MONISTAT 3 Drug Patent Profile

When do Monistat 3 patents expire, and when can generic versions of Monistat 3 launch?

Monistat 3 is a drug marketed by Medtech Products and is included in four NDAs.

The generic ingredient in MONISTAT 3 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 3

A generic version of MONISTAT 3 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19^th, 1993.

Summary for MONISTAT 3

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	238
Clinical Trials:	1
Patent Applications:	3,007
What excipients (inactive ingredients) are in MONISTAT 3?	MONISTAT 3 excipients list
DailyMed Link:	MONISTAT 3 at DailyMed

See drug sales revenues for MONISTAT 3

Recent Clinical Trials for MONISTAT 3

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 3 clinical trials

Pharmacology for MONISTAT 3

Drug Class

Azole Antifungal

US Patents and Regulatory Information for MONISTAT 3

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 3	miconazole nitrate	CREAM;VAGINAL	020827-001	Mar 30, 1998		OTC	Yes	Yes
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-003	Jun 17, 2003		OTC	Yes	No
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984	AB	RX	Yes	Yes
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	020670-002	Apr 16, 1996		OTC	Yes	Yes

Expired US Patents for MONISTAT 3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984	3,717,655
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984	3,839,574

International Patents for MONISTAT 3

See the table below for patents covering MONISTAT 3 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

MONISTAT 3 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONISTAT 3

Introduction to MONISTAT 3

MONISTAT 3 is a popular over-the-counter (OTC) yeast infection treatment produced by Prestige Consumer Healthcare Inc. It is part of the broader MONISTAT product line, which includes various treatment options for yeast infections. Here, we will delve into the market dynamics and financial trajectory of MONISTAT 3.

Market Size and Growth

The yeast infection treatment market, which includes products like MONISTAT 3, is projected to experience significant growth. By 2034, the global yeast infection treatment market is expected to reach USD 10,031.3 million, driven by a Compound Annual Growth Rate (CAGR) of 5.0%[1].

Distribution Channels

MONISTAT 3 is distributed through various channels, each contributing to its market presence:

• Retail Pharmacies/Drug Stores: These remain the primary distribution channels for OTC medications like MONISTAT 3, offering easy access to consumers.
• Hospital Pharmacies: Although less common for OTC products, hospital pharmacies can also stock MONISTAT 3, especially in cases where patients are prescribed the medication during hospital visits.
• Specialty Stores: Some specialty stores focus on women's health or dermatological products, which can also carry MONISTAT 3.
• Online Sales: The rise of online pharmacies and e-commerce platforms has significantly boosted the sales of MONISTAT 3, making it easily accessible to a wider audience[1].

Regional Market Analysis

The market for MONISTAT 3 is diverse and spans multiple regions:

• North America: This region is a significant market for MONISTAT 3, driven by high consumer awareness and easy access to OTC medications. Prestige Consumer Healthcare Inc., the manufacturer, has a strong presence in North America, contributing to the product's success[1][2].
• Europe: Europe is another key market, with countries like Germany, France, and the UK showing substantial demand for yeast infection treatments.
• Asia Pacific: This region is growing rapidly due to increasing healthcare awareness and improving economic conditions, making it a promising market for MONISTAT 3[1].

Financial Performance of Prestige Consumer Healthcare Inc.

Prestige Consumer Healthcare Inc., the parent company of MONISTAT, has shown robust financial performance:

• Revenue Growth: In the second fiscal quarter of 2023, Prestige Consumer Healthcare Inc. reported a record revenue of $289.3 million, with a 4.7% increase over the prior year and a 5.5% increase excluding currency effects[2].
• Segment Revenues: The North American OTC Healthcare segment, which includes MONISTAT, generated $252.054 million in revenues during the same period, highlighting the strong performance of the brand[2].

