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Last Updated: December 28, 2025

SULPHRIN Drug Patent Profile


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Summary for SULPHRIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 40
DailyMed Link:SULPHRIN at DailyMed
Drug patent expirations by year for SULPHRIN

US Patents and Regulatory Information for SULPHRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb SULPHRIN prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088089-001 Dec 28, 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 Sulphrin

Last updated: August 8, 2025


Introduction

Sulphrin, historically a prominent antibiotic derived from the sulfonamide class, holds a pivotal position in the evolution of antimicrobial therapeutics. Despite its decline in mainstream medical practice due to advances in antibiotic development and emerging resistance, understanding the current market dynamics and financial trajectory of Sulphrin provides valuable insights into niche opportunities, legacy drug management, and retrospective market shifts. This analysis synthesizes clinical, regulatory, and economic factors influencing Sulphrin's market landscape.


Historical Context and Pharmacological Profile of Sulphrin

Developed in the 1930s, Sulphrin (sulfanilamide) marked a breakthrough in antimicrobial therapy, pioneering the sulfonamide class [1]. Its mechanism involves inhibiting bacterial folic acid synthesis, rendering it effective against various bacterial infections. Initially regarded as a miracle cure, Sulphrin's widespread application was curtailed by the emergence of resistance and the advent of penicillin and subsequent antibiotics.

Though obsolete in most developed markets, Sulphrin remains entrenched in certain niche applications, especially in regions with limited access to newer agents [2]. Its stability, low cost, and historical availability sustain residual demand, primarily in low-income settings.


Current Market Landscape

1. Geographic and Demographic Segmentation

  • Emerging Markets: Countries with constrained healthcare budgets and less advanced antimicrobial pipelines continue to utilize Sulphrin-based formulations, especially in rural areas [3].
  • Developed Markets: Regulatory obsolescence and safety concerns have relegated Sulphrin to obsolete status. Limited formulations are available mainly through legacy stockpiles or specific dermatological products.

2. Regulatory and Patent Status

Sulphrin has long been off-patent, with no active patent protections, which affects market exclusivity and pricing strategies. Most formulations are available as generics, leading to highly competitive pricing but low margins. Regulatory agencies in developed countries have withdrawn or recommended restricted use due to adverse effects, notably hypersensitivity reactions [4].

3. Competitive Landscape

Modern antibiotics such as trimethoprim-sulfamethoxazole, doxycycline, and others have replaced Sulphrin in many indications. Nonetheless, Sulphrin persists as a cost-effective option where newer drugs are unavailable or unaffordable, opening a narrow yet resilient niche.


Market Dynamics Influencing Sulphrin

A. Demand Factors

  • Cost-Effectiveness: The low price point sustains demand in resource-limited settings [5].
  • Resistance Patterns: Resistance to Sulphrin remains manageable in certain regions, but increasing cases could threaten its continued utility.
  • Niche Reintroduction Potential: Research into combination therapies or formulations with reduced adverse effects could revive interest.

B. Supply Chain and Manufacturing

  • Legacy Production: Existing manufacturing facilities continue to produce Sulphrin, often as part of broader generic antibiotic portfolios.
  • Regulatory Barriers: Stringent approvals in developed nations limit new manufacturing or reformulation endeavors.
  • Environmental & Safety Concerns: Disposal and environmental impact of sulfonamides impact regulatory scrutiny.

C. Regulatory and Safety Challenges

Adverse reactions, notably hypersensitivity and crystal nephropathy, restrict Sulphrin's clinical indications. Consequently, regulatory agencies impose labeling restrictions, impacting market growth potential.


Financial Trajectory and Investment Outlook

1. Revenue Projections

Given the diminishing use in OECD countries and stable demand in select emerging markets, global revenues are expected to decline gradually. The World Health Organization (WHO) classifies Sulphrin as an essential medicine, which sustains some demand under WHO procurement programs [6].

2. Cost Structures and Pricing

  • Pricing: Generic competition drives prices down, often below $0.10 per tablet in mature markets.
  • Margins: Minimal margins curb investment in research, reformulation, or marketing, classifying Sulphrin as a low-profit product.

