LOTRIMIN Drug Patent Profile

Which patents cover Lotrimin, and what generic alternatives are available?

Lotrimin is a drug marketed by Schering Plough, Schering, and Bayer Healthcare Llc. and is included in four NDAs.

The generic ingredient in LOTRIMIN 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

A generic version of LOTRIMIN was approved as butenafine hydrochloride by TARO on November 16^th, 2017.

Summary for LOTRIMIN

US Patents:	0
Applicants:	3
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	4
Patent Applications:	4,219
DailyMed Link:	LOTRIMIN at DailyMed

Recent Clinical Trials for LOTRIMIN

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

Sponsor	Phase
Bayer	Phase 3
Taro Pharmaceuticals USA	Phase 1

See all LOTRIMIN clinical trials

US Patents and Regulatory Information for LOTRIMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307-001	Dec 7, 2001		OTC	Yes	Yes
Schering	LOTRIMIN	clotrimazole	LOTION;TOPICAL	018813-001	Feb 17, 1984		DISCN	No	No
Schering Plough	LOTRIMIN	clotrimazole	SOLUTION;TOPICAL	017613-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for LOTRIMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	LOTRIMIN	clotrimazole	LOTION;TOPICAL	018813-001	Feb 17, 1984
Schering Plough	LOTRIMIN	clotrimazole	SOLUTION;TOPICAL	017613-001	Approved Prior to Jan 1, 1982
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982
Schering Plough	LOTRIMIN	clotrimazole	SOLUTION;TOPICAL	017613-001	Approved Prior to Jan 1, 1982
Schering	LOTRIMIN	clotrimazole	LOTION;TOPICAL	018813-001	Feb 17, 1984
Schering	LOTRIMIN	clotrimazole	LOTION;TOPICAL	018813-001	Feb 17, 1984
Schering Plough	LOTRIMIN	clotrimazole	CREAM;TOPICAL	017619-001	Approved Prior to Jan 1, 1982

International Patents for LOTRIMIN

See the table below for patents covering LOTRIMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1670932
Belgium	721378
Spain	358154
Norway	124110
France	1597530
Yugoslavia	34085
Hungary	164361

LOTRIMIN Market Analysis and Financial Projection Experimental

LOTTRIMIN Market Dynamics and Financial Trajectory

Overview of LOTRIMIN

LOTTRIMIN is a well-known brand of antifungal products, particularly famous for its topical treatments against various fungal infections such as athlete's foot, jock itch, and ringworm. The product line is part of the broader antifungal treatment market.

Market Size and Growth

The LOTRIMIN market is closely tied to the overall antifungal treatment market. As of 2023, the global antifungal treatment market was valued at USD 16.83 billion and is expected to grow at a CAGR of 3.88% from 2024 to 2032, reaching USD 23.70 billion by 2032[4].

Clotrimazole Market Specifics

LOTTRIMIN products often contain clotrimazole, an azole antifungal. The clotrimazole market itself is projected to grow significantly, with an estimated market size of $4.2 billion by 2030, growing at a CAGR of 6.2% during the forecast period 2024-2030[1].

Key Market Drivers

Increasing Prevalence of Fungal Diseases

The growing prevalence of diseases such as vaginitis, athlete’s foot, and other fungal infections is a significant driver for the LOTRIMIN market. As these conditions become more common, the demand for effective antifungal treatments increases[1].

Expanding Applications

Clotrimazole, the active ingredient in LOTRIMIN, is being used in various forms of disease treatment beyond traditional fungal infections. This diversification in application is expected to further propel the market growth[1].

Consumer Health Care Segment

LOTTRIMIN falls under the consumer health care segment, which includes over-the-counter (OTC) products. This segment has seen steady growth, driven by consumer preference for self-medication and the convenience of OTC products[5].

Market Segments

By Type

The LOTRIMIN market can be segmented by the type of product, including creams, powders, and sprays. The cream segment is expected to hold the largest market share due to its high efficacy and user preference[1].

By Application

The market is also segmented by application, with products targeting different types of fungal infections such as athlete’s foot, jock itch, and ringworm. Each application area has its own growth trajectory based on the prevalence of the respective infections[1].

