BUTOCONAZOLE NITRATE - Generic Drug Details

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

Butoconazole nitrate is the generic ingredient in four branded drugs marketed by Padagis Us, Roche Palo, Bayer, and Padagis Israel, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for butoconazole nitrate. One supplier is listed for this compound.

Summary for BUTOCONAZOLE NITRATE

US Patents:	0
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	4
Patent Applications:	1,497
What excipients (inactive ingredients) are in BUTOCONAZOLE NITRATE?	BUTOCONAZOLE NITRATE excipients list
DailyMed Link:	BUTOCONAZOLE NITRATE at DailyMed

Recent Clinical Trials for BUTOCONAZOLE NITRATE

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

Sponsor	Phase
EMS	Phase 2
Padagis LLC	N/A
Perrigo Company	N/A

See all BUTOCONAZOLE NITRATE clinical trials

Pharmacology for BUTOCONAZOLE NITRATE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for BUTOCONAZOLE NITRATE

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

US Patents and Regulatory Information for BUTOCONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923-001	May 18, 2012		RX	No	Yes
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985		DISCN	No	No
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997		DISCN	No	No
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No

Expired US Patents for BUTOCONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985	4,078,071
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	4,078,071
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985	4,078,071
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995	4,078,071

BUTOCONAZOLE NITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Butoconazole Nitrate

Introduction to Butoconazole Nitrate

Butoconazole nitrate is an antifungal medication commonly used to treat vulvovaginal candidiasis (VVC). It belongs to the azole class of antifungal drugs and is known for its efficacy in providing rapid relief from symptoms.

Market Size and Growth Projections

The global butoconazole nitrate market has been experiencing significant growth in recent years. As of 2023, the market size was valued at approximately USD 200 million. It is anticipated to reach USD 350 million by 2032, growing at a compound annual growth rate (CAGR)[4].

Historical Market Performance

The market has seen a substantial surge, with recent years witnessing a swift and significant expansion. This upward trajectory is expected to continue from 2023 to 2031, driven by increasing demand for effective antifungal treatments[1].

Market Segmentation

The butoconazole nitrate market is segmented based on several key factors:

By Type

• Min Purity Less Than 98%
• Min Purity 98%-99%
• Min Purity More Than 99%

These segments help in understanding the quality and purity standards that influence market dynamics and pricing strategies[1].

By Application

• Research
• Medical

The medical application segment is the primary driver, given the widespread use of butoconazole nitrate in treating VVC and other fungal infections[1].

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa

Geographical segmentation highlights regional market trends, regulatory environments, and consumer behaviors that impact the overall market growth[1].

Drivers of Market Growth

Several factors are driving the growth of the butoconazole nitrate market:

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly among immunocompromised patients, is a significant driver. The widespread application of triazole therapeutics has led to an increase in antifungal drug resistance, but butoconazole nitrate remains an effective treatment option[3].

Advancements in Drug Delivery Systems

The development of new drug delivery systems, such as bioadhesive, sustained-release creams, has enhanced the efficacy and convenience of butoconazole nitrate treatments. These advancements have contributed to the drug's popularity and market growth[5].

Regulatory Approvals and Compliance

Regulatory approvals and compliance with stringent quality standards have ensured the safety and efficacy of butoconazole nitrate, further boosting market confidence and adoption[1].

Restraints and Challenges

Despite the growth, the market faces several challenges:

Antifungal Drug Resistance

The increasing resistance to antifungal drugs, including azoles, poses a significant challenge. This resistance can lead to reduced efficacy and may necessitate the development of new therapeutic options[3].

Competitive Landscape

The antifungal market is highly competitive, with several other treatments available, including fluconazole and miconazole. This competition can impact market share and pricing strategies for butoconazole nitrate[5].

Financial Performance and Projections

Revenue Growth

The market is expected to exhibit strong revenue growth, driven by the increasing demand for effective antifungal treatments. The projected growth from USD 200 million in 2023 to USD 350 million by 2032 indicates a robust financial trajectory[4].

