BUTOCONAZOLE NITRATE Drug Patent Profile

When do Butoconazole Nitrate patents expire, and what generic alternatives are available?

Butoconazole Nitrate is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in BUTOCONAZOLE NITRATE is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for BUTOCONAZOLE NITRATE

US Patents:	0
Applicants:	1
NDAs:	1

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 Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997		DISCN	No	No

International Patents for BUTOCONAZOLE NITRATE

See the table below for patents covering BUTOCONAZOLE NITRATE around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	7602509
Switzerland	623040	Process for the preparation of substituted N-alkylimidazoles
Netherlands	183760

Last updated: February 3, 2026

What Is butoconazole nitrate and why does it matter?

Butoconazole nitrate is an azole antifungal medication primarily prescribed for vaginal infections caused by fungi. It inhibits fungal cytochrome P450 enzymes, disrupting cell membrane synthesis, leading to fungal cell death. Approved in multiple countries, including the U.S., Japan, and the European Union, butoconazole is marketed mainly in topical forms such as creams or suppositories.

What is the current market landscape for butoconazole nitrate?

The pharmaceutical market for antifungal agents has seen steady growth driven by increasing incidence of fungal infections, especially in women. Key competitors include clotrimazole, miconazole, and fluconazole. Butoconazole's primary application remains vaginal candidiasis, with an estimated global market size of approximately $600 million annually as of 2022[1].

Key manufacturing and sales strategies encompass:

• Focus on the gynecological segment

• Limited oral formulations, primarily topical

• Prescription-based distribution, with regional variations

The drug's patent status varies: the original patents have expired in several jurisdictions, leading to generic competition, while some formulations or delivery methods may still be under patent protection.

How does the patent landscape affect investment prospects?

Patent expiration creates patent cliffs for butoconazole nitrate, affecting exclusivity periods. Generic entry typically leads to price erosion and reduced margins. For instance, in the U.S., the patent expired around 2010 for certain formulations, enabling multiple generics.

However, innovative delivery methods or combination formulations could be patent-protected, extending market exclusivity. Companies investing in such innovations might sustain higher margins. The regulatory environment influences approval pathways for new formulations or delivery systems.

What are the fundamental factors influencing investment decision-making?

Market Penetration and Growth

The prevalence of vaginal yeast infections is approximately 75% of women at some point, driving demand. Rising awareness and diagnosis rates support continued market growth, compounded by increased access in emerging markets.

Pipeline and Formulation Innovation

Development of new formulations, such as sustained-release topical agents, combination therapies, or oral bioavailability improvements, could enhance competitiveness and prolong product life cycles.

Regional Market Dynamics

North America and Europe constitute mature markets with higher pricing and established prescribers. Emerging markets like Asia and Latin America exhibit growth potential due to increased healthcare access and awareness.

Regulatory Trends

Approval of generics and biosimilars accelerates supply but pressures prices. Conversely, regulatory support for new formulations may enable premium pricing temporarily.

Strategic Alliances and Licensing

Partnerships for formulation development or regional licensing can influence commercialization timelines and market penetration.

What are the financial considerations for investors?

Revenue Trends

Sales are influenced by prescription volumes, pricing strategies, and generic competition. A hypothetical 10% annual growth rate in the primary market segment is plausible, assuming ongoing demand and reformulation success.

Cost Structure

Manufacturing costs are generally low for topical formulations—estimated around 10-15% of sales—allowing for margins of 50-60% in branded markets.

Profitability Risks

Entry of generics typically drives margins down to 10-20% unless protected by patents or formulations. Price erosion may impact revenue substantially post-patent expiry.

R&D Expenses

If companies pursue formulation innovations, R&D costs may range between $10 million and $50 million per project, with longer development timelines (2–3 years).

Investment Horizon

Short-term: Leveraging existing formulations for revenue. Long-term: Investing in R&D for innovative delivery systems extending product lifecycle.

How should investors approach valuation?

Valuation models focus on projected cash flows considering patent status, market share, and pricing. Discounted cash flow (DCF) models adjusted for regional market growth estimate a present enterprise value, factoring in generic competition.

Scenario analysis accounts for:

• Early patent expiration

• Successful development of new formulations

• Regulatory hurdles

• Competitive pricing pressures

Key Takeaways

• Butoconazole nitrate predominantly treats vaginal candidiasis, with a steady global market.

• Patent expirations have led to a surge in generics, pressuring prices and margins.

• Innovation in formulations can extend exclusivity and profitability.

• Emerging markets offer growth potential, with increasing healthcare awareness.

• Investment risk includes patent cliffs, regulatory changes, and competitive dynamics.

FAQs

Q1: What are the main competitors to butoconazole nitrate?
Clotrimazole, miconazole, and fluconazole are primary competitors, with similar indications and formulations.

Q2: How does patent expiry affect the market?
Patent expiry leads to generic competition, typically reducing prices and profit margins, but increases market volume.

Q3: Are there new formulations under development?
Research focuses on sustained-release topical forms and combination therapies, which could extend market exclusivity.

Q4: Which regions offer the highest growth potential?
Emerging markets like Asia and Latin America show increasing demand due to expanding healthcare infrastructure and awareness.

Q5: What regulatory trends could impact market access?
Approval pathways for biosimilars, generics, and innovative formulations influence market entry and pricing strategies.

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References

[1] Market data derived from industry reports, 2022.