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Last Updated: March 26, 2026

Selenium sulfide - Generic Drug Details


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What are the generic drug sources for selenium sulfide and what is the scope of patent protection?

Selenium sulfide is the generic ingredient in three branded drugs marketed by Allergan Herbert, Actavis Mid Atlantic, Cosette, Ivax Pharms, Padagis Us, Pharmobedient Cnsltg, and Chattem, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for selenium sulfide. Two suppliers are listed for this compound.

Summary for selenium sulfide
Drug Prices for selenium sulfide

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Recent Clinical Trials for selenium sulfide

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

SponsorPhase
Indonesia UniversityPhase 4
Chen, Catherine, M.D.N/A
Eastern Virginia Medical SchoolN/A

See all selenium sulfide clinical trials

Medical Subject Heading (MeSH) Categories for selenium sulfide

US Patents and Regulatory Information for selenium sulfide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Herbert EXSEL selenium sulfide LOTION/SHAMPOO;TOPICAL 083892-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ivax Pharms SELENIUM SULFIDE selenium sulfide LOTION/SHAMPOO;TOPICAL 085777-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient Cnsltg SELENIUM SULFIDE selenium sulfide LOTION/SHAMPOO;TOPICAL 088228-001 Sep 1, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Padagis Us SELENIUM SULFIDE selenium sulfide LOTION/SHAMPOO;TOPICAL 089996-001 Jan 10, 1991 RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Actavis Mid Atlantic SELENIUM SULFIDE selenium sulfide LOTION/SHAMPOO;TOPICAL 084394-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chattem SELSUN selenium sulfide LOTION/SHAMPOO;TOPICAL 007936-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cosette SELENIUM SULFIDE selenium sulfide LOTION/SHAMPOO;TOPICAL 086209-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Selenium Sulfide Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Selenium sulfide is an antifungal medication used topically to treat fungal infections of the scalp, such as dandruff and seborrheic dermatitis. Its market trajectory is influenced by factors including disease prevalence, patent expirations, generic competition, and the development of new formulations.

What are the Key Therapeutic Areas for Selenium Sulfide?

Selenium sulfide's primary therapeutic application is in dermatological conditions.

  • Dandruff and Seborrheic Dermatitis: This is the dominant indication, accounting for the vast majority of selenium sulfide usage. Its antifungal properties target Malassezia globosa, a fungus commonly implicated in these scalp conditions.
  • Tinea Versicolor: While less common, selenium sulfide is also indicated for treating tinea versicolor, a superficial fungal infection affecting the skin's pigment.
  • Investigational Uses: Research has explored selenium sulfide's potential in other areas, but these are not established therapeutic uses. Examples include investigations into its role in certain dermatological inflammatory conditions and as an adjuvant therapy in specific cancer types, though these remain in early stages of research and have not translated into significant market impact for the drug itself.

What is the Global Market Size and Growth Outlook for Selenium Sulfide?

The global market for selenium sulfide is characterized by its maturity, with established products and significant generic penetration. Market growth is primarily driven by the prevalence of scalp conditions and accessibility of over-the-counter (OTC) and prescription formulations.

  • Market Size: The global market for selenium sulfide-containing products was estimated to be approximately $500 million to $700 million in 2023. This figure encompasses both branded and generic topical preparations.
  • Projected Growth: The market is expected to experience modest growth, with a Compound Annual Growth Rate (CAGR) of 2% to 4% projected from 2024 to 2029. This growth is attributed to increasing awareness of scalp health, rising disposable incomes in emerging markets, and continued demand for effective dandruff treatments.
  • Regional Dominance: North America and Europe represent the largest markets due to high consumer spending and established healthcare infrastructure. Asia-Pacific is a rapidly growing region, driven by increasing urbanization, changing lifestyles, and a growing middle class.

What are the Key Market Drivers and Restraints?

Several factors influence the market for selenium sulfide.

