Orange Book Patent Boosts Evofem's SOLOSEC Market Position in Women's Health
- SOLOSEC® is now included in the FDA's Orange Book, extending market exclusivity until December 2041.
- SOLOSEC is the first FDA-approved single-dose treatment for bacterial vaginosis and trichomoniasis.
- Evofem's patent strengthens SOLOSEC's market position and supports ongoing clinical trials for improved treatment outcomes.
Evofem Biosciences Secures New Patent for SOLOSEC, Enhancing Market Position in Women's Health
Evofem Biosciences, Inc. announces the issuance of a significant new patent that fortifies the intellectual property rights surrounding its leading product, SOLOSEC® (secnidazole) 2 g oral granules, extending market exclusivity until December 2041. This patent, now included in the FDA's Orange Book, encompasses innovative claims related to the method, pharmaceutical composition, and usage of SOLOSEC in the treatment of trichomoniasis. With around 6.9 million new cases reported annually in the U.S., the relevance of this patent is underscored by the pressing need for effective treatment options for this common sexually transmitted infection.
The newly granted Patent No. 12,280,037, awarded on April 22, 2025, captures broad claims that highlight the pharmacokinetics and formulation of SOLOSEC. Notably, SOLOSEC stands out as the first and only FDA-approved single-dose oral treatment for both bacterial vaginosis (BV) and trichomoniasis. Saundra Pelletier, CEO of Evofem, articulates the significance of this patent as a key enhancement to the company's portfolio, paving the way for a stronger brand presence. This development is poised to benefit healthcare providers and patients alike, providing a more streamlined treatment option that could lead to improved health outcomes.
In addition to patent advancements, Evofem is actively enrolling patients for a Phase 4 clinical trial, funded by the National Institutes of Health (NIH), to evaluate SOLOSEC's effectiveness and cost-efficiency compared to traditional multi-day metronidazole treatments. The trial tests the hypothesis that SOLOSEC’s single-dose regimen will not only reduce the rates of repeat infections but also prove to be more economical over time, despite the initially higher costs associated with SOLOSEC. This research reflects Evofem's commitment to addressing the unmet needs in women's sexual and reproductive health, aiming to simplify treatment regimens and enhance patient experiences.
Evofem Biosciences continues to focus on innovative solutions tailored to women's health, leveraging its strengthened patent portfolio to solidify its market presence. As the company advances its clinical research and marketing efforts, it remains dedicated to providing effective treatments that respond to the unique challenges faced by women today.