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Last Updated: December 22, 2024

MYCELEX-7 COMBINATION PACK Drug Patent Profile


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

Mycelex-7 Combination Pack is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in MYCELEX-7 COMBINATION PACK is clotrimazole. There are eleven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mycelex-7 Combination Pack

A generic version of MYCELEX-7 COMBINATION PACK was approved as clotrimazole by P AND L on July 16th, 1993.

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Summary for MYCELEX-7 COMBINATION PACK
Drug patent expirations by year for MYCELEX-7 COMBINATION PACK
Recent Clinical Trials for MYCELEX-7 COMBINATION PACK

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 4
OnxeoPhase 3
Boehringer IngelheimPhase 3

See all MYCELEX-7 COMBINATION PACK clinical trials

US Patents and Regulatory Information for MYCELEX-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
Bayer Healthcare Llc MYCELEX-7 COMBINATION PACK clotrimazole CREAM, TABLET;TOPICAL, VAGINAL 020389-002 Jun 23, 1994 DISCN No No ⤷  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

MYCELEX-7 COMBINATION PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the MYCELEX-7 Combination Pack

Introduction

The MYCELEX-7 Combination Pack, a non-prescription treatment for vaginal fungal infections, has been a significant player in the self-care market for women's health. This article will delve into the market dynamics and financial trajectory of this product, highlighting its history, consumer preferences, and the broader market context.

Historical Context

The MYCELEX-7 Combination Pack, along with other vaginal antifungal treatments, underwent a significant transition in the early 1990s when the FDA approved the switch from prescription to over-the-counter (OTC) status. This change was a groundbreaking event in self-care for women, reflecting a shift towards greater autonomy in managing common health issues[4].

Market Demand and Consumer Preferences

The transition to OTC status was met with overwhelming demand. Women preferred self-treating vaginal fungal infections without the need for a physician's intervention. This preference led to national shortages of products like Gyne-Lotrimin 7 and Monistat 7 in the early 1990s, as manufacturers underestimated the market demand[4].

Recurrence and Preparation

Vaginal fungal infections, such as vulvovaginal candidiasis (VVC), are recurrent conditions. Many patients purchase multiple packages at a time, preparing for future episodes. This recurring nature of the condition ensures a steady demand for products like the MYCELEX-7 Combination Pack[4].

Product Offerings and Competitors

The MYCELEX-7 Combination Pack competes in a market with several other non-prescription treatments. Key competitors include:

  • Gyne-Lotrimin 7 Cream: Contains 1% clotrimazole with a single, reusable applicator.
  • Monistat 7 Combination Pack: Includes 7 applicators prefilled with 2% miconazole cream and a small tube of miconazole 2% for external use[4].

Product Features and Patient Satisfaction

The MYCELEX-7 Combination Pack typically includes multiple applicators and sometimes an external cream. Patient satisfaction with such products is high, with many reporting quick relief from symptoms. For example, a study on Monistat 7 showed that nearly all patients (91%) reported their infection was cured in a week, and 94% reported quick symptom relief[1].

Pricing and Accessibility

The pricing of OTC vaginal antifungal treatments is generally competitive, making them accessible to a wide range of consumers. However, the cost can still be a barrier for some, especially those without health insurance or living in rural areas where access to pharmacies might be limited[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of OTC drugs. The FDA's approval for the Rx-to-OTC switch in the 1990s was a key factor in the success of these products. However, ongoing regulatory oversight ensures that these products meet safety and efficacy standards, which can impact their market trajectory[4].

Pharmacist Role

Pharmacists play a vital role in educating patients about the proper use of these products. Despite being available in convenience stores and gas stations, the presence of a pharmacist at the point of sale adds significant value in helping patients understand the labeling, instructions, and potential side effects[4].

Financial Trajectory

The financial performance of the MYCELEX-7 Combination Pack and similar products has been robust due to consistent demand and high patient satisfaction.

Sales and Market Share

The market for OTC vaginal antifungal treatments has seen steady sales over the years. The initial surge in demand following the Rx-to-OTC switch has stabilized into a consistent market share for products like MYCELEX-7. Manufacturers have adjusted production to meet this demand, avoiding the shortages seen in the early 1990s[4].

Revenue Growth

Revenue growth for these products is driven by the recurring nature of the condition and the preference for self-treatment. As more women become aware of and comfortable with self-treating vaginal fungal infections, the market continues to grow.

Competitive Strategies

To maintain market share, manufacturers of the MYCELEX-7 Combination Pack and similar products employ several competitive strategies:

Marketing and Education

Educational campaigns and marketing efforts focus on raising awareness about the products and their benefits. Patient education materials, such as those provided by Monistat, are crucial in informing patients about proper use and symptom relief[1].

Product Innovation

Innovations in product formulation and delivery systems can differentiate one product from another. For example, the inclusion of external creams or wipes can enhance patient satisfaction and compliance[1].

Pricing Strategies

Competitive pricing is essential in this market. Manufacturers often offer discounts, coupons, and sample packs to attract and retain customers[1].

Future Outlook

The future outlook for the MYCELEX-7 Combination Pack and similar products is positive, driven by several factors:

Increasing Awareness

As more women become aware of the availability and efficacy of OTC treatments for vaginal fungal infections, demand is likely to increase.

Regulatory Stability

Stable regulatory environments that support OTC status will continue to facilitate easy access to these products.

Technological Advancements

Advancements in antifungal therapies, such as drug synergy and novel compounds, could lead to more effective treatments and potentially new market opportunities[2].

Key Takeaways

  • Market Demand: The demand for OTC vaginal antifungal treatments is driven by the recurring nature of the condition and the preference for self-treatment.
  • Competitive Landscape: The market is competitive, with several products available, but high patient satisfaction and effective marketing can differentiate a product.
  • Regulatory Environment: The FDA's approval for Rx-to-OTC switches has been crucial, and ongoing regulatory oversight ensures safety and efficacy.
  • Financial Performance: The financial trajectory is robust due to consistent demand and high patient satisfaction.
  • Future Outlook: The outlook is positive, driven by increasing awareness, regulatory stability, and potential technological advancements.

FAQs

What is the MYCELEX-7 Combination Pack used for?

The MYCELEX-7 Combination Pack is used for the treatment of vaginal fungal infections, specifically vulvovaginal candidiasis (VVC).

How does the MYCELEX-7 Combination Pack compare to other treatments?

The MYCELEX-7 Combination Pack offers quick symptom relief and high patient satisfaction, similar to other OTC treatments like Monistat 7 and Gyne-Lotrimin 7.

Why did the FDA approve the Rx-to-OTC switch for vaginal antifungal treatments?

The FDA approved the switch to facilitate greater autonomy in self-care for women, reflecting a shift towards more accessible health care options.

What role do pharmacists play in the sale of OTC vaginal antifungal treatments?

Pharmacists play a crucial role in educating patients about the proper use of these products, ensuring they understand the labeling, instructions, and potential side effects.

What are the future prospects for the MYCELEX-7 Combination Pack?

The future outlook is positive, driven by increasing awareness, regulatory stability, and potential technological advancements in antifungal therapies.

Sources

  1. Patient Perceptions and Misperceptions About Vaginal Yeast Infections. Monistat.
  2. Augmenting Azoles with Drug Synergy to Expand the Antifungal Toolbox. MDPI.
  3. The Path Toward Over-The-Counter Abortion Pills. American University Washington College of Law.
  4. Treating Vaginal Fungal Infections. U.S. Pharmacist.

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