MYCELEX Drug Patent Profile

Which patents cover Mycelex, and when can generic versions of Mycelex launch?

Mycelex is a drug marketed by Bayer Healthcare Llc, Bayer Hlthcare, and Bayer Pharms. and is included in seven NDAs.

The generic ingredient in MYCELEX is clotrimazole. There are eleven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycelex

A generic version of MYCELEX was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for MYCELEX

US Patents:	0
Applicants:	3
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	3
Patent Applications:	4,230
DailyMed Link:	MYCELEX at DailyMed

Recent Clinical Trials for MYCELEX

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 4
Onxeo	Phase 3
Boehringer Ingelheim	Phase 3

See all MYCELEX clinical trials

US Patents and Regulatory Information for MYCELEX

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	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	CREAM;VAGINAL	018230-002	Dec 26, 1991		DISCN	No	No
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983		DISCN	Yes	No

Expired US Patents for MYCELEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982

International Patents for MYCELEX

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

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

MYCELEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mycelex (Clotrimazole)

Introduction to Mycelex (Clotrimazole)

Mycelex, known generically as clotrimazole, is an antifungal medication widely used to treat and prevent yeast infections, particularly oropharyngeal candidiasis. It is available in various forms, including troches, creams, and other topical preparations.

Market Overview of Clotrimazole

The clotrimazole market is part of the broader antifungal drugs market, which is experiencing significant growth due to increasing fungal infections and the expanding use of over-the-counter (OTC) antifungal drugs.

• Market Size and Growth: 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].
• Geographical Dominance: North America dominates the market, driven by the high burden of fungal infections and active product development in the region[4].

Key Drivers of the Clotrimazole Market

Several factors are driving the growth of the clotrimazole market:

• Increasing Prevalence of Fungal Infections: The rise in fungal infections such as vaginitis, athlete’s foot, and oropharyngeal candidiasis is a significant driver. For instance, onychomycosis, a fungal infection of the nails, affects up to 14% of the global population[4].
• Growing Application in Disease Treatment: Clotrimazole is increasingly used in various forms of disease treatment, including prophylactic use in immunocompromised patients[5].
• Rise of OTC Drugs: The growing popularity of OTC antifungal drugs, including clotrimazole, has made these medications more accessible to patients[4].

Market Segments and Sales Channels

The clotrimazole market is segmented by type, application, and sales channel:

• Type: The cream segment is expected to hold the largest market share due to its widespread use in treating skin infections[1].
• Application: Clotrimazole is used in treating various fungal infections, including oropharyngeal candidiasis, vaginal yeast infections, and skin infections[5].
• Sales Channels: Online pharmacies are emerging as the fastest-growing segment, enhancing accessibility and convenience for consumers[1].

Financial Performance of Key Players

Major players in the clotrimazole market include Bayer AG, Novartis AG, and GSK plc. Here’s a glimpse into their financial dynamics:

• Revenue and Licensing: Companies like SCYNEXIS report significant revenue from license agreements. For example, SCYNEXIS had $0.7 million in license agreement revenue in Q3 2024, primarily associated with a GSK license agreement[2].
• Research and Development: The R&D expenses for these companies are substantial. SCYNEXIS reported an R&D expense of $8.1 million in Q3 2024, a 25% increase from the previous year, driven by increased CMC and preclinical expenses[2].
• Market Competition: The market is characterized by low concentration, with multiple players competing through product launches, mergers, and strategic partnerships. For instance, the FDA approval of new antifungal drugs like oteseconazole capsules further intensifies market competition[4].

Challenges and Restraints

Despite the growth, the clotrimazole market faces several challenges:

• Side Effects and Substitutes: The sizable number of side effects associated with clotrimazole and the availability of substitutes can restrain market growth. For example, abnormal liver function tests have been reported in patients treated with clotrimazole troches[5].
• Resistance to Antifungal Drugs: Increasing resistance to antifungal drugs is a significant concern that could hinder market growth[4].

Regional Market Dynamics

The regional dynamics play a crucial role in the clotrimazole market:

• North America: This region dominates the market due to the high burden of fungal infections and active product development. The United States, in particular, faces challenges from drug-resistant fungal infections, driving the demand for antifungal drugs[4].
• Asia-Pacific: This region is the fastest-growing market, driven by increasing awareness of fungal infections and the growing use of OTC antifungal drugs[4].

Key Takeaways

• The clotrimazole market is projected to grow significantly, driven by increasing fungal infections and the expanding use of OTC antifungal drugs.
• North America is the dominant region, with online pharmacies emerging as a key sales channel.
• Major players are investing heavily in R&D and strategic partnerships to maintain market competitiveness.
• Despite growth, the market faces challenges from side effects, substitutes, and increasing resistance to antifungal drugs.

FAQs

1. What is the projected market size of the clotrimazole market by 2030?

   • The clotrimazole market is estimated to reach $4.2 billion by 2030[1].

2. Which region dominates the clotrimazole market?

   • North America dominates the clotrimazole market[1].

3. What are the primary drivers of the clotrimazole market?

   • The increasing prevalence of fungal infections and the growing application of clotrimazole in various disease treatments are key drivers[1][4].

4. What are the common side effects associated with clotrimazole?

   • Common side effects include abnormal liver function tests, with elevated SGOT levels reported in about 15% of patients[5].

5. How is the market competition in the antifungal drugs sector?

   • The market is characterized by low concentration with multiple players competing through product launches, mergers, and strategic partnerships[4].

Cited Sources

1. IndustryARC - Clotrimazole Market - Forecast(2017-2025) Research Report
2. SCYNEXIS - Third Quarter 2024 Financial Results and ...
3. PubMed - The economics of follow-on drug research and development
4. Mordor Intelligence - Antifungal Drugs Market Size & Share Analysis - Growth Trends
5. RxList - Mycelex (Clotrimazole): Side Effects, Uses, Dosage ...