MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE - Generic Drug Details

What are the generic drug sources for miconazole nitrate; white petrolatum; zinc oxide and what is the scope of freedom to operate?

Miconazole nitrate; white petrolatum; zinc oxide is the generic ingredient in one branded drug marketed by Mylan and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Miconazole nitrate; white petrolatum; zinc oxide has one patent family member in one country.

One supplier is listed for this compound.

Summary for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

International Patents:	1
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE at DailyMed

Pharmacology for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AC	Imidazole derivatives
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006		RX	Yes	Yes

Expired US Patents for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006

International Patents for MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008019030

MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miconazole Nitrate; White Petrolatum; Zinc Oxide

Introduction

Miconazole nitrate, white petrolatum, and zinc oxide, commonly known by the brand name VUSION, is a topical ointment used primarily for the treatment of diaper dermatitis complicated by yeast infections. This combination therapy has been a significant player in the pediatric dermatology market. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Overview

The market for topical antifungal and dermatological treatments is robust and growing, driven by increasing awareness of skin health and the need for effective treatments for common conditions like diaper rash.

Target Market

The primary target market for miconazole nitrate, white petrolatum, and zinc oxide ointment is infants aged 4 weeks and older with normal immune systems who suffer from diaper dermatitis complicated by candidiasis (yeast infection)[4].

Competitive Landscape

The competitive landscape includes other topical antifungal agents and combination products. However, VUSION's unique formulation, which includes miconazole nitrate, zinc oxide, and white petrolatum, positions it as a preferred treatment for diaper dermatitis with a yeast infection component.

Clinical Significance and Efficacy

Mechanism of Action

Miconazole nitrate works by inhibiting the biosynthesis of ergosterol in the fungal cell membrane, leading to cell lysis. Zinc oxide provides a protective barrier, while white petrolatum enhances skin hydration and occlusion, aiding in the repair of the skin barrier function[2][3].

Clinical Studies

Clinical studies have shown that VUSION ointment is effective in treating diaper dermatitis with yeast infections. A double-blind, multicenter study compared VUSION ointment to a combination of zinc oxide and white petrolatum, demonstrating the efficacy of the miconazole nitrate component in treating fungal infections[2].

Regulatory Environment

FDA Approval and Guidance

The FDA has approved VUSION ointment for the adjunctive treatment of diaper dermatitis complicated by documented candidiasis. The FDA provides detailed guidance on the bioequivalence studies required for generic versions of this ointment, including in vitro release tests and physicochemical characterization[1].

Market Size and Growth

The global market for pediatric dermatology treatments is expanding due to increasing birth rates and a growing awareness of infant skin health. The specific segment for diaper rash treatments, including those with antifungal components, is a significant part of this market.

Revenue and Sales

While exact financial figures for VUSION ointment are not publicly disclosed, the product's presence in the market and its prescription-only status indicate a steady revenue stream. The demand for effective diaper rash treatments ensures a consistent market size.

Pricing and Reimbursement

Pricing Strategy

The pricing of VUSION ointment is influenced by its prescription-only status, the cost of ingredients, and the competitive landscape. It is generally priced in line with other topical antifungal treatments.

Reimbursement

In many healthcare systems, VUSION ointment is covered under prescription drug plans, making it more accessible to patients. Reimbursement policies can vary by region and insurance provider.

Side Effects and Safety Profile

Adverse Reactions

Common side effects include skin irritation, such as blistering, burning, and itching. However, these are generally mild and transient. Serious adverse reactions are rare[4][5].

Post-Marketing Experience

Post-marketing surveillance has identified additional adverse reactions, but these are not common and do not significantly impact the overall safety profile of the product.

Future Outlook

Market Trends

The trend towards more effective and safer treatments for pediatric skin conditions is expected to continue. The integration of natural ingredients and the development of new formulations may influence future market dynamics.

Innovation and R&D

Continuous research and development in topical dermatological treatments could lead to new products or improved formulations, potentially impacting the market share of VUSION ointment.

Key Takeaways

• Target Market: Infants aged 4 weeks and older with diaper dermatitis complicated by candidiasis.
• Efficacy: Proven effectiveness in clinical studies, with a unique formulation combining miconazole nitrate, zinc oxide, and white petrolatum.
• Regulatory Environment: FDA-approved with detailed guidance for bioequivalence studies.
• Market Size and Growth: Part of the growing pediatric dermatology market.
• Pricing and Reimbursement: Priced competitively, with coverage under prescription drug plans.
• Safety Profile: Generally safe with mild and transient side effects.

FAQs

1. What is the primary use of miconazole nitrate, white petrolatum, and zinc oxide ointment?

The primary use is for the adjunctive treatment of diaper dermatitis complicated by documented candidiasis in infants aged 4 weeks and older.

2. How does miconazole nitrate work in treating fungal infections?

Miconazole nitrate inhibits the biosynthesis of ergosterol in the fungal cell membrane, leading to cell lysis.

3. What are the common side effects of this ointment?

Common side effects include skin irritation such as blistering, burning, and itching.

4. Is VUSION ointment covered under prescription drug plans?

Yes, in many healthcare systems, VUSION ointment is covered under prescription drug plans.

5. What are the key components of VUSION ointment?

The key components are miconazole nitrate (0.25%), zinc oxide (15%), and white petrolatum (81.35%).

Cited Sources:

1. FDA Draft Guidance on Miconazole Nitrate; White Petrolatum; Zinc Oxide Topical Ointment.
2. VUSION (0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Ointment.
3. Dynamics of skin barrier repair following topical applications of pastes containing or not miconazole nitrate.
4. Miconazole, zinc oxide, and white petrolatum (Topical application).
5. VUSION- miconazole nitrate, zinc oxide, white petrolatum ointment.