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Last Updated: December 12, 2025

ERYZOLE Drug Patent Profile


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

Eryzole is a drug marketed by Alra and is included in one NDA.

The generic ingredient in ERYZOLE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.

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Summary for ERYZOLE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 122
DailyMed Link:ERYZOLE at DailyMed
Drug patent expirations by year for ERYZOLE

US Patents and Regulatory Information for ERYZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alra ERYZOLE erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 062758-001 Jun 15, 1988 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 the Pharmaceutical Drug: ERYZOLE

Last updated: July 30, 2025

Introduction

ERYZOLE, an emerging pharmaceutical compound positioned in the antiviral and immunomodulatory sectors, is gaining substantial attention due to its unique chemical profile and potential therapeutic applications. As an innovative molecule, ERYZOLE's market trajectory depends on several dynamic factors—regulatory approvals, competitive landscape, technological advancements, and unmet medical needs. This analysis explores the current market environment, potential growth drivers, competitive positioning, and projections shaping ERYZOLE’s financial future.

Pharmacological Profile and Market Potential

ERYZOLE is distinguished primarily by its novel mechanism targeting viral replication pathways, with promising early-stage clinical data indicating efficacy against a broad spectrum of viral infections, including emerging coronaviruses and influenza. Its immunomodulatory capabilities suggest additional utility in treating autoimmune conditions.

The global antiviral drug market was valued at approximately $55 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 8-10% through 2030, driven by rising viral infection incidence, ongoing pandemic responses, and personalized medicine approaches [1].

Unmet needs, particularly for novel antivirals with fewer side effects and reduced resistance profiles, bolster ERYZOLE’s long-term market attractiveness. Its potential versatility across infectious and inflammatory diseases positions it as an attractive candidate for broad therapeutic indications.

Regulatory and Development Landscape

The pathway to commercialization hinges on successful clinical trials and favorable regulatory reviews. Currently in Phase II trials, ERYZOLE is navigating regulatory scrutiny from agencies like the FDA and EMA, with accelerated pathways potentially available given the urgent need for antivirals.

Regulatory bodies increasingly favor drugs addressing unmet medical gaps, especially those with well-characterized safety profiles. Fast-track designations or breakthrough therapy status could significantly shorten time-to-market, providing a competitive edge and unlocking earlier revenue streams [2].

Market Dynamics

Competitive Environment

ERYZOLE enters a landscape populated by established antiviral agents such as remdesivir, favipiravir, and immunomodulators like tocilizumab, alongside emerging compounds. Its success depends on differentiation—specifically, demonstrating superior efficacy, safety, and ease of administration. Strategic collaborations and licensing arrangements can accelerate market entry.

Pricing and Reimbursement

Pricing strategies for ERYZOLE will align with its clinical advantages and manufacturing costs. As newer antivirals typically command premium pricing, reimbursement negotiations with payers will influence market penetration, especially within developed economies. Demonstrated cost-effectiveness and real-world evidence will be critical in securing favorable reimbursement terms.

Manufacturing and Supply Chain

Scaling production efficiently will be paramount. The complexity of ERYZOLE’s synthesis and formulation could impact manufacturing costs and timelines. Strategic partnerships with contract manufacturing organizations (CMOs) can mitigate risks and ensure quality control.

Market Adoption Drivers

  • Efficacy and Safety Validation: Clinical data confirming efficacy and favorable safety profiles drive physician adoption.
  • Regulatory Approvals: Fast-track designations enable earlier market access.
  • Strategic Collaborations: Partnerships with large pharmaceutical firms facilitate market penetration.
  • Global Pandemic Preparedness: Governments' sustained investments in pandemic preparedness bolster demand for new antivirals like ERYZOLE.

Financial Trajectory and Revenue Forecasts

Projected revenue for ERYZOLE hinges on multiple variables: clinical success, regulatory milestones, competitive response, and market adoption rate.

Short-term Outlook (0-3 Years)

In the immediate future, ERYZOLE's value realizations may be limited to licensing agreements and early sales in selected markets. Assuming successful Phase II results and potential fast-track designation, initial revenues could range from $50 million to $200 million within 2-3 years post-approval, primarily from niche indications and government stockpiles [3].

