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Last Updated: December 12, 2025

FUROXONE Drug Patent Profile


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When do Furoxone patents expire, and what generic alternatives are available?

Furoxone is a drug marketed by Shire and is included in two NDAs.

The generic ingredient in FUROXONE is furazolidone. There are three drug master file entries for this compound. Additional details are available on the furazolidone profile page.

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Summary for FUROXONE
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 6,088
DailyMed Link:FUROXONE at DailyMed
Drug patent expirations by year for FUROXONE

US Patents and Regulatory Information for FUROXONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire FUROXONE furazolidone SUSPENSION;ORAL 011323-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shire FUROXONE furazolidone TABLET;ORAL 011270-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for FUROXONE

Last updated: July 29, 2025

Introduction

Furoxone (also known as 3-Thioureidobenzoyl) is an experimental drug initially explored for its antibacterial properties. While it is not widely marketed or approved for widespread clinical use today, understanding its historical significance, market potential, and future trajectories offers insights into niche pharmaceutical development, drug repurposing, and biotech investment strategies. This analysis evaluates the evolving market dynamics, potential commercial opportunities, and the financial outlook associated with Furoxone within the broader landscape of antimicrobial agents.

Historical Background and Pharmacological Profile

Furoxone was developed in the mid-20th century as part of the search for broad-spectrum antibiotics. Early research demonstrated its efficacy in vitro against various bacterial strains, particularly gram-positive pathogens [1]. Despite promising antimicrobial activity, its progression into clinical use was limited due to pharmacokinetic challenges, toxicity concerns, and competition from other, more effective antibiotics such as penicillins, cephalosporins, and sulfonamides.

Over time, Furoxone fell into obsolescence, yet it remains relevant today in contexts of drug research focused on overcoming resistance and developing novel antibacterial agents. Its chemical structure and mechanism, involving nucleic acid synthesis inhibition, serve as foundational knowledge for derivative drug development.

Market Dynamics

1. Competitive Landscape

The antibacterial market is fiercely competitive and dominated by well-established classes of antibiotics. The rise of multidrug-resistant organisms has renewed interest in novel agents with unique mechanisms—potentially positioning compounds like Furoxone for niche or adjunctive therapies [2]. However, the lack of extensive clinical validation, safety data, and regulatory approval constrains its market penetration.

Emerging pharmaceutical companies specializing in revival or optimization of old agents aim to develop Furoxone-based derivatives. This "drug re-engineering" trend reflects a strategic approach to leverage existing pharmacological scaffolds, reducing R&D costs and preclinical safety testing.

2. Regulatory and IP Challenges

Furoxone's status as an experimental or discontinued agent creates substantial hurdles in patent protection and regulatory approval processes. New formulation or derivative patents are crucial for commercial viability. Regulatory pathways, especially in markets like the US and EU, demand rigorous clinical trial results demonstrating safety, efficacy, and manufacturing quality.

The absence of current marketed formulations limits opportunities for direct market entry, pushing developers towards niche indications, topical applications, or combination therapies that could circumvent some regulatory barriers.

3. Emerging Trends and Market Drivers

  • Antimicrobial Resistance (AMR): Growing AMR concerns have reignited interest in traditional antibiotics, including structure-based derivatives inspired by agents like Furoxone.
  • Personalized Medicine: Precision targeting of resistant pathogens may open pathways for specialized antimicrobial therapies where historical drugs are adapted.
  • Biotech Innovation: Platforms in synthetic biology, molecular modification, and drug delivery for old compounds like Furoxone are expanding, potentially renewing their clinical relevance.
  • Funding and Investment Climate: Increased funding from government and private sectors for antibiotic R&D provides opportunities for compounds with historical data and promising mechanisms.

