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. 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 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:	101
Clinical Trials:	1
Patent Applications:	3,368
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
Hospital Central "Dr. Ignacio Morones Prieto"	Phase 4
Universidad Autonoma de San Luis Potosí	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
Medtech Products	MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-001	Feb 2, 2001		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
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984

International Patents for MONISTAT 3

See the table below for patents covering MONISTAT 3 around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	159662
Brazil	6911658
Denmark	139255
Japan	S5039664
Netherlands	7100072
Finland	751886
Austria	296289

Market Dynamics and Financial Trajectory for MONISTAT 3

Last updated: July 31, 2025

Introduction

MONISTAT 3, a prominent brand within the antifungal medication segment, primarily targets vaginal candidiasis, commonly known as yeast infections. As a leading over-the-counter (OTC) treatment, MONISTAT 3’s market performance hinges on diverse factors encompassing demographic trends, healthcare policies, competitive landscape, and evolving consumer preferences. This analysis examines the current market dynamics and forecasts the financial trajectory of MONISTAT 3 within the evolving pharmaceutical landscape.

Market Overview: Positioning of MONISTAT 3

MONISTAT 3 contains miconazole nitrate, an azole antifungal agent, effective for short-term treatment of vaginal yeast infections. It holds a substantial share of OTC antifungal products, benefitting from consumer demand for accessible, self-managed healthcare solutions. The drug's positioning capitalizes on the increasing prevalence of vaginal candidiasis, influenced by factors such as rising awareness, changing lifestyles, and healthcare shifts towards preventative and self-care approaches.

Market Dynamics

Prevalence and Demand Drivers

Vaginal candidiasis affects approximately 75% of women at least once in their lifetime, with recurring infections prevalent among specific demographics (e.g., pregnant women, immunocompromised individuals). The increasing incidence correlates with factors such as antibiotic use, diabetes, hormonal changes, and climate conditions—factors that boost demand for OTC antifungal treatments such as MONISTAT 3. The World Health Organization (WHO) reports rising global awareness and self-medication trends, positioning MONISTAT 3 favorably in accessible healthcare markets.

Consumer Preferences and Self-Care Trends

The shift toward self-care convenience has reinforced demand for OTC treatments. Consumers prefer non-prescription options offering privacy, ease of use, and immediate relief. MONISTAT 3’s three-day dosing regimen aligns with these preferences, boosting its market appeal.

Regulatory Environment and Competitive Landscape

Regulatory agencies worldwide, such as the US Food and Drug Administration (FDA), have maintained the OTC status of MONISTAT 3, facilitating broad accessibility. In the competitive antifungal segment, MONISTAT faces competitors like Clotrimazole (Lotrimin), Tioconazole, and vaginal suppositories from generic manufacturers. Patent stability, regulatory approvals, and brand loyalty influence market share stability.

Market Penetration and Distribution Channels

Distribution occurs through pharmacies, supermarkets, online platforms, and healthcare providers. The growth of e-commerce amplifies access, especially in developing markets. Strategic marketing and educational campaigns have bolstered consumer trust and brand loyalty.

Influence of COVID-19 Pandemic

The pandemic temporarily disrupted retail supply chains but concurrently increased demand for OTC treatments, including antifungals, as consumers postponed clinical visits in favor of self-medication. The outbreak accelerated online sales channels, a trend expected to persist.

Financial Trajectory

Revenue Trends

Market research indicates steady growth in OTC antifungal segment revenues, averaging an annual compound growth rate (CAGR) of over 4% globally. MONISTAT 3, with its established brand presence, is positioned to capitalize on this expansion. In North America, the OTC antifungal market exceeds $600 million annually, with MONISTAT commanding approximately 40% market share domestically.

Pricing Strategies and Market Penetration

Pricing tends to be competitive, balancing affordability and profit margins. Monistat’s pricing strategy reinforces accessibility, often bundled with promotional discounts and multi-pack offerings to boost repeat purchases.

