DOPAMINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for dopamine hydrochloride and what is the scope of patent protection?

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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,011
Patent Applications:	3,496
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

Sponsor	Phase
Stephen Ruedrich	Phase 4
Neurocrine Biosciences	Phase 4
University of Nebraska	Phase 1

See all DOPAMINE HYDROCHLORIDE clinical trials

Pharmacology for DOPAMINE HYDROCHLORIDE

Drug Class

Catecholamine

Medical Subject Heading (MeSH) Categories for DOPAMINE HYDROCHLORIDE

Cardiotonic Agents

Dopamine Agents

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for DOPAMINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Am Regent	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	INJECTABLE;INJECTION	070826-001	Feb 11, 1987		DISCN	No	No
Hospira	DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dopamine hydrochloride	INJECTABLE;INJECTION	018826-003	Sep 30, 1983	AP	RX	Yes	Yes
Igi Labs Inc	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	INJECTABLE;INJECTION	070094-001	Oct 23, 1985		DISCN	No	No
Igi Labs Inc	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	INJECTABLE;INJECTION	070089-001	Oct 23, 1985		DISCN	No	No
Hospira	INTROPIN	dopamine hydrochloride	INJECTABLE;INJECTION	017395-003	Approved Prior to Jan 1, 1982		DISCN	No	No

DOPAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dopamine Hydrochloride

Introduction

Dopamine hydrochloride is a critical medication used in the treatment of various cardiovascular conditions, including shock, low blood pressure, and poor perfusion of vital organs. Here, we delve into the market dynamics and financial trajectory of this essential drug.

Market Size and Growth

The dopamine hydrochloride injection market has been experiencing significant growth. As of 2023, the market size was valued at USD 1.2 billion and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.5% from 2024 to 2031[1].

Key Drivers of Growth

Several factors are driving the growth of the dopamine hydrochloride market:

Increased Prevalence of Cardiovascular Diseases

The rising incidence of heart illnesses and the need for effective treatments to manage low blood pressure and cardiac arrest are major drivers. Cardiovascular diseases, such as cardiogenic shock and hemorrhagic shock, require immediate and effective interventions, making dopamine hydrochloride a vital component in emergency cardiac care[1][3].

Advances in Medical Technology

Developments in more effective formulas and medical technology are also accelerating market growth. Improved formulations and delivery systems enhance the efficacy and safety of dopamine hydrochloride, making it a preferred choice in clinical settings[1].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure and increasing awareness of emergency cardiac care are contributing to the wider adoption of dopamine hydrochloride injections. As healthcare systems improve, especially in developing regions, the demand for this medication is expected to increase[1].

Market Segmentation

The dopamine hydrochloride market is segmented based on several criteria:

Application

The market is segmented into hospitals, clinics, recovery centers, and research methodologies. Hospitals and clinics are the primary users due to the critical nature of the conditions treated with dopamine hydrochloride[1].

Product

The market is segmented by product concentration, including 200mg/250ml, 400mg/250ml, and 800mg/250ml. Each concentration serves different clinical needs and patient requirements[1].

Geography

The market is divided into geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to show significant growth due to its large population and improving healthcare infrastructure[1].

Competitive Landscape

The dopamine hydrochloride market is characterized by the presence of several key players:

Major Companies

Companies such as Pfizer, American Regent, Baxter, Smarth Life Sciences, Hikma, SG Pharma, Shanghai Harvest Pharmaceutical, Wuhan Jiuan Pharmaceutical, Grand Pharma, and Yabang Pharm are prominent in the market. These companies have established themselves through their product offerings and market presence[1].

Research and Development

The R&D landscape is dynamic, with ongoing clinical trials and approvals. For instance, as of 2023, there were numerous clinical trials in various phases, indicating continuous efforts to improve the drug's efficacy and safety[2][3].

Financial Performance

The financial performance of the dopamine hydrochloride market is robust and growing:

Revenue Projections

The market is expected to more than double from its 2023 value of USD 1.2 billion to USD 2.5 billion by 2031. This growth is driven by increasing demand, improved healthcare infrastructure, and advancements in medical technology[1].

