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Last Updated: December 24, 2024

GYNE-LOTRIMIN 3 Drug Patent Profile


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

Gyne-lotrimin 3 is a drug marketed by Bayer Healthcare Llc and is included in three NDAs.

The generic ingredient in GYNE-LOTRIMIN 3 is clotrimazole. There are eleven drug master file entries for this compound. Twenty-eight 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

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

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

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

SponsorPhase
BayerPhase 3
Taro Pharmaceuticals USAPhase 1

See all GYNE-LOTRIMIN 3 clinical trials

US Patents and Regulatory Information for GYNE-LOTRIMIN 3

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 clotrimazole CREAM;VAGINAL 020574-001 Nov 24, 1998 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare Llc GYNE-LOTRIMIN 3 clotrimazole TABLET;VAGINAL 020525-001 Jul 29, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare Llc GYNE-LOTRIMIN 3 COMBINATION PACK clotrimazole CREAM, TABLET;TOPICAL, VAGINAL 020526-002 Jul 29, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

GYNE-LOTRIMIN 3 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gyne-Lotrimin 3

Overview of Gyne-Lotrimin 3

Gyne-Lotrimin 3 is a vaginal antifungal medication, specifically a 2% clotrimazole cream, used to treat vaginal yeast infections (candidiasis). It is part of the broader category of topical drug delivery systems, which are gaining prominence in the pharmaceutical industry.

Market Context

Growing Demand for Topical Drug Delivery

The global Topical Drug Delivery Market is projected to grow at a CAGR of 6.3% from 2024 to 2031, driven by increasing demand for localized treatment options and non-invasive therapeutic methods. This trend is particularly relevant for Gyne-Lotrimin 3, as patients increasingly prefer drug delivery systems that avoid the complexities of injections or oral medications[4].

Increasing Prevalence of Dermatological and Gynecological Conditions

The rise in dermatological conditions, such as skin infections, and gynecological conditions like vaginal yeast infections, significantly drives the demand for targeted therapeutic solutions. Gyne-Lotrimin 3, being a treatment for vaginal yeast infections, benefits from this increased demand for effective and convenient topical formulations[4].

Product Specifics

Mechanism of Action and Usage

Gyne-Lotrimin 3 works by stopping the fungus (yeast) that causes vaginal yeast infections from growing. It is available as a 2% vaginal cream and comes with disposable applicators for ease of use. This product is specifically designed to relieve symptoms of itching, irritation, and discharge associated with vaginal yeast infections[1][2].

Side Effects and Precautions

While generally well-tolerated, Gyne-Lotrimin 3 can cause mild side effects such as vaginal burning, itching, or irritation. Serious side effects, including severe allergic reactions, are less common but require immediate medical attention. Users must be cautious and follow the prescribed dosage to avoid any adverse reactions[1].

Financial Trajectory

Market Valuation and Growth

The Topical Drug Delivery Market, which includes products like Gyne-Lotrimin 3, was valued at USD 109.16 Billion in 2024 and is expected to reach USD 177.97 Billion by 2031. This growth is driven by technological innovations, increasing incidences of skin and gynecological conditions, and a preference for non-invasive treatments[4].

Competitive Landscape

Gyne-Lotrimin 3 operates within a competitive landscape dominated by major pharmaceutical companies such as Bayer AG, Novartis AG, and Johnson & Johnson. The market is characterized by strategic collaborations, outsourcing of drug development and manufacturing, and a focus on emerging markets. These factors contribute to the financial stability and growth potential of products like Gyne-Lotrimin 3[3][4].

Regional Analysis

North America, with its sophisticated healthcare infrastructure and significant patient demographic afflicted by dermatological and gynecological disorders, is a key region for the Topical Drug Delivery Market. This regional dominance enhances market expansion and innovation, benefiting products like Gyne-Lotrimin 3[4].