Emerging Markets and Expansion Potential

Emerging economies, such as parts of Southeast Asia and Latin America, exhibit rising demand for OTC antifungals due to increasing awareness and healthcare infrastructure development. MONISTAT 3’s potential for market expansion hinges on regulatory approvals, localized marketing, and partnerships with distributors.

Impact of Patent and Regulatory Changes

As an established OTC formulation, MONISTAT 3 benefits from patent protection in many jurisdictions. Pending or future patent expirations, particularly in generic markets, could impact pricing and market share, prompting product innovation and formulation improvements to sustain revenue streams.

Forecasted Growth

Considering current trends, MONISTAT 3’s revenues are projected to grow at a CAGR of approximately 3–5% over the next five years, driven by expanding global awareness, rising infection rates, and e-commerce proliferation. Market analyses anticipate a plateauing phase post-2025, contingent upon competitive responses and healthcare policy shifts.

Challenges and Risks

• Intensifying Competition: Entry of generics and alternative formulations may pressure pricing and market share.
• Regulatory Changes: Stricter OTC drug regulations could delay product launches or require reformulations.
• Consumer Awareness: Misinformation and alternative health choices could influence demand.
• Supply Chain Disruptions: Logistics issues, as seen during the pandemic, could impact availability and sales.

Opportunities for Growth

• Product Line Extensions: Introducing longer-duration or combination therapies may enhance market share.
• Digital Transformation: Leveraging online sales and telehealth partnerships can access broader demographics.
• Global Expansion: Targeting developing markets with tailored marketing campaigns can unlock new revenue streams.
• Educational Campaigns: Increasing awareness about yeast infections and self-care can boost consumer adoption.

Conclusion

The financial trajectory of MONISTAT 3 is poised for steady growth within the OTC antifungal segment, driven by demographic trends, consumer preferences, and expanding access. Nevertheless, maintaining market position requires vigilance against competitive pressures, regulatory shifts, and supply chain resilience. Strategic innovation and geographic expansion are critical to sustaining revenue growth and improving profitability.

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Key Takeaways

• Growing Demand: Rising prevalence of vaginal candidiasis and self-care preferences underpin strong demand for MONISTAT 3.
• Market Leadership: MONISTAT’s established brand recognition and OTC status in developed markets provide a formidable market position.
• Revenue Growth Potential: CAGR of 3–5% projected through 2028, fueled by expanding markets and e-commerce channels.
• Competitive Landscape: Increased competition from generics necessitates innovation and aggressive marketing.
• Expansion Strategies: Focus on emerging markets and digital channels offers significant growth opportunities.

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FAQs

1. How does MONISTAT 3 differentiate itself from competitors?
MONISTAT 3’s three-day treatment regimen offers quick relief and convenience, supported by strong brand recognition and regulatory approvals, which differentiate it in the OTC antifungal segment.

2. What are the key growth factors for MONISTAT 3 over the next five years?
Expansion into emerging markets, e-commerce growth, increasing prevalence of vaginal yeast infections, and consumer preference for OTC self-care treatments are pivotal drivers.

3. What threats could impact MONISTAT 3’s financial performance?
Intensified competition, patent expirations, regulation tightening, and supply chain disruptions pose significant risks.

4. How important is digital marketing for MONISTAT 3’s future?
Crucial. Enhanced online presence and telehealth partnerships can extend reach, improve consumer engagement, and adapt to shifting purchasing trends.

5. Are there opportunities for product innovation within the MONISTAT line?
Yes. Developing longer-duration formulations, combination therapies, and targeted formulations for special populations could reinforce market dominance and revenue streams.

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References

1. WHO. "Vaginal candidiasis: Prevalence and health impact." World Health Organization, 2022.
2. MarketWatch. "OTC Antifungal Market Size and Growth," 2023.
3. Statista. "Global OTC healthcare market forecasts," 2023.
4. FDA. "OTC Drug Monographs," 2022.
5. Grand View Research. "Antifungal Drugs Market Analysis," 2023.