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Last Updated: December 22, 2024

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, and what generic alternatives are available?

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

The generic ingredient in DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 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% In Plastic Container

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

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

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% IN PLASTIC CONTAINER clinical trials

Pharmacology for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug Classbeta-Adrenergic Agonist
Mechanism of ActionAdrenergic beta-Agonists

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 020201-001 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-005 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020201-006 Jul 7, 1994 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-003 Oct 19, 1993 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-004 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% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dobutamine Hydrochloride in Dextrose 5% in Plastic Container

Market Overview

The market for Dobutamine Hydrochloride, particularly in its formulation with Dextrose 5% in a plastic container, is experiencing significant growth and is poised for continued expansion. Here’s a detailed look at the market dynamics and financial trajectory of this pharmaceutical product.

Market Size and Growth Projections

The global Dobutamine Hydrochloride market has witnessed substantial growth in recent years and is expected to continue this upward trajectory. According to market research, the market size is anticipated to grow significantly from 2023 to 2031, driven by increasing demand and favorable market dynamics[1][4].

Segmentation and Application

The market is segmented based on type (purity ≥ 98%, purity ≥ 99%) and application (injection solution, other). The injection solution segment is particularly prominent, given the common use of Dobutamine Hydrochloride in critical care settings for patients with heart failure or those requiring inotropic support[1][4].

Geographical Distribution

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own set of market dynamics, with Asia-Pacific and North America being key drivers of growth due to their large patient populations and advanced healthcare infrastructures[1][4].

Key Drivers

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

  • Increasing Prevalence of Heart Failure: The rising incidence of heart failure globally is a significant driver, as Dobutamine Hydrochloride is commonly used to manage this condition[1].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare facilities, especially in emerging markets, are increasing access to this medication[4].
  • Growing Demand for Critical Care Medications: The need for effective inotropic agents in critical care settings is on the rise, contributing to the market's growth[1].

Market Restraints

Despite the positive outlook, there are several restraints that could impact the market:

  • Regulatory Challenges: Strict regulatory requirements and the need for continuous compliance can pose challenges for manufacturers[3].
  • Economic Factors: The cost-effectiveness of Dobutamine Hydrochloride compared to other treatments, such as nesiritide, can influence market dynamics. For instance, studies have shown that while Dobutamine Hydrochloride may not have a robust economic superiority over nesiritide, it remains a viable option due to its effectiveness and lower costs in certain scenarios[2].

Competitive Landscape

The market for Dobutamine Hydrochloride is competitive, with several key players:

  • N-Techem International
  • Poly Pharm
  • Shanghai Ziyuan Pharmaceutical
  • Wuhan Plov Biology
  • Wing Hing Chemical

These companies are involved in various aspects of the market, from production to distribution, and play a crucial role in shaping market dynamics[1].

Product Quality and Safety

The quality and safety of Dobutamine Hydrochloride products are rigorously monitored. For example, the Dobutamine SUN product, which is a clear, colorless to slightly yellow solution for infusion in a pre-filled syringe, has undergone extensive testing to ensure compliance with European guidelines. This includes stability data, batch analytical data, and risk management plans to ensure the product's safety and efficacy[3].

Financial Performance

The financial performance of the Dobutamine Hydrochloride market is robust, with significant revenue projections. The market size is measured in USD million, and the forecast period from 2023 to 2031 indicates sustained and significant expansion. The revenue growth is driven by increasing demand, improved market penetration, and the expansion of healthcare services globally[1][4].

Regional Market Analysis

North America

North America is a major market for Dobutamine Hydrochloride, driven by advanced healthcare infrastructure and a high prevalence of heart failure. The region is expected to continue its strong growth trajectory due to these factors[1][4].

Europe

Europe is another significant market, with a well-established healthcare system and stringent regulatory frameworks. The market here is driven by the need for high-quality critical care medications and the presence of key manufacturers[1][4].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to increasing healthcare spending, a large patient population, and the expansion of healthcare services. This region is expected to be a key driver of global market growth in the coming years[1][4].

Economic Analysis

Economic analyses of Dobutamine Hydrochloride versus other treatments, such as nesiritide, highlight the importance of considering both cost and clinical effectiveness. While nesiritide may not exhibit robust economic superiority over Dobutamine Hydrochloride, the latter remains a cost-effective option in many clinical scenarios[2].

Conclusion

The market for Dobutamine Hydrochloride in Dextrose 5% in a plastic container is poised for significant growth, driven by increasing demand, advancements in healthcare infrastructure, and the need for effective critical care medications. Despite regulatory and economic challenges, the market is expected to expand substantially from 2023 to 2031.

Key Takeaways

  • Market Growth: The Dobutamine Hydrochloride market is expected to grow significantly from 2023 to 2031.
  • Segmentation: The market is segmented by type and application, with the injection solution segment being prominent.
  • Geographical Distribution: Key regions include North America, Europe, and Asia-Pacific.
  • Drivers: Increasing prevalence of heart failure, advancements in healthcare infrastructure, and growing demand for critical care medications.
  • Restraints: Regulatory challenges and economic factors.
  • Competitive Landscape: Several key players are involved in the market.

FAQs

What are the primary applications of Dobutamine Hydrochloride?

Dobutamine Hydrochloride is primarily used as an injection solution for patients with heart failure or those requiring inotropic support.

Which regions are driving the growth of the Dobutamine Hydrochloride market?

North America, Europe, and the Asia-Pacific region are the key drivers of market growth.

What are the main challenges facing the Dobutamine Hydrochloride market?

Regulatory challenges and economic factors, such as the cost-effectiveness compared to other treatments, are significant challenges.

Who are the key players in the Dobutamine Hydrochloride market?

Key players include N-Techem International, Poly Pharm, Shanghai Ziyuan Pharmaceutical, Wuhan Plov Biology, and Wing Hing Chemical.

What is the expected market size of Dobutamine Hydrochloride by 2031?

The market size is expected to grow significantly, though exact figures vary by report; it is anticipated to reach several hundred million USD by 2031[1][4].

Sources

  1. Market Research Intellect: Global Dobutamine Hydrochloride Market Size, Trends and Forecasts Report.
  2. PubMed: Pharmacoeconomic modeling of nesiritide versus dobutamine for patients with decompensated heart failure.
  3. Geneesmiddeleninformatiebank: Public Assessment Report - Dobutamine SUN.
  4. Market Publishers: 2018 Global Dobutamine Hydrochloride Industry Report - History, Present and Future.

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