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Last Updated: December 28, 2024

GYNE-LOTRIMIN COMBINATION PACK Drug Patent Profile


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

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-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 Combination Pack

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

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

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

SponsorPhase
BayerPhase 3
Taro Pharmaceuticals USAPhase 1

See all GYNE-LOTRIMIN COMBINATION PACK clinical trials

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 ⤷  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 COMBINATION PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gyne-Lotrimin Combination Pack

Introduction to Gyne-Lotrimin

Gyne-Lotrimin is an antifungal medication, specifically a clotrimazole vaginal cream, designed to treat vaginal candida (yeast) infections. It is available over-the-counter (OTC) and has been a staple in self-care for women dealing with vaginal yeast infections.

Market Demand and Consumer Behavior

The demand for OTC antifungal treatments like Gyne-Lotrimin has been robust since the FDA approved the Rx-to-OTC switch for vaginal antifungals in the early 1990s. This shift allowed women to self-treat vaginal yeast infections without a physician's intervention, significantly increasing market demand.

Recurrent Nature of Vaginal Yeast Infections

Vaginal yeast infections are recurrent, which means that many women purchase multiple packages of Gyne-Lotrimin to prepare for future episodes. This recurring need drives consistent sales and contributes to the product's market stability[4].

Consumer Preference and Satisfaction

Consumer satisfaction plays a crucial role in the market dynamics of Gyne-Lotrimin. The product has an average rating of 10.0 out of 10 from reviewers, indicating high user satisfaction. This positive feedback can lead to repeat purchases and recommendations, further boosting market demand[1].

Product Variations and Dosage Forms

Gyne-Lotrimin is available in various dosage forms, including creams and suppositories, which cater to different patient preferences.

Cream and Suppository Options

  • Gyne-Lotrimin 3 Vaginal Cream: A 2% clotrimazole cream in a tube with 3 disposable applicators.
  • Gyne-Lotrimin 7 Cream: A 1% clotrimazole cream with a single, reusable applicator[4].

These options allow patients to choose the most comfortable and effective treatment method, enhancing the product's market appeal.

Competitive Landscape

The market for OTC antifungal treatments is competitive, with several brands available.

Comparison with Monistat

  • Monistat 1 Combination Pack: Uses miconazole and has a lower user satisfaction rating compared to Gyne-Lotrimin.
  • Monistat 3 and 7 Combination Packs: Offer different strengths and applicator options, but generally have lower user ratings[1][4].

Gyne-Lotrimin's high user satisfaction and effective treatment outcomes give it a competitive edge in the market.

Pricing and Affordability

The pricing of Gyne-Lotrimin is competitive within the OTC antifungal market.

Cost Considerations

  • While exact pricing may vary, Gyne-Lotrimin is generally priced to be accessible to a wide range of consumers.
  • The availability of different dosage forms and package sizes helps in catering to various budget needs[1][4].

Side Effects and Safety Profile

Like any medication, Gyne-Lotrimin can cause side effects, although they are generally mild and temporary.

Common Side Effects

  • Vaginal burning, itching, discharge, or other irritation not present before use.
  • Less common side effects include skin rash or hives, abdominal or stomach cramps, and headache[2].

A pharmacist's guidance can help patients understand and manage these side effects, ensuring safe and effective use.

Regulatory Environment

The regulatory environment has been favorable for OTC antifungal treatments.

FDA Approval and OTC Status

  • The FDA's approval for the Rx-to-OTC switch has enabled widespread availability of Gyne-Lotrimin.
  • This status allows the product to be sold in various retail outlets, increasing accessibility[4].

Financial Trajectory

The financial performance of Gyne-Lotrimin is influenced by several factors, including market demand, competition, and pricing.

Sales Performance

  • The product's high user satisfaction and recurrent nature of the condition it treats contribute to consistent sales.
  • The ability to purchase the product without a prescription has led to increased sales volumes since its OTC approval[4].

Revenue Growth

  • The market for OTC antifungal treatments has seen steady growth, driven by the increasing preference for self-care and the convenience of OTC products.
  • Gyne-Lotrimin's strong brand reputation and effective treatment outcomes have helped it maintain a significant market share and revenue growth[1][4].

Key Takeaways

  • High Demand: The recurrent nature of vaginal yeast infections ensures consistent demand for Gyne-Lotrimin.
  • Competitive Edge: High user satisfaction and effective treatment outcomes give Gyne-Lotrimin a competitive advantage.
  • Pricing and Affordability: Competitive pricing makes the product accessible to a wide range of consumers.
  • Regulatory Favorability: OTC status has increased accessibility and contributed to sales growth.
  • Financial Stability: Consistent sales and revenue growth due to high demand and user satisfaction.

FAQs

Q: What is Gyne-Lotrimin used for? A: Gyne-Lotrimin is used to treat vaginal candida (yeast) infections.

Q: Is Gyne-Lotrimin available over-the-counter? A: Yes, Gyne-Lotrimin is available over-the-counter (OTC).

Q: What are the common side effects of Gyne-Lotrimin? A: Common side effects include vaginal burning, itching, discharge, or other irritation not present before use.

Q: How do I choose between the different dosage forms of Gyne-Lotrimin? A: The choice between cream and suppository forms depends on personal preference and past satisfaction with the dosage form.

Q: Can I use Gyne-Lotrimin with other products like tampons? A: No, it is advised to avoid using Gyne-Lotrimin with tampons as it can absorb the antifungal, compromising its efficacy[2][4].

Sources

  1. Drugs.com: Gyne-Lotrimin vs Monistat 1 Combination Pack Comparison
  2. Mayo Clinic: Antifungal, azole (vaginal route)
  3. Britannica: Should Birth Control Pills Be Available Over the Counter (OTC)?
  4. U.S. Pharmacist: Treating Vaginal Fungal Infections
  5. RxList: Gyne-Lotrimin (Clotrimazole Vaginal Cream)

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