MYCELEX-G Drug Patent Profile

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

Mycelex-g is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in MYCELEX-G 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-g

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

Summary for MYCELEX-G

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	3
Patent Applications:	3,512
DailyMed Link:	MYCELEX-G at DailyMed

Recent Clinical Trials for MYCELEX-G

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-G clinical trials

US Patents and Regulatory Information for MYCELEX-G

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985		DISCN	No	No

Expired US Patents for MYCELEX-G

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985	3,660,577
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985	3,839,573
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985	3,705,172

International Patents for MYCELEX-G

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

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

MYCELEX-G Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYCELEX-G (Clotrimazole)

Introduction to MYCELEX-G

MYCELEX-G, a brand name for the antifungal drug clotrimazole, is widely used for the treatment of various fungal infections, including dermatophyte infections and candidiasis. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Overview

Global Antifungal Drugs Market

The global antifungal drugs market, within which MYCELEX-G operates, was valued at $16.6 billion in 2020 and is projected to reach $25.0 billion by 2030, growing at a CAGR of 3.9% from 2021 to 2030[4].

U.S. OTC Topical Antifungals Market

In the U.S., the OTC topical antifungals market, which includes products like MYCELEX-G, is expected to grow significantly. This market is anticipated to expand at a CAGR of 3.6% from 2023 to 2031, reaching more than $1.8 billion by the end of 2031[1].

Key Market Dynamics

Drivers

• Increasing Prevalence of Fungal Infections: The rise in cases of fungal infections such as ringworm, athlete’s foot, and candidiasis is a significant driver for the market. This increase is partly due to the growing awareness and diagnosis of these conditions[1][4].
• Rise in Geriatric Population: The aging population is more susceptible to fungal infections, contributing to the demand for antifungal drugs like MYCELEX-G[1].
• Advancements in Healthcare: The rapid growth in the healthcare sector and the early adoption of new technologies are also driving the market forward[1].

Restraints

• Price Sensitivity: The pharmaceutical industry, including antifungal drugs, often faces criticism for high prices. This can affect the market dynamics, especially for products that have generic alternatives[3].
• Regulatory Challenges: Strict regulatory requirements and the need for continuous innovation to stay ahead in the market can pose challenges for manufacturers[3].

Opportunities

• Growing Demand for Topical Treatments: There is an increasing preference for topical treatments over systemic antifungals due to their targeted action and lower side effects. This trend presents an opportunity for products like MYCELEX-G[4].

Financial Trajectory

Market Size and Growth

• The financial trajectory of clotrimazole, the active ingredient in MYCELEX-G, is promising. The market size for clotrimazole is projected to reach $4.2 billion by 2030[2].

Revenue and Sales

• The U.S. OTC topical antifungals market, which includes MYCELEX-G, is expected to see significant revenue growth. The market size in 2022 was $1.3 billion and is forecasted to exceed $1.8 billion by 2031[1].

Competitive Landscape

• MYCELEX-G competes in a market dominated by key players such as Novartis AG, Merck KGaA, Pfizer Inc., Abbott Laboratories, and Bayer AG. The competitive landscape is intense, with multiple generic and branded options available[1][4].

Product Specifics

Dosage Forms

• MYCELEX-G is available in various dosage forms, including solutions, creams, and tablets, which cater to different types of fungal infections and patient preferences[2].

Therapeutic Indications

• Clotrimazole, the active ingredient in MYCELEX-G, is indicated for a wide range of fungal infections, including dermatophyte infections and candidiasis. This broad therapeutic spectrum contributes to its market appeal[5].

Regional Outlook

North America

• North America, particularly the U.S., holds a significant share of the antifungal drugs market. The presence of key players, the development of the healthcare sector, and the rise in cases of mucormycosis and other fungal infections drive the market in this region[4].

Asia-Pacific

• The Asia-Pacific region is expected to register the highest CAGR during the forecast period due to the surge in prevalence of mucormycosis and other chronic diseases that increase the risk of fungal infections[4].

Key Takeaways

• The market for MYCELEX-G is driven by the increasing prevalence of fungal infections and the growing awareness among consumers.
• The U.S. OTC topical antifungals market is expected to grow at a CAGR of 3.6% from 2023 to 2031.
• The financial trajectory of clotrimazole is promising, with a projected market size of $4.2 billion by 2030.
• The competitive landscape is intense, with multiple key players in the market.

FAQs

What is the projected market size for the U.S. OTC topical antifungals market by 2031?

The U.S. OTC topical antifungals market is expected to reach more than $1.8 billion by 2031[1].

What is the CAGR for the global antifungal drugs market from 2021 to 2030?

The global antifungal drugs market is projected to grow at a CAGR of 3.9% from 2021 to 2030[4].

What are the primary drivers for the market growth of MYCELEX-G?

The primary drivers include the increasing prevalence of fungal infections, the rise in the geriatric population, and advancements in the healthcare sector[1][4].

In which regions is the antifungal drugs market expected to see significant growth?

North America is expected to dominate the market, while the Asia-Pacific region is expected to register the highest CAGR during the forecast period[4].

What are the common dosage forms of MYCELEX-G?

MYCELEX-G is available in various dosage forms, including solutions, creams, and tablets[2].

Sources

1. Transparency Market Research: U.S. OTC Topical Antifungals Market Size, Share & Forecast - 2031.
2. Drug Patent Watch: Generic CLOTRIMAZOLE INN equivalents, pharmaceutical patent.
3. Informa Healthcare USA Inc: Pharmaceutical Marketing-Strategy and Cases-Mickey C. Smith.
4. Allied Market Research: Antifungal Drugs Market Size, Share, Growth Report (2030).
5. DrugBank: Clotrimazole: Uses, Interactions, Mechanism of Action.