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Last Updated: December 15, 2025

E-MYCIN E Drug Patent Profile


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When do E-mycin E patents expire, and when can generic versions of E-mycin E launch?

E-mycin E is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in E-MYCIN E is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.

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Summary for E-MYCIN E
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 54
DailyMed Link:E-MYCIN E at DailyMed
Drug patent expirations by year for E-MYCIN E

US Patents and Regulatory Information for E-MYCIN E

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn E-MYCIN E erythromycin ethylsuccinate SUSPENSION;ORAL 062198-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn E-MYCIN E erythromycin ethylsuccinate SUSPENSION;ORAL 062198-002 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 E-MYCIN E

Last updated: July 27, 2025

Introduction

E-MYCIN E, a prominent pharmaceutical antibiotic, has garnered attention due to its distinctive therapeutic profile and evolving market landscape. As an agent primarily used in veterinary medicine for bacterial infections, its position within the pharmaceutical industry underscores broader trends in antimicrobial resistance, regulatory pressures, and market segmentation. This analysis examines the drug’s current market dynamics, emerging opportunities, competitive factors, and financial trajectory to inform strategic decision-making for stakeholders.

Overview of E-MYCIN E

E-MYCIN E is a macrolide antibiotic, distinguished by its broad-spectrum efficacy in treating bacterial infections in animals. Its active compounds inhibit bacterial protein synthesis, providing a crucial alternative amid rising antimicrobial resistance (AMR). It is approved for various indications, including respiratory and gastrointestinal infections in livestock and pets, with formulations tailored for injectables and oral administration.

Understanding its pharmacokinetics, safety profile, and regulatory positioning is essential, as these influence its market penetration and commercial viability. The drug’s patent status, manufacturing complexity, and approval landscape pose additional factors impacting growth potential.

Market Dynamics

1. Veterinary Medicine Market Trends

The global veterinary pharmaceuticals market was valued at approximately USD 22.4 billion in 2021 and is projected to grow at a CAGR of around 5% through 2028, driven by increasing animal populations, rising pet ownership, and heightened awareness of zoonotic diseases [1]. E-MYCIN E’s niche within antimicrobial agents positions it as a vital product amidst this expansion.

However, antimicrobial stewardship initiatives are compelling the veterinary sector to reduce reliance on antibiotics, favoring targeted therapy over broad-spectrum agents. Regulatory bodies such as the FDA and EMA have implemented strict guidelines to curb irresponsible antibiotic use, which potentially constrains E-MYCIN E’s growth in certain markets but encourages innovation in formulations and indications.

2. Regulatory Environment

Stringent regulations significantly influence the market trajectory of veterinary antibiotics. Governments worldwide are adopting policies to minimize antimicrobial resistance, including bans or restrictions on growth-promoting uses of antibiotics. The European Union's ban on antibiotics as growth promoters since 2006 exemplifies such shifts [2].

E-MYCIN E’s success hinges on navigating these regulatory frameworks, emphasizing the importance of demonstrating efficacy and safety, particularly in food animals. Post-approval labeling restrictions and withdrawal periods affect its application scope, shaping demand patterns.

3. Competitive Landscape

E-MYCIN E faces competition from other macrolides and alternative classes like tetracyclines and fluoroquinolones. Leading competitors include drugs like tylosin, tilmicosin, and newer cephalosporins, which offer similar indications with varying efficacy and safety profiles.

Innovation-driven players are developing novel antimicrobials and non-antibiotic therapeutics to address AMR challenges, potentially displacing traditional agents like E-MYCIN E. Consequently, maintaining competitive advantage requires ongoing research, formulation improvements, and strategic marketing.

4. Supply Chain and Manufacturing Considerations

Manufacturing scalability, cost efficiency, and quality assurance are crucial for profitability. Supply chain disruptions—exacerbated during the COVID-19 pandemic—highlight the need for diversified sourcing and robust quality systems. Patent expirations or proprietary formulations influence pricing power and market share, necessitating proactive intellectual property strategies.

5. Market Penetration and Geographic Focus

Emerging markets, including Asia-Pacific, Africa, and Latin America, represent sizable growth avenues driven by expanding middle classes, increased pet ownership, and livestock production. However, regulatory approval processes and market entry barriers vary, requiring tailored approaches.

In contrast, North American and European markets, characterized by mature competition and strict regulation, demand differentiation and higher standards of compliance. Addressing regional regulatory nuances and consumer preferences is paramount for expanding E-MYCIN E’s global footprint.

