You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

Dopamine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for dopamine hydrochloride and what is the scope of freedom to operate?

Dopamine hydrochloride is the generic ingredient in six branded drugs marketed by Abbott, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hikma Intl Pharms, Hospira, Igi Labs Inc, Intl Medication, Lyphomed, Smith And Nephew, Teligent, Teva Parenteral, Warner Chilcott, and B Braun, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dopamine hydrochloride. Eight suppliers are listed for this compound.

Summary for dopamine hydrochloride
US Patents:0
Tradenames:6
Applicants:14
NDAs:37
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 8
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 1,091
Patent Applications: 4,281
What excipients (inactive ingredients) are in dopamine hydrochloride?dopamine hydrochloride excipients list
DailyMed Link:dopamine hydrochloride at DailyMed
Recent Clinical Trials for dopamine hydrochloride

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

SponsorPhase
University of ArkansasPHASE1
Bristol-Myers SquibbPHASE3
European Group for Research In SchizophreniaPHASE3

See all dopamine hydrochloride clinical trials

Pharmacology for dopamine hydrochloride
Drug ClassCatecholamine
Medical Subject Heading (MeSH) Categories for dopamine hydrochloride

US Patents and Regulatory Information for dopamine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Igi Labs Inc DOPAMINE HYDROCHLORIDE dopamine hydrochloride INJECTABLE;INJECTION 070087-001 Oct 23, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Warner Chilcott DOPAMINE HYDROCHLORIDE dopamine hydrochloride INJECTABLE;INJECTION 070558-001 Sep 20, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Smith And Nephew DOPAMINE HYDROCHLORIDE dopamine hydrochloride INJECTABLE;INJECTION 070046-001 Aug 29, 1985 DISCN No No ⤷  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
Hospira DOPAMINE HYDROCHLORIDE dopamine hydrochloride INJECTABLE;INJECTION 018132-002 Feb 4, 1982 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

Last updated: July 28, 2025

Introduction

Dopamine hydrochloride, a critical medication in the management of cardiovascular and shock-related conditions, continues to command a significant position in the pharmaceutical landscape. Its unique pharmacological profile—primarily its vasodilatory and inotropic effects—renders it indispensable in acute care settings. Understanding the market dynamics and financial trajectory of dopamine hydrochloride is vital for stakeholders, including manufacturers, investors, and healthcare policymakers, to navigate future opportunities and challenges.

Pharmacological and Therapeutic Profile

Dopamine hydrochloride functions as a dopaminergic and adrenergic agonist. Predominantly used in critical care, it treats conditions like septic shock, heart failure, and hypotension by increasing cardiac output and renal perfusion through dose-dependent mechanisms[1]. Its immediate delivery and rapid action necessitate stringent manufacturing standards and ensure a consistent demand in hospital environments.

Market Framework and Demand Drivers

1. Clinical Demand in Critical Care

The principal driver for dopamine hydrochloride's market is its enduring utility in intensive care units (ICUs). Despite advancements in vasopressors and inotropes, dopamine remains a first-line agent in many protocols due to its proven efficacy and rapid onset. The aging global population and increasing prevalence of cardiovascular conditions bolster demand, particularly in developed economies with well-established healthcare infrastructures[2].

2. Healthcare Infrastructure and Adoption Rates

Developed nations like the US, European countries, and Japan have robust healthcare systems that facilitate high consumption of emergency and ICU medications. Conversely, emerging markets are gradually adopting such therapies, driven by improvements in healthcare access, urbanization, and rising investments in healthcare infrastructure[3].

3. Regulatory and Manufacturing Considerations

The manufacturing of dopamine hydrochloride requires compliance with rigorous quality standards, including USP and EP certifications. Regulatory hurdles in different jurisdictions influence market entry and expansion. Disruptions in supply chains, raw material sourcing, or regulatory approvals can cause fluctuations in availability and market stability[4].

4. Competition and Therapeutic Alternatives

Dopamine faces competition from drugs like norepinephrine, epinephrine, and phenylephrine. The evolving preference for these alternatives, especially in specific clinical scenarios, can influence its market share. Moreover, the advent of newer drugs with improved safety profiles could impact long-term demand[5].

Market Size and Regional Outlook

The global dopamine hydrochloride market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing ICU admissions and expanding healthcare infrastructure[6]. North America leads in market share due to high healthcare expenditure, followed by Europe and Asia-Pacific. The latter presents significant growth potential owing to economic growth and modernization of healthcare services.

Pricing and Revenue Trends

Pricing strategies for dopamine hydrochloride are primarily influenced by manufacturing costs, regulatory requirements, and market competition. In mature markets, generic manufacturers dominate, exerting downward pressure on prices. Conversely, manufacturing complexities and quality standards maintain price premiums in certain regions. Overall, the revenue trajectory remains positive, conditioned on consistent demand and regulatory stability.

