MYCELEX-7 Drug Patent Profile

Which patents cover Mycelex-7, and what generic alternatives are available?

Mycelex-7 is a drug marketed by Bayer Healthcare Llc and is included in three NDAs.

The generic ingredient in MYCELEX-7 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-7

A generic version of MYCELEX-7 was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for MYCELEX-7

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	3
Patent Applications:	4,110
DailyMed Link:	MYCELEX-7 at DailyMed

Recent Clinical Trials for MYCELEX-7

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-7 clinical trials

US Patents and Regulatory Information for MYCELEX-7

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-7	clotrimazole	CREAM;VAGINAL	018230-002	Dec 26, 1991		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	TABLET;VAGINAL	018182-002	Dec 26, 1991		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020389-002	Jun 23, 1994		DISCN	No	No

International Patents for MYCELEX-7

See the table below for patents covering MYCELEX-7 around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1670932
Belgium	721378
Spain	358154

MYCELEX-7 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mycelex-7 (Clotrimazole)

Introduction to Mycelex-7

Mycelex-7, also known as clotrimazole, is an antifungal medication widely used to treat various fungal infections, including vulvovaginal candidiasis (VVC), thrush, and other forms of candidiasis. Here, we will delve into the market dynamics and financial trajectory of Mycelex-7, a key player in the antifungal market.

Global Antifungal Market Overview

The global antifungal market, particularly the segment focused on vulvovaginal candidiasis treatment, has been experiencing significant growth. The market size for VVC treatment was valued at USD 986.5 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 4.39% from 2022 to 2030, reaching USD 1.64 billion by 2030[1].

Market Segmentation

Drug Class Outlook

Mycelex-7 falls under the clotrimazole category, which is one of the prominent drug classes in the VVC treatment market. Other key drug classes include nystatin, fluconazole, ketoconazole, terbinafine, and terconazole. Clotrimazole is widely used due to its efficacy and availability in various forms, including topical and oral formulations[1].

Route of Administration

Clotrimazole can be administered through different routes, including topical and oral. Topical administration is common for VVC, while oral formulations like lozenges are used for thrush and other oral candidiasis[2].

Distribution Channels

The distribution channels for Mycelex-7 include retail pharmacies, online pharmacies, and hospital pharmacies. Retail pharmacies are anticipated to witness the fastest CAGR, driven by the convenience and accessibility they offer, especially in homecare settings[1].

Regional Market Dynamics

North America

North America dominated the global VVC treatment market in 2021, accounting for more than 37.50% of the overall revenue. This dominance is attributed to high disease prevalence, increased patient awareness, and significant healthcare expenditure in the region. The presence of major pharmaceutical companies also contributes to the region's growth[1].

Asia Pacific

The Asia Pacific region is expected to witness the fastest growth rate during the forecast period. Factors such as the rising disease burden of VVC, increasing testing rates, and government healthcare benefits are driving this growth. Increased awareness and the willingness to seek medical treatments further bolster the market in this region[1].

Financial Trajectory

Market Size and Growth

The global VVC treatment market, which includes Mycelex-7, is projected to grow from USD 1,162.5 million in 2022 to USD 1.64 billion by 2030. This growth is driven by increasing demand for antifungal medications, advancements in therapeutic options, and proactive government measures[1].

Revenue Forecast

The revenue forecast for the VVC treatment market indicates a steady growth trajectory. The market is expected to expand at a CAGR of 4.39% from 2022 to 2030. This growth is supported by the increasing prevalence of fungal infections and the expanding reach of retail and online pharmacies[1].

Competitive Landscape

The antifungal market is highly competitive, with several key players offering a range of antifungal medications. Mycelex-7, being a well-established brand, competes with other antifungal drugs like fluconazole and nystatin. The competitive landscape is influenced by factors such as product innovation, pricing strategies, and distribution channel effectiveness[1].

Growth Drivers

Increasing Disease Prevalence

The rising prevalence of VVC and other fungal infections is a significant driver of the market. This increase is attributed to various factors, including changes in lifestyle, increased use of antibiotics, and rising awareness about fungal infections[1].

Advancements in Therapeutic Options

New approvals, launches, and advancements in therapeutic options are driving the growth of the antifungal market. These advancements include more effective and convenient treatment options, which are appealing to both patients and healthcare providers[1].

Government Measures and Awareness

Proactive government measures and increased patient awareness are also contributing to the market growth. Government initiatives to improve healthcare access and awareness campaigns about fungal infections are crucial in driving the demand for antifungal medications[1].

Challenges and Opportunities

Side Effects and Safety Concerns

While Mycelex-7 is generally well-tolerated, it can cause side effects such as abdominal cramping, diarrhea, itching, and nausea. Managing these side effects and ensuring patient safety are ongoing challenges for the market[2].

Regulatory Environment

The regulatory environment plays a critical role in the antifungal market. Changes in regulations and approval processes can significantly impact the market dynamics. For instance, the shift towards more relaxed distribution channels, such as online pharmacies, can expand the market reach but also poses regulatory challenges[1].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, offer significant opportunities for growth. Increasing healthcare expenditure, government support, and rising awareness about fungal infections in these regions are expected to drive the demand for antifungal medications like Mycelex-7[1].

Key Takeaways

• The global VVC treatment market is expected to grow at a CAGR of 4.39% from 2022 to 2030.
• Mycelex-7, as a key antifungal medication, benefits from the growing demand for VVC treatments.
• North America dominates the market, but the Asia Pacific region is expected to witness the fastest growth.
• Retail pharmacies are anticipated to be the fastest-growing distribution channel.
• Advancements in therapeutic options, government measures, and increasing disease prevalence are major growth drivers.

FAQs

Q: What is the projected market size for the VVC treatment market by 2030? A: The VVC treatment market is projected to reach USD 1.64 billion by 2030[1].

Q: Which region is expected to witness the fastest growth in the VVC treatment market? A: The Asia Pacific region is expected to witness the fastest growth during the forecast period[1].

Q: What are the common side effects of Mycelex-7? A: Common side effects include abdominal or stomach cramping, diarrhea, itching, nausea, and unpleasant mouth sensations[2].

Q: Which distribution channel is anticipated to grow the fastest for Mycelex-7? A: Retail pharmacies are anticipated to witness the fastest CAGR due to their convenience and accessibility[1].

Q: What are the key drivers of the antifungal market growth? A: Key drivers include increasing disease prevalence, advancements in therapeutic options, and proactive government measures[1].

Cited Sources

1. Grand View Research: Vulvovaginal Candidiasis Treatment Market Size Report, 2030.
2. Mayo Clinic: Clotrimazole (mucous membrane, oral route).
3. Digital Commons: The Path Toward Over-The-Counter Abortion Pills.
4. InsightAce Analytic: Acute Vulvovaginal Candidiasis Market Share, Size, Growth, and Forecast.