Drugs and patents in ATC class D10AB - Preparations containing sulfur

Subscribe to access the full database, or Start Trial
Tradename	Generic Name
BENSULFOID	sulfur
LUMASON	sulfur hexafluoride lipid-type a microspheres
TECHNETIUM TC 99M SULFUR COLLOID	technetium tc-99m sulfur colloid
AN-SULFUR COLLOID	technetium tc-99m sulfur colloid kit
>Tradename	>Generic Name

Last updated: February 19, 2026

This analysis examines the patent landscape and market dynamics for pharmaceutical preparations containing sulfur, classified under ATC code D10AB. The landscape reveals established products with expiring patents alongside emerging research focused on novel sulfur-based compounds for dermatological and other applications. Key therapeutic areas include acne treatment, psoriasis management, and treatment of fungal infections.

What are the Key Therapeutic Areas for D10AB Preparations?

Preparations classified under ATC code D10AB primarily target dermatological conditions. These include:

Acne Vulgaris: Sulfur's keratolytic and bacteriostatic properties make it a common ingredient in topical acne treatments.
Psoriasis: Sulfur is utilized for its ability to reduce scaling and inflammation associated with psoriasis.
Seborrheic Dermatitis: Its anti-fungal and anti-inflammatory effects are beneficial in managing this scalp condition.
Fungal Infections (Dermatophytosis): Sulfur has known fungistatic and fungicidal activity against various dermatophytes.
Scabies and Pediculosis: Historically, sulfur preparations have been used as ectoparasiticides.

What is the Current Patent Landscape for Sulfur-Containing Dermatological Preparations?

The patent landscape for D10AB preparations is characterized by a mix of foundational patents on established sulfur compounds and newer filings for formulations and specific therapeutic uses.

Major Active Ingredients and Their Patent Status

Active Ingredient	Primary Use(s)	Key Patent Expiry/Status	Representative Patent Example (Year)
Sulfur (elemental)	Acne, Psoriasis, Seborrheic Dermatitis, Fungal Infections	Generally Off-Patent (Core Compound)	N/A (Historical Use)
Sodium Thiosulfate	Psoriasis, Fungal Infections	Generally Off-Patent (Core Compound)	N/A (Historical Use)
Ammonium Sulfide	Acne, Psoriasis	Generally Off-Patent (Core Compound)	N/A (Historical Use)
Thioglycolic Acid Salts	Depilatories, Keratolytic	Patents for specific formulations and uses may exist.	US20050153919A1 (2005, Formulation)
Selenium Sulfide	Seborrheic Dermatitis, Tinea Versicolor	Core patents expired. Formulation patents may be active.	US4381253A (1983, Formulation)
Calcipotriol (Vitamin D analog)	Psoriasis	Active patents exist for specific forms and combinations.	US5972921A (1999, Combination)

Note: Patent expiry dates are general. Specific claims within patents, such as formulation, method of use, or combination therapies, may have different durations.

Trends in Recent Patent Filings

Recent patent filings related to D10AB preparations indicate several key trends:

Novel Formulations: Focus on improving drug delivery, stability, and patient compliance. This includes microencapsulation, liposomal delivery systems, and sustained-release formulations.
Combination Therapies: Patents often claim combinations of sulfur-containing compounds with other active pharmaceutical ingredients (APIs) to achieve synergistic effects or broader spectrum activity (e.g., sulfur with retinoids for acne, sulfur with antifungals).
New Therapeutic Indications: Research is exploring sulfur compounds for non-dermatological applications, though these may fall under different ATC codes. However, advancements in understanding sulfur's biological mechanisms could lead to new dermatological applications.
Specific Delivery Systems: Development of transdermal patches, microneedle arrays, or specialized topical delivery vehicles designed to enhance penetration and efficacy.
Biosynthesis and Novel Sulfur Donors: Exploration of organic sulfur compounds derived from biological sources or synthesized with improved bioavailability and reduced side effects.

What is the Market Size and Growth Potential for D10AB Preparations?

