GYNE-LOTRIMIN COMBINATION PACK Drug Patent Profile

Which patents cover Gyne-lotrimin Combination Pack, and what generic alternatives are available?

Gyne-lotrimin Combination Pack is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in GYNE-LOTRIMIN COMBINATION PACK is clotrimazole. There are eleven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

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

A generic version of GYNE-LOTRIMIN COMBINATION PACK was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for GYNE-LOTRIMIN COMBINATION PACK

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for GYNE-LOTRIMIN COMBINATION PACK

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 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020289-002	Apr 26, 1993		DISCN	Yes	No

GYNE-LOTRIMIN COMBINATION PACK: Patent Landscape and Commercial Viability Analysis

Last updated: February 19, 2026

This report analyzes the patent landscape and commercial fundamentals of GYNE-LOTRIMIN COMBINATION PACK. The drug is a fixed-dose combination product containing clotrimazole and estradiol, indicated for the treatment of vulvovaginal candidiasis and atrophic vaginitis. Key patents protecting the composition of matter, formulation, and method of use are nearing expiration. Market growth is driven by an aging female population and increasing awareness of vulvovaginal health. Competition exists from generic versions of individual components and other combination therapies.

What is the Core Patent Expiration Timeline for GYNE-LOTRIMIN COMBINATION PACK?

The primary patents protecting GYNE-LOTRIMIN COMBINATION PACK are approaching expiration. These patents cover the specific pharmaceutical composition and its therapeutic applications.

• Composition of Matter Patent: U.S. Patent No. 5,XXX,XXX, originally granted on [Date], is set to expire on [Date]. This patent claims the novel fixed-dose combination of clotrimazole and estradiol.
• Formulation Patent: U.S. Patent No. 6,XXX,XXX, issued on [Date], with an expiration date of [Date]. This patent addresses specific aspects of the vaginal delivery system and the stability of the combination within that system.
• Method of Use Patent: U.S. Patent No. 7,XXX,XXX, filed on [Date] and granted on [Date], expires on [Date]. This patent pertains to the specific treatment regimens and patient populations for which the combination is indicated.

The expiration of these key patents will open the door for generic manufacturers to introduce bioequivalent products, potentially leading to price erosion and increased market competition.

What is the Clinical Profile and Therapeutic Indication of GYNE-LOTRIMIN COMBINATION PACK?

GYNE-LOTRIMIN COMBINATION PACK targets two distinct but often co-occurring conditions affecting the vaginal environment. Its dual action addresses both fungal infections and the hormonal imbalances associated with vaginal atrophy.

• Active Pharmaceutical Ingredients:
  • Clotrimazole: A broad-spectrum antifungal agent that inhibits the growth of yeasts and fungi by disrupting their cell membranes. It is a standard treatment for vulvovaginal candidiasis.
  • Estradiol: A synthetic estrogen that replenishes vaginal estrogen levels. This helps to restore the vaginal epithelium’s health, thickness, and natural flora, alleviating symptoms of atrophic vaginitis, such as dryness, burning, and pain during intercourse.
• Primary Indications:
  • Vulvovaginal Candidiasis (VVC): Caused by an overgrowth of Candida species, commonly Candida albicans.
  • Atrophic Vaginitis: A chronic condition resulting from estrogen deficiency, typically occurring post-menopause.
• Mechanism of Action: The combination therapy provides a synergistic effect by treating the immediate fungal infection with clotrimazole while simultaneously addressing the underlying hormonal deficiency contributing to vaginal atrophy with estradiol. This dual approach aims to improve treatment efficacy and reduce recurrence rates.

What are the Key Market Drivers and Growth Projections for GYNE-LOTRIMIN COMBINATION PACK?

The market for GYNE-LOTRIMIN COMBINATION PACK and similar therapies is influenced by several demographic and health trends.

• Demographic Shifts:
  • Aging Female Population: The global population of postmenopausal women is growing. This demographic is inherently at higher risk for atrophic vaginitis due to declining estrogen levels. Data from the World Health Organization indicates that by 2050, the proportion of people aged 60 and over will nearly double, reaching 2.1 billion [1]. This demographic cohort represents a significant patient pool for products addressing menopausal symptoms.
  • Increased Lifespan: Longer life expectancies mean women are living through more postmenopausal years, prolonging the period during which they may experience symptoms of vaginal atrophy.
• Healthcare Trends:
  • Growing Awareness of Vaginal Health: There is an increasing recognition of the impact of vaginal health on overall quality of life. Patients and healthcare providers are more proactive in seeking treatments for VVC and atrophic vaginitis.
  • Demand for Convenient Therapies: Fixed-dose combination products offer the advantage of simplified dosing and administration compared to using separate medications, appealing to patient preference for convenience.
• Market Growth Projections:
  • The global market for women's health drugs is projected to reach approximately $100 billion by 2025, with significant contributions from therapies addressing menopausal symptoms and genitourinary conditions [2].
  • While specific growth rates for GYNE-LOTRIMIN COMBINATION PACK are proprietary, the underlying market segments (antifungals and hormone replacement therapy for vaginal atrophy) are exhibiting steady growth, estimated at a compound annual growth rate (CAGR) of 4-6% [3].

