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. Forty-five 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:	1
Clinical Trials:	1
Patent Applications:	3,368
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
France	2015913
Belgium	737575
African Intellectual Property Organization (OAPI)	3898

Market Dynamics and Financial Trajectory for MONISTAT 7

Last updated: July 29, 2025

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Introduction

MONISTAT 7, an over-the-counter (OTC) antifungal medication primarily used for the treatment of vulvovaginal candidiasis (VVC), is a notable entrant in the reproductive and women's health segment. Its active ingredient, butoconazole nitrate, is recognized for its proven efficacy, safety, and convenience. As demand for OTC treatments for vaginal infections escalates globally, MONISTAT 7’s market dynamics and financial prospects merit a comprehensive examination, considering emerging trends, competitive landscape, regulatory environment, and consumer behavior shifts.

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Market Overview

The global antifungal market was valued at approximately $13 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030[1]. The segment for OTC vaginal antifungals, including MONISTAT products, constitutes a significant share driven by increased prevalence of vulvovaginal candidiasis, rising health awareness, and consumer preference for self-administration.

Key Drivers:

• Prevalence of VVC: Approximately 75% of women experience at least one episode of VVC during their lifetime; recurrent infections burden healthcare systems and patients alike[2].
• Product Accessibility: Availability of OTC options like MONISTAT reduces the need for clinical visits, facilitating remote diagnosis and treatment.
• Consumer Shift Toward Self-Care: Increased health literacy enables consumers to manage mild infections independently, bolstering demand for OTC formulations.
• Expanding Awareness: Public health campaigns and clinical guidelines emphasizing early treatment drive OTC sales.

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Competitive Landscape

MONISTAT 7 operates on a highly competitive matrix involving both branded and generic OTC antifungal products. The primary competitive set comprises:

• Brand Leaders: MONISTAT (various formulations), Canesten, and Gyne-Lotrimin—offering single or multi-dose regimens.
• Generics and Store Brands: Increasingly capturing market share due to price sensitivity.
• New Entrants: Innovative formulations, including extended-duration creams, suppositories, and oral antifungals, rendering the market more dynamic.

The unique selling proposition of MONISTAT 7 resides in its 7-day application regimen, targeting women seeking effective, minimally invasive treatments without doctor's visits, fostering adherence, and potentially improving outcomes.

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Regulatory Environment

The regulatory landscape significantly shapes MONISTAT 7’s market trajectory.

• Over-the-counter (OTC) classification in major markets such as the U.S. and EU facilitates access, but requires compliance with regulatory standards for safety, efficacy, and labeling.
• Regulatory approvals and health authority endorsements influence consumer trust and market penetration.
• Pending or upcoming regulatory reviews, especially regarding formulations for broader indications or combination products, could further expand or restrict market access.

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Market Dynamics

1. Consumer Preferences and Behavior

The modern consumer favors shorter treatment durations, lower side effect profiles, and clarity in dosing instructions. MONISTAT 7’s 7-day regimen strikes a balance between efficacy and convenience, aligning with consumer needs.

2. Healthcare Provider Role

Physicians endorse OTC antifungals for uncomplicated yeast infections, but they play a crucial role in:

• Diagnosing recurrent infections
• Recommending appropriate OTC treatments
• Monitoring cases resistant to first-line therapies.

3. Geographic Expansion

Emerging markets, like India, Southeast Asia, and Latin America, experience rising demand due to increased healthcare access and health awareness campaigns. These regions represent fertile ground for MONISTAT 7’s growth, though regulatory and supply chain hurdles remain.

4. Digital Marketing and E-Commerce

The proliferation of online pharmacies and telemedicine services accelerates OTC product sales. Personalized marketing campaigns and educational platforms improve brand visibility and consumer engagement for MONISTAT 7.

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Financial Trajectory

1. Revenue Growth Potential

Analysts project the OTC antifungal segment will sustain a CAGR of 6-8% over the next decade. MONISTAT 7, leveraging brand recognition and product differentiation, is positioned to capitalize on:

• Stable or increasing demand for over-the-counter vaginal medications;
• Market expansion into new regions;
• Product line extensions, like combination treatments or longer-acting formulations.

2. Revenue Drivers

• Market Penetration: Deepening presence in existing markets through increased shelf space, pharmacy placements, and consumer marketing.
• New Markets: Regulatory approvals in developing regions could double available markets.
• Pricing Strategies: Tiered pricing and bundling can enhance accessibility and margins.
• Product Innovations: Developing alternate formulations (e.g., topical gels, suppositories) can attract diverse consumer segments.

3. Risk Factors and Challenges

• Pricing Pressures: Generic competition may erode margins.
• Regulatory Delays: Delays or denials of approvals can impede entry into new markets.
• Efficacy Competition: Emerging resistant strains could require reformulation.
• Market Saturation: In mature markets, growth slows unless differentiated through brand or innovation.

4. Investment and R&D Outlook

Innovation in formulation and indication extensions can fuel future revenue streams, supported by investments in R&D. Partnerships with healthcare providers and digital platforms will amplify outreach.

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Market Trends and Future Outlook

• Personalized Medicine: Increasing emphasis on tailored treatments could influence formulation preferences.
• Digital Health Integration: Telehealth services facilitate OTC medication guidance; MONISTAT 7’s ease of use positions it well in this trend.
• Consumer Education: Campaigns targeting recurrent infections or resistant strains could shift demand patterns, emphasizing the importance of product efficacy.

In sum, the market trajectory for MONISTAT 7 appears favorable, aligned with global trends favoring OTC vaginal health products, provided the brand maintains regulatory compliance, innovates effectively, and adapts to consumer preferences.

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Key Takeaways

• Market Expansion: MONISTAT 7 benefits from increasing VVC prevalence and consumer inclination toward self-care, supporting steady growth.
• Competitive Advantage: Its 7-day regimen offers a convenient treatment option, differentiating it from shorter-course or longer-interval competitors.
• Regional Growth Opportunities: Emerging markets present untapped potential, contingent upon navigating regulatory pathways.
• Innovation as Catalyst: Product line extensions and formulation innovations are pivotal for sustained financial growth.
• Regulatory Vigilance: Compliance and proactive engagement with health authorities remain critical to market access and penetration.

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FAQs

1. How does MONISTAT 7 differentiate itself from other OTC antifungals?
MONISTAT 7's key differentiator is its 7-day application regimen, promoting better adherence and clinical outcomes compared to shorter-course treatments, along with established safety and efficacy profiles.

2. What are the main barriers to MONISTAT 7’s global growth?
Regulatory approval delays, high competition from generic brands, pricing pressures, and regional awareness levels serve as primary hurdles.

3. How does consumer behavior influence MONISTAT 7’s market performance?
A shift toward self-care, frustration with traditional healthcare pathways, and telemedicine adoption increase demand for OTC solutions like MONISTAT 7, especially when combined with effective marketing.

4. What future innovations could impact MONISTAT 7’s financial trajectory?
Formulation enhancements, combination therapies for resistant infections, and novel delivery systems could sustain or boost market share.

5. How significant is the role of digital platforms in MONISTAT 7’s marketing strategy?
Digital marketing and e-commerce enable direct engagement with consumers, expand reach into underserved markets, and foster brand loyalty, significantly contributing to sales growth.

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References

1. MarketsandMarkets. "Antifungal Drugs Market," 2022.
2. Centers for Disease Control and Prevention. "Vulvovaginal Candidiasis," 2021.