Last Updated: May 11, 2026

LOTRIMIN ULTRA Drug Patent Profile


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When do Lotrimin Ultra patents expire, and what generic alternatives are available?

Lotrimin Ultra is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in LOTRIMIN ULTRA is butenafine hydrochloride. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lotrimin Ultra

A generic version of LOTRIMIN ULTRA was approved as butenafine hydrochloride by SUN PHARMA CANADA on November 16th, 2017.

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Summary for LOTRIMIN ULTRA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 112
Clinical Trials: 4
What excipients (inactive ingredients) are in LOTRIMIN ULTRA?LOTRIMIN ULTRA excipients list
DailyMed Link:LOTRIMIN ULTRA at DailyMed
Recent Clinical Trials for LOTRIMIN ULTRA

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

SponsorPhase
BayerPhase 3
Taro Pharmaceuticals USAPhase 1

See all LOTRIMIN ULTRA clinical trials

Pharmacology for LOTRIMIN ULTRA

US Patents and Regulatory Information for LOTRIMIN ULTRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc LOTRIMIN ULTRA butenafine hydrochloride CREAM;TOPICAL 021307-001 Dec 7, 2001 OTC 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

LOTRIMIN ULTRA Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Market Position of Lotrimin Ultra?

Lotrimin Ultra is a topical antifungal medication indicated for the treatment of athlete’s foot, jock itch, and ringworm. Its active ingredients include butenafine hydrochloride, a second-generation azole antifungal. Market competition remains intense, with the primary competitors being Lamisil (terbinafine) and Tinactin (tolnaftate). The drug's position hinges on efficacy, formulation, and brand recognition.

How Has Spotting the Market Size Changed?

The global antifungal market, valued at approximately $13.3 billion in 2022, is projected to reach $17.9 billion by 2027, growing at a compound annual growth rate (CAGR) of around 6.2% [1]. The dermatophytic infection segment accounts for a significant portion, with topical agents like Lotrimin Ultra dominating OTC sales.

Regionally, North America accounts for over 45% of sales, driven by high prevalence rates of dermatophyte infections and established OTC markets. Europe follows, with Asia-Pacific showing rapid growth due to increasing urbanization and rising awareness.

How Do Market Dynamics Affect Lotrimin Ultra?

  1. Consumer Demand: Rising prevalence of fungal infections, especially in humid climates and among athletes, maintains consistent demand for effective topical antifungals. Over-the-counter (OTC) availability shapes front-line treatment choices.

  2. Competitive Landscape: Dominance by branded products like Lotrimin Ultra faces pressure from generics and store brands. Patent expirations and formulation patents influence market share shifts.

  3. Regulatory Environment: Approval pathways for OTC antifungals in major markets remain stable; however, evolving regulations concerning safety testing and labeling could influence launch strategies.

  4. Pricing Strategies: As generic formulations proliferate, prices decrease, pressuring branded products' margins. Patent protection offers temporary pricing power.

  5. Distribution Channels: Pharmacy chains and online sales constitute significant channels, with e-commerce showing accelerated growth, particularly post-2020.

What Is the Revenue and Sales Trajectory?

While exact sales data for Lotrimin Ultra alone are proprietary, estimates suggest:

  • U.S. OTC antifungal sales reach approximately $2 billion annually.
  • Lotrimin Ultra's share might be around 15-20% of that market, translating to gross revenues near $300-400 million yearly.

Growth patterns have maintained a steady CAGR of roughly 3-4%, tied to increased infection rates and product awareness.

How Do Patent & Formulation Protections Influence the Financial Outlook?

Lotrimin Ultra’s active ingredient, butenafine, has no current patent exclusivity since the original patent expired in 2012. However, formulation patents, if secured, provide some patent protection against copies for 3-5 years.

Generic versions of butenafine are available, leading to significant price erosion by roughly 50-70% since patent expiration. This erosion impacts the profit margins but sustains volume sales.

What Are the Investment and R&D Implications?

Pharmaceutical companies are investing in formulations with improved bioavailability, reduced side effects, or combination therapies for fungal infections. R&D focus points include:

  • Enhancing formulations for faster action.
  • Developing prescription-only variants with broader antifungal activity.
  • Conducting clinical trials for new indications or resistant strains.

While Lotrimin Ultra itself is a mature product, ongoing innovation sustains its competitive relevance.

How Do Regulatory and Policy Trends Impact the Market?

OTC antifungal drugs follow regulatory guidelines set by agencies like the FDA (U.S.), EMA (Europe), and other national authorities. Recent policy focus on antimicrobial resistance encourages:

  • Restrictive use guidelines.
  • Monitoring resistance patterns.

These regulations aim to ensure safety but may also slow down new product approvals, impacting future revenue potential.

Key Takeaways

  • Market size for topical antifungal treatments; estimates around $13.3 billion globally.
  • Lotrimin Ultra holds a substantial OTC share, with revenues approximately $300-400 million annually in the U.S.
  • Patent expirations have led to increased generic competition, causing significant price reductions.
  • Growth driven by rising infection rates, OTC channel expansion, and branding but constrained by price erosion.
  • Innovation in formulations and new antifungal agents remains a priority for sustained revenue growth.

FAQs

1. What is the primary active ingredient in Lotrimin Ultra?
Butenafine hydrochloride

2. How does patent expiration affect Lotrimin Ultra?
Patent expiration led to generic competition, reducing prices and profit margins but maintaining sales volume.

3. What markets drive demand for Lotrimin Ultra?
North America, Europe, and Asia-Pacific.

4. Are there new formulations or drugs competing with Lotrimin Ultra?
Yes, generics of butenafine and other topical antifungals like terbinafine and tolnaftate.

5. How does OTC regulation influence its market?
OTC status facilitates high-volume sales and broad accessibility but exposes the product to pricing pressures from generics.


Sources
[1] Research and Markets, "Antifungal Market Forecast," 2022.

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