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Last Updated: December 22, 2024

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% Drug Patent Profile


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When do Dobutamine Hydrochloride In Dextrose 5% patents expire, and when can generic versions of Dobutamine Hydrochloride In Dextrose 5% launch?

Dobutamine Hydrochloride In Dextrose 5% is a drug marketed by Hospira and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% 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 Dobutamine Hydrochloride In Dextrose 5%

A generic version of DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% was approved as dobutamine hydrochloride by HOSPIRA on November 29th, 1993.

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Summary for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Drug patent expirations by year for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Recent Clinical Trials for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

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

SponsorPhase
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuN/A
Koç UniversityN/A
Wuhan Union Hospital, ChinaPhase 2/Phase 3

See all DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

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 020269-001 Oct 19, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-005 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-001 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020201-003 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dobutamine Hydrochloride in Dextrose 5%

Introduction

Dobutamine Hydrochloride in Dextrose 5% is a critical medication used for the short-term treatment of patients with cardiac decompensation due to depressed contractility. This article delves into the market dynamics and financial trajectory of this drug, providing insights into its current market status, future projections, and key factors influencing its growth.

Market Size and Growth Projections

The Dobutamine Hydrochloride market is anticipated to experience significant growth over the forecast period from 2023 to 2031. According to market research, the market is expected to develop revenue at a remarkable Compound Annual Growth Rate (CAGR) during this period[2].

Historical and Forecast Period

The study period for the Dobutamine Hydrochloride market spans from 2021 to 2031, with 2023 serving as the base year. Historical data from 2021 to 2023 and forecast data from 2024 to 2031 provide a comprehensive overview of the market's trajectory[2].

Market Segmentation

The Dobutamine Hydrochloride market is segmented based on several key factors:

By Type

The market is categorized into segments based on the purity of Dobutamine Hydrochloride, including purity ≥ 98% and purity ≥ 99%. This segmentation helps in understanding the demand for different purity levels in various applications[2].

By Application

The primary application of Dobutamine Hydrochloride is in injection solutions, but it also has other uses. This segmentation highlights the diverse uses of the drug and their respective market shares[2].

By Geography

The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This regional segmentation provides insights into the drug's demand and growth potential in different parts of the world[2].

Key Drivers and Restraints

Drivers

  • Increasing Demand for Inotropic Support: The growing need for inotropic support in patients with cardiac decompensation drives the demand for Dobutamine Hydrochloride. This is particularly evident in cases of organic heart disease and post-cardiac surgical procedures[3].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing regions, are expected to increase access to this medication, thereby boosting market growth.
  • Rising Incidence of Heart Failure: The increasing incidence of heart failure globally is another significant driver, as Dobutamine Hydrochloride is often used in the short-term management of such conditions[3].

Restraints

  • Side Effects and Contraindications: Dobutamine Hydrochloride can cause marked increases in heart rate and blood pressure, and it is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and those with hypersensitivity to the drug. These factors can limit its use and impact market growth[1][3].
  • Alternative Therapies: The availability of alternative therapies, such as nesiritide, can also act as a restraint. Economic studies have shown that while Dobutamine Hydrochloride is effective, it may not always exhibit robust economic superiority over other treatments[5].

Market Opportunities

  • Emerging Markets: The Asia-Pacific and Middle East regions offer significant growth opportunities due to their large patient populations and improving healthcare systems.
  • Research and Development: Continuous research and development in the field of cardiac medications can lead to new formulations or delivery methods for Dobutamine Hydrochloride, enhancing its market potential.

Challenges

  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring of the drug's safety and efficacy can pose challenges to market growth.
  • Competition from Generics: The presence of generic versions of Dobutamine Hydrochloride can reduce the market share of branded products, impacting revenue.

Financial Trajectory

The financial trajectory of the Dobutamine Hydrochloride market is expected to be positive, with significant revenue growth projected over the forecast period. Here are some key financial aspects:

Revenue Projections

The market is expected to generate substantial revenue, measured in USD million, across various segments. The report provides detailed financial projections, including the value of the market in different regions and segments[2].

Key Players

Companies such as N-Techem International, Poly Pharm, Shanghai Ziyuan Pharmaceutical, Wuhan Plov Biology, and Wing Hing Chemical are key players in the Dobutamine Hydrochloride market. These companies are driving innovation and expansion through their product offerings and strategic initiatives[2].

Stability and Storage Considerations

The stability of Dobutamine Hydrochloride solutions is crucial for their effective use. Studies have shown that Dobutamine Hydrochloride is stable in acidic conditions but susceptible to degradation in light. Proper storage in moisture and oxygen barrier overwrap at room temperature is essential to maintain the drug's efficacy[1][3][4].

Clinical Use and Indications

Dobutamine Hydrochloride in Dextrose 5% is indicated for the short-term treatment of patients with cardiac decompensation due to depressed contractility. It is administered intravenously and is particularly useful in cases resulting from organic heart disease or cardiac surgical procedures[3].

Dosage and Administration

The drug is administered through a calibrated electronic infusion device, starting at a low rate (0.5-1.0 mcg/kg/min) and titrated based on the patient’s response. The solution contains no antimicrobial agents and should be used within a single dose, with any unused portion discarded[1][3].

Contraindications and Warnings

Dobutamine Hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and those with hypersensitivity to the drug. It can cause significant increases in heart rate and blood pressure, and patients with preexisting hypertension are at a higher risk of exaggerated pressor responses[1][3].

Key Takeaways

  • Market Growth: The Dobutamine Hydrochloride market is expected to grow significantly from 2023 to 2031.
  • Segmentation: The market is segmented by type, application, and geography.
  • Drivers: Increasing demand for inotropic support, advancements in healthcare infrastructure, and rising incidence of heart failure drive the market.
  • Restraints: Side effects, contraindications, and alternative therapies are key restraints.
  • Financial Trajectory: The market is projected to generate substantial revenue, with key players driving innovation and expansion.

FAQs

What are the primary indications for Dobutamine Hydrochloride in Dextrose 5%?

Dobutamine Hydrochloride in Dextrose 5% is indicated for the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting from organic heart disease or cardiac surgical procedures[3].

What are the common side effects of Dobutamine Hydrochloride?

Common side effects include marked increases in heart rate and blood pressure, especially systolic pressure. Approximately 10% of adult patients experience rate increases of 30 beats/minute or more, and about 7.5% experience a 50-mm Hg or greater increase in systolic pressure[1][3].

How is Dobutamine Hydrochloride administered?

The drug is administered intravenously through a suitable intravenous catheter or needle, using a calibrated electronic infusion device. The infusion rate is started at 0.5-1.0 mcg/kg/min and titrated based on the patient’s response[1][3].

What are the contraindications for Dobutamine Hydrochloride?

Dobutamine Hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and those who have shown previous manifestations of hypersensitivity to dobutamine[1][3].

What is the expected market growth for Dobutamine Hydrochloride from 2023 to 2031?

The market is expected to develop revenue at a remarkable CAGR during the forecast period from 2023 to 2031, indicating significant and sustained growth[2].

Sources

  1. DailyMed: Dobutamine Hydrochloride in 5% Dextrose Injection[1].
  2. Market Research Intellect: Global Dobutamine Hydrochloride Market Size, Trends and Forecast[2].
  3. FDA: Dobutamine Hydrochloride in 5% Dextrose Injection Label[3].
  4. European Journal of Hospital Pharmacy: Stability of dobutamine 500 mg in 50 ml syringes prepared using a multidispensing method[4].
  5. PubMed: Pharmacoeconomic modeling of nesiritide versus dobutamine for acute decompensated heart failure[5].

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