FEMSTAT Drug Patent Profile

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

Femstat is a drug marketed by Roche Palo and Bayer and is included in three NDAs.

The generic ingredient in FEMSTAT 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 FEMSTAT

US Patents:	0
Applicants:	2
NDAs:	3

US Patents and Regulatory Information for FEMSTAT

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
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985		DISCN	No	No
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No

International Patents for FEMSTAT

See the table below for patents covering FEMSTAT around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	461980
Sweden	7800111
Japan	S5217472	SUBSTITUTED NNALKYLIMIDAZOLE DERIVATIVES
Sweden	7602509
Canada	1077493	DERIVES DE N-ALKYL-IMIDAZOLES SUBSTITUES (DERIVATIVES OF SUBSTITUTED N-ALKYL IMIDAZOLES)
Japan	S635388
Spain	450204

FEMSTAT Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is FEMSTAT and Why Is It Relevant for Investment?

FEMSTAT, also known as Femstat or clotrimazole, is an antifungal agent primarily used for treating vaginal yeast infections, dermatophyte infections, and other superficial fungal conditions. Its market relevance depends on geographic penetration, patent status, and emerging indications, especially in topical and systemic formulations.

What Is the Current Market Landscape for FEMSTAT?

The global antifungal drug market was valued at approximately USD 12 billion in 2022, with a compound annual growth rate (CAGR) approaching 4.5%. Clotrimazole accounts for a significant share due to its high prescription volume and low-cost profile. Key competitors include:

Drug	Market Share (2022)	Price Range	Indicated Uses
Clotrimazole	30%	USD 1-3 per dose	Vaginal, dermatological, buccal infections
Miconazole	20%	USD 2-4 per dose	Similar topical antifungal applications
Terbinafine	15%	USD 4-7 per dose	Dermatophyte infections, systemic formulations
Others	35%	N/A	Includes butenafine, ketoconazole, others

FEMSTAT's competitive advantage lies in its established safety profile and familiarity among clinicians. Market expansion depends on new formulations, patent protections, and regional acceptance.

What Are the Key Development and Patent Dynamics?

• Patent Status: The original patents for clotrimazole expired in the late 1990s. Several formulations are off-patent, leading to generic competition.
• Regulatory Pathways: FEMSTAT formulations approved in multiple markets, including the US (via OTC status for some formulations) and Europe.
• Pipeline and Reformulations: Companies are exploring sustained-release topical gels, oral capsules, and nanoparticle formulations to extend product lifecycle and improve efficacy.

What Are the Investment Fundamentals for FEMSTAT?

Revenue Potential

• Estimated global sales for clotrimazole products are around USD 1.2 billion annually.
• Growth drivers include rising prevalence of fungal infections, increased awareness, and off-label uses.
• Patent expiry on key formulations could challenge revenue streams unless new formulations or regional exclusivities are secured.

Cost Structure and Margins

• Production costs are relatively low due to generic manufacturing.
• Gross margins vary between 50-70%, influenced by branding, formulation complexity, and regional margins.

Competitive and Regulatory Risks

• Price erosion due to generic entry remains a major risk.
• Regulatory delays or restrictions in major markets could impact market share.
• New formulations must demonstrate either superior efficacy or improved compliance to gain adoption.

Market Entry and Expansion Considerations

• Geographic expansion into emerging markets presents growth opportunities.
• Licensing agreements with regional firms can facilitate faster access.
• Entry into niche indications, such as dermatophyte infections resistant to first-line therapies, can provide premium pricing.

Are There Emerging Opportunities or Risks?

Predictive trends include:

• Combination Therapies: Incorporation with antibiotics or corticosteroids for broader indications.
• Formulation Innovations: Nanotechnology-based topical applications or oral bioavailability enhancements.
• Emerging Resistance: Increased fungal resistance could lead to off-label prescribing of FEMSTAT or derivatives for alternative uses.

Risks encompass regulatory hurdles, especially with reformulated products, and competitive pressures from other antifungal classes like echinocandins and azoles.

What Do Financial and Clinical Data Indicate?

• Clinical trials show FEMSTAT is effective, safe, with minimal systemic absorption, favoring topical use.
• Financial data from existing brands highlight high volume but declining revenue due to generic competition.
• Real-world use continues to favor FEMSTAT in primary care settings, but market share shrinking without innovation.

Conclusion

FEMSTAT remains a well-established antifungal, with steady but challenged market dynamics. Investment opportunities may hinge on reformulation, regional licensing, or niche indications, while risks relate to patent expiration and market saturation.

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Key Takeaways

• FEMSTAT is a broadly used antifungal with high familiarity and established safety.
• The market size is large but highly commoditized; profit margins face pressure from generics.
• Growth prospects depend on new formulations, regional expansion, or niche indications.
• Patent expiry and competitive pricing influence revenue stability.
• Innovation in delivery systems and combination therapies could enhance competitiveness.

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FAQs

1. What are the main barriers to FEMSTAT's market growth?
Patent expiration leading to generic competition and pricing erosion.

2. Which regions offer the highest growth potential for FEMSTAT?
Emerging markets like Southeast Asia, Africa, and Latin America.

3. How can a company extend FEMSTAT’s product lifecycle?
Through reformulations, new delivery systems, or securing regional exclusivities.

4. What are the regulatory challenges influencing FEMSTAT?
Approval delays for new formulations and differences in regional safety requirements.

5. Is there a significant risk from emerging fungal resistance affecting FEMSTAT’s market?
While resistant strains are a concern, FEMSTAT’s existing formulations remain effective for most indications. Resistance may influence future prescribing patterns but is not an immediate threat.

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References

[1] MarketsandMarkets, "Antifungal Drugs Market," 2022.
[2] GlobalData, "Topical Antifungal Market Analysis," 2022.
[3] FDA, "Clotrimazole NDA Approvals and Status," 2021.