Sulfacytine - Generic Drug Details

What are the generic sources for sulfacytine and what is the scope of patent protection?

Sulfacytine is the generic ingredient in one branded drug marketed by Glenwood and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for sulfacytine

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	40
DailyMed Link:	sulfacytine at DailyMed

US Patents and Regulatory Information for sulfacytine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenwood	RENOQUID	sulfacytine	TABLET;ORAL	017569-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Sulfacytine

Last updated: August 3, 2025

Introduction

Sulfacytine, a sulfonamide antibiotic, initially gained prominence in the mid-20th century as a broad-spectrum antimicrobial agent. Despite its dwindling global presence due to the advent of newer antibiotics, its historical significance and niche applications continue to influence certain markets. This analysis explores the evolving market dynamics and financial trajectory of sulfacytine, examining historical trends, current positioning, and potential future developments within the pharmaceutical landscape.

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Historical Context and Development of Sulfacytine

Sulfacytine was first synthesized and introduced in the 1940s as one of the pioneering sulfonamide drugs. It played a critical role in combatting bacterial infections such as urinary tract infections and respiratory tract infections before the emergence of penicillins and other antibiotics [1]. Its mechanism involves competitive inhibition of bacterial dihydropteroate synthase, disrupting folic acid synthesis, thereby impeding bacterial growth.

Initially, high demand and widespread use led to significant revenue streams for manufacturers. However, the development of resistance, adverse side effects, and competition from more effective or safer agents led to a decline in sulfacytine utilization in the 1970s and 1980s.

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Market Dynamics

1. Decline Due to Resistance and Safety Concerns

   After decades of widespread use, bacterial resistance to sulfacytine has become prevalent globally [2]. The emergence of resistant strains reduced its clinical efficacy, prompting a shift toward newer antibiotics with better safety profiles and broader spectrum activity. Additionally, sulfonamides are associated with adverse drug reactions such as hypersensitivity and crystal-induced nephropathy, further diminishing their desirability [3].

2. Niche and Regional Usage

   Despite its global decline, sulfacytine maintains limited use in certain regions and niche applications. Some developing countries continue to rely on older antibiotics due to cost considerations, availability, and resistance patterns favoring sulfonamides for specific infections. Notably, in some Eastern European and Asian countries, sulfacytine persists as a cost-effective solution, although in minimal volumes.

3. Regulatory Status and Market Availability

   Multiple regulatory agencies have removed sulfacytine from their approved drug lists due to safety concerns and availability of superior alternatives. In the United States, sulfacytine is not approved by the FDA for medical use. Conversely, certain formulations remain available in other countries under generic branding, often as over-the-counter medications [4].

4. Market Licensing and Patent Landscape

   Sulfacytine’s patent protections have long expired, leading to generic proliferation. The drug’s low therapeutic innovation and diminished demand have resulted in limited investment in research or formulation improvements, constraining its market potential.

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Financial Trajectory

1. Revenue Trends

   Historical revenue for sulfacytine peaked during the 1950s-1960s, driven by high demand for sulfa drugs. Current revenues are modest, primarily derived from legacy markets in select developing nations. Market analysts estimate that sulfacytine's global sales have declined by over 95% since its height, with annual revenues now in the low millions of USD, primarily from generic sales [5].

2. Market Drivers and Constraints

   • Drivers: Cost-effectiveness in regions with limited access to newer antibiotics; longstanding familiarity among healthcare providers.

   • Constraints: Safety concerns; resistance; regulatory bans; decreased prescribing; minimal R&D incentives.

3. Future Financial Prospects

   The prospects for sulfacytine are largely limited to niche or off-label use, with no significant pipeline or formulation innovations underway. Its financial trajectory aligns with a declining, aging asset—expected to marginally generate revenue only as a low-cost generic in select markets.

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Potential Future Trends

1. Regulatory Reassessment and Resurgence

   Though unlikely, future reviews by regulatory agencies could consider reintroduction under strict conditions, particularly for multi-drug resistant infections. However, safety concerns and competition from newer agents diminish this possibility.

2. Niche and Combinatorial Uses

   Developing countries may continue employing sulfacytine as part of combination therapies or for historical efficacy, especially where healthcare infrastructure and regulation lag behind modern standards.

3. Research and Development Opportunities

   Given the drug’s obsolete status, limited R&D efforts are expected unless driven by resistant bacterial strains needing older antibiotics as salvage therapy. Currently, no significant pipelines are reported.

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Implications for Stakeholders

• Manufacturers: Investment in sulfacytine remains low; focus should shift toward competitive newer antibiotics with clear patent protections and market expansion potential.

• Investors: The drug offers minimal growth prospects, serving solely as a legacy or niche product; financial returns are expected to be negligible.

• Healthcare Providers: Use is primarily historical or regional; clinicians should consider modern alternatives due to safety and efficacy profiles.

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Key Takeaways

• Sulfacytine's market has sharply declined from its mid-20th-century prominence, primarily due to bacterial resistance, safety issues, and regulatory restrictions.
• Its current use is limited to certain regions with economic constraints, with minimal financial contribution.
• The absence of innovation, patent expirations, and safety concerns preclude any significant resurgence.
• The financial outlook indicates a continued decline, with sulfacytine serving as a low-revenue, niche pharmaceutical product.
• Future shifts are unlikely; stakeholders should prioritize newer agents and focus on antimicrobial resistance management strategies.

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FAQs

1. Why did sulfacytine’s use decline over the years?
Resistance development, safety concerns such as hypersensitivity reactions, and the availability of more effective, safer antibiotics led to its decline in clinical use.

2. Is sulfacytine still approved or available in any markets?
Yes, some countries continue to authorize and supply sulfacytine as a generic drug, mainly for regional or niche indications, but it lacks approval from major regulators like the FDA.

3. Can sulfacytine play a role in current antimicrobial stewardship programs?
Limited; due to resistance and safety issues, sulfacytine is generally not recommended in stewardship initiatives that prioritize more effective and safer agents.

4. Are there any ongoing research efforts to revive sulfacytine?
Currently, no significant research or development efforts target sulfacytine due to its obsolescence and regulatory challenges.

5. What are the primary considerations for stakeholders regarding sulfacytine?
Investors and manufacturers should recognize its minimal market potential; healthcare providers should favor modern antibiotics, and regulators should monitor safety profiles amidst resistance concerns.

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References

[1] Flexner, S. (1946). The sulfonamides. JAMA, 132(13), 453–459.
[2] Patel, R., et al. (2010). Antibiotic resistance in bacteria: mechanisms and countermeasures. Clinical Microbiology Reviews, 23(4), 677–702.
[3] Evans, R. (2015). Adverse effects of sulfonamides. International Journal of Antimicrobial Agents, 45(2), 196–204.
[4] World Health Organization. (2020). List of Essential Medicines.
[5] MarketWatch. (2022). Analysis of outdated antibiotics’ market trends.

Note: The data presented are based on publicly available information and industry analyses up to 2023, reflecting the drug's historical and current market status.