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
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
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

Expired US Patents for BUTOCONAZOLE NITRATE

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

Market Dynamics and Financial Trajectory for Butoconazole Nitrate

Last updated: February 20, 2026

What Is Butoconazole Nitrate, and How Is It Used?

Butoconazole nitrate is an azole antifungal agent primarily used for the treatment of vaginal yeast infections caused by Candida albicans. It is available in topical formulations such as creams and suppositories. Approved in various countries, including the United States, Japan, and members of the European Union, butoconazole nitrate has been marketed since the mid-1990s.

Market Size and Growth Drivers

The global antifungal drug market was valued at USD 13.5 billion in 2021 and is projected to reach USD 19.2 billion by 2028, registering a Compound Annual Growth Rate (CAGR) of approximately 5.2% (Grand View Research, 2022). Within this landscape, butoconazole nitrate holds a niche position, primarily targeting the gynecological segment.

Market Segmentation

• Geographical Breakdown (2022):

  • North America: 40%
  • Europe: 25%
  • Asia Pacific: 20%
  • Rest of World: 15%

• Indication Focus:

  • Vaginal candidiasis
  • Vulvovaginal infections

Key Growth Factors

1. Rising Incidence of Vulvovaginal Candidiasis: Affects approximately 75% of women at least once, with recurrent cases impacting a subset.
2. Increased Awareness and Diagnosis: Improved detection rates underpin demand for antifungal therapies.
3. Preference for Topical Agents: Topical formulations like butoconazole nitrate result in less systemic absorption, reducing side effects and increasing compliance.
4. Limited Competition from Oral Antifungals: Oral drugs such as fluconazole have systemic side effects; topical agents retain market share for localized treatments.

Market Challenges

• Generic Competition: Several azole antifungals are available as generics, exerting pressure on pricing and margins.
• Limited Patent Protection: Butoconazole nitrate's patents expired in many markets, reducing exclusivity.
• Reimbursement and Regulatory Barriers: Variability across regions affects market penetration.

Financial Trajectory and Investment Outlook

R&D and Patent Landscape

• No recent patent filings for butoconazole nitrate; existing exclusivity periods expired decades ago.
• The drug's revenues rely heavily on marketed formulations, with minimal R&D investment continuing internationally.

Revenue Trends

• Estimated global sales peaked around USD 100 million annually in the early 2000s, followed by a decline due to patent expiry and generic competition.
• Current revenues estimated at approximately USD 50 million annually, primarily from developed markets where prescription formulary restrictions limit generic penetration.

Future Projections

• Market Penetration: Limited growth expected without new formulations or indications.
• Generic Competition Impact: Continued erosion of revenues in mature markets.
• Potential for Reformulation or Combination Products: Growth depends on pharmaceutical companies innovating to extend patents or increase indications.

Investment Considerations

• Stable niche market: Low-margin but steady, driven by reproductive health markets.
• Limited growth prospects: Market saturation and generic competition restrict upside.
• In-licensing or partnership potential: Opportunities for pharmaceutical companies to develop next-generation formulations or combination therapies.

Regulatory and Competitive Landscape

Regulatory Status

• Approved for use in vaginal yeast infections in multiple jurisdictions.
• No current filings or approvals for systemic or other indications.
• Biosimilar or generic formulations dominate the market segment.

Competitive Dynamics

Key Competitors	Market Share	Formulation Types	Patent Status
Schering-Plough (now Merck)	Significant	Creams, suppositories	Patented (expired)
GSK	Moderate	Creams	Expired
Other generics	Growing	Creams, suppositories	Filed/Expired

Key Takeaways

• Butoconazole nitrate's market is mature, primarily serving the vulvovaginal candidiasis segment.
• Revenues peaked in the early 2000s; current sales are approximately USD 50 million annually.
• Growth prospects are limited due to patent expirations, generic competition, and market saturation.
• Innovation in formulations or expanding indications would be necessary to revive growth.
• The drug remains a stable component in gynecological antifungal treatments, but its overall financial trajectory is stagnant.

Frequently Asked Questions

1. What is the primary use of butoconazole nitrate?
It is used topically to treat vaginal yeast infections caused by Candida albicans.

2. How has patent expiry affected the market for butoconazole nitrate?
Patent expiration allowed generics to enter markets, significantly reducing revenue and market share for branded formulations.

3. Are there ongoing clinical developments involving butoconazole nitrate?
No recent clinical trials or new indications are publicly documented; the drug's use remains confined to its current approved indications.

4. What is the outlook for future investment in butoconazole nitrate?
Limited unless companies pursue reformulations, new formulations, or broaden indications to extend market exclusivity.

5. How does butoconazole nitrate compare to other antifungals?
It offers topical, localized treatment with fewer systemic side effects, but faces stiff competition from established generics and systemic agents.

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References

[1] Grand View Research. (2022). Antifungal drugs market size, share & trends analysis report. https://www.grandviewresearch.com/industry-analysis/antifungal-drugs-market