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Last Updated: December 12, 2025

GYNE-LOTRIMIN 3 COMBINATION PACK Drug Patent Profile


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When do Gyne-lotrimin 3 Combination Pack patents expire, and when can generic versions of Gyne-lotrimin 3 Combination Pack launch?

Gyne-lotrimin 3 Combination Pack is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in GYNE-LOTRIMIN 3 COMBINATION PACK is clotrimazole. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gyne-lotrimin 3 Combination Pack

A generic version of GYNE-LOTRIMIN 3 COMBINATION PACK was approved as clotrimazole by P AND L on July 16th, 1993.

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Summary for GYNE-LOTRIMIN 3 COMBINATION PACK
Drug patent expirations by year for GYNE-LOTRIMIN 3 COMBINATION PACK
Recent Clinical Trials for GYNE-LOTRIMIN 3 COMBINATION PACK

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SponsorPhase
BayerPhase 3
Taro Pharmaceuticals USAPhase 1

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US Patents and Regulatory Information for GYNE-LOTRIMIN 3 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 3 COMBINATION PACK clotrimazole CREAM, TABLET;TOPICAL, VAGINAL 020526-002 Jul 29, 1996 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for GYNE-LOTRIMIN 3 Combination Pack

Last updated: July 31, 2025


Introduction

The pharmaceutical landscape continues to evolve with a focus on combination therapies that enhance treatment adherence and efficacy. GYNE-LOTRIMIN 3 Combination Pack exemplifies this trend by offering a multi-modal approach to treating common gynecological infections. This report analyzes the current market dynamics, anticipated financial trajectory, and strategic considerations affecting GYNE-LOTRIMIN 3's commercial success.


Product Overview

GYNE-LOTRIMIN 3 Combination Pack combines antifungal, antibacterial, and anti-inflammatory agents, targeting conditions like bacterial vaginosis, vulvovaginal candidiasis, and other mixed gynecological infections. Its formulation aims to streamline treatment regimens, improve patient compliance, and reduce recurrence rates.


Market Dynamics

1. Growing Prevalence of Gynecological Infections

Globally, the incidence of vulvovaginal candidiasis and bacterial vaginosis remains high, driven by factors such as sexual activity, antibiotic use, hormonal fluctuations, and hygiene practices. According to the World Health Organization (WHO), approximately 30-50% of women experience at least one episode of vulvovaginal candidiasis in their lifetime. The rising prevalence underscores intrinsic demand for effective combination therapies that address multifactorial infections simultaneously.

2. Patient Preference for Simplified Regimens

The shift toward fixed-dose combinations (FDCs) is fueled by patient-centric care, offering convenience, reduced treatment duration, and improved adherence. GYNE-LOTRIMIN 3's multi-agent profile aligns with this trend, making it a preferred choice among clinicians aiming to streamline treatment protocols.

3. Competitive Landscape

The market is saturated with monotherapies and dual-drug formulations but remains relatively under-penetrated by triple-combination products targeting complex gynecological infections. Leading competitors include brands like Clindamycin, Metronidazole, and Fluconazole. However, the introduction of GYNE-LOTRIMIN 3 positions it favorably for capturing unmet needs, especially in markets emphasizing holistic treatment.

4. Regulatory and Prescriber Acceptance

Regulatory pathways for combination products can be complex, requiring rigorous safety and efficacy data. Nonetheless, positive clinical outcomes and the increasing preference among physicians for multidrug regimens facilitate market acceptance. Approval from regulatory bodies such as the FDA and EMA will directly influence commercialization potential.

5. Pricing, Reimbursement, and Accessibility

Pricing strategies for GYNE-LOTRIMIN 3 will directly impact its market penetration. Competitive pricing, supported by reimbursement policies and insurance coverage, will be critical, especially in emerging markets where affordability influences prescribing behaviors.


Financial Trajectory

1. Initial Market Penetration and Adoption

In the first 1-2 years post-launch, sales are anticipated to be modest but steady, focusing on key markets with high infection prevalence. Early adopters—gynecologists and infectious disease specialists—will validate clinical utility, driving word-of-mouth and prescription volume.

2. Growth Phase (Years 3-5)

Market expansion is expected as awareness grows, additional indications are recognized, and formulary inclusion improves. Promotional efforts emphasizing superior efficacy, safety profile, and treatment adherence can accelerate uptake. Reimbursement approvals will further amplify sales growth.

