MICONAZOLE NITRATE - Generic Drug Details

What are the generic sources for miconazole nitrate and what is the scope of patent protection?

Miconazole nitrate is the generic ingredient in seventeen branded drugs marketed by Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for miconazole nitrate. Fifty suppliers are listed for this compound.

Summary for MICONAZOLE NITRATE

US Patents:	1
Tradenames:	17
Applicants:	14
NDAs:	30
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	7
Patent Applications:	5,196
Drug Prices:	Drug price trends for MICONAZOLE NITRATE
What excipients (inactive ingredients) are in MICONAZOLE NITRATE?	MICONAZOLE NITRATE excipients list
DailyMed Link:	MICONAZOLE NITRATE at DailyMed

See drug prices for MICONAZOLE NITRATE

See drug sales revenues for MICONAZOLE NITRATE

Recent Clinical Trials for MICONAZOLE NITRATE

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

Sponsor	Phase
Aesculape CRO Belgium BV	Phase 2
Population Council	Phase 1
Galeno Desenvolvimento de Pesquisas Clínicas	Phase 2

See all MICONAZOLE NITRATE clinical trials

Pharmacology for MICONAZOLE NITRATE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE NITRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074366-001	Feb 22, 1996		DISCN	No	No
P And L	MICONAZOLE 7	miconazole nitrate	CREAM;VAGINAL	074164-001	Mar 29, 1996		OTC	No	No
Actavis Mid Atlantic	M-ZOLE 7 DUAL PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	074586-001	Jul 17, 1997		DISCN	No	No
Medtech Products	MONISTAT 3	miconazole nitrate	CREAM;VAGINAL	020827-001	Mar 30, 1998		OTC	Yes	Yes
Taro	MICONAZOLE 3	miconazole nitrate	CREAM;VAGINAL	076773-001	Mar 2, 2005		OTC	No	No

Expired US Patents for MICONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001
Medtech Products	MONISTAT 3	miconazole nitrate	SUPPOSITORY;VAGINAL	018888-001	Aug 15, 1984
Insight Pharms	MONISTAT-DERM	miconazole nitrate	LOTION;TOPICAL	017739-001	Approved Prior to Jan 1, 1982
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982

MICONAZOLE NITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miconazole Nitrate

Introduction to Miconazole Nitrate

Miconazole nitrate is an antifungal medication widely used in the treatment of various fungal infections, including vaginal candidiasis, external skin infections, and oral thrush. Its versatility and effectiveness have made it a staple in the pharmaceutical industry.

Market Size and Growth Projections

The global Miconazole Nitrate market has experienced significant growth in recent years and is projected to continue this trend. By 2031, the market is expected to see substantial expansion, driven by increasing demand and technological advancements[1][4].

• Current Market Size: The global Miconazole Nitrate market size was notable in 2023, with projections indicating a continued upward trend.
• Growth Projections: The market is forecasted to grow at a significant CAGR from 2023 to 2031, reflecting robust growth rates in the foreseeable future[1][4].

Market Segmentation

The Miconazole Nitrate market is segmented based on type and application, as well as geographical regions.

• Type: The market is segmented into oral and cream forms. The oral segment accounted for a noticeable share in 2023 and is expected to experience significant growth[4].
• Application: Key applications include vaginal treatment, external skin treatment, and oral treatment. The vaginal treatment segment is expected to expand at a significant CAGR throughout the forecast period[1][4].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the Miconazole Nitrate market.

• Increasing Prevalence of Fungal Infections: The rising incidence of fungal infections, particularly among immunocompromised individuals and the elderly, is a major driver[3].
• Technological Advancements: Advances in antifungal drug formulations and delivery systems are enhancing treatment efficacy and patient adherence[3].
• Improved Diagnostic Techniques: Earlier and more accurate diagnosis of fungal infections is driving demand for effective treatments like Miconazole Nitrate[3].
• Prophylactic Use: The trend of prophylactic antifungal use in high-risk populations is further supporting market expansion[3].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several restraints and challenges.

