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Last Updated: December 19, 2025

MONISTAT 7 COMBINATION PACK Drug Patent Profile


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When do Monistat 7 Combination Pack patents expire, and what generic alternatives are available?

Monistat 7 Combination Pack is a drug marketed by Medtech Products and is included in one NDA.

The generic ingredient in MONISTAT 7 COMBINATION PACK 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 Combination Pack

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

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Summary for MONISTAT 7 COMBINATION PACK
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 101
Clinical Trials: 1
Patent Applications: 3,368
What excipients (inactive ingredients) are in MONISTAT 7 COMBINATION PACK?MONISTAT 7 COMBINATION PACK excipients list
DailyMed Link:MONISTAT 7 COMBINATION PACK at DailyMed
Drug patent expirations by year for MONISTAT 7 COMBINATION PACK
Recent Clinical Trials for MONISTAT 7 COMBINATION PACK

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

SponsorPhase
Universidad Autonoma de San Luis PotosíPhase 4
Hospital Central "Dr. Ignacio Morones Prieto"Phase 4

See all MONISTAT 7 COMBINATION PACK clinical trials

US Patents and Regulatory Information for MONISTAT 7 COMBINATION PACK

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 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020288-002 Apr 26, 1993 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MONISTAT 7 COMBINATION PACK

Last updated: August 3, 2025

Introduction

The MONISTAT 7 Combination Pack, a leading antifungal therapy, plays a pivotal role in the treatment of vaginal candidiasis. With rising prevalence and increasing awareness of women's sexual health, the product's market dynamics are evolving rapidly. This analysis explores the current landscape, key drivers, competitive positioning, and future financial outlook of the MONISTAT 7 Combination Pack within the global pharmaceutical industry.

Product Overview

The MONISTAT 7 Combination Pack comprises a single-dose oral medication combined with topical therapy, typically aimed at providing comprehensive management of vulvovaginal candidiasis. The formulation frequently includes Fluconazole (an oral antifungal) paired with an external antifungal cream, offering both systemic and local relief. Its combination approach appeals to consumers seeking effective and convenient treatment options.

Market Dynamics

Medical and Demographic Drivers

The global burden of vaginal yeast infections underscores the demand for effective antifungal therapies. According to the Centers for Disease Control and Prevention (CDC), up to 75% of women will experience at least one episode of vulvovaginal candidiasis in their lifetime, with recurrent cases impacting a significant subset [1]. The increasing incidence is attributable to factors such as antibiotic overuse, hormonal changes, diabetes, and immunosuppression, which compromise vaginal flora.

Moreover, demographic shifts, including delayed childbearing and increased awareness of intimate health, have fueled demand for user-friendly combination therapies like MONISTAT 7. The product's capacity for rapid symptom relief aligns with consumer preferences for effective and convenient treatments.

Regulatory and Clinical Trends

Regulatory agencies have recently emphasized the safety and efficacy of antifungal agents through updated guidelines, reinforcing the importance of combination therapies in recurrent or complicated infections. Clinical studies affirm that combination packs enhance compliance and clinical outcomes, bolstering their positioning in the market.

Market Penetration and Competitive Landscape

The antifungal market is fragmented, dominated by key players such as Johnson & Johnson, Bayer, and Sandoz. MONISTAT 7 competes not only on therapeutic efficacy but also on packaging convenience, affordability, and consumer marketing. Its combination pack appeals particularly to women seeking comprehensive treatment in a single purchasing decision.

However, the proliferation of generic formulations and OTC alternatives constrains pricing power and margins, compelling manufacturers to innovate continually. MONISTAT’s longstanding brand reputation and FDA approval provide a competitive edge, although competition remains high.

Pricing and Reimbursement Factors

Pricing strategies are critical, especially given OTC availability in many markets. Insurance coverage and reimbursement policies in regions like the US influence demand. In markets where reimbursed or subsidized, higher market penetration is achievable; otherwise, price sensitivity may restrict sales growth.