3. Maturation and Market Saturation (Years 6+)

Long-term, the product's financial trajectory depends on its ability to sustain market share against generics and new entrants. Lifecycle management strategies like line extensions or combination updates may prolong revenue streams.

4. Contributing Factors to Revenue

  • Market Penetration Rate: High in regions with prevalent gynecological infections; lower in markets with limited access.
  • Pricing Strategy: Balanced between affordability and profitability.
  • Regulatory Approvals: Streamlined processes enable quicker market entry and expansion.
  • Competitor Dynamics: Intense competition may compress margins unless GYNE-LOTRIMIN 3 offers clear clinical advantages.
  • Reimbursement and Insurance Coverage: Critical in maximizing prescription volume.

Strategic Considerations

To optimize financial trajectory, manufacturers should:

  • Invest in robust clinical trials to demonstrate superior outcomes.
  • Secure regulatory approvals promptly.
  • Engage healthcare providers through targeted education.
  • Implement aggressive yet sustainable pricing strategies.
  • Expand to emerging markets with high prevalence and unmet needs.

Regulatory and Market Access Outlook

Navigating regulatory landscapes is paramount. GYNE-LOTRIMIN 3’s success hinges on securing approvals by demonstrating safety, efficacy, and quality. Additionally, fostering relationships with payers and healthcare authorities will facilitate market access, especially in resource-constrained settings where affordability is essential.


Potential Risks and Mitigation

  • Regulatory Delays: Need for comprehensive clinical data; proactive regulatory engagement.
  • Market Competition: Differentiation through clinical benefits and value propositions.
  • Pricing Pressures: Strategic pricing aligned with market expectations.
  • Patient Acceptance: Education campaigns to boost adherence and trust.

Key Market Opportunities

  • Rising awareness of the benefits of combination therapy.
  • Increasing discretionary spending on gynecological health.
  • Expansion into OTC segments where permissible.
  • Utilization of digital health platforms for promotion and adherence.

Conclusion

GYNE-LOTRIMIN 3 Combination Pack is poised to capitalize on the persistent global demand for effective, simplified gynecological infection treatments. Its financial trajectory will be shaped by strategic regulatory engagement, targeted marketing, and competitive positioning. The product’s success will depend on its ability to meet evolving market needs and establish a durable presence across diverse geographies.


Key Takeaways

  • The increasing prevalence of gynecological infections supports sustained demand for multi-agent therapies like GYNE-LOTRIMIN 3.
  • Market success depends on regulatory approvals, clinical validation, and strategic pricing.
  • Combining product efficacy with clinician and patient education will drive adoption.
  • Early entry and expansion into emerging markets offer significant growth prospects.
  • Lifecycle management and differentiation from competitors are critical for long-term revenue stability.

FAQs

Q1: What are the main therapeutic advantages of GYNE-LOTRIMIN 3?
A1: It offers a combined approach to treat multifactorial gynecological infections, simplifying regimens, improving adherence, and reducing recurrence.

Q2: Which markets hold the highest growth potential for GYNE-LOTRIMIN 3?
A2: Emerging markets in Asia, Africa, and Latin America, where gynecological infection prevalence is high and healthcare access is expanding, exhibit significant growth potential.

Q3: What barriers could impede the financial success of GYNE-LOTRIMIN 3?
A3: Regulatory delays, aggressive competition, pricing pressures, and limited reimbursement avenues could hinder profits.

Q4: How does GYNE-LOTRIMIN 3 compare to monotherapies?
A4: It addresses multiple pathogens simultaneously, reducing treatment complexity and potentially decreasing the likelihood of resistance, offering clinical advantages over monotherapies.

Q5: What strategies can maximize GYNE-LOTRIMIN 3's market penetration?
A5: Investing in clinical evidence, obtaining regulatory approvals, strategic pricing, healthcare provider education, and market expansion targeting high-prevalence regions are essential.


Sources
[1] World Health Organization. “Gynecological Infections: Global Prevalence.” WHO, 2022.
[2] MarketResearch.com. “Global Gynecological Infection Treatment Market Analysis,” 2023.
[3] FDA. “Regulatory Pathways for Combination Products,” 2022.

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