Dobutamine hydrochloride - Generic Drug Details

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

Dobutamine hydrochloride is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hospira, Luitpold, Slate Run Pharma, Teligent, Teva Parenteral, Watson Labs, Watson Labs Inc, and Lilly, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for dobutamine hydrochloride. Six suppliers are listed for this compound.

Summary for dobutamine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	16
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	117
Patent Applications:	1,115
What excipients (inactive ingredients) are in dobutamine hydrochloride?	dobutamine hydrochloride excipients list
DailyMed Link:	dobutamine hydrochloride at DailyMed

Recent Clinical Trials for dobutamine hydrochloride

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

Sponsor	Phase
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu	N/A
Koç University	N/A
Wuhan Union Hospital, China	Phase 2/Phase 3

See all dobutamine hydrochloride clinical trials

Pharmacology for dobutamine hydrochloride

Drug Class	beta-Adrenergic Agonist
Mechanism of Action	Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for dobutamine hydrochloride

Adrenergic beta-1 Receptor Agonists

Cardiotonic Agents

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for dobutamine hydrochloride

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

US Patents and Regulatory Information for dobutamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-003	Oct 19, 1993		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-002	Oct 19, 1993		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074634-001	Sep 27, 1996		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020201-002	Oct 19, 1993	AP	RX	Yes	Yes
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-001	Oct 19, 1993		DISCN	No	No
Baxter Hlthcare	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020255-004	Oct 19, 1993	AP	RX	Yes	Yes

Expired US Patents for dobutamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982

Dobutamine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dobutamine Hydrochloride

Introduction

Dobutamine Hydrochloride, a small molecule drug developed by Eli Lilly & Co., has been a cornerstone in the treatment of heart failure and other cardiovascular conditions since its FDA approval in 1978. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth

The global Dobutamine Hydrochloride market is experiencing significant growth. As of 2023, the market size is estimated to be around USD 1.2 billion. Projections indicate that this figure will rise to USD 2.1 billion by 2032, reflecting a Compound Annual Growth Rate (CAGR) of 6.5%[4].

Key Drivers of Growth

Several factors are driving the growth of the Dobutamine Hydrochloride market:

Increasing Prevalence of Heart Failure

Heart failure, the primary indication for Dobutamine Hydrochloride, is becoming more prevalent due to an aging population and rising rates of hypertension, diabetes, and other cardiovascular risk factors. This increasing demand for effective treatments contributes to the market's expansion[1].

Clinical Efficacy and Safety

Dobutamine Hydrochloride has a well-established track record of safety and efficacy, making it a preferred choice among clinicians for managing heart failure. Its ability to increase cardiac output and alleviate symptoms such as shortness of breath and fatigue further solidifies its market position[1][2].

Diagnostic Applications

In addition to therapeutic use, Dobutamine Hydrochloride is used in diagnostic procedures like dobutamine stress echocardiography (DSE), which evaluates ischemia in patients unable to exercise. This dual utility enhances its market value[3].

Competitive Landscape

The market for Dobutamine Hydrochloride is characterized by intense competition, particularly among major pharmaceutical companies. Key players include:

Eli Lilly & Co.

As the original developer, Eli Lilly & Co. holds a significant position in the market. However, other companies like Novartis AG, GSK Plc, AstraZeneca PLC, Pfizer Inc., and Sanofi are also actively involved in research and development related to adrenergic receptor agonists[1].

Pfizer's Role

Pfizer, the sole manufacturer of dobutamine in vials and a major producer of flexible container products, plays a critical role in the supply chain. Despite recent manufacturing challenges and shortages, Pfizer continues to be a key player in ensuring the availability of Dobutamine Hydrochloride[3].

Challenges and Shortages

The market has faced recent challenges, including a shortage of Dobutamine Hydrochloride due to manufacturing issues and increased demand. This shortage has impacted both therapeutic and diagnostic applications, particularly affecting patients with advanced heart failure and those undergoing DSE[3].

Supply Chain Resilience

Efforts to build resilience into medical supply chains, as recommended by the National Academies of Science, Engineering, and Medicine (NASEM) under the CARES Act, are crucial in mitigating future shortages. Regular updates and management recommendations from the FDA and the American Society of Health System Pharmacists also help in managing these challenges[3].

Geographical Distribution

The development and distribution of Dobutamine Hydrochloride are concentrated in several key countries:

United States, China, and Japan

These countries are at the forefront of drug development and production, with significant contributions from other regions as well. The global nature of the market ensures a broad reach and accessibility of the drug[1].

Financial Projections

The financial trajectory of Dobutamine Hydrochloride is positive, driven by increasing demand and a growing market size. Here are some key financial projections:

Market Size Growth

From USD 1.2 billion in 2023 to USD 2.1 billion by 2032, the market is expected to grow substantially, driven by the increasing prevalence of heart failure and the drug's established efficacy[4].

Revenue Streams

Revenue is generated through both therapeutic and diagnostic uses. The drug's versatility in clinical settings ensures a steady and growing revenue stream.

Key Takeaways

• Market Growth: The global Dobutamine Hydrochloride market is projected to grow at a CAGR of 6.5% from 2023 to 2032.
• Clinical Efficacy: The drug's well-established safety and efficacy profile in treating heart failure and its diagnostic applications drive market demand.
• Competitive Landscape: Major pharmaceutical companies are involved, with Eli Lilly & Co. and Pfizer playing significant roles.
• Challenges: Recent shortages have impacted the market, but efforts to enhance supply chain resilience are underway.
• Geographical Distribution: The market is global, with key contributions from the United States, China, and Japan.

FAQs

Q: What is the primary indication for Dobutamine Hydrochloride? A: Dobutamine Hydrochloride is primarily indicated for the treatment of heart failure, a condition characterized by the heart's inability to pump blood effectively[1].

Q: Who developed Dobutamine Hydrochloride? A: Dobutamine Hydrochloride was developed by Eli Lilly & Co.[1].

Q: What are the diagnostic applications of Dobutamine Hydrochloride? A: It is used in procedures like dobutamine stress echocardiography (DSE) to evaluate ischemia in patients unable to exercise[3].

Q: Why did the Dobutamine Hydrochloride market face recent shortages? A: The shortages were due to manufacturing challenges, increased demand, and delays in obtaining components from third-party suppliers[3].

Q: What is the projected market size of Dobutamine Hydrochloride by 2032? A: The market is projected to grow to USD 2.1 billion by 2032, with a CAGR of 6.5% from 2023[4].

Cited Sources

1. Patsnap Synapse: A Comprehensive Review of Dobutamine Hydrochloride's R&D Innovations.
2. DailyMed: DOBUTamine Hydrochloride in 5% Dextrose Injection.
3. American College of Cardiology: Guidance For Clinicians on Dobutamine Shortage.
4. Dataintelo: Dobutamine Hydrochloride Market Research Report 2032.