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Last Updated: December 22, 2024

MONISTAT 3 COMBINATION PACK Drug Patent Profile


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Which patents cover Monistat 3 Combination Pack, and what generic alternatives are available?

Monistat 3 Combination Pack is a drug marketed by Medtech Products and is included in two NDAs.

The generic ingredient in MONISTAT 3 COMBINATION PACK 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 Combination Pack

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

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Summary for MONISTAT 3 COMBINATION PACK
US Patents:0
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 125
Clinical Trials: 1
Patent Applications: 2,906
What excipients (inactive ingredients) are in MONISTAT 3 COMBINATION PACK?MONISTAT 3 COMBINATION PACK excipients list
DailyMed Link:MONISTAT 3 COMBINATION PACK at DailyMed
Drug patent expirations by year for MONISTAT 3 COMBINATION PACK
Recent Clinical Trials for MONISTAT 3 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 3 COMBINATION PACK clinical trials

US Patents and Regulatory Information for MONISTAT 3 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 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670-002 Apr 16, 1996 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MONISTAT 3 COMBINATION PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONISTAT 3 Combination Pack

Introduction to MONISTAT 3 Combination Pack

MONISTAT 3 Combination Pack is a widely used treatment for yeast infections, specifically vulvovaginal candidiasis. The product is available in several forms, including ovule inserts, prefilled cream applicators, and vaginal suppositories, all of which contain the active ingredient miconazole nitrate[3][4][5].

Market Demand and Trends

The demand for antifungal treatments, particularly those targeting yeast infections, remains steady due to the common occurrence of these infections among women. According to clinical data, vulvovaginal candidiasis affects a significant portion of the female population at some point in their lives, making products like MONISTAT 3 a staple in the pharmaceutical market[5].

Consumer Preferences

  • Consumers often prefer treatments that are easy to use, effective, and provide quick relief. The MONISTAT 3 Combination Pack, with its various application methods (ovules, prefilled cream, and suppositories), caters to different user preferences, enhancing its market appeal[2][4].

Competitive Landscape

  • The antifungal market is competitive, with several brands offering similar treatments. However, MONISTAT's established reputation and the convenience of its 3-day treatment regimen help it maintain a strong market position[3].

Product Variations and Their Impact

Ovule Inserts

  • The ovule inserts, combined with contoured disposable applicators and external itch relief cream, offer a comprehensive treatment solution. This format is particularly popular due to its ease of use and the inclusion of anti-itch cream for external relief[1].

Prefilled Cream Applicators

  • The prefilled cream applicators provide a ready-to-use solution, which is highly convenient for users. This format also includes external itch relief cream, making it a preferred choice for many[2].

Vaginal Suppositories

  • Vaginal suppositories are another option, often preferred by those who find inserts or creams less comfortable. The inclusion of disposable applicators and external itch relief cream enhances the overall user experience[4].

Clinical Efficacy and Safety

Efficacy

  • Clinical trials have shown that MONISTAT 3 Vaginal Suppositories are effective in treating vulvovaginal candidiasis, although the clinical cure rates may be slightly lower compared to 7-day treatments. This efficacy supports the product's market presence and consumer trust[5].

Safety

  • The product is generally well-tolerated, with common side effects including vulvovaginal burning, itching, or irritation, which occur in a small percentage of users. This safety profile contributes to its widespread acceptance[5].

Financial Performance

Sales and Revenue

  • MONISTAT 3 Combination Pack has consistently generated significant revenue due to its high demand and market penetration. The product's availability in various forms helps to capture a broader market share, contributing to its financial success.

Market Share

  • As a well-established brand, MONISTAT holds a substantial share of the antifungal market. The 3-day treatment option, in particular, appeals to consumers looking for a quick and effective solution, thereby maintaining a strong financial trajectory.

Pricing Strategy

Competitive Pricing

  • The pricing of MONISTAT 3 Combination Pack is competitive with other antifungal treatments on the market. The inclusion of additional products like external itch relief cream adds value, justifying the pricing strategy and helping to maintain customer loyalty.

Cost-Effectiveness

  • For consumers, the 3-day treatment regimen is often more cost-effective than longer treatment options, which can be a significant factor in purchasing decisions and contributes to the product's financial performance.

Marketing and Distribution

Marketing Efforts

  • Effective marketing campaigns, including online advertising, in-store promotions, and educational materials, help to raise awareness and drive sales of MONISTAT 3 Combination Pack.

Distribution Channels

  • The product is widely available through various distribution channels, including pharmacies, online retailers, and healthcare providers, ensuring broad accessibility and contributing to its market success.

Regulatory Environment

Approval and Compliance

  • MONISTAT 3 Combination Pack is approved for the treatment of vulvovaginal candidiasis and complies with all relevant regulatory requirements. This compliance is crucial for maintaining market presence and consumer trust.

Safety Monitoring

  • Continuous safety monitoring and reporting of adverse effects ensure that the product remains safe for use, which is essential for its ongoing market success and financial stability.

Future Outlook

Market Growth

  • The antifungal market is expected to continue growing, driven by increasing awareness and the prevalence of fungal infections. MONISTAT 3 Combination Pack is well-positioned to benefit from this growth.

Innovation and Expansion

  • Continuous innovation, such as the development of new application methods or formulations, can help MONISTAT maintain its competitive edge and expand its market share.

Key Takeaways

  • Market Demand: Steady demand due to the common occurrence of yeast infections.
  • Product Variations: Multiple application methods cater to different user preferences.
  • Clinical Efficacy: Proven effectiveness in treating vulvovaginal candidiasis.
  • Financial Performance: Consistent revenue generation due to high demand and market penetration.
  • Pricing Strategy: Competitive pricing with added value through additional products.
  • Marketing and Distribution: Effective marketing and broad distribution channels.
  • Regulatory Compliance: Compliance with regulatory requirements ensures safety and market presence.

Frequently Asked Questions (FAQs)

Q: What are the different forms of MONISTAT 3 Combination Pack?

  • The MONISTAT 3 Combination Pack is available in ovule inserts, prefilled cream applicators, and vaginal suppositories, all of which include external itch relief cream[1][2][4].

Q: How effective is MONISTAT 3 in treating yeast infections?

  • MONISTAT 3 has been shown to be effective in treating vulvovaginal candidiasis, although the clinical cure rates may be slightly lower compared to 7-day treatments[5].

Q: What are the common side effects of MONISTAT 3?

  • Common side effects include vulvovaginal burning, itching, or irritation, which occur in a small percentage of users[5].

Q: Is MONISTAT 3 safe to use during pregnancy or for diabetic patients?

  • The effectiveness and safety of MONISTAT 3 have not been established in pregnancy or for diabetic patients[5].

Q: How should MONISTAT 3 be stored?

  • MONISTAT 3 suppositories should be stored at 59–86°F (15–30°C)[5].

Sources:

  1. Monistat® 3-Day Yeast Infection Treatment Combination Pack (Ovule) - Monistat.
  2. MONISTAT® 3-Day Treatment Combination Pack Prefilled Cream - Monistat.
  3. MONISTAT® 3-Day Treatment for Yeast Infections - Monistat.
  4. MONISTAT® 3-Day Treatment Combination Pack Suppositories - Monistat.
  5. MONISTAT 3™ (miconazole nitrate, 200 mg) Vaginal Suppositories - DailyMed.

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