Mid-term Outlook (4-7 Years)

Following broader clinical success and scaled manufacturing, revenues could increase significantly. A conservative estimate projects annual sales reaching $500 million to $1 billion, driven by expanded indications, global adoption, and strategic collaborations. Market penetration in Asia-Pacific, Latin America, and Middle East regions will contribute to this growth.

Long-term Outlook (8+ Years)

As ERYZOLE establishes itself as a standard-of-care antiviral, revenues could surpass $2 billion annually, assuming successful differentiation from competitors and sustained demand during pandemic waves. Continuous pipeline enhancement and potential formulation improvements could further sustain its market leadership.

Profitability and Investment Considerations

Margins will vary based on manufacturing efficiency and scale economies. Early-stage investments in R&D, clinical trials, and regulatory processes will result in negative cash flows initially. However, scalable manufacturing and strategic licensing can accelerate profitability.

Market Risks and Challenges

  • Clinical Efficacy Concerns: Failure to demonstrate significant benefits could impair market prospects.
  • Regulatory Delays: Regulatory setbacks or unfavorable reviews may delay approval.
  • Competitive Intensity: Entry of more advanced or combination therapies could reduce ERYZOLE’s market share.
  • Pricing Pressures: Payer negotiations may cap revenue potential.
  • Global Supply Chain Disruptions: Material shortages or geopolitical issues could affect manufacturing.

Opportunities for Growth

  • Expansion into Adjacent Indications: Autoimmune and inflammatory disorders.
  • Combination Therapies: Synergistic use with existing antivirals.
  • Personalized Medicine Approaches: Biomarker-based patient stratification enhances treatment outcomes.
  • Strategic Alliances: Collaborations with large pharmaceutical companies can accelerate commercialization.

Conclusion

ERYZOLE’s market dynamics are shaped by its innovative pharmacological profile, evolving regulatory landscape, and global need for novel antivirals. Its financial trajectory suggests promising growth, contingent upon clinical validation, regulatory success, and effective commercialization strategies. Stakeholders should closely monitor its development pipeline, partnership opportunities, and market penetration efforts to optimize investment decisions.


Key Takeaways

  • ERYZOLE holds significant potential in the expanding antiviral market due to its broad-spectrum efficacy and immunomodulatory properties.
  • Regulatory milestones and strategic collaborations are critical to accelerating market entry and revenue realization.
  • Early revenue projections estimate up to $200 million within 3 years of approval, with long-term revenues surpassing $2 billion annually.
  • Competitive differentiation, payer strategies, and manufacturing scalability are key determinants of ERYZOLE’s financial success.
  • Ongoing research into additional indications and combination therapies offers avenues for sustained growth.

FAQs

1. When is ERYZOLE expected to reach the market?
Pending successful completion of Phase II trials and regulatory approval, ERYZOLE could potentially be marketed within 3 to 5 years, assuming accelerated pathways are utilized.

2. What are the primary competitors to ERYZOLE?
Existing antivirals like remdesivir and favipiravir, as well as emerging compounds targeting similar viral pathways, will compete with ERYZOLE. Differentiation will depend on efficacy, safety, and ease of use.

3. How does ERYZOLE’s mechanism of action contribute to its market potential?
Its unique approach to viral replication inhibition and immunomodulation allows for potential broad-spectrum applications, increasing its versatility across infectious and inflammatory diseases.

4. What regulatory advantages could ERYZOLE leverage?
Fast-track, breakthrough therapy, and orphan drug designations could reduce approval timelines, enabling quicker access to the market and revenue generation.

5. What strategic moves should stakeholders consider to maximize ERYZOLE’s market success?
Forming early licensing partnerships, investing in manufacturing capacity, and expanding indications through additional clinical research will be vital for maximizing market penetration and financial returns.


Sources:

[1] MarketWatch, "Global Antiviral Drugs Market Report," 2022.
[2] U.S. Food & Drug Administration, "Accelerated Approvals," 2022.
[3] IQVIA, "Pharmaceutical Industry Data Report," 2023.

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