Technological and Regulatory Trends

Technological Advancements

Continuous innovations in drug formulations and delivery technology are creating new opportunities for topical drugs. Advanced manufacturing methods, such as additive manufacturing, and the use of AI in pharmaceuticals are driving the development of more effective and personalized treatments, which can positively impact the financial trajectory of Gyne-Lotrimin 3[3][4].

Regulatory Landscape

The regulatory landscape for topical drug delivery systems is stringent, with a focus on safety and efficacy. While regulatory obstacles can sometimes delay commercialization, favorable regulatory frameworks in regions like North America support the growth of the market. Compliance with these regulations is crucial for maintaining market share and financial stability[4].

Key Drivers and Challenges

Key Drivers

  • Increasing Demand for Non-Invasive Therapeutics: Patients prefer drug delivery systems that are easy to use and avoid invasive procedures, driving the demand for products like Gyne-Lotrimin 3.
  • Technological Innovations: Advances in drug formulations and delivery technology enhance the efficacy and convenience of topical treatments.
  • Growing Prevalence of Gynecological Conditions: The rise in vaginal yeast infections increases the demand for targeted therapeutic solutions[4].

Challenges

  • Regulatory Obstacles: Stringent rules concerning the safety and efficacy of novel topical medication formulations can sometimes postpone commercialization.
  • Competitive Pressure: The market faces competition from alternative drug delivery systems, such as oral, injectable, and transdermal systems, which may offer more dependable or effective outcomes in some cases[4].

Future Outlook

Market Projections

The Topical Drug Delivery Market, including products like Gyne-Lotrimin 3, is expected to continue its growth trajectory driven by technological innovations, increasing demand for non-invasive treatments, and a growing prevalence of dermatological and gynecological conditions. The market is projected to reach USD 177.97 Billion by 2031, indicating a strong financial outlook for Gyne-Lotrimin 3 and similar products[4].

Strategic Insights

To align with the latest market trends and regulatory shifts, pharmaceutical companies should focus on:

  • Innovative Drug Formulations: Investing in research to improve the efficacy and convenience of topical drug delivery systems.
  • Regulatory Compliance: Ensuring strict adherence to safety and efficacy regulations to avoid delays in commercialization.
  • Market Expansion: Targeting emerging markets with growing healthcare demands and increasing disposable incomes[3][4].

Key Takeaways

  • Growing Market Demand: The Topical Drug Delivery Market is growing due to increasing demand for non-invasive treatments and rising prevalence of gynecological conditions.
  • Technological Innovations: Advances in drug formulations and delivery technology are driving the market forward.
  • Regulatory Compliance: Adherence to stringent safety and efficacy regulations is crucial for market success.
  • Competitive Landscape: The market is competitive, with major pharmaceutical companies driving innovation and growth.

FAQs

What is Gyne-Lotrimin 3 used for?

Gyne-Lotrimin 3 is used to treat vaginal yeast infections (candidiasis) and relieve symptoms of itching, irritation, and discharge associated with this condition[1].

How does Gyne-Lotrimin 3 work?

Gyne-Lotrimin 3 works by stopping the fungus (yeast) that causes vaginal yeast infections from growing[1].

What are the common side effects of Gyne-Lotrimin 3?

Common side effects include mild vaginal burning, itching, or irritation. Serious side effects can include severe allergic reactions[1].

What is the expected growth of the Topical Drug Delivery Market?

The Topical Drug Delivery Market is expected to grow at a CAGR of 6.3% from 2024 to 2031, reaching USD 177.97 Billion by 2031[4].

What are the key drivers of the Topical Drug Delivery Market?

Key drivers include increasing demand for non-invasive therapeutics, technological innovations, and the growing prevalence of dermatological and gynecological conditions[4].

Sources

  1. WebMD: Clotrimazole 7 Vaginal - Uses, Side Effects, and More.
  2. Taro: Clotrimazole 2% 3 Day Vaginal Cream.
  3. Global Pharma Tek: Top 12 Pharmaceutical Industry Trends in 2024.
  4. GlobeNewswire: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031.

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