The market for D10AB preparations is mature for established, off-patent ingredients like elemental sulfur. Growth in these segments is primarily driven by:

Generic Competition: Widespread availability of generic products due to patent expiry keeps prices competitive.
Over-the-Counter (OTC) Availability: Many sulfur-based topical treatments for acne and seborrheic dermatitis are available OTC, contributing to high volume sales.
Price Sensitivity: Healthcare systems and consumers often favor cost-effective treatments for chronic but manageable conditions.

However, potential for growth exists in:

Patented Formulations: Advanced formulations offering improved efficacy, tolerability, or convenience can command premium pricing and capture market share from older products.
Combination Products: Patented combinations with synergistic effects may address unmet needs and secure market exclusivity.
Emerging Markets: Growing demand for dermatological treatments in developing economies can drive volume growth for both generic and branded products.
Niche Applications: Development of sulfur-based therapies for less common or recalcitrant dermatological conditions could create new market segments.

Market Segment Examples

Segment	Typical Active Ingredient(s)	Market Status	Growth Drivers
Acne Treatments	Sulfur, Salicylic Acid, Benzoyl Peroxide	Mature, High Generic Penetration	OTC availability, affordability, broad consumer base
Psoriasis Treatments	Sulfur, Coal Tar, Vitamin D analogs	Mature and Developing (depending on formulation)	Chronic nature of disease, need for effective management
Seborrheic Dermatitis Treatments	Selenium Sulfide, Ketoconazole, Sulfur	Mature	Chronic condition management, OTC options
Antifungal Preparations	Sulfur, Tolnaftate, Clotrimazole	Mature	High prevalence of fungal infections

What are the Key Regulatory Considerations for D10AB Preparations?

Regulatory pathways for D10AB preparations depend on their classification (prescription vs. OTC) and intended use.

Prescription vs. Over-the-Counter (OTC)

OTC Products: Ingredients like elemental sulfur for acne or seborrheic dermatitis are often regulated as OTC drugs. This involves adherence to monograph standards (e.g., FDA's OTC Drug Monograph system in the U.S.) or specific OTC drug applications. Labeling requirements are strict regarding indications, usage, and warnings.
Prescription Products: Preparations requiring a prescription, especially those with novel formulations, combinations, or for more severe conditions, undergo rigorous clinical trials to demonstrate safety and efficacy before marketing approval.

Common Regulatory Hurdles

Demonstrating Efficacy: For new indications or formulations, robust clinical data is required. This includes well-designed randomized controlled trials.
Safety Profile: Sulfur, while generally safe in topical preparations, can cause irritation, dryness, and photosensitivity. Manufacturers must thoroughly assess and document the safety profile, particularly for new formulations or higher concentrations.
Good Manufacturing Practices (GMP): All manufacturers must adhere to GMP regulations to ensure product quality, consistency, and purity.
Labeling and Claims: Marketing claims must be substantiated by evidence and comply with regulatory guidelines. Off-label promotion is prohibited.
International Harmonization: Navigating different regulatory requirements across major markets (e.g., FDA, EMA, PMDA) requires strategic planning.

Who are the Key Players in the D10AB Market?

The D10AB market includes a range of companies, from large multinational pharmaceutical corporations to smaller specialty dermatology companies and generic manufacturers.

Major Market Participants

Generic Manufacturers: Companies focusing on producing off-patent sulfur-based dermatological products at competitive prices. Examples include Teva Pharmaceuticals, Sandoz, and Mylan (now Viatris).
Branded Pharmaceutical Companies: Companies marketing established or newly developed sulfur-containing preparations, often with proprietary formulations or combination therapies. Examples might include L'Oréal (La Roche-Posay, Vichy), Johnson & Johnson, and Bayer, depending on specific product lines and regions.
Dermatology-Focused Companies: Specialty firms that may focus on developing innovative topical treatments, including those with sulfur components.
Cosmeceutical Brands: Many skincare brands incorporate sulfur into products for acne and oil control, operating in a less strictly regulated space than pharmaceuticals.

What are the Future Prospects and Emerging Technologies?

The future of D10AB preparations is likely to involve refinement of existing applications and exploration of new therapeutic modalities.

