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Last Updated: December 22, 2024

ETHIONAMIDE - Generic Drug Details


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

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

There are four drug master file entries for ethionamide. One supplier is listed for this compound.

Summary for ETHIONAMIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 5
Patent Applications: 6,477
What excipients (inactive ingredients) are in ETHIONAMIDE?ETHIONAMIDE excipients list
DailyMed Link:ETHIONAMIDE at DailyMed
Recent Clinical Trials for ETHIONAMIDE

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

SponsorPhase
TASK Applied SciencePhase 2
Samsung Medical CenterPhase 1
University of Cape TownPhase 2/Phase 3

See all ETHIONAMIDE clinical trials

Pharmacology for ETHIONAMIDE
Drug ClassAntimycobacterial
Medical Subject Heading (MeSH) Categories for ETHIONAMIDE

US Patents and Regulatory Information for ETHIONAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms TRECATOR ethionamide TABLET;ORAL 013026-002 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

ETHIONAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethionamide

Introduction

Ethionamide is a crucial second-line antitubercular drug used in the treatment of tuberculosis (TB), particularly for patients with drug-resistant strains of the disease. Understanding the market dynamics and financial trajectory of ethionamide is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for TB drugs, including ethionamide, is influenced by several factors:

Demand and Supply Conditions

The demand for ethionamide is driven by the prevalence of drug-resistant TB, which remains a significant public health concern globally. The supply side is characterized by a limited number of manufacturers and a complex supply chain that can lead to stock-outs and treatment disruptions[3].

Market Trends

The TB drugs market is expected to grow due to increasing cases of drug-resistant TB and the need for effective treatment regimens. The market is also seeing the development of new drugs and combination therapies, such as the collaboration between BioVersys and GSK to develop alpibectir, which could potentially enhance the efficacy of existing drugs like ethionamide[2].

Market Dynamics

Drivers

  • Increasing Prevalence of Drug-Resistant TB: The rise in drug-resistant TB cases drives the demand for second-line drugs like ethionamide.
  • Public-Private Collaborations: Collaborations between companies like BioVersys and GSK are accelerating the development of new TB treatments, which can complement or enhance the use of ethionamide[2].
  • Global Health Initiatives: Organizations such as the Global Fund and UNITAID play a crucial role in shaping the market by ensuring access to high-quality medicines and diagnostics, including ethionamide[3].

Restraints

  • Resistance Mechanisms: Ethionamide faces challenges due to the development of resistance mechanisms in Mycobacterium tuberculosis. Studies have shown that mutations in the EthA enzyme can reduce the stability of the enzyme-ligand complex, leading to resistance[5].
  • Supply Chain Issues: Stock-outs and supply chain disruptions can impact the availability of ethionamide, affecting its market performance[3].

Opportunities

  • Combination Therapies: The potential to use ethionamide in combination with new drugs, such as alpibectir, offers opportunities for enhanced treatment outcomes and market growth[2].
  • Market Expansion: Expanding access to underserved populations through market-shaping activities and strategic collaborations can increase the market size for ethionamide[3].

Challenges

  • Low Therapeutic Index: Ethionamide has a low therapeutic index, which means it has a narrow margin between the effective dose and the toxic dose, making it challenging to use[5].
  • Regulatory and Economic Factors: The market is influenced by regulatory environments and economic factors, including funding from global health organizations and government policies.

Competitive Landscape

The competitive landscape for ethionamide involves several key players:

Manufacturers and Suppliers

Companies such as those profiled in the United States Tuberculosis Drugs Market report are major manufacturers and suppliers of ethionamide. These companies compete based on factors such as product quality, pricing, and distribution networks[1].

Strategic Collaborations

Collaborations between pharmaceutical companies, research institutions, and global health organizations are crucial in advancing the development and availability of ethionamide. For example, the collaboration between BioVersys and GSK is significant in this context[2].