• Regulatory Changes: Environmental and safety regulations can significantly impact the production, pricing, and distribution of Miconazole Nitrate[4].
• Raw Material Availability: Fluctuations in raw material availability can affect the manufacturing process and market dynamics[4].
• Competition: The antifungal drugs market is competitive, with several key players vying for market share. This competition can sometimes restrain growth[3].

Key Players and Market Strategies

Several key players are active in the Miconazole Nitrate market, each with their own strategies to strengthen their market position.

• Actavis and Perrigo: These companies are focusing on building their product portfolios and expanding their business in the global market[4].
• Barrier Therapeutics: Although not exclusively focused on Miconazole Nitrate, companies like Barrier Therapeutics have developed products that include Miconazole Nitrate, such as Vusion(r) Ointment, which is used for diaper dermatitis complicated by candidiasis[2].

Regional Analysis

The market growth varies across different regions.

• North America and Europe: These regions have a well-established market for antifungal drugs, including Miconazole Nitrate.
• Asia-Pacific: This region is expected to grow at a significant rate, driven by increasing awareness and improving healthcare infrastructure[3].
• Other Regions: South America, the Middle-East, and Africa are also expected to contribute to the market growth, albeit at varying rates[1].

Financial Performance and Projections

The financial performance of the Miconazole Nitrate market is robust and projected to continue growing.

• Revenue Projections: The market is expected to generate significant revenue, with the global antifungal drugs market, which includes Miconazole Nitrate, projected to reach $22 billion by 2030[3].
• CAGR: The market is forecasted to grow at a CAGR of around 4.2% from 2023 to 2030, indicating a strong financial trajectory[3].

Technological and Innovational Trends

Technological advancements are a crucial factor in the growth of the Miconazole Nitrate market.

• Novel Drug Formulations: The development of novel antifungal agents and advancements in drug delivery systems are enhancing treatment efficacy and patient adherence[3].
• Genomics and Molecular Biology: Innovations in genomics and molecular biology are generating new market opportunities by targeting resistant fungal strains[3].

Consumer Behavior and Awareness

Consumer behavior and awareness play a significant role in the market dynamics.

• Increasing Awareness: Growing awareness of fungal infections and their treatments is driving demand for antifungal drugs like Miconazole Nitrate[3].
• Patient Adherence: Improvements in drug formulations and delivery systems are enhancing patient adherence, contributing to market growth[3].

Environmental and Safety Regulations

Environmental and safety regulations are important in shaping the chemical and pharmaceutical industries.

• Regulatory Compliance: Companies must comply with environmental and safety regulations, which can impact production, pricing, and distribution[4].

Key Takeaways

• The Miconazole Nitrate market is experiencing significant growth driven by increasing demand and technological advancements.
• Key applications include vaginal treatment, external skin treatment, and oral treatment.
• The market is segmented into oral and cream forms, with the oral segment showing notable growth.
• Regional growth varies, with the Asia-Pacific region expected to grow significantly.
• Technological advancements and increasing awareness are key drivers of market growth.

FAQs

What are the primary applications of Miconazole Nitrate?

Miconazole Nitrate is primarily used for vaginal treatment, external skin treatment, and oral treatment.

Which segment of the Miconazole Nitrate market is expected to grow the most?

The vaginal treatment segment is expected to expand at a significant CAGR throughout the forecast period.

What are the key drivers of the Miconazole Nitrate market growth?

Key drivers include the increasing prevalence of fungal infections, technological advancements, improved diagnostic techniques, and the trend of prophylactic antifungal use in high-risk populations.

Who are some of the key players in the Miconazole Nitrate market?

Key players include Actavis, Perrigo, and other pharmaceutical companies that focus on antifungal treatments.

What is the projected market size of the global antifungal drugs market by 2030?

The global antifungal drugs market, which includes Miconazole Nitrate, is projected to reach $22 billion by 2030.

Cited Sources:

1. Market Research Intellect - Global Miconazole Nitrate Market Size, Scope And Forecast Report
2. GlobeNewswire - Barrier Therapeutics Announces Chief Financial Officer
3. GlobeNewswire - Antifungal Drugs Strategic Business Report 2024-2030
4. Cognitive Market Research - Global Miconazole Nitrate Market Report 2024 Edition