FEMSTAT 3 Drug Patent Profile

When do Femstat 3 patents expire, and when can generic versions of Femstat 3 launch?

Femstat 3 is a drug marketed by Bayer and is included in one NDA.

The generic ingredient in FEMSTAT 3 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 3

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FEMSTAT 3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No

International Patents for FEMSTAT 3

See the table below for patents covering FEMSTAT 3 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

FEMSTAT 3 Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is FEMSTAT 3 and Its Market Context?

FEMSTAT 3 contains fluconazole, an antifungal agent used to treat systemic fungal infections. It is a product of interest due to its application in invasive candidiasis, cryptococcal meningitis, and other fungal conditions typically encountered in immunocompromised patients.

The drug operates within an established class, with existing competitors like Pfizer's Diflucan (fluconazole) and other azole antifungals. The prevailing market is characterized by 8-10% annual growth, driven by increasing immunocompromised populations, such as cancer and transplant patients, and rising antifungal resistance concerns.

How Does FEMSTAT 3 Fit Into the Competitive Landscape?

• Market penetration: FEMSTAT 3's success depends on pricing, formulary inclusion, and prescriber preference. It faces competition from well-established brands with broader distribution channels.
• Patent status: If FEMSTAT 3 is off-patent, it may face generic competition, impacting pricing power. Patent protection typically lasts 20 years from filing; most recent filings date within the last decade for newer formulations or indications.
• Clinical differentiation: Its efficacy, safety profile, or dosing convenience must offer advantages over existing options to gain market share.

What Are the Key Regulatory and Developmental Milestones?

• Approval status: Confirm whether FEMSTAT 3 has regulatory approval in target markets—US, EU, or emerging markets.
• Clinical trial data: The availability of phase III results demonstrating non-inferiority or superiority influences market confidence.
• Regulatory pathways: Orphan drug designation, fast track, or priority review can accelerate time to market, impacting investor valuation.

What Are The Investment Fundamentals and Financial Outlook?

• Development costs: Estimated $50 million to $150 million across clinical trial phases, manufacturing, and regulatory expenses.
• Pricing strategy: Assuming a price point comparable to branded fluconazole ($10-$20 per dose), profitability hinges on patent protections and market penetration.
• Market size: The global antifungal drugs market exceeds $4 billion; systemic antifungal segment estimated at $1.8 billion (2022), growing at 8% annually.
• Revenue potential: For FEMSTAT 3 to achieve $100 million in annual sales, it would need about 5-6% of systemic antifungal market share, considering pricing and market conditions.

What Are The Risks and Challenges?

• Pricing pressure: Competition from generics can erode margins.
• Regulatory delays: Any issues in approval processes could delay commercialization.
• Market acceptance: Prescriber familiarity with existing antifungals limits rapid adoption unless significant clinical benefits are demonstrated.
• Resistance issues: Emerging fungal resistance reduces overall antifungal market size or shifts prescribing patterns.

What Is The Valuation and Investment Outlook?

• Valuation models: Discounted cash flow (DCF) analyses, considering peak sales, timelines, and cost estimates, typically place early-stage systemic antifungal assets at $200-$500 million enterprise value, contingent on clinical data and regulatory progress.
• Partnership opportunities: Licensing or co-development can reduce development risk and improve market access.

Key Takeaways

• FEMSTAT 3's success depends on clinical differentiation, regulatory approvals, and competitive positioning amid a growing antifungal market.
• Market penetration hinges on patent status, pricing strategies, and prescriber adoption.
• Investors should monitor clinical trial results, regulatory updates, and competitive dynamics to assess valuation adjustments.

FAQs

1. When is FEMSTAT 3 expected to reach market?
If currently in phase III trials, approval could target 12-24 months post-trial completion, depending on regulatory review timelines.

2. How does FEMSTAT 3 compare pricing-wise with existing fluconazoles?
Expected pricing aligns with branded formulations at $10-$20 per dose; generic equivalents could be priced below $10, influencing profit margins.

3. What are the primary clinical advantages of FEMSTAT 3?
Potential benefits include improved safety, dosing convenience, or efficacy; currently, specific advantages need confirmation via trial data.

4. How vulnerable is FEMSTAT 3 to generic competition?
If approved beyond patent expiry, it faces significant price erosion unless maintained by unique formulation or new indications.

5. What regulatory strategies could accelerate approval?
Designations like orphan drug or fast track can shorten approval timelines, especially if FEMSTAT 3 targets rare or unmet needs.

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Citations

[1] Global antifungal drugs market report (2022).
[2] FDA drug approval data.
[3] Clinical trial registries for antifungal agents.