Emerging Areas of Research and Development

Targeted Drug Delivery: Advanced delivery systems that can deliver sulfur more effectively to specific skin layers or target sebaceous glands could enhance efficacy and reduce side effects. This includes nanotechnology-based carriers and smart formulations.
Synergistic Combinations: Continued research into combining sulfur with other active ingredients to treat complex dermatological conditions like severe acne, recalcitrant psoriasis, or difficult-to-treat fungal infections.
Understanding Sulfur's Mechanism: Deeper investigation into how sulfur interacts with skin cells, the microbiome, and inflammatory pathways may uncover novel therapeutic targets and applications.
Bioavailability and Tolerability Enhancement: Development of sulfur derivatives or formulations that are better absorbed and cause less irritation, expanding its utility for sensitive skin types or longer treatment durations.
Sulfur in Wound Healing and Scarring: Preliminary research suggests sulfur's potential role in promoting wound healing and reducing scarring, which could open new therapeutic avenues.

Technological Advancements

3D Skin Bioprinting: Used for testing the efficacy and safety of topical sulfur formulations in a more predictive and ethical manner.
Artificial Intelligence (AI) in Drug Discovery: AI algorithms can be employed to identify novel sulfur-containing compounds with desired properties or to predict optimal formulations.
Advanced Analytical Techniques: Sophisticated methods for characterizing sulfur compounds and their interactions within skin models are crucial for R&D.

Key Takeaways

The market for ATC Class D10AB preparations, sulfur-containing dermatological treatments, is characterized by a mature segment of off-patent, widely available products. Growth opportunities lie in the development of novel, patented formulations and combination therapies that offer improved efficacy, tolerability, and patient convenience. Key therapeutic areas remain acne, psoriasis, and seborrheic dermatitis, with ongoing research exploring broader applications. Regulatory compliance, particularly regarding safety and efficacy demonstration for new products, is paramount. Emerging technologies in drug delivery and a deeper understanding of sulfur's biological mechanisms will shape future market dynamics.

Frequently Asked Questions

Are there any patents protecting elemental sulfur for acne treatment? Elemental sulfur itself, as a pure chemical entity, is generally off-patent for its basic therapeutic uses like acne treatment due to its long history of use. Patents in this area would typically cover novel formulations, delivery systems, specific combinations with other APIs, or new methods of use.
What is the typical duration of patent protection for a new dermatological formulation containing sulfur? A new formulation patent, if granted, typically provides 20 years of protection from the filing date. However, patent term extensions may be available in some jurisdictions to compensate for regulatory review delays, potentially extending market exclusivity.
How does the regulatory pathway for an over-the-counter (OTC) sulfur preparation differ from a prescription-only one? OTC sulfur preparations often rely on established monographs or specific OTC drug applications, requiring demonstration of safety and effectiveness for self-medication. Prescription products, especially those with novel APIs, formulations, or for more serious conditions, demand more extensive clinical trials and a New Drug Application (NDA) or equivalent, involving a more rigorous review process by regulatory authorities.
Can sulfur-containing preparations be used for conditions other than dermatological issues? While D10AB specifically pertains to dermatological preparations, sulfur itself has historical and potential applications in other areas, such as in the synthesis of certain pharmaceuticals or as a component in industrial processes. However, for direct human therapeutic use outside of skin conditions, separate ATC classifications and regulatory pathways would apply.
What are the main challenges in developing new sulfur-based dermatological drugs? Challenges include the potential for skin irritation and dryness associated with sulfur, the need for effective delivery systems to enhance penetration and reduce side effects, and the high bar for demonstrating significant clinical improvement over existing, often generic, treatments. Developing novel compounds with a substantially improved risk-benefit profile is also a significant hurdle.

[1] United States Patent and Trademark Office. (n.d.). USPTO. Retrieved from https://www.uspto.gov/ [2] European Patent Office. (n.d.). Espacenet. Retrieved from https://worldwide.espacenet.com/ [3] World Health Organization. (n.d.). WHO Collaborating Centre for Drug Statistics Methodology. Retrieved from https://www.whocc.no/ [4] U.S. Food and Drug Administration. (n.d.). FDA. Retrieved from https://www.fda.gov/

Drugs in ATC Class D10AB

Drugs in ATC Class: D10AB - Preparations containing sulfur

Patent Landscape and Market Dynamics for ATC Class D10AB: Sulfur-Containing Preparations