Clotrimazole - Generic Drug Details

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

Clotrimazole is the generic ingredient in twelve branded drugs marketed by Bayer Healthcare Llc, Fougera Pharms, Glenmark Pharms, Taro, Schering Plough, P And L, Schering, Novitium Pharma, Sciegen Pharms Inc, Teva, Trupharma, Bayer Hlthcare, Teva Pharms, Bayer Pharms, Hikma, Padagis Us, and Thinq Pharm-cro Pvt, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for clotrimazole. Twenty-eight suppliers are listed for this compound.

Summary for clotrimazole

US Patents:	0
Tradenames:	12
Applicants:	17
NDAs:	31
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	37
Patent Applications:	7,060
Drug Prices:	Drug price trends for clotrimazole
Drug Sales Revenues:	Drug sales revenues for clotrimazole
What excipients (inactive ingredients) are in clotrimazole?	clotrimazole excipients list
DailyMed Link:	clotrimazole at DailyMed

See drug prices for clotrimazole

See drug sales revenues for clotrimazole

Recent Clinical Trials for clotrimazole

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

Sponsor	Phase
Assiut University	N/A
Shanghai Pudong Decoding Life Institutes	N/A
Second Affiliated Hospital of Wenzhou Medical University	N/A

See all clotrimazole clinical trials

Pharmacology for clotrimazole

Drug Class

Azole Antifungal

Medical Subject Heading (MeSH) Categories for clotrimazole

14-alpha Demethylase Inhibitors

Anti-Infective Agents, Local

Antifungal Agents

Anatomical Therapeutic Chemical (ATC) Classes for clotrimazole

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for clotrimazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	LOTRIMIN	clotrimazole	LOTION;TOPICAL	018813-001	Feb 17, 1984		DISCN	No	No
Taro	TRIVAGIZOLE 3	clotrimazole	CREAM;VAGINAL	021143-001	Apr 12, 2000		OTC	No	No
Fougera Pharms	CLOTRIMAZOLE	clotrimazole	CREAM;TOPICAL	078338-001	Sep 2, 2008	AB	RX	No	No
Schering Plough	LOTRIMIN	clotrimazole	SOLUTION;TOPICAL	017613-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for clotrimazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering Plough	LOTRIMIN	clotrimazole	SOLUTION;TOPICAL	017613-001	Approved Prior to Jan 1, 1982
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982

Clotrimazole Market Analysis and Financial Projection Experimental

Clotrimazole Market Dynamics and Financial Trajectory

Market Overview

The clotrimazole market is poised for significant growth, driven by several key factors. The global clotrimazole market is estimated to reach $4.2 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period of 2024-2030[1][4].

Market Size and Growth

As of 2023, the global clotrimazole market size was approximately $2.8 billion. This figure is expected to more than double by 2030, indicating a robust growth trajectory. The market's expansion is fueled by the increasing prevalence of fungal infections and the growing application of clotrimazole in various disease treatments[1][4].

Geographical Distribution

North America currently dominates the clotrimazole market, accounting for about 34% of the market share in 2023. This dominance is attributed to the high prevalence of diseases such as athlete's foot and vaginitis, which are commonly treated with clotrimazole. Europe and the Asia-Pacific region also hold significant market shares, with the latter expected to be the fastest-growing market due to its large and growing population and improving healthcare infrastructure[1][4].

Application and Types

Clotrimazole is used in various forms, including suppositories, tablets, creams, powders, and sprays. The cream segment is anticipated to hold the largest market share due to its widespread use in treating skin infections such as athlete's foot and other dermatological conditions. The drug is applied in treating a range of fungal infections, including vaginitis, otomycosis, paronychia, and tinea of feet and hands[1][4].

Sales Channels

The market is segmented by sales channels into hospital pharmacies, drug stores and retail pharmacies, online pharmacies, and others. Online pharmacies are emerging as the fastest-growing segment, driven by the convenience and accessibility they offer to consumers[1].

Key Drivers

• Increasing Prevalence of Fungal Infections: The rising incidence of fungal infections globally is a significant driver of the clotrimazole market. Conditions such as athlete's foot, vaginitis, and other dermatological fungal infections are becoming more common, increasing the demand for antifungal treatments[1][3][4].
• Innovation in Drug Delivery Systems: Technological advancements in drug delivery systems, such as the development of topical creams, ointments, and vaginal formulations, have enhanced patient convenience and adherence to treatment. These innovations are expected to continue driving market growth[3][4].
• Expansion of Healthcare Infrastructure: The expansion of healthcare infrastructure in emerging markets, particularly in the Asia-Pacific region, is increasing access to healthcare services and driving the demand for effective antifungal treatments like clotrimazole[3].

