MONISTAT-DERM Drug Patent Profile

Which patents cover Monistat-derm, and when can generic versions of Monistat-derm launch?

Monistat-derm is a drug marketed by Insight Pharms and is included in two NDAs.

The generic ingredient in MONISTAT-DERM 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-derm

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

Summary for MONISTAT-DERM

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	1
Patent Applications:	4,160
DailyMed Link:	MONISTAT-DERM at DailyMed

Recent Clinical Trials for MONISTAT-DERM

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

Sponsor	Phase
Universidad Autonoma de San Luis Potosí	Phase 4
Hospital Central "Dr. Ignacio Morones Prieto"	Phase 4

See all MONISTAT-DERM clinical trials

US Patents and Regulatory Information for MONISTAT-DERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for MONISTAT-DERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982	3,717,655
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982	3,839,574
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982	3,717,655
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982	3,839,574

International Patents for MONISTAT-DERM

See the table below for patents covering MONISTAT-DERM around the world.

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	212669
Zambia	13669	IMIDAZOLE DERIVATIVES
Germany	1940388	1-(BETA-ARYL) AETHYLIMIDAZOLDERIVATE, IHRE HERSTELLUNG UND DIESE ENTHALTENDE FUNGIZIDE UND BAKTERIZIDE MITTEL
Belgium	737575

MONISTAT-DERM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MONISTAT-DERM

Market Overview

MONISTAT-DERM, containing 2% miconazole nitrate, is a widely used antifungal drug for the treatment of various fungal infections, including vulvovaginal candidiasis, tinea pedis, tinea cruris, tinea corporis, and cutaneous candidiasis. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Global Antifungal Market Context

The global antifungal market, which includes treatments for yeast infections like MONISTAT-DERM, is experiencing significant growth. The yeast infection treatment market is projected to reach USD 10,031.3 million by 2034, growing at a CAGR of 5.0% from 2024 to 2034[4].

Segmentation and Market Size

Vulvovaginal Candidiasis (VVC) Treatment Market

The vulvovaginal candidiasis treatment market, a key segment for MONISTAT-DERM, was valued at USD 986.5 million in 2021 and is expected to grow at a CAGR of 4.39% from 2022 to 2030, reaching USD 1.64 billion by 2030[1].

Drug Class and Route of Administration

MONISTAT-DERM falls under the topical antifungal segment, which is a significant part of the overall antifungal market. The drug is available in various forms, including creams, ovules, and suppositories, catering to different routes of administration and patient preferences[2][3].

Regional Growth

Asia Pacific

The Asia Pacific region is expected to witness the fastest growth rate in the VVC treatment market due to the rising disease burden and increasing testing rates. Positive changes such as government healthcare benefits, increased consumer awareness, and a willingness to seek medical treatments are driving growth in this region[1].

North America and Europe

North America and Europe are also significant markets for MONISTAT-DERM, with established healthcare systems and high awareness of antifungal treatments. These regions contribute substantially to the overall revenue of the antifungal market[4].

Distribution Channels

The distribution of MONISTAT-DERM is diverse, including retail pharmacies, hospital pharmacies, specialty stores, and online sales. Retail pharmacies and online sales are increasingly popular channels, contributing to the drug's accessibility and market growth[4].

Competitive Landscape

MONISTAT-DERM competes with other antifungal drugs like Diflucan (fluconazole). While Diflucan is an oral antifungal, MONISTAT-DERM offers topical treatment options, which can provide faster relief for certain types of infections. The choice between these drugs often depends on the severity and type of infection, as well as patient preference[5].

Financial Performance

Revenue Forecast

The global VVC treatment market, which includes MONISTAT-DERM, is forecasted to grow from USD 1,162.5 million in 2022 to USD 1.64 billion by 2030. This growth is driven by increasing demand for effective antifungal treatments and the introduction of new therapeutic options[1].

Market Share

While specific market share data for MONISTAT-DERM is not provided, the drug's presence in multiple segments (creams, ovules, suppositories) and its effectiveness against a broad spectrum of fungi contribute to its significant market presence.

Drivers and Restraints

Drivers

• Increasing Disease Burden: The rising incidence of fungal infections, particularly VVC, drives the demand for antifungal treatments.
• Advanced Therapeutic Options: New approvals and launches of antifungal drugs enhance the market growth.
• Government Initiatives: Proactive government measures, such as healthcare benefits, increase access to antifungal treatments[1].

Restraints

• Resistance and Side Effects: Although rare, resistance to miconazole and side effects like local irritation, itching, and burning can affect market growth[2][3].

Clinical Pharmacology and Effectiveness

MONISTAT-DERM's active ingredient, miconazole nitrate, inhibits the biosynthesis of ergosterol, damaging the fungal cell wall membrane. It is effective against various species of fungi, including Candida albicans, Trichophyton rubrum, and Malassezia furfur[2][3].

Key Takeaways

• Growing Market: The global VVC treatment market is expected to grow significantly, driven by increasing disease burden and advanced therapeutic options.
• Regional Growth: Asia Pacific is expected to be the fastest-growing region due to rising disease burden and increasing testing rates.
• Competitive Landscape: MONISTAT-DERM competes with other antifungals like Diflucan but offers distinct advantages in terms of topical application and faster relief.
• Financial Performance: The market is forecasted to reach USD 1.64 billion by 2030, with MONISTAT-DERM contributing significantly due to its broad spectrum of effectiveness.

FAQs

1. What is MONISTAT-DERM used for?

MONISTAT-DERM is used for the topical treatment of various fungal infections, including tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis, and vulvovaginal candidiasis.

2. How does MONISTAT-DERM work?

MONISTAT-DERM works by inhibiting the biosynthesis of ergosterol, which damages the fungal cell wall membrane, leading to the death of the fungal cells.

3. What are the common side effects of MONISTAT-DERM?

Common side effects include local irritation, itching, and burning. However, these are generally mild and temporary.

4. How is MONISTAT-DERM administered?

MONISTAT-DERM is available in various forms, including creams, ovules, and suppositories, allowing for different routes of administration depending on the type and severity of the infection.

5. What is the forecasted market size for the VVC treatment market by 2030?

The VVC treatment market is expected to reach USD 1.64 billion by 2030, growing at a CAGR of 4.39% from 2022 to 2030[1].

Cited Sources:

1. Grand View Research: Vulvovaginal Candidiasis Treatment Market Size Report, 2030.
2. Insight Pharmaceuticals LLC: PRODUCT MONOGRAPH MONISTAT* Derm Cream miconazole nitrate vaginal cream USP 2%.
3. RxList: Monistat-Derm (Miconazole): Side Effects, Uses, Dosage.
4. Future Market Insights: Yeast Infection Treatment Market Revenue Forecast 2024-2034.
5. SingleCare: Monistat vs. Diflucan: Differences, similarities, and which is better for yeast infections.