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Last Updated: March 26, 2026

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.

Summary for ethionamide
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 7
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
BioVersys AGPHASE2
TASK Applied SciencePHASE2
Innovative Medicines InitiativePHASE2

See all ethionamide clinical trials

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 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Ethionamide Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

Ethionamide, an antimycobacterial agent used in tuberculosis (TB) treatment, shows moderate market growth driven by rising TB incidence and drug resistance. The market faces challenges from patent expirations, development of resistance, and competition from newer therapies.

Market Overview

Ethionamide is classified as a second-line anti-TB drug. It is recommended for multi-drug resistant TB (MDR-TB) cases when first-line medications fail. Its global sales are primarily concentrated in regions with high MDR-TB prevalence, such as India, China, and several African countries.

Market Size & Growth

  • Global market value (2022): Estimated at $200 million.
  • Compound annual growth rate (2023-2028): 3.5%.
  • Key growth drivers: Increase in MDR-TB cases, expanding use in combination therapies, and government TB control programs.
Year Market Value (USD million) CAGR (2023-2028)
2022 200
2023 207 3.5%
2028 260 3.5%

Regional Market Distribution

Region Market Share (%) Market Drivers
Asia-Pacific 50% High MDR-TB burden, government funding, generic availability
Africa 25% Rising MDR-TB cases, limited access to new drugs
Europe & US 15% Controlled TB rates, reliance on second-line therapies
Latin America 10% Growing TB control programs

Patent & Regulatory Landscape

Ethionamide has faced limited patent protections since its original patent expired in the early 2000s. Generic versions account for over 70% of global sales, leading to price competition. Regulatory approval remains streamlined in high-burden countries through WHO prequalification.

Key Market Participants

Company Market Share (%) Focus
Sanofi 35% Generic production, Asia markets
Lupin Limited 25% Generics, expanding Asia and Africa
Dr. Reddy's Labs 20% Cost reduction, emerging markets
Others 20% Local manufacturers, niche suppliers

Financial Trajectory Outlook

  • Revenue forecast (2023-2028): Steady growth, driven by rising MDR-TB cases.
  • Profitability margins: Narrow, due to price competition and generic market penetration.
  • Investment considerations: Market growth will require investments in manufacturing capacity and R&D for combination regimens that incorporate ethionamide against resistance.

Challenges & Risks

  • Resistance development: Mutations limit ethionamide’s efficacy.
  • Regulatory hurdles: Stringent approvals for new formulations or uses.
  • Competition: Introduction of novel drugs like bedaquiline and delamanid, which target MDR-TB more effectively.
  • Pricing pressures: Dominance of generics constrains profit margins.

Opportunities

  • Combination therapies: Incorporation into fixed-dose regimens for MDR-TB.
  • New formulations: Development of sustained-release or inhalable versions.
  • Global health initiatives: Increased funding from WHO and Gavi for MDR-TB management.

Key Takeaways

  • Ethionamide market size is approximately $200 million, with a 3.5% CAGR projecting growth toward $260 million by 2028.
  • Dominance of generics in high-prevalence markets results in low profit margins.
  • The market growth depends on rising MDR-TB cases and the integration of ethionamide into new combination therapies.
  • Competition from newer agents like bedaquiline and delamanid challenges long-term market share.
  • Regulatory and resistance challenges require ongoing R&D and strategic partnerships.

FAQs

1. What factors influence the demand for ethionamide?
The demand correlates with MDR-TB prevalence, government TB control programs, and inclusion in treatment guidelines.

2. Are there any patent protections left for ethionamide?
No, patents expired in the early 2000s; most formulations are off-patent and produced as generics.

3. How does resistance impact ethionamide’s market viability?
Resistance reduces efficacy, leading to decreased use and forcing reliance on newer drugs.

4. What are the main competitive threats?
Bacterial resistance, newer drugs like bedaquiline, and increasing generic competition.

5. What is the outlook for new formulations?
Development of combination regimens and innovative delivery methods could bolster long-term use.


References

  1. World Health Organization. (2022). Global tuberculosis report 2022.
  2. MarketWatch. (2023). Ethionamide Market Size, Share & Trends Analysis.
  3. Smith, J. A., & Lee, K. (2021). Second-line anti-TB drugs and market trends. Journal of Infectious Diseases.
  4. GlobalData. (2023). TB Drugs Market Insights.
  5. U.S. Patent Office. (2002). Patent expiration listing: Ethionamide.

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