Drivers:

  • High Prevalence of Scalp Conditions: Dandruff and seborrheic dermatitis affect a significant portion of the global population, creating consistent demand for effective treatments like selenium sulfide. Reports indicate that dandruff affects up to 50% of adults at some point in their lives.
  • Over-the-Counter (OTC) Availability: The availability of many selenium sulfide products without a prescription enhances accessibility and drives sales volume. This lowers the barrier to entry for consumers seeking relief.
  • Cost-Effectiveness: Selenium sulfide is generally a cost-effective treatment option compared to newer or more specialized therapies, making it attractive to a broad consumer base, particularly in price-sensitive markets.
  • Established Safety Profile: Decades of clinical use have established a well-understood safety and efficacy profile for selenium sulfide, reassuring both consumers and healthcare providers.

Restraints:

  • Generic Competition: The patent landscape for selenium sulfide is largely expired, leading to intense competition from generic manufacturers. This drives down prices and limits revenue growth for individual products.
  • Availability of Alternative Treatments: A growing array of alternative dandruff and seborrheic dermatitis treatments, including shampoos containing ketoconazole, zinc pyrithione, and salicylic acid, offer consumers choice and may appeal to those seeking different mechanisms of action or perceived benefits.
  • Perception of Olfactory Properties: Some consumers find the odor associated with selenium sulfide formulations to be unpleasant, potentially impacting brand preference and product adoption.
  • Limited New Product Innovation: The mature nature of the selenium sulfide market has resulted in limited significant R&D investment in novel formulations or delivery systems, contributing to slower market dynamism.

What is the Competitive Landscape and Key Players?

The selenium sulfide market is highly fragmented with numerous manufacturers, primarily focusing on generic production.

  • Key Product Types: The market is dominated by topical shampoos and lotions. Concentrations typically range from 1% to 2.5%.
  • Leading Manufacturers (Generic Focus):
    • Perrigo Company plc: A significant player in the OTC pharmaceutical market, offering various selenium sulfide shampoos under private label and its own brands.
    • Haleon plc (formerly GSK Consumer Healthcare): Owns the Selsun Blue brand, a prominent selenium sulfide shampoo in many markets.
    • Laboratories V.V.S. (France): A European manufacturer producing selenium sulfide-based products.
    • Local and Regional Generic Manufacturers: Numerous smaller companies operate in specific geographic regions, contributing to market fragmentation.
  • Branded vs. Generic Share: The market is heavily skewed towards generic products, which account for an estimated 70% to 80% of the total market volume. Branded products, such as Selsun Blue, hold a smaller but significant share, often differentiated by formulation, marketing, and consumer loyalty.

What is the Patent Landscape and Exclusivity Status?

The original patents protecting selenium sulfide as a therapeutic agent have long expired. This has opened the door for widespread generic manufacturing.

  • Original Patents: The foundational patents for selenium sulfide's use in treating fungal scalp conditions expired in the mid-to-late 20th century.
  • Current Status: There are no active market exclusivity patents for the basic selenium sulfide molecule for its primary indications.
  • Potential for New IP: While the core compound is off-patent, intellectual property could potentially be sought for:
    • Novel formulations (e.g., improved stability, enhanced delivery, reduced odor).
    • New combinations with other active ingredients.
    • Specific manufacturing processes.
    • New therapeutic indications (though currently limited). As of late 2023, there are no significant newly patented formulations poised to disrupt the generic-dominated market.

What are the Pricing and Reimbursement Trends?

Pricing for selenium sulfide products is competitive, influenced by generic availability and market positioning. Reimbursement is largely limited to prescription-strength formulations in specific healthcare systems.

  • Pricing:
    • OTC Products: A 12-ounce bottle of generic selenium sulfide shampoo typically retails between $5 and $15, depending on the brand and retailer. Branded products like Selsun Blue may range from $8 to $20 for a similar size.
    • Prescription-Strength (2.5%): These formulations are priced higher, often ranging from $15 to $30 per bottle, but still remain relatively affordable compared to many specialized dermatological treatments.
  • Reimbursement:
    • United States: OTC selenium sulfide products are generally not covered by insurance. Prescription-strength formulations may be reimbursed by some health insurance plans, but coverage varies widely and often requires prior authorization.
    • Europe: Reimbursement policies differ by country. In some nations, prescription-strength selenium sulfide may be covered by national health services, particularly for diagnosed cases of seborrheic dermatitis or severe dandruff.
    • Other Regions: Reimbursement is inconsistent and often tied to public health programs or specific medical conditions.

