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Last Updated: March 26, 2026

Sulfur - Generic Drug Details


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What are the generic sources for sulfur and what is the scope of freedom to operate?

Sulfur is the generic ingredient in two branded drugs marketed by Poythress and Bracco, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for sulfur.

Summary for sulfur
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 82
DailyMed Link:sulfur at DailyMed
Recent Clinical Trials for sulfur

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

SponsorPhase
Children's Hospital of PhiladelphiaPHASE2
Al-Mustansiriyah UniversityNA
National Cancer Institute (NCI)PHASE2

See all sulfur clinical trials

US Patents and Regulatory Information for sulfur

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Poythress BENSULFOID sulfur POWDER;TOPICAL 002918-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684-001 Oct 15, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bracco LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684-001 Oct 15, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Bracco LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684-001 Oct 15, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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 the Pharmaceutical Drug Sulfur

Last updated: February 15, 2026

Sulfur is a foundational chemical element with applications spanning agricultural, industrial, and medical sectors. Its role in pharmaceuticals is limited but notable in certain niche areas, primarily as a component in dermatological treatments.

Market Overview

The global sulfur market was valued at approximately $4.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030, reaching around $7.2 billion by 2030 [1]. The pharmaceutical segment accounts for a small, but stable, share of this market, estimated at less than 5%.

Pharmaceutical Applications

Sulfur is used in dermatology, notably in topical treatments for acne, seborrheic dermatitis, and psoriasis. These products utilize sulfur's keratolytic and antimicrobial properties. Major pharmaceutical brands incorporate sulfur in over-the-counter (OTC) formulations, though no sulfur-based drug has attained blockbuster status with exclusive patent rights.

Market Drivers

  • Increasing prevalence of skin conditions such as acne and psoriasis, stimulating demand for sulfur-based topical formulations.
  • Consumer preference for OTC remedies reduces barriers to market entry and proliferation.
  • Continuous research into sulfur's medical properties, including antimicrobial effects, sustains baseline demand.

Market Challenges

  • Limited patentability of sulfur in pharmaceutical formulations restricts exclusivity and profitability.
  • The existence of alternative treatments, such as benzoyl peroxide and salicylic acid, diminishes sulfur's market share.
  • Regulatory hurdles for new sulfur-based drugs are minimal but do exist, primarily concerning formulation safety standards.

Financial Trajectory

The revenue potential for sulfur as a pharmaceutical active ingredient remains stable but modest. Companies leverage existing products rather than investing heavily in new sulfur drug development due to low patentability and competition.

  • R&D Spending: Minimal, primarily directed at formulation improvements and safety testing.
  • Commercialization Costs: Low, given the mature nature of sulfur formulations.
  • Profit Margins: Stable, but not significant; OTC sulfur products generate margins comparable to other dermatological OTCs.

Competitive Landscape

Leading OTC brands in sulfur formulations include:

  • Teva's "Sulfur & Salicylic Acid" formulations.
  • Johnson & Johnson's OTC sulfur ointments.
  • Localized regional brands with minor market shares.

No pharmaceutical company holds exclusive rights over sulfur, emphasizing commoditization over innovation.

Regulatory and Policy Environment

The regulatory landscape for sulfur-based drugs is straightforward, with product approval primarily contingent on safety and efficacy data. No recent regulatory changes significantly influence sulfur's market dynamics [2].

Future Outlook

The foreseeable growth of sulfur in pharmaceuticals hinges on:

  • Emerging niche applications, such as antimicrobial wound dressings.
  • Incremental formulation innovations to improve efficacy and user experience.
  • Market growth in regions with limited access to advanced dermatological drugs, such as certain parts of Africa and Asia.

However, the overall pharmaceutical market for sulfur will remain limited compared to its industrial and agricultural sectors.


Key Takeaways

  • The pharmaceutical use of sulfur constitutes a small segment within a broader sulfur market valued at nearly $5 billion in 2022.
  • Demand centers on OTC dermatological products; no blockbuster sulfur-based drugs exist.
  • Growth is driven by skin condition prevalence and consumer preference, but low patentability and competition limit expansion.
  • Financial returns are moderate, with steady revenues stemming from mature formulations.
  • Future developments are likely to be incremental, with limited prospects for significant market disruption.

FAQs

1. Why is sulfur used in dermatology?
Sulfur has keratolytic and antimicrobial properties effective in treating acne, seborrheic dermatitis, and psoriasis.

2. Are there patent protections on sulfur-based drugs?
No; sulfur formulations are generally considered low-hanging fruit, with no exclusive patents limiting generic or OTC manufacturing.

3. What are alternatives to sulfur in dermatology?
Benzoyl peroxide and salicylic acid are common substitutes offering similar or improved efficacy.

4. How significant is sulfur's market share in pharmaceuticals?
Less than 5% of the total sulfur market; revenue potential remains limited.

5. Can sulfur see growth through new applications?
Potential exists in niche markets such as antimicrobial wound dressings, but widespread adoption remains unlikely.


Citations

[1] Market Research Future, "Sulfur Market Research Report," 2022.
[2] FDA, "Regulatory Guidelines for Topical Dermatological Drugs," 2020.

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