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Last Updated: March 26, 2026

Crotamiton - Generic Drug Details


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

Crotamiton is the generic ingredient in two branded drugs marketed by Journey and Legacy Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for crotamiton. Three suppliers are listed for this compound.

Summary for crotamiton
US Patents:0
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 94
Clinical Trials: 2
What excipients (inactive ingredients) are in crotamiton?crotamiton excipients list
DailyMed Link:crotamiton at DailyMed
Recent Clinical Trials for crotamiton

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

SponsorPhase
College of Physicians and Surgeons PakistanEARLY_PHASE1
University of AleppoPHASE3
Tishreen University HospitalPHASE3

See all crotamiton clinical trials

US Patents and Regulatory Information for crotamiton

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Journey EURAX crotamiton CREAM;TOPICAL 006927-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Legacy Pharma CROTAN crotamiton LOTION;TOPICAL 087204-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Journey EURAX crotamiton LOTION;TOPICAL 009112-003 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  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

Market Dynamics and Financial Trajectory for Crotamiton

Last updated: February 13, 2026

Overview:
Crotamiton is a topical agent primarily indicated for scabies and dermatological conditions such as pruritus. It is marketed under various brand names, including Eurax, in select markets. Its pharmacological profile combines anti-pruritic and scabicidal properties, leading to its application primarily in dermatology.


Market Size and Growth Trends

Global Market:
The global antiparasitic dermatology market, which includes drugs treating scabies, lice, and other parasitic skin infestations, was valued at approximately $1.2 billion in 2022. Crotamiton's market share within this segment remains modest compared to permethrin and ivermectin, but specific regional usage sustains niche demand, especially where price sensitivity limits alternative treatments.

Regional Variations:

  • Asia-Pacific: Demonstrates the highest growth rates (CAGR of 6-8%), driven by increasing dermatological care awareness and parasitic infections in rural populations (~$400 million market in 2022).
  • Europe: Mature market with stable demand; annual sales approximate $250 million, with gradual decline due to convenient alternatives.
  • North America: Limited market penetration; estimated at $100 million annually, influenced by favorable reimbursement policies for newer, more convenient therapies.

Competitive Landscape

Crotamiton faces competition from agents such as permethrin, ivermectin, and lindane, which often outcompete it based on efficacy, safety profiles, or ease of use.

Drug Class Key Competitors Market Penetration Advantages Limitations
Scabicidal Agents Permethrin, Ivermectin High in North America and Europe Well-studied, easy to apply, oral options Resistance, safety concerns in certain populations
Anti-pruritic drugs Hydrocortisone, Diphenhydramine Moderate Rapid relief, OTC availability Limited for scabies, short-term use

Patent Status:
Crotamiton is off-patent in most jurisdictions since its initial patent expiration around the early 2000s, which constrains exclusive marketing opportunities, leading to generic manufacturing and price competition.


Regulatory and Patent Landscape

Regulatory Approvals:
Crotamiton has received approval in various markets with differences in indications. It is an OTC treatment in some countries for pruritus but may require prescription for scabies treatment elsewhere.

Patent Expiry:
Most protection expired by 2010-2015, resulting in increased availability of generics. Limited recent patent filings suggest minimal innovation interest in maintaining exclusivity.

Implication:
Generic competition has driven prices downward, limiting profit margins. Market share depends chiefly on brand loyalty, regional prescribing habits, and price sensitivity.


Sales & Revenue Projections

Historical Sales Data:

  • Estimated global sales peaked near $150 million annually during the early 2010s across branded and generic forms.
  • Post patent expiry, sales declined with generic proliferation, stabilizing around $80 million in 2022.

Forecast Scenarios:

  • If a new formulation or combination therapy enters the market, annual sales could increase by 10-15% over the next 5 years.
  • Absence of innovation and the presence of more convenient therapies might lead to annual declines of 2-4%, especially in mature markets.
Year Sales Estimate Growth/Decline Rate Notes
2022 $80 million - Post-patent, stabilized sales
2025 $80-85 million Stable to slight growth Potential new formulations impact
2030 $70-75 million Decline (if no innovation) Competition intensifies

Emerging Factors Influencing Market Dynamics

  • Resistance Development: Emerging resistance to permethrin and ivermectin for scabies complicates treatment choices, possibly re-opening niche roles for crotamiton where others fail.

  • Regulatory Trends: Governments and health authorities increasingly authorize OTC use for certain indications, potentially expanding accessible markets but compressing margins.

  • Product Innovation: The absence of recent patent filings indicates limited R&D activity, but research into topical combinations or formulations could renewal interest.

  • Market Entry Barriers: Complexity in regulatory harmonization and regional approval differences inhibit new competitors in certain markets.


Summary of Financial Trajectory

  • The declining trend driven by generics is expected to continue unless innovative formulations or new indications are approved.
  • Potential exists for niche repositioning based on resistance and safety considerations.
  • Market growth hinges on regional regulatory shifts, emerging resistance patterns, and product innovation activity.

Key Takeaways

  • Crotamiton’s market has contracted post-patent expiry, with annual sales stabilized around $80 million globally.
  • It faces significant competition from newer, more convenient agents, leading to limited growth prospects without innovation.
  • Resistance issues might provide short-term niche opportunities.
  • The regional variation in regulation and market maturity impacts sales potential.
  • Future profitability will depend on regulatory adaptations, formulation improvements, and market acceptance of combination or OTC therapies.

FAQs

1. Why has Crotamiton’s market share declined globally?
Because generic formulations entered the market post-patent expiration, leading to lower prices and reduced profitability for branded versions.

2. Are there new formulations or indications for Crotamiton?
Current evidence suggests minimal recent innovation; most formulations remain unchanged since initial approvals.

3. How does resistance influence the market for Crotamiton?
Resistance to permethrin and ivermectin in scabies may create niche demand for crotamiton if resistance limits alternatives.

4. What regulatory barriers affect Crotamiton’s market expansion?
Regional differences in approval status and OTC versus prescription requirements limit global scalability and market penetration.

5. What is the outlook for Crotamiton sales in developing markets?
Potential remains due to lower-cost formulations, but growth depends on regulatory acceptance, resistance patterns, and healthcare infrastructure.


Sources

[1] Market research databases, 2023 estimates.
[2] European Medicines Agency filings.
[3] U.S. Food and Drug Administration records.
[4] Industry reports and company disclosures.

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