What are the Future Outlook and Potential Opportunities?

The future outlook for selenium sulfide is one of stable but slow growth. Opportunities lie in specific market segments and product enhancements.

  • Market Stability: The consistent demand for dandruff and seborrheic dermatitis treatments will ensure a steady market for selenium sulfide.
  • Emerging Markets: Growth potential exists in developing economies in Asia and Latin America as consumer awareness and disposable incomes rise.
  • Formulation Improvements: While major breakthroughs are unlikely, incremental improvements in formulation could capture niche markets. This might include:
    • Developing formulations with improved cosmetic feel or reduced odor.
    • Creating combination products that offer broader efficacy.
    • Exploring targeted delivery systems for enhanced scalp penetration.
  • Pediatric and Sensitive Scalp Formulations: There is a potential for dedicated products catering to specific user groups, such as children or individuals with sensitive scalps, provided they can demonstrate distinct advantages and obtain regulatory approval.

Key Takeaways

Selenium sulfide remains a staple treatment for common scalp conditions, primarily dandruff and seborrheic dermatitis. The market is mature and characterized by extensive generic competition due to expired patents. Growth is projected to be modest, driven by disease prevalence and accessibility, particularly in emerging markets. While significant innovation is not anticipated, opportunities may exist in formulation enhancements and niche market segments. Pricing is competitive, and reimbursement is typically limited to prescription-strength versions in specific healthcare systems.

Frequently Asked Questions

1. What is the typical concentration of selenium sulfide in over-the-counter dandruff shampoos?

Over-the-counter (OTC) dandruff shampoos typically contain selenium sulfide at a 1% concentration. Prescription-strength formulations are generally 2.5%.

2. Are there any significant new drug applications for selenium sulfide currently under review?

As of late 2023, there are no significant new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for novel selenium sulfide formulations for its established indications that are expected to radically alter the market landscape. Most current developments focus on generic alternatives or minor formulation tweaks.

3. How does selenium sulfide compare in efficacy to other common anti-dandruff ingredients like ketoconazole or zinc pyrithione?

Selenium sulfide is considered an effective antifungal agent against Malassezia globosa, the primary cause of dandruff. Studies show comparable efficacy to ketoconazole in many cases, with both being effective in reducing scaling and itching. Zinc pyrithione is also effective but operates through different mechanisms and is often considered milder. Individual responses can vary.

4. What are the primary side effects associated with selenium sulfide topical products?

Common side effects include scalp irritation, dryness, and oiliness. Temporary hair discoloration (especially in blonde or chemically treated hair) and a distinctive odor can also occur. Allergic reactions are rare. It is crucial to follow product instructions and rinse thoroughly.

5. What is the projected market share for selenium sulfide in the global anti-dandruff market by 2030?

While precise market share figures are proprietary, the global anti-dandruff market is diverse. Selenium sulfide is estimated to hold between 8% to 15% of the global anti-dandruff market share by volume in 2030, maintaining its position as a significant, albeit not dominant, player due to the strong presence of other active ingredients and branded alternatives.

Citations

[1] Global dermatology market research reports (various publishers). [2] Pharmaceutical market analysis databases (e.g., IQVIA, Evaluate Pharma). [3] U.S. Food and Drug Administration (FDA) drug approval databases. [4] European Medicines Agency (EMA) drug approval databases. [5] Company annual reports and investor presentations of key pharmaceutical manufacturers. [6] Clinical trial registries (e.g., ClinicalTrials.gov) for investigational uses. [7] Scientific literature and review articles on dermatological treatments.

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