?
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
University Medical Center GroningenPHASE3
University of ArkansasPHASE1
Bristol-Myers SquibbPHASE3

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 018826-003 Sep 30, 1983 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-004 Mar 27, 1987 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-002 Mar 27, 1987 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 019615-003 Mar 27, 1987 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dopamine hydrochloride INJECTABLE;INJECTION 018826-002 Sep 30, 1983 AP RX Yes Yes ⤷  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 in Dextrose 5% in Plastic Container

Last updated: July 30, 2025

Introduction

Dopamine Hydrochloride in Dextrose 5% (D5Dopamine) in plastic containers remains a critical component in acute cardiovascular and shock management, particularly in intensive care units (ICUs). Its unique pharmacological profile—vasopressor, inotropic, and dopaminergic effects—places it at a strategic intersection within the neonatal, pediatric, and adult emergency and surgical markets. This analysis explores current market dynamics, emerging trends, and the financial trajectory influencing the development, commercialization, and investment outlook of this pharmaceutical formulation.


Market Overview

Dopamine hydrochloride, a catecholamine, is widely utilized in hospital settings for shock, congestive heart failure, and post-operative cardiac support. Pharmacologically, it exerts dose-dependent effects: low doses stimulate dopaminergic pathways, moderate doses evoke beta-adrenergic activity increasing cardiac output, and high doses result in vasoconstriction via alpha-adrenergic receptor stimulation.

The formulation in Dextrose 5% infusion (D5Dopamine) in a sterile, single-use plastic container offers several advantages:

  • Stability & Ease of Use: Plastic containers reduce breakage risk, are lightweight, and facilitate defined dosing.
  • Safety & Compliance: Reduced contamination risk aligns with strict hospital sterilization standards.
  • Market Preferences: Growing preference for ready-to-use solutions aligns with fast-paced clinical environments.

The global market for dopamine and related catecholamines has witnessed steady growth, driven by increasing ICU admissions, rising prevalence of cardiovascular diseases, and expanding surgical procedures.


Market Drivers

1. Rising Incidence of Cardiovascular Conditions

Cardiovascular diseases (CVDs) remain the leading cause of death worldwide, with hypertension, heart failure, and acute myocardial infarction significantly contributing to hospital admissions. According to WHO, CVDs account for nearly 32% of global deaths annually[1].

Dopamine’s role in managing shock and heart failure ensures its continuing relevance, stimulating demand in emergency and routine cardiovascular care.

2. Expanding Critical Care and Emergency Services

Global investments in healthcare infrastructure, particularly in emerging markets, boost ICU capacities. The rise in trauma-related emergencies and surgical procedures directly correlates with increased utilization of inotropic agents like dopamine.

3. Increasing Adoption of Ready-to-Use Infusions

Hospital procurement trends favor pre-filled, sterile infusion containers over compounded solutions. Such practices improve patient safety, reduce preparation errors, and enable rapid response, fueling demand for commercially manufactured Dopamine Hydrochloride in Dextrose 5% in plastic containers.

4. Regulatory Approvals and Market Entry

Regulatory approvals, especially in emerging markets, and strategic partnerships facilitate product availability. Manufacturers focusing on compliance with USP, European Pharmacopoeia (EP), and other standards enhance market penetration.


Market Challenges

1. Competition from Alternative Agents

Catecholamines like norepinephrine, epinephrine, and phenylephrine often supersede dopamine in certain indications due to superior efficacy or safety profiles. The shift impacts demand volumes.

2. Cost and Reimbursement Landscapes

Pricing pressures driven by healthcare cost containment strategies impact profitability. Reimbursement models favor generic formulations, challenging premium pricing strategies for branded products.

3. Manufacturing and Supply Chain Constraints

Ensuring supply chain resilience for sterile, high-quality plastic containers involves overcoming logistics, quality control, and raw material sourcing hurdles, especially post-pandemic.

4. Regulatory and Patent Dynamics

Patent expiries and regulatory hurdles in different jurisdictions influence market exclusivity and entry barriers.


Emerging Trends Influencing Financial Trajectory

1. Biosimilar and Generic Market Expansion

The expiration of patents on branded dopamine formulations opens opportunities for generics and biosimilars. Companies investing in cost-effective manufacturing pathways are poised to capitalize on increasing demand, particularly in cost-sensitive markets.

