MONISTAT 7 Drug Patent Profile

Which patents cover Monistat 7, and when can generic versions of Monistat 7 launch?

Monistat 7 is a drug marketed by Medtech Products and is included in three NDAs.

The generic ingredient in MONISTAT 7 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 7

A generic version of MONISTAT 7 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19^th, 1993.

Summary for MONISTAT 7

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1
Patent Applications:	3,007
What excipients (inactive ingredients) are in MONISTAT 7?	MONISTAT 7 excipients list
DailyMed Link:	MONISTAT 7 at DailyMed

Recent Clinical Trials for MONISTAT 7

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 7 clinical trials

Pharmacology for MONISTAT 7

Drug Class

Azole Antifungal

US Patents and Regulatory Information for MONISTAT 7

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medtech Products	MONISTAT 7	miconazole nitrate	CREAM;VAGINAL	017450-002	Feb 15, 1991		OTC	Yes	Yes
Medtech Products	MONISTAT 7	miconazole nitrate	SUPPOSITORY;VAGINAL	018520-002	Feb 15, 1991		OTC	Yes	Yes
Medtech Products	MONISTAT 7 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020288-002	Apr 26, 1993		OTC	Yes	Yes

International Patents for MONISTAT 7

See the table below for patents covering MONISTAT 7 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
Belgium	737575
Denmark	137947
Czechoslovakia	194656	FUNGICIDE AND BACTERICIDE FOR PLANTS TREATMENT AND METHOD OF MAKING THE SAME

MONISTAT 7 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONISTAT 7

Introduction

MONISTAT 7, a popular over-the-counter (OTC) treatment for yeast infections, is part of a broader market that is experiencing significant growth. Here, we will delve into the market dynamics and financial trajectory of MONISTAT 7, as well as the broader yeast infection treatment market.

Market Overview

The yeast infection treatment market is projected to reach USD 10,031.3 million by 2034, growing at a CAGR of 5.0% driven by factors such as personalized medicine and increasing awareness about women's health[1].

Product Profile: MONISTAT 7

MONISTAT 7 is a nightly low-dose yeast infection treatment that distributes smaller amounts of the active ingredient, miconazole, over a week. The treatment comes in various packages, including a 7-day treatment combination pack and a single tube with disposable applicators[3].

Market Segmentation

The yeast infection treatment market is segmented by region, treatment type, indication, route of administration, form, and distribution channel.

Regional Analysis

• North America: This region is a significant market for MONISTAT 7, with the United States and Canada being key countries. The market here is driven by high healthcare spending and a well-established distribution network[1].
• Europe: Countries like Germany, Italy, France, and the UK also contribute substantially to the market. Europe's market growth is supported by a strong healthcare system and increasing demand for OTC treatments[1].
• Latin America: Countries such as Mexico, Brazil, and Argentina are growing markets, driven by increasing healthcare access and awareness[1].

Treatment Type

MONISTAT 7 falls under the category of topical antifungal treatments. This segment is popular due to its ease of use and effectiveness in treating yeast infections[1].

Indication

The primary indication for MONISTAT 7 is vaginal yeast infections, which are common among women. The product is also recommended for pregnant women and patients with diabetes due to its safety profile[3].

Route of Administration

MONISTAT 7 is administered topically, using prefilled cream applicators or a tube with disposable applicators. This route is preferred for its direct application to the affected area[3].

Form

The product is available in cream form, which is easy to apply and provides quick relief from symptoms[3].

Distribution Channel

MONISTAT 7 is widely available through various distribution channels, including pharmacies, online retailers, and healthcare providers. This broad availability contributes to its market success[1].

Financial Performance

While specific financial data for MONISTAT 7 alone is not publicly available, the overall performance of its parent company and the broader market provides insights.

Parent Company Performance

Prestige Consumer Healthcare Inc., the company behind MONISTAT, has reported strong revenue growth. For the first nine months of fiscal 2024, the company's net income was $159.9 million, with diluted earnings per share increasing to $3.19 compared to the prior year[2].

Market Attractiveness

The yeast infection treatment market is attractive due to its growing demand and the presence of well-established brands like MONISTAT. The market's attractiveness is further enhanced by the increasing preference for OTC treatments and the expanding distribution channels[1].

Drivers and Restraints

Drivers

• Increasing Awareness: Growing awareness about women's health and the importance of treating yeast infections effectively drives the market.
• Personalized Medicine: The trend towards personalized medicine is expected to boost the market, as treatments like MONISTAT 7 are tailored to individual needs.
• Expanding Distribution Channels: The availability of MONISTAT 7 through various distribution channels, including online retailers, enhances its reach and accessibility[1].

Restraints

• Competition: The market is competitive, with several brands offering similar treatments, which can impact MONISTAT 7's market share.
• Regulatory Changes: Changes in regulatory policies can affect the approval and marketing of OTC treatments like MONISTAT 7[1].

Market Trends

OTC Preference

There is a growing preference for OTC treatments over prescription medications, driven by convenience and cost-effectiveness. This trend benefits products like MONISTAT 7[1].

Digital Health

The rise of digital health platforms and online pharmacies is increasing the accessibility of OTC treatments, further boosting the market[1].

Country Level Analysis

United States

The U.S. market is a significant contributor to the global yeast infection treatment market. MONISTAT 7 is widely recognized and used in the U.S., benefiting from a strong distribution network and high consumer awareness[1].

Canada

Canada also represents a substantial market, with MONISTAT 7 being one of the preferred treatments due to its efficacy and safety profile[1].

Key Takeaways

• The yeast infection treatment market is projected to grow significantly, driven by personalized medicine and increasing awareness.
• MONISTAT 7 is a key player in this market, known for its effectiveness and safety profile.
• The product's availability through various distribution channels and its suitability for different patient groups contribute to its market success.
• The financial performance of Prestige Consumer Healthcare Inc. indicates strong revenue growth, which is likely influenced by the success of products like MONISTAT 7.

FAQs

1. What is the projected market size for the yeast infection treatment market by 2034?

   • The yeast infection treatment market is projected to reach USD 10,031.3 million by 2034[1].

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

   • Key drivers include increasing awareness about women's health, the trend towards personalized medicine, and expanding distribution channels[1].

3. What are the different forms in which MONISTAT 7 is available?

   • MONISTAT 7 is available in a 7-day treatment combination pack and a single tube with disposable applicators[3].

4. Why is MONISTAT 7 recommended for pregnant women and patients with diabetes?

   • MONISTAT 7 is recommended for these groups due to its safety profile and effectiveness in treating yeast infections[3].

5. How does the rise of digital health platforms impact the market for MONISTAT 7?

   • The rise of digital health platforms and online pharmacies increases the accessibility of MONISTAT 7, further boosting its market reach[1].

Cited Sources:

1. Future Market Insights, "Yeast Infection Treatment Market Revenue Forecast 2024-2034".
2. Prestige Consumer Healthcare Inc., "Reports Third Quarter Fiscal 2024".
3. hcp.monistat.com, "MONISTAT® 7-Day Treatment for Yeast Infections".