Pricing

The pricing of dopamine hydrochloride varies based on the concentration and formulation. For example, the cost can range from USD 0.04 to USD 0.15 per milliliter depending on the product and manufacturer[2].

Regulatory Environment

Dopamine hydrochloride has received regulatory approvals globally, with the first approval granted in the United States in February 1974. Its orphan drug status highlights its importance in treating rare and critical conditions[3].

Therapeutic Applications

Dopamine hydrochloride is primarily used to treat:

Cardiovascular Conditions

It is used to manage cardiogenic shock, hemorrhagic shock, and hypotension. The drug's mechanism of action involves agonism of dopamine receptors, which helps in improving heart function and blood circulation[2][3].

Neurological Effects

While its primary use is in cardiovascular care, dopamine hydrochloride also interacts with dopamine receptors in the brain, which can have implications for neurological conditions. However, its use in neurological disorders is more nuanced and requires careful consideration of its pharmacokinetics and potential side effects[3].

Challenges and Opportunities

Despite the growth, there are challenges and opportunities in the dopamine hydrochloride market:

Side Effects and Toxicity

Dopamine hydrochloride can have significant side effects, including cardiac arrhythmias, nausea, vomiting, and involuntary movements. Managing these side effects is crucial for patient safety[2].

Market Competition

The market is competitive, with several players vying for market share. Innovation in formulations and delivery systems, as well as strategic partnerships, can provide opportunities for growth[1][3].

Emerging Markets

The Asia-Pacific region and other emerging markets present significant opportunities due to their growing healthcare needs and improving infrastructure[1].

"Dopamine hydrochloride is classified as an orphan drug, which means it is intended to treat rare diseases or conditions that affect a small number of patients. This regulatory designation provides certain incentives to pharmaceutical companies to develop drugs for these specific indications."[3]

Key Takeaways

• Market Growth: The dopamine hydrochloride market is expected to grow from USD 1.2 billion in 2023 to USD 2.5 billion by 2031, with a CAGR of 9.5%.
• Key Drivers: Increased prevalence of cardiovascular diseases, advances in medical technology, and expanding healthcare infrastructure drive market growth.
• Market Segmentation: The market is segmented by application, product concentration, and geography.
• Competitive Landscape: Major players include Pfizer, American Regent, and Baxter, among others.
• Financial Performance: Revenue is projected to more than double by 2031, driven by increasing demand and improved healthcare infrastructure.
• Therapeutic Applications: Primarily used to treat cardiogenic shock, hemorrhagic shock, and hypotension.

FAQs

Q: What is the current market size of the dopamine hydrochloride injection market?

A: The market size was valued at USD 1.2 billion in 2023[1].

Q: What is the projected growth rate of the dopamine hydrochloride market?

A: The market is expected to grow at a CAGR of 9.5% from 2024 to 2031[1].

Q: What are the primary therapeutic applications of dopamine hydrochloride?

A: It is primarily used to treat cardiogenic shock, hemorrhagic shock, and hypotension[2][3].

Q: Who are the major players in the dopamine hydrochloride market?

A: Major players include Pfizer, American Regent, Baxter, Smarth Life Sciences, and others[1].

Q: What are the key drivers of growth in the dopamine hydrochloride market?

A: Increased prevalence of cardiovascular diseases, advances in medical technology, and expanding healthcare infrastructure are key drivers[1].

Sources

1. Market Research Intellect - Dopamine Hydrochloride Injection Market Size And Forecast
2. DrugBank Online - Dopamine: Uses, Interactions, Mechanism of Action
3. Patsnap Synapse - Deep Scientific Insights on Dopamine hydrochloride's R&D Progress
4. Market Research Reports - Global Dopamine Hydrochloride Market Growth 2024-2030
5. Frontiers in Pharmacology - The Role of Dopamine in the Stimulant Characteristics of Novel Psychoactive Substances (NPS)