DOBUTREX Drug Patent Profile

Which patents cover Dobutrex, and when can generic versions of Dobutrex launch?

Dobutrex is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in DOBUTREX is dobutamine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dobutrex

A generic version of DOBUTREX was approved as dobutamine hydrochloride by HOSPIRA on November 29^th, 1993.

Summary for DOBUTREX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	9
Patent Applications:	765
DailyMed Link:	DOBUTREX at DailyMed

Recent Clinical Trials for DOBUTREX

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

Sponsor	Phase
Rigshospitalet, Denmark	Phase 2
Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat	Phase 2
Simon Spies Fonden	Phase 2

See all DOBUTREX clinical trials

US Patents and Regulatory Information for DOBUTREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for DOBUTREX

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

International Patents for DOBUTREX

See the table below for patents covering DOBUTREX around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2317710
Australia	5438573
Denmark	527178

DOBUTREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dobutamine

Introduction to Dobutamine

Dobutamine, a sympathomimetic medication, is widely used in the treatment of heart failure, cardiac stress tests, and other cardiac conditions. It is administered parenterally to provide inotropic support, particularly in cases of depressed contractility due to organic heart disease or cardiac surgical procedures.

Market Size and Growth Projections

The global dobutamine market has been valued at USD 100 billion in 2023 and is projected to reach USD 140.71 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.2% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The global rise in cardiovascular disease cases is a primary driver for the widespread use of dobutamine. As the incidence of heart failure, myocardial infarction, and other cardiac conditions increases, the demand for dobutamine is expected to soar[1].

Advances in Diagnostic Techniques and Medical Technology

Improvements in diagnostic techniques and medical technology have enhanced the identification and management of heart conditions, further driving the market for dobutamine. These advancements allow for more accurate diagnoses and effective treatment plans, which in turn increase the use of dobutamine[1].

Aging Population and Lifestyle Factors

The aging population and changing lifestyles that contribute to heart-related illnesses are significant factors driving market expansion. As people age, the risk of cardiovascular diseases increases, leading to a higher demand for cardiac medications like dobutamine[1].

Healthcare Infrastructure and Reimbursement Schemes

Developments in healthcare infrastructure and favorable reimbursement schemes also play a crucial role in the availability and use of dobutamine. Rising healthcare costs, combined with advantageous reimbursement policies, make dobutamine more accessible to patients, thereby propelling market growth[1].

Market Segmentation

By Application

The dobutamine market is segmented based on its applications, which include:

• Chronic Heart Failure: Dobutamine is used to support heart function in patients with chronic heart failure.
• Myocardial Infarction: It is used in the management of heart attacks.
• Postoperative Hypotension: Dobutamine helps in maintaining blood pressure after surgical procedures.
• Others: This includes various other cardiac conditions where inotropic support is necessary[1].

By Product

The market is also segmented by product type, primarily including:

• Injection 200mg
• Injection 250mg[1].

By Geography

Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics influenced by local healthcare systems, economic conditions, and prevalence of cardiovascular diseases[1].

Competitive Landscape

The dobutamine market is characterized by a competitive landscape involving several major players. Companies such as Ivax Pharmaceuticals, Physicians Total Care, Baxter Healthcare, Sanofi, Teva Canada, Pfizer, Bedford Laboratories, Novartis, Sterimax, and Teligent are key participants in this market. These companies are engaged in continuous research and development to improve medication efficacy and safety, which further drives market growth[1].

Recent Developments

Hikma Pharmaceuticals Launch

In June 2023, Hikma Pharmaceuticals launched Dobutamine Injection, USP, in the US, expanding its portfolio of sterile injectable medicines. This launch highlights the growing demand for dobutamine and the commitment of pharmaceutical companies to meet this demand[4].

Financial Performance

Revenue and Sales

The US sales of Dobutamine Injection, USP, in 250mg/20mL vials were approximately $2 million in the 12 months ending April 2023, according to IQVIA. This figure indicates a steady market presence and revenue generation for dobutamine products[4].

Research and Development

Ongoing Initiatives

Ongoing research initiatives focused on creating better formulations and distribution strategies are expected to further boost the market. These initiatives aim to enhance the efficacy and safety of dobutamine, making it a more preferred option for cardiac treatments[1].

Market Dynamics Analysis

Porter’s Five Forces Analysis

The market dynamics are analyzed using Porter’s Five Forces model, which includes:

• Buyers' Bargaining Power: The power of buyers, such as hospitals and healthcare providers, to negotiate prices.
• Suppliers' Bargaining Power: The power of suppliers, such as raw material providers and manufacturers, to influence market conditions.
• Threat of New Entrants: The ease or difficulty with which new companies can enter the market.
• Threat of Substitutes: The availability of alternative medications or treatments.
• Degree of Competition: The level of competition among existing market players[1].

Challenges and Opportunities

Challenges

Despite the growth prospects, the dobutamine market faces challenges such as the potential for side effects and the need for continuous monitoring during administration. Additionally, the market is subject to regulatory changes and the availability of generic alternatives, which can impact pricing and market share[1].

Opportunities

The market presents several opportunities, including the increasing demand for cardiac medications due to rising cardiovascular disease prevalence and the potential for new formulations and delivery methods. Ongoing research and development initiatives also offer opportunities for market expansion and innovation[1].

Key Takeaways

• The global dobutamine market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases.
• Advances in diagnostic techniques and medical technology, along with favorable reimbursement schemes, are key drivers of market growth.
• The market is segmented by application, product type, and geography, with major players continuously innovating to improve medication efficacy and safety.
• Recent launches by companies like Hikma Pharmaceuticals highlight the growing demand and commitment to meeting this demand.
• Ongoing research and development initiatives are expected to further boost the market.

FAQs

1. What is the projected growth rate of the global dobutamine market? The global dobutamine market is expected to grow at a CAGR of 3.2% from 2024 to 2031[1].

2. What are the primary drivers of the dobutamine market growth? The primary drivers include the increasing prevalence of cardiovascular diseases, advances in diagnostic techniques and medical technology, and favorable reimbursement schemes[1].

3. Which companies are key players in the dobutamine market? Key players include Ivax Pharmaceuticals, Physicians Total Care, Baxter Healthcare, Sanofi, Teva Canada, Pfizer, Bedford Laboratories, Novartis, Sterimax, and Teligent[1].

4. What are the main applications of dobutamine? The main applications include chronic heart failure, myocardial infarction, postoperative hypotension, and other cardiac conditions[1].

5. What recent development has Hikma Pharmaceuticals made in the dobutamine market? Hikma Pharmaceuticals launched Dobutamine Injection, USP, in the US in June 2023, expanding its portfolio of sterile injectable medicines[4].

Sources

1. Market Research Intellect. Global Dobutamine Market Size and Forecast.
2. NCBI. Early Recognition and Initial Management of Sepsis in Adult Patients.
3. PubMed. The economics of follow-on drug research and development.
4. PR Newswire. Hikma exceeds 150 injectable medicines in the US with launch of Dobutamine Injection, USP.
5. NCBI. Dobutamine - StatPearls.