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Last Updated: January 5, 2025

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Tromethamine - Generic Drug Details


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

Tromethamine is the generic ingredient in one branded drug marketed by Hospira and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for tromethamine. One supplier is listed for this compound.

Summary for tromethamine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 28
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 340
Clinical Trials: 86
Patent Applications: 537
What excipients (inactive ingredients) are in tromethamine?tromethamine excipients list
DailyMed Link:tromethamine at DailyMed
Recent Clinical Trials for tromethamine

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

SponsorPhase
Chung-Ang University Gwangmyeong HospitalN/A
Benova (Tianjin) Innovative medicine Research Co., Ltd.Phase 3
Northwestern UniversityEarly Phase 1

See all tromethamine clinical trials

Medical Subject Heading (MeSH) Categories for tromethamine

US Patents and Regulatory Information for tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira THAM tromethamine SOLUTION;INJECTION 013025-002 Approved Prior to Jan 1, 1982 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

Tromethamine Market Analysis and Financial Projection

Tromethamine Market Dynamics and Financial Trajectory

Market Overview

Tromethamine, also known as tris(hydroxymethyl)aminomethane, is an organic compound that plays a crucial role in various medical and pharmaceutical applications. It is widely used as a buffering agent and pH regulator, contributing significantly to the stability and efficacy of pharmaceutical formulations and drug delivery systems.

Market Drivers

Several key factors are driving the growth of the tromethamine market:

Pharmaceutical Formulation Development

Tromethamine is essential in the pharmaceutical industry for maintaining the pH of formulations, which enhances the stability and effectiveness of drugs. The increasing demand for novel drug formulations and advanced drug delivery systems is a significant driver of market growth[1].

Growing Healthcare Expenditure

The rise in healthcare expenditure and the increased focus on patient care and treatment have boosted the demand for pharmaceutical products and medical applications. Tromethamine's role in pharmaceutical preparations, surgical procedures, and diagnostic applications is pivotal in this context[1].

Cosmetics and Research Laboratories

Apart from pharmaceuticals, tromethamine is also used in the cosmetics industry and research laboratories, further diversifying its market demand[1].

Market Restraints

Despite the positive growth trends, there are several factors that could hinder the tromethamine market:

Regulatory Compliance

Compliance with stringent regulatory requirements can be a challenge for market players. Adapting to changing regulatory landscapes is crucial for sustaining growth[1].

Competition from Alternative Buffering Agents

The presence of alternative buffering agents can pose a competitive threat to tromethamine. Continuous innovation and research are necessary to maintain its market position[1].

Market Dynamics

The tromethamine market is influenced by several dynamics:

Advancements in the Pharmaceutical Industry

Continuous advancements in pharmaceutical technology and the development of new drug delivery systems are driving the demand for tromethamine. These advancements often require precise pH control, which tromethamine provides[1].

Healthcare Expenditure and Infrastructure

The growth in healthcare expenditure and improvements in healthcare infrastructure, particularly in emerging economies, are creating new opportunities for the tromethamine market. Regions like North America, Europe, and the Asia Pacific are seeing significant growth due to these factors[1].

Research and Development

Investment in research and development is crucial for discovering new applications and formulations for tromethamine. Exploring its potential in novel drug delivery systems and specialized medical applications can create new market opportunities[1].

Regional Analysis

The tromethamine market is analyzed across several key regions:

North America

North America currently holds the largest market share, driven by the robust healthcare infrastructure and high awareness of the importance of pharmaceutical formulations. The U.S. and Canada are particularly significant markets due to their proactive approach to advanced healthcare services[1][2].

Europe

Europe is another major region, with a strong pharmaceutical industry and stringent regulatory frameworks that support the use of tromethamine in various medical applications[1].

Asia Pacific

The Asia Pacific region is expected to be highly lucrative, with governments and healthcare entities implementing initiatives to improve maternal health and address postpartum hemorrhage. Countries like India are focusing on enhancing maternal health indicators, which is driving the demand for tromethamine[2].