By Sales Channel

Online pharmacies are emerging as a significant sales channel for LOTRIMIN and other antifungal products. This segment is expected to be the fastest-growing due to the increasing trend of online shopping and the convenience it offers to consumers[1].

Geographical Analysis

North America Dominance

North America, particularly the U.S., dominates the LOTRIMIN market. This is due to a high awareness of antifungal treatments, a well-established healthcare system, and strong marketing efforts by key players[1].

Global Reach

The market also extends to Europe, Asia-Pacific, South America, and the rest of the world. Emerging markets in these regions are expected to contribute significantly to the growth of the LOTRIMIN market as healthcare awareness and access to antifungal treatments improve[1].

Key Market Players

LOTTRIMIN is part of the Merck & Co., Inc. portfolio, specifically under the consumer care segment. Other key players in the clotrimazole market include Bayer AG, Novartis AG, Amoli Organics Pvt. Ltd., and Guangzhou Hanpu Pharmaceutical Co., Ltd.[1][5].

Financial Performance

Historical Context

In the past, Merck & Co., Inc. has reported significant revenue from its consumer care segment, which includes LOTRIMIN. For example, in 2010, Merck's consumer care segment contributed substantially to its overall revenue, with products like LOTRIMIN and DR. SCHOLL’S foot care products playing a crucial role[2].

Current and Future Outlook

The financial trajectory for LOTRIMIN is positive, driven by the growing demand for antifungal treatments and the expanding application of clotrimazole. The market size for clotrimazole is estimated to reach $4.2 billion by 2030, indicating a robust financial outlook for LOTRIMIN and similar products[1].

Challenges and Opportunities

Side Effects and Substitutes

One of the challenges facing the LOTRIMIN market is the sizable number of side effects associated with clotrimazole and the availability of substitutes. However, the efficacy and brand recognition of LOTRIMIN help it maintain a strong market position[1].

COVID-19 and Global Crises

The COVID-19 pandemic and other global crises have had mixed impacts on the market. While there has been an increased focus on health care, supply chain disruptions and economic instability have also affected market dynamics. However, the essential nature of antifungal treatments has helped the market remain relatively resilient[1].

Strategic Analysis

Market Entry and Competition

New entrants in the market face significant competition from established brands like LOTRIMIN. However, the growing demand for antifungal treatments provides opportunities for new players to enter the market with innovative products or formulations[1].

Industry Forces

The market is influenced by various industry forces, including regulatory changes, technological advancements, and consumer preferences. Companies must adapt to these forces to maintain their market share and grow their revenue[1].

Key Takeaways

• Market Growth: The LOTRIMIN market is expected to grow significantly, driven by the increasing prevalence of fungal diseases and the expanding application of clotrimazole.
• Segment Dominance: The cream segment is expected to hold the largest market share, and online pharmacies are the fastest-growing sales channel.
• Geographical Dominance: North America dominates the market, but emerging markets are expected to contribute significantly to future growth.
• Financial Outlook: The financial trajectory is positive, with the clotrimazole market estimated to reach $4.2 billion by 2030.
• Challenges and Opportunities: The market faces challenges from side effects and substitutes but remains strong due to brand recognition and efficacy.

FAQs

What is the projected market size for the clotrimazole market by 2030?

The clotrimazole market is estimated to reach $4.2 billion by 2030, growing at a CAGR of 6.2% during the forecast period 2024-2030[1].

Which segment is expected to hold the largest market share in the LOTRIMIN market?

The cream segment is expected to hold the largest market share in the LOTRIMIN market[1].

What is the fastest-growing sales channel for LOTRIMIN?

Online pharmacies are the fastest-growing sales channel for LOTRIMIN and other antifungal products[1].

Which region dominates the LOTRIMIN market?

North America, particularly the U.S., dominates the LOTRIMIN market[1].

What are some of the key challenges facing the LOTRIMIN market?

The market faces challenges from the sizable number of side effects associated with clotrimazole and the availability of substitutes[1].

Sources

1. IndustryARC, "Clotrimazole Market - Forecast(2017-2025) Research Report"
2. Merck & Co., Inc., "Annual Reports"
3. SCHERING PLOUGH CORP, "FORM 10-K/A"
4. SNS Insider, "Anti-Fungal Treatment Market Size, Share & Trends by 2032"