Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 118

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 118
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 subject to any extensions or disclaimers.

Under the terms of the Douglas license agreement, we are the exclusive licensee of four granted U.S. patents and four pending U.S. patent applications. The granted patents are expected to expire in 2034 or 2039, including any patent term adjustment, extensions or disclaimers, and the U.S. applications, if granted, are expected to have patent terms that expire in 2039 and 2040.

We also rely upon trade secret rights to protect our product candidates as well as other technologies that may be used to discover, validate and commercialize our current or any future product candidates. We presently seek protection, in part, through confidentiality and proprietary information agreements.

Trademarks

We hold a domestic registration for the trademark Daré Bioscience and our registration for the XACIATO trademark in the U.S. is pending. In accordance with the terms of the ADVA-Tec license agreement, we are the exclusive licensee of the Ovaprene registered trademark.

Competition 

We are solely focused on women’s health. Women’s health is a broad category that encompasses health conditions that are unique to women, as well as conditions that affect both men and women, but that may affect women differently. Women’s health products include drug, medical device, cosmetic and dietary supplement products, and generally are products designed for post-pubescent females. The women’s health sector is very fragmented, highly competitive and subject to rapid and significant change. We anticipate that our product candidates may compete not only with FDA-approved, prescription and over-the-counter, branded and generic drug products, but also compounded drug products, medical devices, dietary supplements, and cosmetics. We face and will continue to face intense competition from a variety of businesses, including large, fully integrated, well-established pharmaceutical companies and specialty pharmaceutical companies that already possess a significant share of the women’s health market, as well as generics manufacturers, compounding pharmacies and other drug compounding facilities, and dietary supplements manufacturers. In addition, academic and other research institutions are and could be engaged in research and development efforts for products in the therapeutic areas targeted by our product candidates. Our success is highly dependent upon our ability to acquire or in-license, develop and obtain regulatory approval for innovative products on a cost-effective basis and to market them successfully, either on our own or together with strategic partners, or to make our proprietary formulations available as compounded drugs. Many of our potential competitors have greater clinical, regulatory, manufacturing, marketing, distribution, compliance and financial 

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