Supply Chain and Distribution

A robust global supply chain ensures availability across pharmacies, clinics, and e-commerce platforms. The convenience of OTC access in various countries enhances sales volume, while strategic partnerships with distributors optimize reach.

Financial Trajectory

Historical Performance

While precise sales figures for MONISTAT 7 are proprietary, industry estimates position Monistat (the moniker for the active product) as a multi-hundred million dollar brand globally. The combination pack format often commands premium pricing, bolstering margins.

Forecasted Growth

Market analysts project a compound annual growth rate (CAGR) of approximately 5-7% for the antifungal sector through 2030, driven by demographic trends, rising prevalence, and product innovation [2]. Specifically, the combination pack segment could outperform overall market growth owing to consumer demand for convenience and comprehensive solutions.

Strategic Investments and Innovation

To sustain growth, manufacturers may invest in formulation improvements, such as longer-acting agents or fewer dosing requirements. Digital marketing campaigns targeting women’s health and targeted distribution channels can expand market penetration.

Revenue Breakdown and Profitability

Assuming an approximate global revenue contribution in the hundreds of millions, the combination pack format’s higher price point and premium positioning favor healthy margins. However, price competition from generics and OTC competitors may compress profitability margins in some regions.

Emerging Markets and Future Opportunities

Emerging markets such as Asia-Pacific, Latin America, and Africa represent significant growth avenues due to increasing healthcare awareness and urbanization. Regulatory approvals and local manufacturing capabilities will be vital in expanding reach.

Furthermore, expanding indications, such as recurrent vulvovaginal candidiasis, parental use, or pediatric applications, could diversify revenue streams.

Challenges and Risks

  • Market Competition: Intense competition from established brands and generic formulations threatens market share and pricing.
  • Regulatory Hurdles: Variations in approval processes across countries may delay product launches or restrict formulations.
  • Pricing Pressures: OTC availability and reimbursement policies can influence pricing strategies and profit margins.
  • Public Perception and Awareness: Lack of awareness about the benefits of combination therapy versus monotherapy can impede demand.

Conclusion

The MONISTAT 7 Combination Pack is positioned within a growing and dynamic market characterized by rising demand, consumer preference for convenience, and an evolving competitive landscape. Strategic innovation, geographic expansion, and effective marketing will be critical in translating market dynamics into favorable financial outcomes.

Key Takeaways

  • The global prevalence of vulvovaginal candidiasis supports sustained demand for combination antifungal therapies like MONISTAT 7.
  • Market growth will be driven by demographic shifts, increased awareness, and the convenience offered by combination packs.
  • Competitive differentiation relies on brand reputation, regulatory strategy, distribution, and pricing.
  • Emerging markets present substantial growth opportunities, particularly if regulatory hurdles are efficiently navigated.
  • Ongoing innovation and targeted marketing are essential to maintain market share amid intensifying competition.

FAQs

  1. What is the primary advantage of the MONISTAT 7 Combination Pack?
    It offers a comprehensive, single-dose treatment combining oral and topical antifungals, ensuring rapid symptom relief and improved compliance.

  2. How does the global prevalence of vaginal candidiasis influence MONISTAT 7's market?
    High prevalence and recurrent cases increase demand, especially as awareness and diagnosis improve, supporting steady sales growth.

  3. What are the main competitive threats to MONISTAT 7?
    Generic formulations, OTC competitors, and newer antifungal agents pose pricing and market share risks.

  4. How does OTC availability affect the product’s financial trajectory?
    OTC status enables widespread access, increasing volume;however, it can exert downward pressure on pricing and margins.

  5. What strategies can enhance MONISTAT 7’s market penetration?
    Focused marketing campaigns, expansion into emerging markets, regulatory approval of extended indications, and product innovation are key.


Sources:

[1] CDC. “Vaginal Yeast Infections (Vaginal Candidiasis).” Centers for Disease Control and Prevention, 2021.

[2] MarketsandMarkets. “Antifungal Drugs Market by Type, Application, and Region - Global Forecast to 2026.” 2022.

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