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Last Updated: December 22, 2024

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. 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 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: 125
Clinical Trials: 1
Patent Applications: 3,007
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
Hospital Central "Dr. Ignacio Morones Prieto"Phase 4
Universidad Autonoma de San Luis PotosíPhase 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 ⤷  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 7 COMBINATION PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONISTAT 7 Combination Pack

Introduction

MONISTAT 7 Combination Pack, a popular over-the-counter (OTC) antifungal treatment for vaginal yeast infections, is a product of Insight Pharmaceuticals LLC. To understand its market dynamics and financial trajectory, we need to delve into several key areas, including market trends, consumer behavior, competitive landscape, and the financial health of the parent company.

Market Trends in OTC Antifungal Treatments

The market for OTC antifungal treatments, particularly those targeting vaginal yeast infections, has seen steady demand due to the common nature of the condition. Yeast infections are a frequent health issue for many women, making products like MONISTAT 7 a staple in many pharmacies and online retail platforms[2].

Consumer Behavior

Consumers often prefer OTC treatments for their convenience and ease of access. MONISTAT 7, with its 7-day treatment regimen and combination pack that includes both vaginal applicators and external itch relief cream, caters to this preference. The product's effectiveness and user-friendly design contribute to its popularity among women seeking quick and reliable solutions for yeast infections[1][4].

Competitive Landscape

The antifungal market is competitive, with several brands offering similar products. However, MONISTAT 7 has established a strong presence due to its well-known brand name and the comprehensive nature of its combination pack. Other brands, such as those from Perrigo, have also entered the market, sometimes through patent challenges, indicating a dynamic and competitive environment[5].

Brand Loyalty and Market Share

MONISTAT, as a brand, enjoys significant brand loyalty due to its long history and proven efficacy. This loyalty helps in maintaining a substantial market share despite the presence of competitors. The brand's reputation is further enhanced by its recommendation for pregnant women and patients with diabetes, which adds to its trustworthiness[1][2].

Financial Health of Insight Pharmaceuticals LLC

Insight Pharmaceuticals LLC, the manufacturer of MONISTAT 7, operates within the broader context of its parent company, Prestige Brands Holdings (PBH). Here are some key financial insights:

Revenue Growth and Challenges

Prestige Brands Holdings has faced challenges in achieving organic revenue growth. Despite this, the company has managed to generate steady cash flow, partly through debt-funded acquisitions. However, the shift towards online purchases and increased competition from e-commerce channels have posed significant challenges to PBH's traditional retail model[3].

Debt and Financial Strains

PBH's financial health is marked by high levels of debt, with a Net Debt/EBITDA ratio of 4.7x. This has limited the company's ability to engage in further mergers and acquisitions, forcing a focus on debt reduction. The company's financial strains have been exacerbated by the COVID-19 pandemic, which has accelerated the shift to online shopping and further pressured traditional brick-and-mortar retailers[3].

Impact of Market Trends on Financial Performance

The steady demand for MONISTAT 7 and other OTC products has been a stabilizing factor for PBH's financial performance. However, the broader market trends, such as the rise of e-commerce and changing consumer preferences, have necessitated strategic adjustments to maintain market share and financial stability.

Marketing and Distribution Strategies

To maintain its market position, Insight Pharmaceuticals LLC has to adapt its marketing and distribution strategies:

Online Presence

Given the increasing importance of online shopping, the company needs to enhance its e-commerce capabilities to reach consumers more effectively. This includes optimizing product listings, improving customer service, and leveraging digital marketing channels[3].

Retail Partnerships

Maintaining strong relationships with traditional retailers while also expanding into online marketplaces is crucial. This dual approach helps in ensuring that MONISTAT 7 remains widely available across different sales channels[3].

Regulatory Environment

The regulatory environment for OTC drugs like MONISTAT 7 is stringent, with products needing to comply with FDA guidelines. Any changes in regulatory requirements can impact the product's marketing and distribution. For instance, clear labeling and instructions, as well as adherence to safety standards, are essential for maintaining FDA approval[4].

Consumer Education and Awareness

Consumer education plays a critical role in the success of MONISTAT 7. The company invests in informing consumers about the proper use of the product, potential side effects, and the importance of completing the full treatment course. This education helps in building trust and ensuring effective treatment outcomes[1][2].

Side Effects and Safety Profile

While MONISTAT 7 is generally well-tolerated, it can cause side effects such as vaginal irritation, itching, or burning. Serious side effects, though rare, include allergic reactions and abdominal pain. The company must ensure that consumers are aware of these potential side effects to maintain a positive safety profile[2][4].

Key Takeaways

  • Market Demand: Steady demand for OTC antifungal treatments drives the market for MONISTAT 7.
  • Competitive Landscape: The product faces competition but maintains a strong market presence due to its brand reputation and comprehensive treatment package.
  • Financial Health: Insight Pharmaceuticals LLC operates within the financially strained context of Prestige Brands Holdings, with challenges in organic revenue growth and high debt levels.
  • Marketing Strategies: Adapting to online market trends and maintaining strong retail partnerships are crucial for continued success.
  • Regulatory Compliance: Strict adherence to FDA guidelines is essential for product approval and market presence.
  • Consumer Education: Educating consumers on proper use and potential side effects is vital for building trust and ensuring effective treatment.

FAQs

Q: What is the active ingredient in MONISTAT 7 Combination Pack?

A: The active ingredient in MONISTAT 7 Combination Pack is miconazole nitrate[1][4].

Q: How is MONISTAT 7 Combination Pack used?

A: The product includes 7 prefilled cream applicators to be inserted into the vagina at bedtime for 7 consecutive nights, along with an external itch relief cream to be applied twice daily as needed[1][4].

Q: What are the common side effects of MONISTAT 7?

A: Common side effects include vaginal irritation, itching, or burning. Serious side effects can include allergic reactions and abdominal pain[2][4].

Q: Is MONISTAT 7 suitable for pregnant women and patients with diabetes?

A: Yes, MONISTAT 7 is recommended for pregnant women and patients with diabetes[1].

Q: How has the shift to online shopping affected the sales of MONISTAT 7?

A: The shift to online shopping has presented both opportunities and challenges. While it has expanded the reach of the product, it has also increased competition and pressured traditional retail channels[3].

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