Product Variants and Market Attractiveness

MONISTAT 3 is available in several variants, each catering to different consumer preferences:

• MONISTAT 3-Day Treatment Combination Pack: This includes Ovule inserts, suppositories, or prefilled cream applicators, along with external itch relief cream. The variety in packaging and application methods enhances market attractiveness[3].
• Market Attractiveness Analysis: The multiple forms of MONISTAT 3 make it more appealing to a broader range of consumers, contributing to its market attractiveness. The product's effectiveness and convenience are key drivers of its market success[1].

Drivers and Restraints

Drivers

• Increasing Demand for OTC Medications: The trend towards self-medication and the convenience of OTC products drive the demand for MONISTAT 3.
• Personalized Medicine: The rise of personalized medicine, where treatments are tailored to individual needs, is expected to further boost the market for yeast infection treatments[1].
• Strong Marketing and Brand Presence: Prestige Consumer Healthcare Inc.'s robust marketing strategies and the established brand reputation of MONISTAT contribute significantly to its market success[2].

Restraints

• Competition: The yeast infection treatment market is competitive, with various brands and generic alternatives available.
• Regulatory Changes: Changes in regulatory environments can impact the availability and marketing of OTC medications like MONISTAT 3[1].

Market Trends

• Online Shopping: The increasing trend of online shopping has significantly impacted the sales of MONISTAT 3, making it more accessible to consumers worldwide.
• Consumer Awareness: Growing consumer awareness about health and wellness is driving the demand for effective and convenient treatments like MONISTAT 3[1].

Consumer Behavior and Preferences

Consumers are increasingly looking for convenient, effective, and less-concentrated treatments. MONISTAT 3's 3-day treatment option, which includes less-concentrated doses, aligns well with these preferences. The product's ease of use and the inclusion of external itch relief cream enhance its appeal to consumers[3].

Technological and Regulatory Landscape

The market for yeast infection treatments is influenced by technological advancements and regulatory changes:

• Technological Advancements: Improvements in drug delivery systems and the development of new formulations can impact the market.
• Regulatory Changes: Regulatory bodies may impose new guidelines or restrictions that could affect the marketing and distribution of MONISTAT 3[4].

Key Takeaways

• Market Growth: The yeast infection treatment market, including MONISTAT 3, is expected to grow significantly by 2034.
• Distribution Channels: MONISTAT 3 is distributed through various channels, with retail pharmacies and online sales being key contributors.
• Financial Performance: Prestige Consumer Healthcare Inc. has shown strong financial performance, driven by the success of its OTC brands like MONISTAT.
• Product Variants: The multiple forms of MONISTAT 3 enhance its market attractiveness.
• Drivers and Restraints: Increasing demand for OTC medications, personalized medicine, and strong marketing are key drivers, while competition and regulatory changes are restraints.

FAQs

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

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

2. What are the primary distribution channels for MONISTAT 3?

The primary distribution channels include retail pharmacies/drug stores, hospital pharmacies, specialty stores, and online sales[1].

3. How has Prestige Consumer Healthcare Inc. performed financially in recent years?

Prestige Consumer Healthcare Inc. reported a record revenue of $289.3 million in the second fiscal quarter of 2023, with a 4.7% increase over the prior year[2].

4. What are the different variants of MONISTAT 3 available in the market?

MONISTAT 3 is available in combination packs with Ovule inserts, suppositories, or prefilled cream applicators, along with external itch relief cream[3].

5. What are the key drivers of the market for MONISTAT 3?

The key drivers include increasing demand for OTC medications, the rise of personalized medicine, and strong marketing and brand presence[1][2].

Cited Sources:

1. Future Market Insights - Yeast Infection Treatment Market Revenue Forecast 2024-2034
2. Prestige Consumer Healthcare Inc. - News Releases - Second Quarter Results
3. MONISTAT - MONISTAT 3-Day Treatment for Yeast Infections
4. Cognitive Market Research - Miconazole Market Report 2024 (Global Edition)