Challenges and Limitations

• Side Effects and Substitutes: Despite its effectiveness, clotrimazole has a number of side effects, and the availability of substitutes in the market can pose a challenge to its growth. However, the benefits of clotrimazole often outweigh these limitations[1].
• COVID-19 Impact: The COVID-19 pandemic had a mixed impact on the clotrimazole market, with increased demand for antifungal treatments balanced by supply chain disruptions and challenges in patient access to healthcare services[3].

Competitive Landscape

The global clotrimazole market is highly competitive, with both large multinational pharmaceutical companies and specialized manufacturers. Key players include Bayer AG, Erregierre SPA, Novartis AG, Amoli Organics Pvt. Ltd., and Guangzhou Hanpu Pharmaceutical Co., Ltd. These companies are focused on expanding their product portfolios, investing in research and development, and engaging in strategic collaborations to strengthen their market position[1][3].

Regional Growth

• Asia-Pacific: This region is expected to be the fastest-growing market for clotrimazole, driven by the rising incidence of fungal infections, increasing demand for OTC antifungal products, and expanding healthcare infrastructure in countries like China and India[3].
• Latin America and Middle East & Africa: These regions, although smaller, are expected to experience steady growth due to increasing awareness of the importance of proper treatment of fungal infections and the expansion of healthcare coverage[3].

Innovative Formulations and Therapeutic Applications

The development and approval of novel clotrimazole-based formulations, such as combination products and extended-release preparations, are key trends in the market. These innovative products offer more effective and convenient treatment options, potentially improving patient adherence and overall disease management. Ongoing research to explore new therapeutic applications for clotrimazole, such as its use in managing other skin conditions or in combination with other active ingredients, represents additional opportunities for market growth[3].

Financial Trajectory

The financial trajectory of the clotrimazole market is promising, with a projected market size of $4.2 billion by 2030. Here are some key financial highlights:

• Market Size in 2023: $2.8 billion[1][4].
• Projected Market Size in 2030: $4.2 billion[1][4].
• CAGR: 6.2% during the forecast period of 2024-2030[1][4].

Key Takeaways

• The clotrimazole market is driven by the increasing prevalence of fungal infections and the growing application of clotrimazole in various disease treatments.
• North America dominates the market, but the Asia-Pacific region is expected to be the fastest-growing segment.
• Online pharmacies are emerging as a significant sales channel.
• Innovation in drug delivery systems and the expansion of healthcare infrastructure in emerging markets are key growth drivers.
• The market faces challenges from side effects and the availability of substitutes but is expected to continue growing due to its effectiveness and new therapeutic applications.

FAQs

Q: What is the projected market size of the clotrimazole market by 2030? A: The clotrimazole market is estimated to reach $4.2 billion by 2030[1][4].

Q: What is the CAGR of the clotrimazole market during the forecast period of 2024-2030? A: The CAGR of the clotrimazole market is 6.2% during the forecast period of 2024-2030[1][4].

Q: Which region is expected to be the fastest-growing market for clotrimazole? A: The Asia-Pacific region is expected to be the fastest-growing market for clotrimazole, driven by the rising incidence of fungal infections and expanding healthcare infrastructure[3].

Q: What are the key drivers of the clotrimazole market? A: The key drivers include the increasing prevalence of fungal infections, innovation in drug delivery systems, and the expansion of healthcare infrastructure in emerging markets[1][3][4].

Q: Who are the key players in the clotrimazole market? A: Key players include Bayer AG, Erregierre SPA, Novartis AG, Amoli Organics Pvt. Ltd., and Guangzhou Hanpu Pharmaceutical Co., Ltd.[1][3].

Sources:

1. IndustryARC, "Clotrimazole Market - Forecast(2017-2025) Research Report".
2. MDPI, "Clotrimazole Fluidizes Phospholipid Membranes and Localizes at ...".
3. DataHorizzonResearch, "Clotrimazole Market Size, Share & Forecast 2033".
4. IndustryARC, "Clotrimazole Market - Forecast(2024 - 2030) - IndustryARC".