Financial Trajectory

The financial outlook for the tromethamine market is promising:

Market Size and Growth Rate

The tromethamine market is projected to grow at a steady CAGR during the forecast period. While the exact CAGR is not specified, the market is expected to expand significantly driven by the increasing demand for pharmaceutical formulations and drug delivery systems[1].

Revenue Projections

Although specific revenue figures for the tromethamine market are not provided, the overall pharmaceutical market trends suggest a substantial increase in revenue. For instance, related markets like the carboprost tromethamine market are expected to reach significant revenue milestones, such as $2.09 billion by 2028[5].

Impact of Covid-19

The Covid-19 pandemic had a temporary impact on the tromethamine market:

Supply Chain Disruptions

Disruptions in the pharmaceutical supply chain and reduced elective surgeries affected market dynamics. However, as healthcare systems recover, the market is expected to regain momentum[1].

Key Industry Developments

Several key developments are shaping the market:

New Formulations and Manufacturing Expansions

Companies are introducing new tromethamine formulations with improved stability and enhanced drug delivery capabilities. Additionally, manufacturing expansions are being undertaken to meet the increasing demand for tromethamine in pharmaceutical applications[1].

Regulatory Support

Regulatory support and favorable healthcare policies, especially in regions like North America, are propelling market growth. These policies and initiatives are crucial for the adoption and expansion of tromethamine in various medical applications[2].

Future Outlook

The future outlook for the tromethamine market is positive:

Continued Growth in Pharmaceutical Formulations

The increasing demand for pharmaceutical formulations and drug delivery systems will continue to drive market growth. Ongoing research and development, market expansion, and strategic collaborations will be essential for sustained growth[1].

Expanding Applications

Tromethamine's applications in cosmetics and research laboratories will also contribute to its market growth. The versatility of tromethamine makes it a valuable component across multiple industries[1].

Key Takeaways

  • Growing Demand in Pharmaceuticals: The increasing demand for novel drug formulations and advanced drug delivery systems is a significant driver of the tromethamine market.
  • Healthcare Expenditure: Rising healthcare expenditure and improvements in healthcare infrastructure are boosting the demand for tromethamine.
  • Regional Growth: North America, Europe, and the Asia Pacific are key regions driving market growth.
  • Research and Development: Continuous investment in research and development is crucial for discovering new applications and formulations.
  • Regulatory Support: Favorable healthcare policies and regulatory support are essential for market expansion.

FAQs

Q: What is the primary use of tromethamine in the pharmaceutical industry? A: Tromethamine is primarily used as a buffering agent and pH regulator in pharmaceutical formulations and drug delivery systems.

Q: Which regions are expected to drive the growth of the tromethamine market? A: North America, Europe, and the Asia Pacific are expected to be the key regions driving the growth of the tromethamine market.

Q: How did the Covid-19 pandemic affect the tromethamine market? A: The Covid-19 pandemic caused temporary disruptions in the pharmaceutical supply chain and reduced elective surgeries, but the market is expected to regain momentum as healthcare systems recover.

Q: What are the main drivers of the tromethamine market? A: The main drivers include the increasing demand for pharmaceutical formulations, growing healthcare expenditure, and advancements in the pharmaceutical industry.

Q: What role does regulatory support play in the tromethamine market? A: Regulatory support and favorable healthcare policies are crucial for the adoption and expansion of tromethamine in various medical applications.

Sources

  1. MarkWide Research: Tromethamine market 2024-2032 | Size, Share, Growth[1].
  2. Polaris Market Research: Carboprost Tromethamine Market Size, Analysis Report, 2024-2032[2].
  3. Oregon Department of Consumer and Business Services: Prescription Drug Price Transparency Program results and Annual Report 2024[3].
  4. Market Research Intellect: Global Ketorolac Tromethamine Market Size and Forecast[4].
  5. OpenPR: Carboprost Tromethamine Market Size, Insights, Outlook, Overview And Report To 2024-2033[5].

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