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:	82
Clinical Trials:	4
Patent Applications:	1,802
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
Perrigo Company	N/A
Padagis LLC	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
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985		DISCN	No	No
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997		DISCN	No	No
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

Expired US Patents for BUTOCONAZOLE NITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985	4,078,071
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	4,078,071
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995	4,078,071
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	5,993,856
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	5,266,329
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	4,551,148

Market Dynamics and Financial Trajectory for Butoconazole Nitrate

Last updated: July 27, 2025

---

Introduction

Butoconazole nitrate, a broad-spectrum antifungal agent primarily prescribed for vulvovaginal candidiasis and other superficial fungal infections, has historically maintained a niche but steady position within the pharmaceutical landscape. Understanding its market dynamics and projected financial trajectory involves analyzing variables such as clinical demand, regulatory environments, competitive landscape, innovation opportunities, and macroeconomic influences. This report provides a comprehensive assessment of these factors, guiding stakeholders in strategic decision-making.

---

Market Overview and Historical Context

Originally approved in the late 1980s, butoconazole nitrate became a core component in topical antifungal therapy, especially in gynecological infections. Its initial market scope was limited geographically, with substantial adoption in North America and Europe, facilitated by favorable regulatory pathways and clinician familiarity. Over time, generic formulations increased accessibility, globally expanding its reach; however, emerging competitive antifungals and pharmaceutical innovations have influenced its market positioning.

The compound's patent protections expired long ago, transitioning its market to generic manufacturers. This shift generally results in reduced prices and narrower profit margins but stabilizes volume-driven growth.

---

Current Market Dynamics

1. Clinical Demand and Prescribing Trends

The demand for butoconazole nitrate hinges on the prevalence of vulvovaginal candidiasis, estimated to affect approximately 75% of women during their lifetime, with recurrent cases in about 5-8% [1]. Prescription patterns are influenced by:

• Guideline Recommendations: Consensus guidelines from organizations like the CDC and WHO support topical azoles, including butoconazole, as first-line therapy.
• Patient Preference and Compliance: The availability of a one-day regimen enhances adherence, favoring its continued use.
• Evolution of Resistance: Rising antifungal resistance, notably among non-albicans Candida species, may impact efficacy perceptions, though butoconazole remains effective against most strains.

2. Competitive Landscape

The antifungal market is competitive, with several agents vying for dominance:

• Alternative Azoles: Clotrimazole, miconazole, and ketoconazole offer similar efficacy, often at lower costs.
• Newer Agents: Itraconazole and fluconazole, primarily systemic agents, have a broader spectrum but may not be first-line for superficial infections.
• Other Drug Classes: Nystatin and terbinafine also serve specific indications but have limited overlap with butoconazole’s niche.

Generic proliferation has intensified price competition, squeezing profit margins especially for established brands.

3. Regulatory and Patent Status

As a generic product, butoconazole nitrate faces minimal regulatory barriers today. However, patent protections have long expired, and any current formulation exclusivities are limited, leading to a commoditized market primarily driven by price competition.

4. Demographic and Epidemiological Factors

Global increases in sexually transmitted infections and rising awareness about women's reproductive health sustain demand. Notably:

• The rise in immunocompromised populations (e.g., HIV/AIDS, cancer treatments) may increase superficial fungal infections.
• Aging populations and improved healthcare access in emerging markets expand the potential patient base.

---

Future Market Trajectory

1. Innovation and Pipeline Developments

Innovation in antifungal therapy presents both challenges and opportunities:

• Formulation Improvements: Research into sustained-release topical formulations or combinational therapies could differentiate products.
• Novel Delivery Systems: Intravaginal devices or patches may increase compliance and efficacy.
• Biomarker-Based Therapy: Diagnostic advances may enable targeted antifungal therapy, optimizing treatment outcomes.

Currently, no significant R&D pipelines are targeting butoconazole nitrate explicitly, but incremental improvements in formulations and delivery are anticipated.

2. Market Penetration in Emerging Economies

Emerging markets, including Asia-Pacific and Africa, show increasing penetration by generics, facilitated by affordability and improving healthcare infrastructure. Pharmaceutical companies focusing on cost-effective distribution can capitalize on these opportunities.

