GYNE-LOTRIMIN Drug Patent Profile

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

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

The generic ingredient in GYNE-LOTRIMIN 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

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

Summary for GYNE-LOTRIMIN

US Patents:	0
Applicants:	1
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	4
Patent Applications:	3,878
DailyMed Link:	GYNE-LOTRIMIN at DailyMed

Recent Clinical Trials for GYNE-LOTRIMIN

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

Sponsor	Phase
Bayer	Phase 3
Taro Pharmaceuticals USA	Phase 1

See all GYNE-LOTRIMIN clinical trials

US Patents and Regulatory Information for GYNE-LOTRIMIN

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	clotrimazole	CREAM;VAGINAL	018052-002	Nov 30, 1990		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN 3	clotrimazole	TABLET;VAGINAL	020525-001	Jul 29, 1996		DISCN	Yes	No
Bayer Healthcare Llc	GYNE-LOTRIMIN	clotrimazole	TABLET;VAGINAL	017717-002	Nov 30, 1990		DISCN	Yes	No

International Patents for GYNE-LOTRIMIN

See the table below for patents covering GYNE-LOTRIMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	370074
Sweden	341633
Germany	1670932

GYNE-LOTRIMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gyne-Lotrimin

Introduction to Gyne-Lotrimin

Gyne-Lotrimin, containing the active ingredient Clotrimazole, is a widely used antifungal medication primarily for treating vaginal yeast infections (candidiasis). This medication is available over-the-counter and is known for its effectiveness in relieving symptoms such as itching, burning, and abnormal discharge associated with vaginal yeast infections[2].

Market Share and Dominance

In the vaginal yeast infection treatment category, Gyne-Lotrimin has maintained a significant market share. As of 1994, Gyne-Lotrimin held a 21.7% share of the market, second only to Monistat 7, which had a 46.2% share. Despite the entry of lower-priced competitors, Gyne-Lotrimin and Monistat 7 together accounted for 67.9% of the $87.5 million market in food stores[1].

Brand Loyalty and Consumer Preference

Brand loyalty plays a crucial role in the vaginal yeast infection treatment market. Consumers who have used Gyne-Lotrimin, especially those who were previously prescribed the medication, tend to stick with the brand due to its proven effectiveness and trust in the product. Pharmacists often recommend Gyne-Lotrimin based on its strong reputation and consumer satisfaction[1].

Competitive Landscape

The market for vaginal yeast infection treatments is competitive, with several brands vying for market share. While Gyne-Lotrimin and Monistat 7 are the market leaders, other brands like Mycelex-7 and FemCare have also gained traction, particularly in price-conscious markets. Mycelex-7, for example, saw a 159% increase in sales in one year, highlighting the impact of pricing strategies on market dynamics[1].

Financial Performance

The financial performance of Gyne-Lotrimin has seen some fluctuations. In the 12 months ending in February 1994, Gyne-Lotrimin's dollar volume plummeted by 20%, despite its strong market share. This decline was partly due to the increasing competition from lower-priced alternatives[1].

Global Candidiasis Drugs Market

The broader global candidiasis drugs market, which includes treatments for various types of candidiasis, is expected to grow. This market is projected to increase by USD 638.67 million during the period from 2019 to 2023, with a CAGR of almost 4%. The growth is driven by rising awareness about candidiasis and advances in the diagnosis of antifungal-resistant pathogens[3].

Clotrimazole Market Outlook

The Clotrimazole market, which includes Gyne-Lotrimin, is anticipated to grow significantly. By 2030, the Clotrimazole market is estimated to reach $4.2 billion, growing at a CAGR of 6.2% from 2024 to 2030. This growth is fueled by the increasing prevalence of diseases such as vaginitis and athlete’s foot, as well as the expanding application of Clotrimazole in various forms of disease treatment[4].

Sales Channels and Distribution

The distribution of Gyne-Lotrimin and other Clotrimazole products is evolving, with online pharmacies becoming a significant sales channel. Online pharmacies are expected to be the fastest-growing segment in the Clotrimazole market, offering consumers convenient access to these medications at competitive prices[4].

Challenges and Opportunities

Despite its strong market position, Gyne-Lotrimin faces challenges from lower-priced competitors and the potential for private-label products. However, the brand's reputation and consumer loyalty provide a solid foundation for continued market presence. The growing awareness about candidiasis and the increasing demand for effective treatments present opportunities for Gyne-Lotrimin to maintain and potentially expand its market share[1][3].

Key Players and Market Competition

The market for antifungal medications, including Gyne-Lotrimin, is competitive with several key players such as Bayer AG, Novartis AG, and others. These companies invest in research and development to improve existing products and expand their product portfolios, which can impact the market dynamics and financial trajectory of Gyne-Lotrimin[4].

Consumer Feedback and Effectiveness

Consumer feedback on Gyne-Lotrimin is generally positive, with many users reporting quick and effective relief from symptoms. For example, a user named Lisa McLean shared her experience of using Gyne-Lotrimin cream, highlighting its ease of use and effectiveness in treating her vaginal yeast infection[2].

Side Effects and Precautions

While Gyne-Lotrimin is generally well-tolerated, it can cause side effects such as vaginal irritation, itching, or burning. It is crucial for users to follow the instructions provided and consult a healthcare professional if symptoms persist or worsen[2][5].

Key Takeaways

• Market Share: Gyne-Lotrimin holds a significant market share in the vaginal yeast infection treatment category.
• Brand Loyalty: Consumer loyalty is a critical factor in maintaining market share.
• Financial Performance: Despite market share, Gyne-Lotrimin's dollar volume has seen fluctuations due to competition.
• Market Growth: The broader candidiasis drugs market and Clotrimazole market are expected to grow significantly.
• Sales Channels: Online pharmacies are becoming a key sales channel.
• Challenges and Opportunities: Gyne-Lotrimin faces competition but has opportunities for growth due to increasing demand for effective treatments.

Frequently Asked Questions

What is Gyne-Lotrimin used for?

Gyne-Lotrimin is used primarily to treat vaginal yeast infections (candidiasis). It contains the active ingredient Clotrimazole, which is an antifungal agent[2].

How effective is Gyne-Lotrimin?

Gyne-Lotrimin is highly effective in relieving symptoms such as itching, burning, and abnormal discharge associated with vaginal yeast infections. Many users report quick and effective relief from symptoms[2].

What are the common side effects of Gyne-Lotrimin?

Common side effects include vaginal irritation, itching, or burning. More severe reactions such as swelling, severe itching, or difficulty breathing require medical attention[2][5].

Can Gyne-Lotrimin be purchased online?

Yes, Gyne-Lotrimin can be purchased online from various pharmacies, offering consumers convenient access to the medication at competitive prices[2][4].

Is Gyne-Lotrimin available over-the-counter?

Yes, Gyne-Lotrimin is available over-the-counter, making it accessible for those seeking prompt relief from fungal infections without needing a prescription[2].

Cited Sources

1. Supermarket News: "A Personal Decision" by Michael Slezak.
2. Houston Foot Specialists: "Gyne-Lotrimin (Clotrimazole) 15g Cream".
3. Marketscreener: "Global Candidiasis Drugs Market 2019-2023 | Evolving Opportunities with Astellas Pharma and Bayer".
4. IndustryARC: "Clotrimazole Market - Forecast(2017-2025) Research Report".
5. Cleveland Clinic: "Clotrimazole vaginal cream".