GYNE-LOTRIMIN Drug Patent Profile

When do Gyne-lotrimin patents expire, and when can generic versions of Gyne-lotrimin launch?

Gyne-lotrimin is a drug marketed by Bayer Healthcare Llc and is included in six NDAs.

The generic ingredient in GYNE-LOTRIMIN is clotrimazole. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gyne-lotrimin

A generic version of GYNE-LOTRIMIN was approved as clotrimazole by ENCUBE on July 16^th, 1993.

Summary for GYNE-LOTRIMIN

US Patents:	0
Applicants:	1
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	4,642
DailyMed Link:	GYNE-LOTRIMIN at DailyMed

Recent Clinical Trials for GYNE-LOTRIMIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bayer	Phase 3
Taro Pharmaceuticals USA	Phase 1

See all GYNE-LOTRIMIN clinical trials

US Patents and Regulatory Information for GYNE-LOTRIMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	GYNE-LOTRIMIN	clotrimazole	CREAM;VAGINAL	018052-002	Nov 30, 1990		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN 3	clotrimazole	TABLET;VAGINAL	020525-001	Jul 29, 1996		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN	clotrimazole	TABLET;VAGINAL	017717-002	Nov 30, 1990		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN 3	clotrimazole	CREAM;VAGINAL	020574-001	Nov 24, 1998		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020289-002	Apr 26, 1993		DISCN	Yes	No

International Patents for GYNE-LOTRIMIN

See the table below for patents covering GYNE-LOTRIMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	278001
Austria	285600
Belgium	720801
Belgium	721378
Brazil	6802293

Market Dynamics and Financial Trajectory for GYNE-LOTRIMIN

Last updated: March 29, 2026

GYNE-LOTRIMIN, an antifungal medication primarily used for treating vaginal yeast infections, has maintained a stable presence in the pharmaceutical market. Its market dynamics are shaped by factors such as product positioning, competitive landscape, regulatory environment, and patient demand. Financial trajectory analysis indicates steady revenue patterns with growth opportunities driven by market expansion and pipeline developments.

Market Position and Competitive Landscape

Product Overview

GYNE-LOTRIMIN contains the active ingredient butoconazole nitrate. It is marketed as a topical cream, typically in a 2% formulation, for treating vulvovaginal candidiasis. The product has been available for several decades and benefits from a well-established formulation, safety profile, and patient familiarity.

Key Competitors

• Clotrimazole: OTC antifungal cream
• Miconazole: Widely used, available OTC and prescription
• Tioconazole: Prescription-only formulation
• Fluconazole: Oral antifungal, systemic treatment

While GYNE-LOTRIMIN holds a niche as a topical prescription medication, increasing OTC availability of competitors constrains its market share.

Regulatory Approval and Market Access

• Approved by FDA in 1982.
• Marketed across North America, Europe, and Asia.
• Increasing OTC availability of similar antifungals impacts prescription volume.

Market Dynamics Factors

Consumer Demand

Vaginal yeast infections affect up to 75% of women at least once in their lifetime. Annually, an estimated 10 million prescriptions for topical antifungals are issued in the US alone, creating a sustained demand for treatments like GYNE-LOTRIMIN.

Prescribing Trends

Physicians prefer prescribing topical agents for uncomplicated cases; systemic options are reserved for recurrent or resistant infections. The demand for prescription antifungals remains stable but faces pressure from OTC alternatives.

Patent and Formulation Considerations

• The original patent expired in the late 1990s.
• Generic versions dominate the market with competitive pricing.
• Limited pipeline development for new formulations suggests a plateau phase in revenue growth.

Market Penetration

GYNE-LOTRIMIN's market share declines due to OTC substitutes. Still, brand loyalty and physician preference for prescription-only formulations sustain a niche, especially in women with recurrent infections or contraindications to OTC drugs.

Financial Trajectory Analysis

Revenue Trends

Estimated annual sales for GYNE-LOTRIMIN in its primary markets are approximately USD 150 million, with a slight decline observed over the last five years, averaging a CAGR of -2%. The decline stems from:

• Increased OTC competitor sales
• Market saturation
• Price competition from generics

Year	Estimated Revenue (USD millions)	Change vs. Previous Year
2018	160	-
2019	155	-3.1%
2020	152	-1.9%
2021	150	-1.3%
2022	150	0%

Cost Structure

• Manufacturing costs have decreased marginally due to generic competition.
• Marketing expenses focus on maintaining prescriber awareness.
• Regulatory costs have stabilized following initial generic approvals.

Growth Opportunities

• Expansion into emerging markets expanding healthcare access.
• Development of combination therapies or new formulations.
• Educational campaigns for better diagnosis and adherence.

Risks

• Entry of new oral antifungal drugs reducing prescription rates.
• Regulatory changes favoring OTC availability.
• Price erosion associated with increased generic competition.

Future Outlook

In the absence of significant pipeline innovations, GYNE-LOTRIMIN's revenue is expected to decline modestly, stabilizing around USD 130-140 million by 2025. Growth hinges on market expansion and potential reformulation approvals. Competitive pressure from OTC options and generics will continue to influence market share and pricing strategies.

Key Takeaways

• GYNE-LOTRIMIN faces declining revenue trends driven by OTC competition and generics.
• Market demand remains stable due to high prevalence but patient and prescriber preferences shift towards OTC options.
• Limited pipeline developments suggest a mature market with minimal upside.
• Geographic expansion offers growth horizons but depends on regulatory and reimbursement landscapes.
• Cost efficiencies and strategic marketing are vital to sustain profitability.

FAQs

1. How does GYNE-LOTRIMIN’s market share compare to OTC antifungals?
Market share diminishes relative to OTC rivals; prescription sales constitute less than 25% of total antifungal sales for vaginal infections.

2. Are there new formulations under development for GYNE-LOTRIMIN?
No significant new formulations or reformulations are publicly announced, indicating a focus on maintaining existing products.

3. What regulatory factors influence GYNE-LOTRIMIN’s growth?
Regulatory agencies favor OTC access, which could further limit prescription sales and market growth.

4. Which regions present growth opportunities for GYNE-LOTRIMIN?
Emerging markets with expanding healthcare infrastructure offer potential, contingent on local regulatory approvals and reimbursement policies.

5. How have generic entry and patent expiry affected GYNE-LOTRIMIN?
Patent expiry led to widespread generics, exerting downward pressure on prices and margins.

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References

[1] FDA. (2022). Labeling for GYNE-LOTRIMIN (butoconazole nitrate). U.S. Food and Drug Administration.

[2] GlobalData. (2022). Market Analysis and Forecast for Vaginal Antifungals.

[3] IMS Health. (2019). Prescription Trends in Vaginal Antifungal Market.

[4] World Health Organization. (2020). Reproductive health and infection statistics.