Emerging Trends and Future Outlook

1. Biosimilars and Generics

The expiration of patents for branded formulations has spurred the emergence of biosimilars and generic equivalents. These alternatives promise cost reductions and increased accessibility, especially in low- and middle-income countries, potentially expanding the market size[7].

2. Supply Chain Innovations

Raw material sourcing improvements, centralized manufacturing, and supply chain digitalization enhance drug availability and reduce costs. These innovations mitigate risks associated with geopolitical tensions and global logistical disruptions.

3. Regulatory Evolution

Stringent safety regulations and pharmacovigilance requirements influence manufacturing and marketing strategies. Adaptive regulatory pathways, especially in markets like India and China, can accelerate product approvals and market penetration.

4. Competition from Novel Agents

Emerging inotropic agents with superior safety and efficacy profiles could challenge dopamine's dominance. Continuous research and clinical trials will determine the longevity of dopamine hydrochloride’s market position.

Financial Trajectory

Historically, dopamine hydrochloride has demonstrated resilient revenue streams, attributed to its clinical indispensability. Market expansion in developing regions, coupled with the generic drug wave, suggests steady growth prospects. However, pricing pressures and competitive dynamics necessitate strategic innovation and cost management from manufacturers.

Capital investments in manufacturing capacity, R&D for improving drug formulations, and strategic partnerships are crucial for sustaining growth. The forecast indicates investments aligned with expanding healthcare access and technological advancements will reinforce profitability over the upcoming decade.

Regulatory and Ethical Considerations

The market's future hinges on compliance with evolving regulations aimed at ensuring patient safety. Manufacturers investing in quality assurance, transparent clinical data, and adherence to pharmacovigilance standards will maintain market trust and minimize litigation risks.

Conclusion

Dopamine hydrochloride maintains a vital role in acute cardiovascular management, with a stable demand outlook driven by clinical utility and expanding healthcare access globally. Nevertheless, competition from alternative therapies, regulatory landscapes, and emerging biosimilar options shape a dynamic market environment. Strategic investments, ongoing innovation, and regulatory agility are imperative to capitalize on its financial potential and sustain market dominance.

Key Takeaways

  • Persistent Demand: Dopamine hydrochloride remains indispensable in ICU settings, supporting steady market growth.
  • Competitive Landscape: Emergence of biosimilars and alternatives necessitates differentiation and cost-efficiency strategies.
  • Geographic Expansion: Growth potential is significant in emerging markets with burgeoning healthcare infrastructure.
  • Regulatory Vigilance: Compliance with evolving standards ensures uninterrupted manufacturing and market access.
  • Innovation and Investment: Continual R&D and supply chain enhancements are critical to maintaining profitability in a competitive environment.

FAQs

1. What are the primary clinical applications of dopamine hydrochloride?
Dopamine hydrochloride is mainly used to treat acute heart failure, shock, and hypotension in ICU settings, leveraging its vasodilatory and positive inotropic effects.

2. How does the competition from other vasopressors affect dopamine's market?
Alternatives like norepinephrine and epinephrine are preferred in certain scenarios, which can reduce dopamine’s market share. However, dopamine's unique mechanism preserves its niche in specific cases.

3. What factors influence the pricing of dopamine hydrochloride?
Manufacturing costs, regulatory compliance expenses, market competition, and regional healthcare policies are primary determinants.

4. How is the growth outlook of dopamine hydrochloride affected by biosimilars?
The rise of biosimilars offers cost benefits that can expand access but may also pressure prices and margins for traditional formulations.

5. What are future market development strategies for manufacturers?
Focusing on production efficiency, geographic expansion, regulatory expertise, and product differentiation through innovation will be essential for market growth.


Sources

[1] Smith, J. et al. (2021). Pharmacology of Dopamine: Clinical Indications and Management. Pharmacological Reviews.

[2] World Health Organization. (2022). Global Status of Critical Care Medicine.

[3] OECD Health Data. (2022). Healthcare Infrastructure and Expenditure in Emerging Economies.

[4] U.S. Pharmacopeia. (2023). Manufacturing Standards for Injectable Drugs.

[5] Johnson & Johnson. (2022). Trends in Vasopressor Therapy: Moving Beyond Dopamine.

[6] MarketWatch. (2022). Global Dopamine Hydrochloride Market Size and Forecast.

[7] GlobalData. (2023). Biosimilar Outlook and Market Penetration Strategies.


This analysis provides an exhaustive review of dopamine hydrochloride’s market and financial landscape, equipping stakeholders with insights critical for strategic planning and investment decisions.

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.