MONISTAT 1 COMBINATION PACK Drug Patent Profile

Which patents cover Monistat 1 Combination Pack, and when can generic versions of Monistat 1 Combination Pack launch?

Monistat 1 Combination Pack is a drug marketed by Medtech Products and is included in one NDA.

The generic ingredient in MONISTAT 1 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Monistat 1 Combination Pack

A generic version of MONISTAT 1 COMBINATION PACK was approved as miconazole nitrate by ACTAVIS PHARMA on November 19^th, 1993.

Summary for MONISTAT 1 COMBINATION PACK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1
Patent Applications:	3,007
What excipients (inactive ingredients) are in MONISTAT 1 COMBINATION PACK?	MONISTAT 1 COMBINATION PACK excipients list
DailyMed Link:	MONISTAT 1 COMBINATION PACK at DailyMed

Recent Clinical Trials for MONISTAT 1 COMBINATION PACK

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 1 COMBINATION PACK clinical trials

US Patents and Regulatory Information for MONISTAT 1 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 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes

Expired US Patents for MONISTAT 1 COMBINATION PACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001	5,514,698
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001	6,153,635

International Patents for MONISTAT 1 COMBINATION PACK

See the table below for patents covering MONISTAT 1 COMBINATION PACK around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69930725
South Korea	20010034150
Brazil	9907150

MONISTAT 1 COMBINATION PACK Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for MONISTAT 1 Combination Pack

Introduction

The MONISTAT 1 Combination Pack, a product of Insight Pharmaceuticals, is a highly regarded over-the-counter (OTC) treatment for vaginal yeast infections. This single-dose treatment has garnered significant market attention due to its efficacy, convenience, and strong brand reputation.

Market Positioning

MONISTAT is the number one gynecologist-recommended brand for OTC vaginal antifungal treatments in the US, according to the ProVoice Survey[2][3].

• This recommendation from healthcare professionals significantly enhances the product's credibility and trust among consumers.

Product Features and Benefits

The MONISTAT 1 Combination Pack includes:

• An Ovule® insert with 1200 mg of Miconazole Nitrate, the maximum strength dose available OTC.
• A contoured disposable applicator.
• A tube of external itch relief cream[1][2][3].
• The product is designed for use day or night, making it ideal for active women who cannot wait until bedtime to start treatment.

Clinical Efficacy

Clinical studies have shown that the MONISTAT 1 Combination Pack provides multi-symptom relief, curing most vaginal yeast infections and relieving associated external itching and irritation. It works 4x faster than the leading prescription pill, fluconazole, in relieving symptoms[2][4].

Consumer Preferences and Behavior

• Busy women with active lifestyles prefer the MONISTAT 1 Combination Pack due to its convenience and rapid relief.
• The product's ability to be used at any time, whether day or night, is a significant selling point for women who engage in frequent physical activity or have hectic schedules[1][2].

Competitive Landscape

The vaginal antifungal market is competitive, but MONISTAT's strong brand reputation and clinical efficacy set it apart.

• MONISTAT treats more of the most common species responsible for vaginal yeast infections than fluconazole, making it a preferred choice for many consumers[2].

Pricing Strategy

The MONISTAT 1 Combination Pack is priced competitively, typically ranging between $18 and $20, depending on the retailer[1][2].

• This pricing strategy makes the product accessible to a wide range of consumers while maintaining profitability.

Sales Performance

Given its popularity and strong market positioning, the MONISTAT 1 Combination Pack is a best-seller in its category.

• The product's sales are driven by its effectiveness, convenience, and the trust it has built among both healthcare professionals and consumers.

Financial Trajectory

The financial performance of the MONISTAT 1 Combination Pack can be inferred from several key indicators:

• Revenue Growth: The product's consistent sales and market dominance suggest a stable and potentially growing revenue stream.
• Market Share: As the number one gynecologist-recommended brand, MONISTAT likely holds a significant market share in the OTC vaginal antifungal segment.
• Profitability: The combination of high demand, competitive pricing, and low production costs (given the OTC status and mass production) likely contributes to high profitability for Insight Pharmaceuticals.

Challenges and Opportunities

• Regulatory Environment: While the product is OTC, any changes in regulatory requirements or the introduction of new prescription treatments could impact sales.
• Consumer Education: There is an ongoing need to educate consumers about the differences between various yeast infection treatments and the benefits of MONISTAT.
• Innovation: Continuous innovation in product formulation and delivery methods can help maintain market leadership and attract new consumers.

Consumer Perceptions and Misperceptions

Studies have shown that patients often have misperceptions about vaginal yeast infections and their treatments. For example, many believe that relief from symptoms takes longer than it actually does with MONISTAT. Educating consumers about the rapid relief provided by MONISTAT can further boost sales[4].

Expert Opinions

Healthcare professionals, particularly gynecologists, play a crucial role in recommending MONISTAT. Their endorsement is based on the product's clinical efficacy and patient satisfaction, which reinforces its market position.

"MONISTAT treats more of the most common species responsible for vaginal yeast infections than fluconazole," highlighting its broad-spectrum efficacy[2].

Statistics and Data

• A study involving 300 women treated with either MONISTAT 1 Combination Pack or fluconazole showed that MONISTAT provided symptom relief 4x faster than fluconazole[4].
• The product's ability to relieve itching, burning, and irritation significantly faster than prescription alternatives is a key selling point.

Key Takeaways

• Market Leadership: MONISTAT is the number one gynecologist-recommended brand for OTC vaginal antifungal treatments.
• Clinical Efficacy: The product provides rapid relief from symptoms, working 4x faster than the leading prescription pill.
• Consumer Preference: Busy women prefer MONISTAT due to its convenience and effectiveness.
• Financial Performance: The product is likely a significant contributor to Insight Pharmaceuticals' revenue and profitability.

FAQs

1. What is included in the MONISTAT 1 Combination Pack?

   • The pack includes an Ovule® insert with 1200 mg of Miconazole Nitrate, a contoured disposable applicator, and a tube of external itch relief cream[1][2].

2. How quickly does MONISTAT 1 Combination Pack provide relief from symptoms?

   • MONISTAT provides symptom relief 4x faster than the leading prescription pill, fluconazole, with relief from itching and irritation starting as soon as 1 hour[2][4].

3. Can MONISTAT 1 Combination Pack be used during the day?

   • Yes, the product can be used day or night, making it convenient for women with active lifestyles[1][2].

4. Is MONISTAT 1 Combination Pack recommended by healthcare professionals?

   • Yes, MONISTAT is the number one gynecologist-recommended brand for OTC vaginal antifungal treatments in the US[2][3].

5. What are the potential side effects of using MONISTAT 1 Combination Pack?

   • While generally safe, users should consult a doctor or pharmacist before use, especially if taking prescription blood thinning medicines like warfarin, as it may cause bleeding or bruising[3].

Sources:

1. https://www.monistat.com/yeast-infection-treatment/monistat-1-day-antifungal/monistat-1-day-treatment-combination-pack
2. https://bevmo.com/products/12898
3. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e
4. https://hcp.monistat.com/sites/monistat_hcp/files/2020-07/Patient_Perceptions_and_Misperceptions.pdf