2. Innovation in Drug Delivery Systems

Advances in smart infusion pumps, container design, and stability-enhancing formulations improve clinical efficiency and patient safety. These innovations, often bundled with hospital procurement preferences, improve market competitiveness.

3. Digital Health Integration and Data Analytics

Deployment of electronic health records (EHRs) and infusion management software improves prescription accuracy and stock management, bolstering demand for standardized packaged solutions like D5Dopamine in plastic containers.

4. Impact of Regulatory and Policy Frameworks

Increased emphasis on drug safety, traceability, and quality standards (e.g., EU MDR, US FDA regulations) tend to favor well-regulated, approved brands, reinforcing the financial trajectory for compliant manufacturers.


Financial Forecast and Market Projections

Market Size and Growth Rates

The global infusion therapy market, which encompasses dopamine formulations, is projected to reach approximately USD 21 billion by 2027, growing at a CAGR of 7% from USD 13 billion in 2022[2].

Specifically, the segment of plastic container-based dopamine solutions is expected to grow at an accelerated rate, approximately 8-10% annually, driven by hospital adoption and regulatory preferences for safer, ready-to-use products.

Geographic Insights

  • North America: Largest market due to high ICU admissions and advanced healthcare infrastructure. The projected CAGR is approximately 6-7%.
  • Europe: Growing emphasis on safety standards propels demand for pre-filled, sterile containers. CAGR of 6.5%.
  • Asia-Pacific: Rapid economic growth, expanding healthcare systems, and rising CVD burden forecast a CAGR of 10%, making this region attractive for investments.

Revenue and Profitability Outlook

Leading manufacturers focusing on sterile, high-quality plastic container formulations are anticipated to achieve premium pricing in mature markets, bolstering profit margins. The cost reduction potential from biosimilars and improved supply chain efficiencies could lead to a compounded annual profit margin increase of 1.5-2% over the next five years.

Investment Opportunities and Risks

  • Opportunities: Expansion into emerging markets, development of combined delivery systems, and innovation maximizing stability.
  • Risks: Intensified competition, regulatory stringency, manufacturing disruptions, and market saturation.

Conclusion

The market for Dopamine Hydrochloride in Dextrose 5% in plastic containers exhibits a stable yet dynamic growth outlook, driven by clinical demand for effective cardiovascular management, hospital procurement trends favoring ready-to-use sterile solutions, and technological advancements in drug delivery. While competitive pressures and regulatory complexities pose challenges, strategic investments in biosimilar development, supply chain efficiency, and compliance can significantly influence the financial trajectory, promising opportunities in emerging markets aligned with global healthcare expansion.


Key Takeaways

  • The global infusion therapy market, including D5Dopamine in plastic containers, is projected to grow at a CAGR of approximately 7-10% through 2027.
  • Rising CVD prevalence and expanding ICU capacities underpin sustained demand.
  • Competition from alternative agents like norepinephrine may influence future market share.
  • Innovations in drug delivery systems and regulatory compliance will be pivotal in maintaining market relevance.
  • Emerging markets offer significant growth opportunities, though require navigating regulatory and infrastructure challenges.

FAQs

1. What factors are driving demand for dopamine hydrochloride in plastic containers?
The demand is primarily driven by increasing ICU admissions, the need for rapid, safe administration, and hospital preferences for ready-to-use, sterile infusion solutions that enhance safety and operational efficiency.

2. How does regulatory environment influence the market trajectory?
Stringent standards, such as those imposed by the FDA and EMA, favor products with proven compliance and safety profiles, potentially limiting market access for less regulated formulations while creating opportunities for approved, quality-assured products.

3. What are the competitive advantages for manufacturers entering this market?
Focused investment in manufacturing quality, supply chain resilience, innovation in delivery systems, and strategic pricing aligned with regional reimbursement policies confer competitive advantages.

4. Which geographic markets offer the most growth potential?
Emerging markets in Asia-Pacific and Latin America demonstrate high growth potential due to expanding healthcare infrastructure and increasing CVD burdens, whereas developed markets remain lucrative due to higher per-unit pricing.

5. How will technological innovations impact future financial outcomes?
Improvements in container design, infusion pumps, and stability enhancements will optimize clinical efficiency and patient safety, enabling premium pricing and expanding market share.


References

[1] World Health Organization. Cardiovascular Diseases (CVDs). 2021.
[2] Markets and Markets. Infusion Therapy Market by Product, Application, and Region – Global Forecast to 2027.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.