Evofem Strengthens SOLOSEC IP with New U.S. Patent

Evofem Biosciences, Inc. (OTCQB: EVFM) has received a significant boost to its intellectual property portfolio with a new U.S. patent from the United States Patent and Trademark Office (USPTO). The patent, titled "Method and Pharmaceutical Composition for Treating or Preventing Trichomoniasis and Uses Thereof," extends the company's protection for its SOLOSEC® product until 2040, providing an additional five years beyond the previous expiration date of 2035.

The new patent covers the treatment of trichomoniasis with SOLOSEC® 2g oral granules, focusing on pharmacokinetics and formulation features. This extension is expected to result in the issuance of a U.S. patent once administrative processes are completed. The allowed patent application is directed to treating Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC® (secnidazole) 2g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Evofem expects the resulting patent to be Orange Book-listable.

Trichomoniasis is the most common non-viral sexually transmitted infection (STI) globally, with an estimated 6.9 million new infections with T. vaginalis in the U.S. each year. The infection is often undiagnosed and untreated, contributing to the spread of the disease and its associated complications. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take, with one oral dose containing a complete course of treatment.



Evofem acquired global rights to SOLOSEC® in July 2024 and relaunched the product in the U.S. in November 2024. The company's women's health-focused commercial team is now promoting SOLOSEC® as the first and only single-dose oral antibiotic FDA-approved to treat both bacterial vaginosis (BV) in females 12 years of age and older and trichomoniasis in people 12 years of age and older.

Saundra Pelletier, Chief Executive Officer of Evofem, expressed her enthusiasm about the new patent: "This new U.S. patent extends SOLOSEC's IP protection by a full five years, from 2035 to 2040. This extension, for the treatment of trichomoniasis, significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand with its single-dose regimen."

The extended patent protection for SOLOSEC® provides Evofem with several strategic advantages:

1. Market exclusivity: With the extended patent, Evofem maintains its market leadership in the treatment of bacterial vaginosis and trichomoniasis, preserving its market share and dominance in these therapeutic areas.
2. Investment in marketing and brand building: The additional five years of protection enables Evofem to invest more resources in marketing and building the SOLOSEC® brand, further solidifying its position in the market and increasing patient awareness and prescriber preference for the product.
3. Revenue stream protection: The extended patent ensures that Evofem can continue to generate revenue from SOLOSEC® sales without facing competition from generic alternatives until 2040. This stability in revenue allows the company to reinvest in research and development, expand its product portfolio, and maintain its financial health.
4. Investor attraction: The extended patent protection provides a longer runway for Evofem to build value for its investors, as the company can now expect to generate revenue from SOLOSEC® sales for an additional five years. This increased potential for returns may attract more investors to the company.

In conclusion, Evofem Biosciences' new U.S. patent for SOLOSEC® strengthens the company's intellectual property portfolio and provides strategic advantages in the market for treating bacterial vaginosis and trichomoniasis. The extended patent protection allows Evofem to maintain market exclusivity, invest in marketing and brand building, protect its revenue stream, and attract investors. With this new patent, Evofem is well-positioned to continue its growth and success in the women's health market.