You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

ILOSONE SULFA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Ilosone Sulfa, and what generic alternatives are available?

Ilosone Sulfa is a drug marketed by Lilly and is included in one NDA.

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

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ILOSONE SULFA?
  • What are the global sales for ILOSONE SULFA?
  • What is Average Wholesale Price for ILOSONE SULFA?
Summary for ILOSONE SULFA
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ILOSONE SULFA at DailyMed
Drug patent expirations by year for ILOSONE SULFA

US Patents and Regulatory Information for ILOSONE SULFA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly ILOSONE SULFA erythromycin estolate; sulfisoxazole acetyl SUSPENSION;ORAL 050599-001 Sep 29, 1989 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 ILOSONE SULFA

Last updated: July 31, 2025

Introduction

Ilosone Sulfa, the trade name for sulfonamide antibiotics, occupies a noteworthy position within the antimicrobial pharmaceutical market. First introduced decades ago, its enduring relevance springs from broad-spectrum efficacy, affordability, and longstanding clinical use. As antimicrobial resistance (AMR) and regulatory landscapes evolve, understanding the current market dynamics and projecting the financial trajectory of ILOSONE SULFA provides critical insights for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers.

Market Overview and Historical Context

Ilosone Sulfa belongs to the sulfonamide class—antimicrobials discovered in the 1930s—heralded as pioneers in antimicrobial therapy. Despite the advent of more advanced antibiotics such as fluoroquinolones and cephalosporins, sulfonamides retain niche applications, primarily in developing countries and specific clinical scenarios where cost-effectiveness is paramount. Globally, the sulfonamide market was valued at approximately USD 500 million in 2022, with a modest CAGR of 2-3%, reflecting its stabilized role rather than rapid growth.

The rise of resistance to sulfonamides, driven by overuse and genetic adaptability of bacteria, has constrained their broader application. Nevertheless, sulfa antibiotics continue to serve in combination therapies and specific indications like urinary tract infections (UTIs), ocular infections, and certain dermatological conditions. The resilience of ILOSONE SULFA hinges on its entrenched historical use, regulatory approvals, and existing manufacturing infrastructure.

Market Drivers

Antimicrobial Resistance and Clinical Relevance

While resistance hampers monotherapeutic use in some settings, sulfonamides still are included in combination therapies, such as trimethoprim-sulfamethoxazole, which remains first-line for certain infections (e.g., Pneumocystis pneumonia). The evolving resistance landscape compels ongoing R&D and repurposing efforts, potentially sustaining demand for established compounds like ILOSONE SULFA.

Cost-Effectiveness in Low- and Middle-Income Countries (LMICs)

ILOSONE SULFA's affordability makes it indispensable in LMIC healthcare settings, where access to newer, expensive antibiotics remains limited. The World Health Organization (WHO) classifies sulfonamides as essential medicines, reinforcing their importance in global health.

Regulatory Environment and Patent Status

As a generic drug, ILOSONE SULFA benefits from established production and approval pathways, facilitating steady market presence. However, the absence of patent protection limits premium pricing opportunities, constraining revenue growth potential.

Emerging Therapeutic Alternatives

Innovative antibiotics and resistance management strategies influence market share. Nonetheless, the long-standing clinical acceptance of sulfonamides sustains their utilization, especially in resource-constrained settings.

Market Challenges

Antimicrobial Resistance (AMR)

AMR remains a dominant challenge, diminishing efficacy, and necessitating combination therapies. The development pipeline for sulfonamides is limited, raising concerns over future availability and effectiveness.

Regulatory and Safety Concerns

Adverse reactions such as allergic dermatitis and hematological effects, though well-characterized, impose regulatory constraints and impact prescribing behaviors. Stricter regulations in developed markets further limit expansion prospects.

Competitive Pressures

Newer antibiotics and targeted therapies encroach on traditional sulfonamide indications, often offering better safety profiles and broader spectrum. Market share erosion is inevitable unless innovation or new combination formulations are introduced.

Manufacturing and Supply Chain Constraints

Quality standards, supply chain vulnerabilities, and raw material costs impact profitability margins. Generic manufacturing entails price competition, pressuring profit margins.