3. Regulatory and Policy Impacts

Healthcare policies favoring generics and biosimilars could further intensify price competition but also facilitate broad access. Conversely, stringent regulatory hurdles for combination formulations or innovative dosage forms might slow innovation-driven growth.

4. Impact of Digital and Telemedicine Platforms

The rise of telemedicine enhances prescription rates for over-the-counter and prescription antifungals. Digital health platforms can promote awareness, adherence, and early diagnosis, subtly boosting demand.

---

Financial Trajectory and Investment Outlook

Given its status as a generic, butoconazole nitrate’s revenue generation is predominantly volume-driven with thin margins. The financial outlook is characterized by:

• Stable but Declining Margins: Price erosion sustained by generic competition and market commoditization.
• Potential Growth in Volume Markets: Demography and epidemiology indicate steady demand in reproductive health sectors.
• Limited Innovation-Driven Revenue: Minimal investment in R&D limits prospects for significant patent-based returns.

Pharmaceutical firms focusing on cost-efficient production, global distribution, and strategic marketing can sustain profitability. Mergers or partnerships for technology upgrade or combination therapy formulations could unlock new revenue streams.

---

Regulatory Considerations and Challenges

Regulatory bodies, including FDA and EMA, emphasize manufacturing quality, bioequivalence, and safety profiles. As a generic, butoconazole nitrate’s regulatory pathway remains straightforward, but increasing scrutiny over compounding and counterfeit drugs calls for strengthened supply chain oversight.

Potential regulatory challenges include:

• Market Entry Barriers in New Territories: Local registration processes can delay or restrict market access.
• Compliance with Biosimilar and Generic Regulations: Ensuring adherence to evolving standards may involve additional costs.

---

Key Takeaways

• Steady Market with Price Competition: butoconazole nitrate continues to serve a niche within the superficial antifungal space, but profits are increasingly squeezed by generics.
• Demand Driven by Epidemiology and Demographics: The persistent prevalence of vulvovaginal candidiasis and growth in reproductive health awareness underpin ongoing demand.
• Innovation as a Differentiator: While direct innovation is limited, formulation enhancements and delivery innovations could offer competitive advantages.
• Emerging Markets Offer Growth Potential: The increasing adoption of affordable generics in emerging economies unlocks expansion opportunities.
• Strategic Focus on Cost and Distribution: To maximize profits, pharmaceutical players must prioritize cost-effective manufacturing and broad access channels.

---

FAQs

1. Is butoconazole nitrate facing obsolescence in the antifungal market?
No. Its role as a topical antifungal remains relevant, particularly for vulvovaginal infections. However, market share stabilization depends on competitive pricing and formulation innovations.

2. What are the primary competitors of butoconazole nitrate in the market?
Main competitors include generic formulations of clotrimazole, miconazole, and ketoconazole, along with systemic antifungals like fluconazole for certain indications.

3. How do regulatory policies affect the market for butoconazole nitrate?
Regulatory agencies facilitate its approval as a generic, promoting market entry and maintaining low prices. Stricter regulations nonethless increase compliance costs but do not significantly impede its availability.

4. Will new formulations or delivery systems boost butoconazole nitrate’s market?
Potentially. Innovations such as sustained-release gels or vaginal inserts could improve adherence and efficacy, but currently, significant R&D investments are limited.

5. What is the outlook for profitability in the butoconazole nitrate market?
Profitability is expected to remain stable but limited due to intense price competition and thin margins. Long-term growth hinges on market expansion, cost reduction, and incremental innovation.

---

Conclusion

Butoconazole nitrate remains a resilient yet commoditized antifungal agent. Its market trajectory is largely influenced by demographic trends, regulatory environments, and competitive pressures within the generic drug landscape. Strategic positioning emphasizing cost efficiency, expanding geographic reach, and pursuing incremental formulation innovations will be critical for sustaining profitability and market relevance.

---

Sources

[1] Sobel J.D. Vulvovaginal Candidiasis. Clin Infect Dis. 2007;44 Suppl 1(Suppl 1):S13-6.