4. Commercialization Prospects

Given the current landscape, Furoxone’s primary commercial prospects rest on:

  • Derivative Development: Creating safer, more potent derivatives with improved bioavailability.
  • Niche Indications: Targeting resistant infections, hospital-acquired infections (HAIs), or topical dermatological applications.
  • Strategic Partnerships: Collaborations with biotech firms and academic institutions for clinical validation and formulation innovation.

Financial Trajectory and Investment Outlook

1. Revenue Potential

As a pre-approval candidate or niche drug, Furoxone-related products are unlikely to generate immediate significant revenues. Instead, the financial model hinges on:

  • R&D Investment: Development costs for optimization, preclinical, and clinical trials.
  • Licensing and Partnership Revenue: Partnering with larger pharmaceutical firms for commercialization.
  • Market Penetration: Penetration into hospital formularies or specialty clinics, given particularly resistant infections.

2. Cost Factors and Investment Risks

Key costs include toxicology studies, clinical trial phases (I-III), manufacturing scale-up, and regulatory submission fees. The risks involve:

  • Regulatory Delays or Denials: Due to safety or efficacy concerns.
  • Market Acceptance: Inertia among clinicians accustomed to existing antibiotics.
  • Competitive Dynamics: Entrenched players in the antimicrobial market.

3. Future Financial Trajectories

  • Optimistic Scenario: Successful development of a derivative or reformulation that addresses safety and efficacy concerns, leading to regulatory approval and commercialization—potentially generating multi-million dollar annual revenues within 5–7 years.
  • Base Case: Continued research with promising preclinical data, attracting niche investors, with limited or no immediate revenue until regulatory and clinical milestones are achieved.
  • Downside Scenario: Project delays, safety issues, or commercial failures reducing or nullifying investment returns.

Conclusion: Strategic Outlook

Furoxone's future market potential resides primarily in targeted development efforts aimed at overcoming historical limitations. The current global emphasis on combating antimicrobial resistance makes it a candidate for niche utility rather than broad-spectrum blockbuster status. Commercial success depends on strategic innovation, substantial R&D investment, and partnerships to refine safety profiles and demonstrate clinical benefit. As the antimicrobial market continues to evolve, agents like Furoxone could contribute to a diversified antibiotic arsenal, provided clinical and regulatory hurdles are navigated successfully.


Key Takeaways

  • Furoxone has limited current market activity but exhibits potential as a foundational scaffold for derivative antibiotics.
  • Market growth is driven by the urgent need for new antibiotics amid rising AMR, though commercialization remains challenging.
  • Development focus shifts to niche indications and combating drug-resistant infections using modified formulations.
  • Financial prospects hinge upon successful clinical development, strategic partnerships, and addressing safety and regulatory concerns.
  • Investment opportunities should weigh the high risks associated with drug reformulation against the significant unmet needs in antimicrobial resistance.

FAQs

1. Is Furoxone currently approved for clinical use?
No, Furoxone is not approved for widespread clinical use. It remains an investigational or discontinued compound with limited regulatory approval history, mainly serving as a research tool or chemical scaffold.

2. Can Furoxone be repurposed for modern therapy?
Potentially. Current research focuses on developing derivatives or formulations that improve safety and efficacy, making repurposing plausible in niche therapeutic areas such as resistant bacterial infections.

3. What are the main challenges in commercializing Furoxone?
The primary challenges include toxicity concerns, pharmacokinetic limitations, regulatory hurdles, patent protection issues, and competition from existing antibiotics.

4. How does antimicrobial resistance influence Furoxone's market prospects?
The surge in resistant bacteria increases interest in novel antimicrobials, creating opportunities for agents like Furoxone if safety and efficacy hurdles are overcome, positioning it as part of the next-generation antibiotic pipeline.

5. Who are the key players involved in Furoxone development today?
Currently, no major pharmaceutical firms are actively marketing Furoxone; development efforts are likely limited to small biotech companies and academic collaborations aimed at derivatives or innovative applications.


Sources:
[1] Historical pharmacological data.
[2] WHO Global Antimicrobial Resistance Surveillance Report.

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