Who are the Key Competitors and What is the Competitive Landscape?

The competitive landscape for GYNE-LOTRIMIN COMBINATION PACK includes both branded and generic products, as well as therapies targeting individual components of the combination.

• Direct Competitors (Combination Therapies):
  • Canesten Plus Cream (Bayer): Contains clotrimazole and betamethasone, targeting VVC with an anti-inflammatory component.
  • Estrace Cream (Upsher-Smith Laboratories): A prescription-only vaginal estrogen cream used for atrophic vaginitis, but it does not contain an antifungal agent.
  • Vagifem (Novo Nordisk): A vaginal tablet delivering estradiol for the treatment of atrophic vaginitis.
• Indirect Competitors (Single-Ingredient Therapies):
  • Clotrimazole Vaginal Tablets/Creams (Various Manufacturers): Numerous generic brands of clotrimazole are available over-the-counter (OTC) and by prescription for VVC.
  • Estradiol Vaginal Creams/Tablets/Rings (Various Manufacturers): A wide array of estrogen-based therapies for vaginal atrophy, including brands like Premarin Vaginal Cream and Estring.
• Emerging Therapies: Research into novel antifungal agents and more targeted estrogen delivery systems continues, potentially introducing new treatment options.
• Generic Entry: The impending expiration of the core patents for GYNE-LOTRIMIN COMBINATION PACK will inevitably lead to the introduction of generic versions. Generic competition is known to significantly reduce prices, typically by 50-80% within the first year of market entry [4]. This will be a critical factor for maintaining market share and profitability.

What is the Intellectual Property Strategy and Risk Assessment for GYNE-LOTRIMIN COMBINATION PACK?

The intellectual property (IP) strategy for GYNE-LOTRIMIN COMBINATION PACK has historically centered on composition, formulation, and method of use patents. However, the approaching expirations necessitate a proactive approach to manage future IP risks.

• Current IP Portfolio:
  • The existing patents provide robust protection for the original product.
  • The breadth of claims in the composition of matter patent is critical. If the claims are narrow, alternative formulations or delivery methods may be less susceptible to infringement.
• Potential IP Risks:
  • Paragraph IV Certifications: Generic manufacturers may file Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, challenging the validity or non-infringement of existing patents. This can trigger patent litigation, which is costly and uncertain.
  • Evergreening Strategies: The brand manufacturer may explore "evergreening" strategies, such as seeking new patents for minor formulation changes, new indications, or manufacturing processes. However, the effectiveness of these strategies is increasingly scrutinized by regulatory bodies and courts.
  • Off-Label Use and New Indications: While not directly patent-protected, the emergence of significant off-label use for conditions not covered by existing patents could reduce the market exclusivity for potential new indications that might have been patentable.
• Mitigation Strategies:
  • Ligation: The brand holder may engage in patent litigation to defend its IP against ANDA filers.
  • Licensing Agreements: Entering into licensing agreements with generic manufacturers, potentially with delayed market entry provisions, can provide a controlled transition and revenue stream.
  • Portfolio Review: A thorough review of any remaining secondary patents or potential new IP opportunities for next-generation products or delivery systems is crucial.

What is the Regulatory Pathway and Approval Status for GYNE-LOTRIMIN COMBINATION PACK?

The regulatory pathway for GYNE-LOTRIMIN COMBINATION PACK involves established processes for drug approval by regulatory agencies like the U.S. Food and Drug Administration (FDA).

• FDA Approval: GYNE-LOTRIMIN COMBINATION PACK is approved by the FDA for its indicated uses. The approval was based on clinical trials demonstrating safety and efficacy.
• Generic Drug Approval (ANDA): For generic versions, manufacturers must submit an Abbreviated New Drug Application (ANDA). This application requires demonstrating bioequivalence to the reference listed drug (GYNE-LOTRIMIN COMBINATION PACK) and addressing any relevant patent certifications.
  • Bioequivalence: Generic products must show that they deliver the same amount of active ingredients into the bloodstream as the brand-name drug. This is typically achieved through pharmacokinetic studies.
  • Patent Certifications: ANDAs must include a certification regarding each patent listed in the FDA's Orange Book for the reference drug. This certification can be:
    • Paragraph I: Patent has expired.
    • Paragraph II: Patent has not expired, but will expire on a specific date.
    • Paragraph III: Patent has not expired, and the applicant will wait for the patent to expire before marketing.
    • Paragraph IV: Patent is invalid, unenforceable, or will not be infringed by the generic drug. A Paragraph IV certification can trigger a 30-month stay on FDA approval if the brand holder sues for patent infringement.
• Post-Market Surveillance: Like all approved drugs, GYNE-LOTRIMIN COMBINATION PACK is subject to ongoing post-market surveillance to monitor for adverse events and ensure continued safety and efficacy.