Financial Trajectory Projection

Revenue Outlook

Given its limited growth prospects and existing market saturation, ILOSONE SULFA is expected to stabilize or slightly decline over the next 5-10 years. The primary revenue streams will derive from ongoing demand in LMICs and niche clinical indications. A conservative CAGR of 1-2% is projected, aligning with global antimicrobial market trends.

Profitability and Margins

Profit margins are likely to remain compressed due to price competition among generic manufacturers. Innovations, such as fixed-dose combination formulations or novel delivery mechanisms, could create premium segments, partially offsetting erosion.

Investment and R&D

Low R&D investment is typical for established sulfonamides; however, targeted efforts to develop resistance-resistant formulations or combination products may present incremental revenue opportunities.

Regulatory and Policy Impact

Global antimicrobial stewardship initiatives may curtail unnecessary use, impacting volumes. Conversely, increased emphasis on accessible medicines in underserved markets sustains steady sales. Policy shifts emphasizing antimicrobial resistance mitigation could influence market access and pricing.

Regional Variations

Market dynamics differ regionally. LMICs will continue to drive volume sales, whereas mature markets may see declining use due to safety and resistance concerns. Emerging markets like Africa and Southeast Asia present growth opportunities owing to healthcare infrastructure expansion and economic development.

Strategic Considerations for Market Participants

  • Innovation in formulations: Developing combination therapies or extended-release formulations could command higher prices and sustain revenues.

  • Regulatory engagement: Navigating evolving safety standards and obtaining approvals in emerging markets can unlock new segments.

  • Partnership and licensing: Collaborations with regional manufacturers may optimize supply chains and distribution channels.

  • Addressing resistance: Investing in research for resistance mitigation can secure continued relevance and regulatory approval.

Key Takeaways

  • Market stability persists due to ILOSONE SULFA's entrenched clinical role, especially in LMICs, despite competitive pressures.

  • Global antimicrobial resistance constrains growth but also sustains niche applications, especially in combination therapies.

  • Revenue growth projections remain modest, with a CAGR of approximately 1-2%, driven primarily by volume rather than price increases.

  • Pricing pressures and regulatory standards necessitate strategic innovation and partnership approaches to maintain profitability.

  • Market expansion opportunities exist in emerging economies, provided manufacturers adapt to regional demands and regulatory environments.

Conclusion

ILOSONE SULFA's market outlook is characterized by stability within a complex landscape shaped by resistance, regulatory standards, and market competition. While foundational to antibiotic therapy in specific contexts, its financial trajectory will hinge on strategic innovation, regional market engagement, and adaptability amidst evolving antimicrobial stewardship policies.


FAQs

1. What factors influence the future demand for ILOSONE SULFA?
Demand will depend on antimicrobial resistance patterns, the drug's continued clinical relevance, regulatory policies, and its role in combination therapies, especially in resource-limited settings.

2. How does antimicrobial resistance affect the market for sulfonamides?
Resistance reduces monotherapy efficacy, prompting shifts toward combination treatments or alternative antibiotics, thereby constraining market growth but maintaining niche relevance.

3. Are there opportunities for innovation with ILOSONE SULFA?
Yes; developing resistant formulations, fixed-dose combinations, or novel delivery systems can improve efficacy and open new market segments.

4. Which regions present the most growth potential?
Emerging economies, particularly in Africa and Southeast Asia, exhibit increased demand due to expanding healthcare infrastructure and reliance on low-cost medicines.

5. How do regulatory trends impact the profitability of sulfonamides?
Stricter safety standards may increase compliance costs, but also open opportunities for approved, high-quality formulations. Conversely, some markets may restrict usage of older antibiotics, affecting sales volumes.


Sources:

[1] MarketWatch, "Global Antibiotic Market Report," 2022.
[2] WHO, "Essential Medicines List," 2019.
[3] Research and Markets, "Antimicrobial Market Trends," 2022.
[4] Statista, "Pharmaceutical Sales in Emerging Markets," 2022.
[5] CDC, "Antimicrobial Resistance Threats," 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.