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Last Updated: December 22, 2024

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-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 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

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

SponsorPhase
BayerPhase 3
Taro Pharmaceuticals USAPhase 1

See all GYNE-LOTRIMIN 3 COMBINATION PACK clinical trials

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 ⤷  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 COMBINATION PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gyne-Lotrimin 3 Combination Pack

Introduction to Gyne-Lotrimin 3 Combination Pack

Gyne-Lotrimin 3 Combination Pack is a widely used over-the-counter (OTC) antifungal medication designed to treat vaginal yeast infections. The product contains clotrimazole, a potent antifungal agent, and is available in various formulations, including creams and suppositories.

Historical Context and FDA Approval

The FDA approval for the Rx-to-OTC switch of vaginal antifungals in the early 1990s marked a significant milestone in self-care for women. This transition allowed products like Gyne-Lotrimin to be sold without a prescription, making them more accessible to the general public. However, this shift also led to unexpected demand, resulting in national shortages of products like Gyne-Lotrimin 7 and Monistat 7 in the late 1990s[1].

Market Demand and Consumer Behavior

The demand for OTC vaginal antifungals has been driven by the recurrent nature of vaginal yeast infections (VVC) and the convenience of self-treatment. Many women prefer to treat these infections without consulting a physician, leading to a high demand for products like Gyne-Lotrimin 3. Consumers often purchase multiple packages at once, anticipating future episodes and valuing the convenience of having the medication readily available[1].

Product Offerings and Formulations

Gyne-Lotrimin 3 Combination Pack includes a 0.74 oz (21 g) tube of 2% clotrimazole vaginal cream and three disposable applicators. This 3-day treatment is designed to cure most vaginal yeast infections and is preferred by many due to its shorter treatment duration compared to 7-day treatments. The product also comes with an educational brochure to guide users through the treatment process[4].

Competitive Landscape

The market for OTC vaginal antifungals is competitive, with several products available, including Vagistat-3 Combination Pack and Monistat 3 Cream. Each product offers similar formulations but may differ in active ingredients (e.g., miconazole vs. clotrimazole) and application methods (suppositories, creams, or combination packs)[1].

Pricing and Accessibility

The pricing of Gyne-Lotrimin 3 Combination Pack is generally competitive within the market. A single treatment pack is typically priced affordably, making it accessible to a wide range of consumers. The convenience and effectiveness of the product contribute to its market appeal and financial stability[4].

Role of Pharmacists

Pharmacists play a crucial role in the sale and use of Gyne-Lotrimin 3. They provide valuable advice on product selection, usage, and potential interactions with other medications. The presence of a pharmacist at the point of sale adds significant value by helping patients understand the labeling, warnings, and contraindications associated with the product[1].

Usage Instructions and Precautions

To ensure effective treatment, users are advised to insert the cream or suppository at night to maximize contact time with the vaginal mucosa and reduce the risk of accidental ejection or leakage. It is also recommended to avoid using tampons during treatment, as they can absorb the antifungal medication and compromise its efficacy. Sanitary pads can help absorb any leakage and protect clothing[1][2].

Warnings and Contraindications

Gyne-Lotrimin 3 comes with several warnings and contraindications. Users should not use the product if they experience abdominal pain, fever, or foul-smelling vaginal discharge, as these symptoms may indicate a more serious condition. First-time users with vaginal itch and discomfort should consult a doctor before using the product. Additionally, the product should not be used during pregnancy without medical supervision[2].

Impact on Birth Control

It is important to note that clotrimazole vaginal cream may reduce the effectiveness of certain birth control methods, such as condoms, diaphragms, or vaginal spermicides. Users should be aware of these potential interactions to ensure their contraceptive methods remain effective[2].

Financial Trajectory

The financial trajectory of Gyne-Lotrimin 3 Combination Pack has been stable and profitable due to its widespread use and high demand. The product's affordability and effectiveness contribute to its market success. The recurring nature of vaginal yeast infections ensures a consistent customer base, which in turn supports the financial health of the product.

Revenue and Sales

The revenue generated from Gyne-Lotrimin 3 is substantial, driven by its popularity and the frequent need for treatment among women. Sales figures are consistently high, reflecting the product's position as a leading OTC antifungal treatment.

Market Share

Gyne-Lotrimin 3 holds a significant market share in the OTC vaginal antifungal market. Its brand recognition and trust among consumers contribute to its market dominance.

Future Outlook

The future outlook for Gyne-Lotrimin 3 remains positive. With the ongoing demand for self-treatment options and the product's proven efficacy, it is likely to continue as a market leader. Advances in marketing and distribution strategies, as well as potential expansions into new markets, could further enhance its financial performance.

Key Takeaways

  • Market Demand: High demand driven by the recurrent nature of vaginal yeast infections.
  • Product Formulations: Available in 3-day and 7-day treatments, with various application methods.
  • Competitive Landscape: Competitive market with several similar products.
  • Pricing and Accessibility: Affordably priced, making it accessible to a wide range of consumers.
  • Role of Pharmacists: Crucial in providing advice and ensuring proper use.
  • Usage Instructions and Precautions: Specific instructions to ensure efficacy and safety.
  • Financial Trajectory: Stable and profitable due to high demand and recurring need for treatment.

FAQs

Q: What is Gyne-Lotrimin 3 Combination Pack used for?

A: Gyne-Lotrimin 3 Combination Pack is used to treat vaginal yeast infections caused by Candida.

Q: How do I use Gyne-Lotrimin 3?

A: Insert one applicatorful of cream into the vagina every night for 3 consecutive nights. Avoid using tampons during treatment.

Q: Can I use Gyne-Lotrimin 3 during pregnancy?

A: No, Gyne-Lotrimin 3 should not be used during pregnancy except under the advice and supervision of a doctor.

Q: Does Gyne-Lotrimin 3 affect birth control methods?

A: Yes, it may reduce the effectiveness of certain birth control methods such as condoms, diaphragms, or vaginal spermicides.

Q: What if my symptoms do not improve within 3 days?

A: If there is no improvement within 3 days, you may have a condition other than a yeast infection. Stop using the product and see your doctor.

Sources

  1. U.S. Pharmacist - Treating Vaginal Fungal Infections
  2. RxList - Gyne-Lotrimin (Clotrimazole Vaginal Cream)
  3. Britannica - Should Birth Control Pills Be Available Over the Counter (OTC)?
  4. Northgate Pronto - Gyne Lotrimin Vaginal Cream, 3 Day Treatment 1 ea
  5. FDA - 20-574 Gyne Lotrimin Final Print Label

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