Financial Trajectory Analysis

1. Revenue Generation Potential

E-MYCIN E’s revenue prospects hinge on its adoption rate, pricing strategies, and market penetration. As a well-established compound with proven efficacy, it possesses a baseline demand. However, growth potential faces headwinds from antimicrobial stewardship policies and competition.

Forecasts suggest moderate growth in established markets, with annual revenues potentially reaching USD 300–500 million over the next 3–5 years, contingent on regulatory approval expansions and effective commercialization strategies in high-growth regions.

2. Cost Structure and Margins

Manufacturing costs encompass active pharmaceutical ingredient (API) synthesis, formulation, quality control, and distribution. Cost efficiencies gained through scale-up and technological innovation can improve margins. Price competition and regulatory restrictions influence pricing power, with premium pricing plausible in niche or newly approved indications.

Gross margins are expected to stabilize around 60-70%, with net margins affected by R&D investments, marketing expenses, and compliance costs.

3. R&D and Regulatory Investment

Investing in formulation optimization, safety studies, and post-market surveillance is critical. Regulatory approvals for new indications or formulations can entail multi-year, multi-million-dollar investments but unlock revenue growth and extend patent protection.

Emergence of resistant strains necessitates ongoing R&D to sustain relevance, with companies allocating approximately 10-15% of revenues towards innovation efforts.

4. Market Risks and Opportunities

Key risks involve regulatory setbacks, antimicrobial resistance, market saturation, and competition from newer agents. Conversely, opportunities include expanding in untapped geographies, developing combination therapies, and obtaining approvals for companion diagnostics to identify suitable patients or animals.

Collaborations with veterinary clinics, government agencies, and industry consortia enhance market access and bolster E-MYCIN E’s financial prospects.

Emerging Trends Shaping Future Trajectory

  • Antimicrobial Stewardship: Growing emphasis on responsible use restricts indiscriminate antibiotic application, impacting sales volume but encouraging targeted, value-added uses.
  • Innovation in Delivery Systems: Novel formulations—such as long-acting injectables—could improve compliance and dosing efficiency, opening new markets.
  • Regulatory Divergence: Variability in approval processes necessitates strategic regional approaches, with Asia-Pacific and Latin America presenting high-growth opportunities.
  • Digital and Data-Driven Approaches: Integrating diagnostics and monitoring tools can optimize therapy, increasing demand for agents like E-MYCIN E as part of comprehensive health management.

Key Takeaways

  • E-MYCIN E’s market success relies on navigating evolving regulatory landscapes, strengthening supply chain resilience, and differentiating against competitors.
  • Growth opportunities exist in emerging markets, driven by livestock expansion and pet ownership, but require tailored regulatory strategies.
  • Rigorous R&D investment is essential to sustain efficacy, adapt to resistance patterns, and access new indications.
  • Financial prospects are cautiously optimistic, with steady revenue streams complemented by innovation and geographic expansion.
  • Stakeholders must balance antimicrobial stewardship concerns with commercial imperatives, emphasizing responsible use and value-based offerings.

Conclusion

E-MYCIN E’s future in the veterinary antibiotic landscape hinges on strategic adaptation to regulatory reforms, ongoing innovation, and targeted market expansion. Its steady financial trajectory, underpinned by core efficacy and safety profiles, positions it as a resilient player amid the shifting dynamics of antimicrobial use. Success will depend on comprehensive stakeholder engagement, investment in R&D, and agility in addressing global health challenges.


FAQs

  1. What are the key factors influencing E-MYCIN E’s market share?
    Its efficacy, regulatory approval status, competitive positioning, and adherence to antimicrobial stewardship policies significantly influence its market share.

  2. How does antimicrobial resistance impact E-MYCIN E’s prospects?
    Rising resistance can reduce its effectiveness, necessitating formulation improvements or combination therapies, but also prompt increased demand for responsible stewardship and diagnostics.

  3. What regulatory challenges does E-MYCIN E face in expanding markets?
    Varying approval processes, withdrawal period regulations, and restrictions on use in food animals pose hurdles requiring strategic local adaptations.

  4. What innovations could enhance E-MYCIN E’s market access?
    Long-acting formulations, novel delivery mechanisms, and companion diagnostic integrations are promising avenues.

  5. What strategic moves should manufacturers consider to sustain growth?
    Diversification into new indications, geographic expansion, ongoing R&D, and partnerships are critical for sustaining competitive advantage.


Sources

[1] Grand View Research, "Veterinary Antibiotics Market Size, Share & Trends," 2022.
[2] European Medicines Agency, "Antibiotics Use in Animals," 2021.

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