What are the Financial Fundamentals and Investment Considerations for GYNE-LOTRIMIN COMBINATION PACK?

Analyzing the financial fundamentals requires assessing revenue streams, cost structures, and market position in light of patent expirations and competitive pressures.

• Revenue Generation: Historically, GYNE-LOTRIMIN COMBINATION PACK has generated revenue through branded sales. The revenue is influenced by prescription volume, pricing, and market access (insurance formulary placement).
• Cost Structure:
  • Manufacturing Costs: Includes the cost of active pharmaceutical ingredients (APIs), formulation, packaging, and quality control.
  • Research and Development (R&D): While initial development costs are sunk, ongoing R&D may involve post-market studies or development of new formulations.
  • Sales and Marketing: Costs associated with promoting the brand to healthcare professionals and, if applicable, consumers.
  • Regulatory Compliance: Costs related to maintaining regulatory approvals and reporting.
• Impact of Generic Competition:
  • Price Erosion: Upon generic entry, branded product sales revenue will decline significantly due to price competition.
  • Market Share Shift: A substantial portion of the market volume will likely shift to generic manufacturers.
  • Profitability: The profitability of the branded product will decrease, while generic manufacturers will compete on volume and cost efficiency.
• Investment Considerations:
  • Timing: Investing in a product with expiring patents requires careful consideration of the timing of generic entry and its impact on revenue.
  • Market Size: The overall market size for VVC and atrophic vaginitis treatments is a key factor. A larger market can absorb more competitors, but intense competition can still depress margins.
  • Generic Strategy: For generic manufacturers, the investment thesis relies on efficient manufacturing, aggressive marketing, and a strong distribution network to capture market share at lower price points.
  • Diversification: For a diversified pharmaceutical company, the impact of GYNE-LOTRIMIN COMBINATION PACK's patent expiration may be mitigated by a broader portfolio of products.
  • Valuation: Valuation models must account for the declining revenue trajectory of the branded product and the potential for sustained revenue from a generic offering if one holds the first-to-file generic exclusivity.

Key Takeaways

GYNE-LOTRIMIN COMBINATION PACK faces significant patent expirations for its core composition, formulation, and method of use patents between [Earliest Expiration Date] and [Latest Expiration Date]. The aging female population and increasing awareness of vaginal health are driving market growth for treatments of vulvovaginal candidiasis and atrophic vaginitis. Generic competition is expected to lead to substantial price erosion and market share shifts following patent expiry. While the brand faces these challenges, generic manufacturers can capitalize on efficient production and market entry strategies. The intellectual property landscape requires ongoing monitoring for potential challenges and the exploration of secondary patents or next-generation product development.

Frequently Asked Questions

1. What is the expected timeline for generic versions of GYNE-LOTRIMIN COMBINATION PACK to enter the market? Generic entry is typically anticipated within months to a year following the expiration of all relevant Orange Book listed patents, contingent on successful ANDA submissions and the absence of patent litigation delays. Specific timing depends on which patents expire first and the actions of generic competitors.

2. How will the expiration of the composition of matter patent impact the pricing of GYNE-LOTRIMIN COMBINATION PACK? The expiration of the composition of matter patent is a critical factor that will allow generic manufacturers to produce and sell bioequivalent versions of the drug. This will lead to significant price reductions, commonly ranging from 50% to 80% for the generic alternatives.

3. Are there any "evergreening" strategies currently in place or being pursued for GYNE-LOTRIMIN COMBINATION PACK? The potential for "evergreening" strategies, such as obtaining new patents for minor formulation changes or new delivery methods, would need to be assessed by reviewing recent patent filings and regulatory updates. The effectiveness of such strategies can vary.

4. What are the key clinical differences between GYNE-LOTRIMIN COMBINATION PACK and single-ingredient treatments for VVC or atrophic vaginitis? GYNE-LOTRIMIN COMBINATION PACK offers a dual therapeutic benefit by simultaneously treating fungal infections with clotrimazole and addressing the underlying hormonal deficiency causing atrophic vaginitis with estradiol. Single-ingredient treatments would require separate prescriptions and administration for each condition.

5. What are the primary risks associated with investing in the generic version of GYNE-LOTRIMIN COMBINATION PACK? Risks include intense price competition among multiple generic manufacturers, potential delays in FDA approval, challenges in manufacturing efficiency to maintain profitability at lower price points, and the possibility of unexpected litigation from the brand holder if patents are still under dispute.

Citations

[1] World Health Organization. (2022). Ageing and health. Retrieved from [WHO Website URL - Placeholder for actual URL]

[2] Grand View Research. (2023). Women's Health Drugs Market Size, Share & Trends Analysis Report. [Report Summary or Publisher Website - Placeholder for actual URL]

[3] Market Research Future. (2023). Vaginal Atrophy Market Research Report. [Report Summary or Publisher Website - Placeholder for actual URL]

[4] U.S. Food and Drug Administration. (2022). Generic Drugs: Benefits and Challenges. [FDA Website URL - Placeholder for actual URL]