Financial Trajectory

Funding and Investments

The financial trajectory of ethionamide is supported by significant investments from various sources. For instance, BioVersys' Series C financing round was extended by CHF 12.3 million, partly due to GSK's equity investment, which will support further clinical development of TB treatments, including those involving ethionamide[2].

Market Size and Forecasts

The United States Tuberculosis Drugs Market report provides insights into the market size and forecasts up to 2032. The market is expected to grow, driven by the increasing demand for effective TB treatments. Ethionamide, as a key second-line drug, is likely to benefit from this growth[1].

Cost and Pricing

The cost of goods sold and pricing strategies play a critical role in the financial performance of ethionamide. Efforts by organizations like UNITAID and the Global Fund to ensure better products at lower prices can impact the market dynamics and financial trajectory of the drug[3].

Key Trends and Future Prospects

New Treatment Regimens

The development of new treatment regimens, including combination therapies, is a key trend. Ethionamide is being evaluated in combination with other drugs to enhance its efficacy and overcome resistance[2].

Market Shaping Activities

Global health organizations are involved in market-shaping activities to increase access to high-quality medicines, including ethionamide. These activities aim to improve supply chain efficiency, reduce stock-outs, and enhance the overall market impact[3].

Company Profiles and Competitive Position

Companies involved in the manufacture and supply of ethionamide are profiled in detailed market reports. These profiles include information on their competitive position, market share, and strategic initiatives. For example, manufacturers like those mentioned in the United States Tuberculosis Drugs Market report are key players in the market[1].

Conclusion

Ethionamide remains a vital drug in the treatment of drug-resistant TB, with its market dynamics influenced by a range of factors including demand driven by disease prevalence, public-private collaborations, and global health initiatives. Despite challenges such as resistance mechanisms and supply chain issues, the financial trajectory of ethionamide is supported by significant investments and market-shaping activities.

Key Takeaways

  • Growing Demand: Increasing cases of drug-resistant TB drive the demand for ethionamide.
  • Public-Private Collaborations: Collaborations are crucial for developing new treatments and enhancing existing ones.
  • Supply Chain Challenges: Stock-outs and supply chain disruptions can impact the availability of ethionamide.
  • Financial Support: Significant investments from various sources support the development and availability of ethionamide.
  • Market Growth: The market for ethionamide is expected to grow, driven by the need for effective TB treatments.

FAQs

Q1: What are the main drivers of the ethionamide market? The main drivers include the increasing prevalence of drug-resistant TB, public-private collaborations, and global health initiatives aimed at improving access to effective treatments.

Q2: What are the challenges faced by ethionamide in the market? Ethionamide faces challenges such as the development of resistance mechanisms, supply chain disruptions, and a low therapeutic index.

Q3: How do public-private collaborations impact the ethionamide market? Public-private collaborations, such as the one between BioVersys and GSK, accelerate the development of new treatments and enhance the efficacy of existing drugs like ethionamide.

Q4: What is the role of global health organizations in the ethionamide market? Global health organizations like UNITAID and the Global Fund play a crucial role in market-shaping activities, ensuring access to high-quality medicines, and improving supply chain efficiency.

Q5: What is the expected market growth for ethionamide? The market for ethionamide is expected to grow, driven by the increasing demand for effective TB treatments and supported by significant investments and market-shaping activities.

Sources

  1. ResearchAndMarkets.com, "United States Tuberculosis Drugs Market: Prospects, Trends Analysis, Market Size and Forecasts up to 2032"[1].
  2. BioVersys, "BioVersys Announces Expansion of Strategic Collaboration with GSK and Extension of its Series C Round by CHF 12.3 Million"[2].
  3. The Global Fund, "Sourcing & Market Dynamics Strategic Review Process"[3].
  4. MDPI, "Ethionamide Preconditioning Enhances the Proliferation and Migration of Human Wharton’s Jelly-Derived Mesenchymal Stem Cells"[4].
  5. MDPI, "Insights into the Mechanism of Ethionamide Resistance in Mycobacterium tuberculosis through an in silico Structural Evaluation of EthA and Mutants Identified in Clinical Isolates"[5].

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