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Last Updated: January 5, 2025

THAM Drug Patent Profile


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

Tham is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in THAM is potassium chloride; sodium chloride; tromethamine. There are two hundred and forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the potassium chloride; sodium chloride; tromethamine profile page.

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Summary for THAM
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 340
Patent Applications: 1,791
What excipients (inactive ingredients) are in THAM?THAM excipients list
DailyMed Link:THAM at DailyMed
Drug patent expirations by year for THAM

US Patents and Regulatory Information for THAM

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
Hospira THAM-E potassium chloride; sodium chloride; tromethamine INJECTABLE;INJECTION 013025-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

THAM Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for THAM (Tromethamine)

Market Overview

Tromethamine, commonly known as THAM, is an organic compound that serves as a buffering agent and pH regulator in various medical and pharmaceutical applications. The market for THAM is experiencing significant growth, driven by its increasing use in the pharmaceutical and healthcare industries[1].

Key Applications of THAM

THAM is widely used in several critical medical applications:

  • Pharmaceutical Formulations: It is used to maintain the pH of formulations and enhance the stability of drugs. This is particularly important in the development of novel drug formulations and drug delivery systems[1].
  • Medical Procedures: THAM is used in surgical procedures and diagnostic applications, especially in cases of metabolic acidosis associated with cardiac bypass surgery and cardiac arrest[2][5].
  • Emergency Medicine: It is considered for use in critically ill patients, such as those with severe acidemia due to sepsis, hemorrhagic shock, or COPD/asthma exacerbations[2].

Market Drivers

Several factors are driving the growth of the THAM market:

  • Pharmaceutical Formulation Development: The increasing demand for novel drug formulations and drug delivery systems is a significant driver. THAM's role in maintaining pH and enhancing stability is crucial in these applications[1].
  • Growing Healthcare Expenditure: Rising healthcare expenditure and an increased focus on patient care and treatment contribute to the demand for pharmaceutical products and medical applications where THAM is used[1].
  • Research and Development: Continued investment in R&D can lead to the discovery of new applications and formulations for THAM, further expanding its market[1].

Market Restraints

Despite the positive growth, there are several challenges:

  • Regulatory Limitations: The FDA-approved indications for THAM are limited to metabolic acidosis associated with cardiac bypass surgery and cardiac arrest. Any other use is considered off-label, which can limit its adoption[2].
  • Cost: THAM is relatively expensive compared to other buffering agents like sodium bicarbonate. The cost can range from $200 to $2,000 per 500 mL bottle, depending on the hospital and patient charges[2].
  • Lack of Clinical Trials: There is a lack of randomized clinical trials showing that resolving acidosis with THAM improves patient outcomes, which can affect its widespread acceptance[2].

Market Dynamics

The THAM market is influenced by several dynamics:

  • Advancements in Pharmaceutical Industry: The market is driven by advancements in pharmaceutical formulations and drug delivery systems. Adapting to these advancements is crucial for market players to sustain growth[1].
  • Healthcare Expenditure: The rising healthcare expenditure and focus on patient care drive the demand for THAM in medical applications[1].
  • Regulatory Landscape: Compliance with regulatory frameworks varies by region and can impact the market. Understanding and adapting to these regulations is essential for market players[1].

Regional Analysis

The THAM market is analyzed across key regions:

  • North America: Currently holds the largest market share, driven by a well-developed healthcare infrastructure and a strong pharmaceutical industry[1].
  • Europe and Asia Pacific: These regions also exhibit significant growth due to their expanding healthcare sectors and increasing demand for pharmaceutical products[1].

Competitive Landscape

The competitive landscape of the THAM market is characterized by:

  • Market Expansion: Companies are expanding their manufacturing facilities to meet the increasing demand for THAM in pharmaceutical applications[1].
  • New Formulations: Introduction of new tromethamine formulations with improved stability and drug delivery capabilities is a key competitive strategy[1].

Impact of Covid-19

The Covid-19 pandemic had a temporary impact on the THAM 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].

Financial Trajectory

The financial trajectory of the THAM market is positive:

  • Growth Projections: The market is expected to grow at a steady CAGR during the forecast period, driven by increasing demand for pharmaceutical formulations and drug delivery systems[1].
  • Revenue Streams: The market generates revenue from sales in the pharmaceutical, healthcare, and cosmetic industries. The high cost of THAM compared to other buffering agents contributes to its revenue, despite the limited FDA-approved indications[2].

Key Industry Developments

  • Manufacturing Expansion: Companies are expanding their manufacturing facilities to meet the increasing demand for THAM, indicating a strong financial outlook[1].
  • Research and Development: Continued investment in R&D is expected to lead to new applications and formulations, further driving market growth and revenue[1].

Analyst Suggestions

Analysts suggest that industry participants should focus on:

  • Research and Development: Exploring new applications and formulations for THAM to create new market opportunities[1].
  • Market Expansion: Targeting emerging markets and establishing strategic partnerships to drive market expansion[1].
  • Strategic Collaborations: Collaborating with other companies to enhance market presence and develop new products[1].

Future Outlook

The future outlook for the THAM market is positive:

  • Sustained Growth: The market is expected to witness steady growth driven by the increasing demand for pharmaceutical formulations, drug delivery systems, and cosmetic products[1].
  • New Opportunities: Continued investment in R&D and market expansion will be essential for sustained market growth and financial stability[1].

Key Takeaways

  • Growing Demand: Increasing demand in pharmaceutical and healthcare industries drives market growth.
  • Regulatory Challenges: Limited FDA-approved indications and high costs are significant restraints.
  • Regional Variations: North America leads the market, followed by Europe and Asia Pacific.
  • Competitive Strategies: Market expansion, new formulations, and strategic collaborations are key competitive strategies.
  • Positive Outlook: The market is expected to grow steadily, driven by R&D and market expansion.

FAQs

What are the primary uses of THAM in medical applications?

THAM is primarily used in medical applications to correct metabolic acidosis, particularly in cases associated with cardiac bypass surgery and cardiac arrest. It is also considered for use in critically ill patients with severe acidemia due to various conditions[2][5].

Why is THAM relatively expensive compared to other buffering agents?

THAM is relatively expensive due to its specialized use and limited FDA-approved indications. The cost can range from $200 to $2,000 per 500 mL bottle, depending on the hospital and patient charges[2].

How has the Covid-19 pandemic affected the THAM market?

The Covid-19 pandemic caused temporary disruptions in the pharmaceutical supply chain and reduced elective surgeries, affecting market dynamics. However, as healthcare systems recover, the market is expected to regain momentum[1].

What are the key drivers of the THAM market?

The key drivers include the increasing demand for novel drug formulations and drug delivery systems, growing healthcare expenditure, and continued investment in research and development[1].

What are the potential future developments in the THAM market?

Future developments are expected to include new formulations with improved stability and drug delivery capabilities, market expansion into emerging economies, and strategic collaborations to enhance market presence[1].

Sources

  1. MarkWide Research: Tromethamine market 2024-2032 | Size, Share, Growth.
  2. ALIEM: Your Patient In Extremis: THAM To The Rescue?
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. Texas Department of State Health Services: 2024 Price Increase Report.
  5. FDA: THAM Solution (tromethamine injection) label.

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