Key Players and Market Share

The market is dominated by several key players, including Merck, Biosynth Carbosynth, United States Biological, and others. These companies have a significant presence in the market and contribute to the overall revenue through their product offerings and research initiatives[1].

Competitive Landscape

The competitive landscape of the butoconazole nitrate market is characterized by:

Market Leaders

Companies like Merck and Biosynth Carbosynth are prominent players, known for their extensive product portfolios and strong research and development capabilities[1].

Recent Developments

The market has seen several recent developments, including new product launches, partnerships, and mergers and acquisitions. These activities are aimed at enhancing market presence and expanding product offerings[1].

Clinical Efficacy and Safety

Clinical trials have consistently demonstrated the efficacy and safety of butoconazole nitrate:

Clinical Trials

A randomized, parallel, investigator-blind, multicenter study compared the safety and efficacy of a single vaginal dose of butoconazole nitrate 2% bioadhesive, sustained-release cream with a seven-day schedule of miconazole nitrate vaginal cream. The results showed that butoconazole nitrate provided rapid relief from symptoms and was as effective as, if not more so than, the seven-day miconazole treatment[5].

Patient Outcomes

The clinical trials indicated that butoconazole nitrate significantly reduced the severity of symptoms and achieved high clinical cure rates, with minimal adverse events compared to other treatments[5].

Market Outlook

The market outlook for butoconazole nitrate is positive, driven by several factors:

Growth Catalysts

The increasing prevalence of fungal infections, advancements in drug delivery systems, and regulatory approvals are key growth catalysts[1][3].

Constraints

Despite the positive outlook, the market faces constraints such as antifungal drug resistance and competitive pressures[3].

Opportunities and Challenges

The market presents opportunities for innovation in drug delivery and treatment regimens. However, it also faces challenges related to resistance and competition, which need to be addressed through continuous research and development[1][3].

Porter's 5 Forces Framework

Threat of New Entrants

The threat of new entrants is moderate due to the presence of established players and the need for significant investment in research and development.

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low, as the market is dominated by a few key players who have control over the supply chain.

Bargaining Power of Buyers

The bargaining power of buyers is moderate, as they have several treatment options available, but butoconazole nitrate's efficacy and convenience make it a preferred choice.

Threat of Substitute Products

The threat of substitute products is high due to the competitive nature of the antifungal market.

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, with several players competing for market share through innovative products and pricing strategies[1].

Key Takeaways

• Market Growth: The butoconazole nitrate market is expected to grow significantly from 2023 to 2032.
• Segmentation: The market is segmented by type, application, and geography.
• Drivers: Increasing prevalence of fungal infections, advancements in drug delivery systems, and regulatory approvals drive the market.
• Challenges: Antifungal drug resistance and competitive pressures are key challenges.
• Financial Performance: The market is projected to reach USD 350 million by 2032.
• Clinical Efficacy: Butoconazole nitrate has been shown to be highly effective and safe in clinical trials.

FAQs

What is the current market size of butoconazole nitrate?

The current market size of butoconazole nitrate was valued at approximately USD 200 million in 2023[4].

What is the projected growth rate of the butoconazole nitrate market?

The market is expected to grow at a compound annual growth rate (CAGR) and reach USD 350 million by 2032[4].

What are the primary applications of butoconazole nitrate?

The primary applications are in the medical field, particularly for treating vulvovaginal candidiasis (VVC)[1].

How does butoconazole nitrate compare to other antifungal treatments?

Butoconazole nitrate has been shown to be as effective as, if not more so than, other treatments like miconazole nitrate in clinical trials[5].

What are the key challenges facing the butoconazole nitrate market?

The key challenges include antifungal drug resistance and competitive pressures from other antifungal treatments[3].

Sources

1. Market Research Intellect: Global Butoconazole Nitrate Market Size, Scope And Forecast Report.
2. Annual Reports: KV Pharmaceutical Company Annual Report 2008.
3. Unbound Medicine: Butoconazole journal articles from PubMed.
4. Dataintelo: Butoconazole Nitrate Market Research Report 2032.
5. PubMed: Butoconazole nitrate 2% for vulvovaginal candidiasis. New, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate.