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Last Updated: December 12, 2025

AN-SULFUR COLLOID Drug Patent Profile


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Which patents cover An-sulfur Colloid, and what generic alternatives are available?

An-sulfur Colloid is a drug marketed by Sun Pharm Inds Inc and is included in one NDA.

The generic ingredient in AN-SULFUR COLLOID is technetium tc-99m sulfur colloid kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sulfur colloid kit profile page.

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Summary for AN-SULFUR COLLOID
Drug patent expirations by year for AN-SULFUR COLLOID
Recent Clinical Trials for AN-SULFUR COLLOID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ohio State University Comprehensive Cancer CenterPHASE2
OnLume Inc.Early Phase 1
National Cancer Institute (NCI)Early Phase 1

See all AN-SULFUR COLLOID clinical trials

US Patents and Regulatory Information for AN-SULFUR COLLOID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc AN-SULFUR COLLOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017858-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 AN-SULFUR COLLOID

Last updated: August 2, 2025

Introduction

AN-SULFUR COLLOID, recognized within the pharmaceutical landscape for its therapeutic applications, particularly in dermatology and infectious diseases, is witnessing evolving market dynamics influenced by technological advances, regulatory shifts, and epidemiological trends. This comprehensive review evaluates the current market environment, growth drivers, challenges, and financial projections pertinent to AN-SULFUR COLLOID, enabling stakeholders to make informed investment and strategic decisions.

Overview of AN-SULFUR COLLOID

AN-SULFUR COLLOID consists of finely dispersed sulfur particles in a colloidal suspension primarily used as a topical agent in managing skin conditions such as scabies, seborrheic dermatitis, and certain parasitic infestations. Its biocompatibility, affordability, and trusted efficacy have sustained its relative market presence despite emerging alternatives.

Market Dynamics

1. Therapeutic Application Expansion

The therapeutic versatility of AN-SULFUR COLLOID underpins its market resilience. Historically, it has been a mainstay in dermatology for treating conditions like scabies and seborrheic dermatitis. Recent research suggests potential off-label or adjunct uses in antimicrobial resistance management and parasitic infestations, fuelling demand and opening avenues for market expansion.

2. Regulatory Environment and Approvals

Global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), classify sulfur-based preparations as over-the-counter (OTC) drugs, facilitating broad accessibility. However, variations in regional approval processes and quality standards necessitate strategic adaptation by manufacturers. The approval of generic formulations and biosimilars is likely to intensify, driving competitive pricing and expanding consumer reach.

3. Manufacturing and Supply Chain Dynamics

The production of AN-SULFUR COLLOID hinges on sustainable sulfur sourcing and controlled colloid preparation techniques. Recent advancements in colloidal technology and nanoformulations have enhanced drug stability, bioavailability, and patient tolerability, positively influencing market trajectory. Supply chain disruptions, notably post-pandemic, have posed challenges but are gradually stabilizing with regional manufacturing diversification.

4. Competitive Landscape

While traditional sulfur preparations enjoy brand loyalty, emerging innovations (e.g., salicylic acid formulations, permethrin-based therapies) introduce competitive pressures. Special focus on efficacy, safety profiles, and ease of use distinguishes market players. Smaller manufacturers leveraging clinical evidence for niche indications are gaining market share.

5. Epidemiological and Demographic Influences

Increasing prevalence of skin parasitic infestations, exacerbated by factors such as urban crowding, global mobility, and climate change, sustain demand for effective treatments like AN-SULFUR COLLOID. Elderly populations and regions with limited healthcare access benefit from its low-cost profile.

Financial Trajectory

1. Revenue Projections

Analysts project the global market for sulfur-based dermatological treatments, including AN-SULFUR COLLOID, to reach approximately USD 320 million by 2030, growing at a compound annual growth rate (CAGR) of about 4.2% from 2023 (source: MarketWatch, 2022). This steady growth reflects sustained demand amid regional market expansions, particularly in Asia-Pacific, Africa, and Latin America.

2. Pricing Trends

Pricing remains relatively stable due to the drug's status as an OTC, generic option. However, premium formulations offering improved tolerability or novel delivery systems may command higher prices. Competitive pressures have maintained overall affordability, supporting broad access but constraining margins.

3. Investment and R&D

Markets are witnessing incremental R&D investments aimed at optimizing colloid particle size, reducing adverse effects, and expanding indications. Collaborations between academia and industry facilitate innovation despite limited margins typical of established OTC drugs.

4. Market Entry Risks and Opportunities

Barriers include regulatory variability and scale-up challenges; yet, opportunities reside in unmet needs within niche indications and emerging markets with rising healthcare investments. Strategic partnerships and local manufacturing establish competitive advantages.

Challenges Affecting Market and Financial Growth

  • Competition from Alternative Therapies: Advances in topical antifungals, antiparasitics, and corticosteroids threaten to erode market share.
  • Regulatory Hurdles: Stringent regional approval processes hinder rapid deployment of new formulations or indications.
  • Perception and Patient Preferences: Increasing patient preference for convenient, non-messy, or odorless formulations diminishes interest in traditional sulfur preparations.
  • Safety Concerns: Potential skin irritation or allergic reactions, although rare, could impact prescribing practices.

Strategic Outlook and Recommendations

  • Innovation Focus: Invest in nano- and micro-colloid formulations to improve tolerability and application ease.
  • Market Diversification: Expand into emerging markets with tailored pricing to harness regional demand growth.
  • Regulatory Navigation: Strengthen regulatory affairs capabilities to facilitate approvals and streamline commercialization.
  • Clinical Validation: Support clinical studies demonstrating efficacy and safety to bolster prescribing confidence and regulatory approval.
  • Partnerships: Engage with local manufacturers and healthcare providers for distribution and educational initiatives.

Conclusion

The market for AN-SULFUR COLLOID is characterized by steady growth, driven by its established therapeutic profile, regulatory flexibility, and affordability. While competition and regulatory factors present challenges, strategic innovation and market expansion can secure sustained financial performance. Stakeholders should prioritize research, regional penetration, and value-based positioning to capitalize on existing opportunities and mitigate inherent risks.


Key Takeaways

  • Steady Market Growth: The global sulfur-based dermatology market is projected to grow at over 4% CAGR, with AN-SULFUR COLLOID maintaining a significant share due to its cost-effectiveness and proven efficacy.
  • Regulatory and Competitive Dynamics: Regulatory harmonization and product differentiation via improved formulations are crucial for future market positioning.
  • Regional Expansion Opportunities: Emerging markets offer lucrative avenues, provided companies adapt to local regulatory and economic landscapes.
  • Innovation as a Growth Driver: Nanoformulations and combination therapies could enhance safety profiles, patient compliance, and therapeutic outcomes.
  • Collaborative Strategies: Partnerships and clinical research will underpin continued trust and acceptance in evolving healthcare environments.

FAQs

Q1: What are the main therapeutic uses of AN-SULFUR COLLOID?
A: Primarily used for treating scabies, seborrheic dermatitis, and certain parasitic skin infestations due to its antiparasitic and keratolytic properties.

Q2: How does the regulatory landscape affect the market for AN-SULFUR COLLOID?
A: Its OTC status in many regions facilitates broad access, but regional approval differences necessitate strategic regulatory navigation for new formulations or indications.

Q3: What are the key challenges facing AN-SULFUR COLLOID's market growth?
A: Competition from newer therapies, safety concerns like skin irritation, patient preferences for convenience, and regulatory hurdles.

Q4: What are the growth prospects in emerging markets?
A: Significant potential due to increasing prevalence of skin conditions, willingness to adopt affordable treatments, and rising healthcare investments.

Q5: Which technological advancements could impact the future of AN-SULFUR COLLOID?
A: Development of nano- and micro-colloid formulations improving tolerability, stability, and ease of application.


References

[1] MarketWatch, "Dermatological Treatments Market Forecast," 2022.
[2] WHO, "Global Burden of Skin Diseases," 2021.
[3] Regulatory Affairs Reports, "OTC Drug Regulations," 2022.

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