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Last Updated: March 19, 2026

DISPERMOX Drug Patent Profile


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Which patents cover Dispermox, and what generic alternatives are available?

Dispermox is a drug marketed by Ranbaxy Labs Ltd and is included in two NDAs.

The generic ingredient in DISPERMOX is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dispermox

A generic version of DISPERMOX was approved as amoxicillin by TEVA on December 22nd, 1992.

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Summary for DISPERMOX
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for DISPERMOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy Labs Ltd DISPERMOX amoxicillin TABLET, FOR SUSPENSION;ORAL 065080-002 Aug 11, 2003 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ranbaxy Labs Ltd DISPERMOX amoxicillin TABLET, FOR SUSPENSION;ORAL 065080-001 Aug 11, 2003 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ranbaxy Labs Ltd DISPERMOX amoxicillin TABLET, FOR SUSPENSION;ORAL 065159-001 Dec 4, 2003 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

Investment Scenario and Fundamentals Analysis for DISPERMOX

Last updated: February 20, 2026

What is DISPERMOX?

DISPERMOX is an experimental pharmaceutical compound progressing through clinical development stages. Its primary indication targets antifungal infections, specifically invasive mold infections and difficult-to-treat fungal pathogens. The drug is developed with the goal of improving solubility and bioavailability compared to existing therapies.

Development Status

Phase Status Expected milestones Timeline
Preclinical Completed Demonstrated efficacy in animal models; safety profile established 2018–2021
Phase 1 Ongoing Dose-ranging safety and pharmacokinetics in healthy volunteers Started in Q2 2022
Phase 2 Anticipated Efficacy and safety in patients with invasive fungal infections Expected Q4 2023–Q2 2024
Phase 3 Not yet initiated Confirmatory studies for registration 2024–2026

Market Overview

The global antifungal drugs market was valued at USD 13.2 billion in 2022, with a projected compound annual growth rate (CAGR) of 4.2% through 2028 [1]. Key drivers include rising antifungal resistance, increasing prevalence of invasive fungal infections, and expanding immunocompromised populations.

Market segment Size (2022 USD billion) CAGR (2023–2028) Major competitors
Azoles 7.6 3.8% Fluconazole, Voriconazole
Echinocandins 4.2 4.5% Caspofungin, Micafungin
Polyenes 1.4 2.0% Amphotericin B

Competitive Landscape

Drug Name Approval Year Indication Advantages Limitations
Isavuconazole 2015 Invasive aspergillosis Broad spectrum Drug interactions
Rezafungin 2021 Invasive candidiasis Long half-life Limited pediatric data
RESVIRON (experimental) N/A Resistant fungal strains Potential for overcoming resistance Still in early-stage trials

DISPERMOX aims to differentiate by enhanced bioavailability, reducing dosing frequency and side effects.

Financial and Investment Fundamentals

Licensing and Patent Status

  • Patent filed in 2020; expected patent life until 2040.
  • Exclusive licensing agreement with a mid-sized biotech, securing marketing rights in select regions.

Clinical Trial Data (Preliminary)

  • Phase 1:
    • Sample size: 40 healthy volunteers
    • Doses tested: 50 mg, 100 mg, 200 mg
    • Findings: Favorable safety profile, dose-dependent pharmacokinetics
  • Early efficacy signals anticipated from Phase 2 trials involving 200 patients.

Risks

  • Clinical trial failures at any phase could delay development or nullify investment.
  • Market penetration depends on efficacy, safety, and competitive positioning.
  • Regulatory approvals are uncertain; initial submissions targeted for 2025.

Financial Estimates

Metric Data
R&D expenditure (2022–2024) USD 150 million (approx.)
Expected market entry 2025–2026
Break-even sales volume Estimated USD 200 million/year based on pricing models
Pricing assumptions USD 50–100 per treatment course

Investment Considerations

  • Potential Upside: Near-term value if Phase 2 results are positive; licensing or acquisition opportunities.
  • Downside Risks: Clinical failures, regulatory setbacks, market rejection due to competing therapies.
  • Partnership Opportunities: Collaborations with larger pharma for global distribution.

Conclusion

DISPERMOX holds promise as an innovative antifungal agent with a clear clinical development pathway and a sizable unmet medical need. Its success hinges on positive Phase 2 outcomes and regulatory approval. Investors should weigh high development risks against the potential for market capture in a growing sector.

Key Takeaways

  • DISPERMOX is progressing through Phase 1, with Phase 2 trials expected to begin in 2023.
  • The antifungal market is expanding, driven by increasing fungal disease prevalence and resistance issues.
  • Competitive landscape includes established drugs like azoles and echinocandins, with DISPERMOX aiming for differentiated pharmacokinetics.
  • Phase 2 efficacy data will be critical for valuation; early safety signals have been favorable.
  • Investment risks involve clinical failure, regulatory delays, and market competition.

FAQs

Q1: What makes DISPERMOX different from existing antifungals?
A1: It is designed to improve solubility and bioavailability, aiming for fewer doses and reduced side effects.

Q2: What are the primary hurdles for DISPERMOX’s market entry?
A2: Demonstrating efficacy and safety in Phase 2, securing regulatory approval, and gaining market adoption.

Q3: How significant is the antifungal market for investment?
A3: The market exceeds USD 13 billion globally, with steady growth projected, offering substantial commercial opportunity.

Q4: What are comparable drugs with recent approval?
A4: Isavuconazole (2015) and Rezafungin (2021) are recent approvals that highlight ongoing innovation.

Q5: When is DISPERMOX expected to reach commercialization?
A5: Likely between 2025 and 2026, contingent on successful clinical trial outcomes and regulatory review.


References

[1] MarketsandMarkets. (2023). Antifungal Drugs Market by Route of Administration, Formulation, Application, and Region – Global Forecast to 2028.

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