MONISTAT Drug Patent Profile

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

Monistat is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms. and is included in twelve NDAs.

The generic ingredient in MONISTAT is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Monistat

A generic version of MONISTAT was approved as miconazole nitrate by ACTAVIS PHARMA on November 19^th, 1993.

Summary for MONISTAT

US Patents:	0
Applicants:	4
NDAs:	12
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1
Patent Applications:	5,186
DailyMed Link:	MONISTAT at DailyMed

Recent Clinical Trials for MONISTAT

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

Sponsor	Phase
Universidad Autonoma de San Luis Potosí	Phase 4
Hospital Central "Dr. Ignacio Morones Prieto"	Phase 4

See all MONISTAT clinical trials

US Patents and Regulatory Information for MONISTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Medtech Products	MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-001	Feb 2, 2001		OTC	Yes	Yes
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984	AB	RX	Yes	Yes

Expired US Patents for MONISTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982

International Patents for MONISTAT

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	212669
Zambia	13669	IMIDAZOLE DERIVATIVES
Germany	1940388	1-(BETA-ARYL) AETHYLIMIDAZOLDERIVATE, IHRE HERSTELLUNG UND DIESE ENTHALTENDE FUNGIZIDE UND BAKTERIZIDE MITTEL

MONISTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Monistat

Introduction

Monistat, a brand of antifungal medications, is a key player in the treatment of yeast infections, including vulvovaginal candidiasis (VVC) and other fungal infections. To understand the market dynamics and financial trajectory of Monistat, it is essential to delve into the broader yeast infection treatment market, as well as the specific factors influencing its growth.

Global Yeast Infection Treatment Market Overview

The global yeast infection treatment market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 6,158.8 million and is projected to reach USD 10,031.3 million by 2034, growing at a compound annual growth rate (CAGR) of 5.0% from 2024 to 2034[4].

Market Drivers

Increasing Prevalence of Yeast Infections

The rise in autoimmune disorders and the increasing incidence of yeast infections are major drivers of the market. This is particularly evident in regions with high disease prevalence and growing patient awareness[4].

Advanced Therapeutic Options

The advent of novel antifungal treatments and the approval of new drugs are significant factors contributing to market growth. Monistat, with its range of antifungal products, benefits from these advancements[4].

Regional Growth

North America, particularly the United States, dominates the yeast infection treatment market, accounting for around 90.5% of the North American market share in 2022. This region is expected to continue its growth trajectory due to population growth, an aging population, and increasing health consciousness[4].

Monistat's Position in the Market

Monistat, owned by companies like Johnson & Johnson or other pharmaceutical giants, is a well-established brand in the antifungal treatment segment.

Product Portfolio

Monistat offers a variety of antifungal products, including oral treatments, suppositories, and topical creams. These products are widely used for treating genital candidiasis, oropharyngeal/esophageal candidiasis (thrush), and other fungal infections[4].

Market Share and Revenue

While specific revenue figures for Monistat are not publicly disclosed, its market share can be inferred from the overall growth of the yeast infection treatment market. Given its strong brand presence and wide range of products, Monistat is likely a significant contributor to the revenue of its parent company.

Financial Trajectory

Revenue Growth

The yeast infection treatment market's projected CAGR of 5.0% from 2024 to 2034 suggests a positive financial trajectory for brands like Monistat. As the market expands, driven by increasing patient awareness and the advent of new treatments, Monistat is poised to benefit from this growth[4].

Regional Performance

In regions like North America, where Monistat has a strong presence, the market is expected to grow steadily. The United States, in particular, is projected to experience a CAGR of 5.2% during the forecast period, which is likely to reflect positively on Monistat's revenue[4].

Competitive Landscape

Key Players

The yeast infection treatment market is competitive, with several major players including Astellas Pharma Inc., Astra Zeneca, Abbott Laboratories, and others. Monistat competes in this landscape by offering a diverse range of antifungal products and leveraging its brand recognition[4].

Market Strategies

To maintain its market position, Monistat's parent company likely focuses on marketing and advertising efforts, as well as continuous product innovation. For instance, Prestige Consumer Healthcare Inc., a company involved in similar consumer healthcare products, allocates significant funds to advertising and marketing, which can be a strategy adopted by Monistat's parent company as well[2].

Factors Influencing Growth

Patient Awareness and Education

Increasing patient awareness about yeast infections and the availability of effective treatments is a crucial factor driving the market. Educational campaigns and healthcare initiatives contribute to this growth[4].

Government Policies and Healthcare Benefits

Positive changes in government policies and healthcare benefits, especially in regions like Asia Pacific, are expected to drive growth in the yeast infection treatment market. These policies often include better access to healthcare services and increased funding for public health programs[1].

New Drug Approvals and Therapeutic Advancements

The approval of new antifungal drugs and advancements in therapeutic options are significant drivers of the market. Monistat benefits from these advancements as they expand their product portfolio to include newer and more effective treatments[1].

Challenges and Opportunities

Resistance to Antifungal Drugs

One of the challenges facing the yeast infection treatment market, including Monistat, is the growing resistance to antifungal drugs. This necessitates continuous innovation and the development of new therapeutic options[4].

Emerging Markets

Emerging markets, particularly in Asia Pacific and Latin America, present significant opportunities for growth. Increasing healthcare expenditure and rising disease burden in these regions are expected to drive demand for antifungal treatments[1].

Key Takeaways

• The global yeast infection treatment market is projected to grow at a CAGR of 5.0% from 2024 to 2034.
• Monistat benefits from its strong brand presence and diverse product portfolio.
• North America, particularly the United States, is a dominant region for Monistat.
• Increasing patient awareness, new drug approvals, and government policies are key drivers of the market.
• Emerging markets and continuous product innovation offer significant growth opportunities.

FAQs

What is the projected growth rate of the global yeast infection treatment market?

The global yeast infection treatment market is projected to grow at a CAGR of 5.0% from 2024 to 2034[4].

Which region dominates the yeast infection treatment market?

North America, particularly the United States, dominates the yeast infection treatment market, accounting for around 90.5% of the North American market share in 2022[4].

What are the key drivers of the yeast infection treatment market?

Key drivers include increasing patient awareness, the advent of novel antifungal treatments, and positive changes in government policies and healthcare benefits[1][4].

What challenges does the yeast infection treatment market face?

The market faces challenges such as growing resistance to antifungal drugs, which necessitates continuous innovation and the development of new therapeutic options[4].

Which companies are major players in the yeast infection treatment market?

Major players include Astellas Pharma Inc., Astra Zeneca, Abbott Laboratories, and others. Monistat competes in this landscape by offering a diverse range of antifungal products[4].

Sources

1. Grand View Research: Vulvovaginal Candidiasis Treatment Market Size Report, 2030.
2. Prestige Consumer Healthcare Inc.: Reports Second Quarter and Fiscal 2025 Results.
3. PubMed: National trends in prescription drug expenditures and projections for 2024.
4. Future Market Insights: Yeast Infection Treatment Market Revenue Forecast 2024-2034.