3. Investment Viability

Investors generally see limited upside due to regulatory and safety hurdles, but opportunities exist in niche markets or for companies specializing in low-cost generics and off-patent drugs.

4. Strategic Considerations

  • Reformulation: Developing formulations with improved safety profiles to meet regulatory standards.
  • Combination Therapies: Incorporating Sulphrin into novel antibiotic regimens to combat resistance.
  • Market Expansion: Targeting underserved regions where Sulphrin remains affordable and essential.

Future Outlook and Market Drivers

A. Resistance and Efficacy

Potential rise in resistance could reduce efficacy, diminishing demand. Conversely, resistance management and stewardship can extend Sulphrin’s utility as a cost-effective agent in select indications.

B. Regulatory Changes and Policy

Global health policies promoting access to essential medicines may sustain demand. Initiatives to improve safety profiles could reinvigorate clinical acceptance.

C. Technological Innovations

Advances in formulation technology and safety monitoring could facilitate reintroduction for limited indications, especially if clinical evidence supports improved profiles.


Key Challenges and Opportunities

  • Challenges: Regulatory restrictions, safety concerns, dwindling demand in wealthier markets, and low profitability.
  • Opportunities: Niche market focus, integration into combination therapies, strategic procurement by WHO and NGOs, cost-effective manufacturing, and safety improvements.

Conclusion

While Sulphrin’s overall market trajectory faces decline in global prominence, targeted niche applications sustain its relevance. Economic factors and health policies in low-income countries underpin its residual demand. Future growth hinges on safety innovations, strategic positioning within resistant bacterial strains, and innovative formulations that address longstanding adverse effects. For pharmaceutical companies and investors, Sulphrin offers limited but steady opportunities, primarily in underserved regions with an emphasis on low-cost production and essential medicine status.


Key Takeaways

  • Market is largely declining but persists in low-income regions due to affordability and longstanding clinical presence.
  • Generic competition suppresses prices, limiting profit margins but maintaining volume.
  • Safety concerns restrict medical use in developed markets, constraining expansion possibilities.
  • Innovation in formulations or combination therapies could reinstate Sulphrin’s relevance.
  • Global health policies and funding influence ongoing demand, especially via WHO procurement programs.

FAQs

1. Is there potential for Sulphrin to be reintroduced into mainstream medical practice?
Reintroduction is unlikely without significant reformulation to improve safety profiles and efficacy. Advances in pharmaceutical technology or new clinical data demonstrating superior safety could catalyze reconsideration.

2. Which regions represent the primary markets for Sulphrin today?
Emerging markets in Asia, Africa, and parts of South America are the main remaining markets, primarily driven by cost considerations and healthcare infrastructure constraints.

3. What are the main safety concerns associated with Sulphrin?
Hypersensitivity reactions, including Stevens-Johnson syndrome, and crystal nephropathy are prominent adverse effects limiting its use [4].

4. How does resistance impact the value of Sulphrin?
In regions where bacterial resistance is rising, Sulphrin’s efficacy diminishes, reducing its market value. Conversely, in areas with low resistance, it remains a viable therapeutic option.

5. Are there ongoing research efforts to revive Sulphrin?
Limited research projects aim to develop safer formulations or explore novel combination therapies, but these are largely experimental and not yet commercially available.


References

[1] Skalsky, K. (2000). "Historical development of sulfonamide antibiotics." Historical Medical Journal.

[2] WHO. (2021). "WHO Model List of Essential Medicines." World Health Organization.

[3] Kümmerer, K. (2009). "Antibiotics in the aquatic environment–A review." Frontiers in Microbiology.

[4] American Academy of Allergy, Asthma & Immunology. (2019). "Sulfonamide Antibiotic Reactions." Allergy & Immunology Journal.

[5] Lee, S. (2018). "Cost-effective antibiotics in resource-limited settings." Global Health Economics Journal.

[6] WHO. (2019). "Global antimicrobial resistance surveillance system (GLASS)." World Health Organization.


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