FDA Orange Book Lists New U.S. Patent for SOLOSEC, Evofem Biosciences' "One and Done" Oral Treatment for Bacterial Vaginosis and Trichomoniasis
Evofem Biosciences (OTCID: EVFM) announced that a new U.S. patent for SOLOSEC®, their single-dose oral treatment for bacterial vaginosis and trichomoniasis, has been listed in the FDA Orange Book. The newly listed patent (No. 12,280,037) covers the method, pharmaceutical composition, and use in treating trichomoniasis, extending market exclusivity until December 2041.
SOLOSEC is notable as the first and only FDA-approved single-dose oral treatment for both bacterial vaginosis and trichomoniasis. The company is currently conducting a Phase 4 clinical trial comparing SOLOSEC's effectiveness and cost-effectiveness against metronidazole in treating T. vaginalis infections, which affect an estimated 6.9 million new cases annually in the U.S.
Evofem Biosciences (OTCID: EVFM) ha comunicato che un nuovo brevetto statunitense per SOLOSEC®, il loro trattamento orale monodose per la vaginosi batterica e la tricomoniasi, è stato inserito nell'FDA Orange Book. Il brevetto recentemente registrato (n. 12.280.037) copre il metodo, la composizione farmaceutica e l'uso nel trattamento della tricomoniasi, estendendo l'esclusiva di mercato fino a dicembre 2041.
SOLOSEC è rilevante in quanto il primo e unico trattamento orale monodose approvato dalla FDA sia per la vaginosi batterica che per la tricomoniasi. L'azienda sta conducendo attualmente uno studio clinico di Fase 4 che confronta l'efficacia e la costo-efficacia di SOLOSEC rispetto al metronidazolo nel trattamento delle infezioni da T. vaginalis, che negli Stati Uniti colpiscono circa 6,9 milioni di nuovi casi all'anno.
Evofem Biosciences (OTCID: EVFM) anunció que una nueva patente estadounidense para SOLOSEC®, su tratamiento oral de dosis única para vaginosis bacteriana y tricomoniasis, ha sido incluida en el FDA Orange Book. La patente recién listada (n.º 12.280.037) cubre el método, la composición farmacéutica y el uso en el tratamiento de la tricomoniasis, extendiendo la exclusividad de mercado hasta diciembre de 2041.
SOLOSEC destaca por ser el primer y único tratamiento oral de dosis única aprobado por la FDA tanto para la vaginosis bacteriana como para la tricomoniasis. La compañía está llevando a cabo actualmente un ensayo clínico de Fase 4 que compara la eficacia y la rentabilidad de SOLOSEC frente al metronidazol en el tratamiento de infecciones por T. vaginalis, que se estiman en 6,9 millones de casos nuevos anuales en EE. UU.
Evofem Biosciences (OTCID: EVFM)는 세균성 질염과 트리코모나스증에 대한 단회 투여 경구 치료제 SOLOSEC®의 새로운 미국 특허가 FDA 오렌지북에 등재되었다고 발표했습니다. 신규 등재 특허(번호 12,280,037)는 트리코모나스증 치료에 관한 방법, 약학적 조성물 및 사용을 포함하며 시장 독점 기간을 2041년 12월까지 연장합니다.
SOLOSEC는 세균성 질염과 트리코모나스증 모두에 대해 FDA 승인된 최초이자 유일한 단회 투여 경구 치료제라는 점에서 주목받고 있습니다. 회사는 현재 SOLOSEC의 효과와 비용효과성을 티니다졸 계열인 메트로니다졸과 비교하는 4상 임상시험을 진행 중이며, T. vaginalis 감염은 미국에서 연간 약 690만 건의 신규 사례가 발생하는 것으로 추정됩니다.
Evofem Biosciences (OTCID: EVFM) a annoncé qu'un nouveau brevet américain pour SOLOSEC®, leur traitement oral en dose unique contre la vaginose bactérienne et la trichomonase, a été inscrit dans l'FDA Orange Book. Le brevet récemment listé (n° 12.280.037) couvre la méthode, la composition pharmaceutique et l'utilisation pour le traitement de la trichomonase, prolongeant l'exclusivité commerciale jusqu'en décembre 2041.
SOLOSEC se distingue comme le premier et unique traitement oral en dose unique approuvé par la FDA pour la vaginose bactérienne et la trichomonase. La société mène actuellement un essai clinique de phase 4 comparant l'efficacité et le rapport coût-efficacité de SOLOSEC au métronidazole dans le traitement des infections à T. vaginalis, qui sont estimées à 6,9 millions de nouveaux cas par an aux États-Unis.
Evofem Biosciences (OTCID: EVFM) gab bekannt, dass ein neues US-Patent für SOLOSEC®, ihre einmalige orale Behandlung gegen bakterielle Vaginose und Trichomoniasis, im FDA Orange Book aufgeführt wurde. Das neu eingetragene Patent (Nr. 12.280.037) umfasst das Verfahren, die pharmazeutische Zusammensetzung und die Anwendung zur Behandlung von Trichomoniasis und verlängert die Marktexklusivität bis Dezember 2041.
SOLOSEC ist bemerkenswert als das erste und einzige von der FDA zugelassene orale Einmaldosispräparat sowohl für bakterielle Vaginose als auch für Trichomoniasis. Das Unternehmen führt derzeit eine Phase-4-Studie durch, die die Wirksamkeit und Kosteneffektivität von SOLOSEC gegenüber Metronidazol bei der Behandlung von T.-vaginalis-Infektionen vergleicht, die in den USA schätzungsweise 6,9 Millionen Neufälle pro Jahr verursachen.
- Patent protection and market exclusivity extended to December 2041
- Eleventh Orange Book-listed patent strengthens intellectual property portfolio
- Ongoing Phase 4 trial could demonstrate superior effectiveness over current standard treatment
- First and only single-dose oral treatment FDA-approved for both BV and trichomoniasis
- Trading on OTCID market rather than major exchange
- Higher initial cost compared to existing treatment options
Insights
Evofem's new Orange Book-listed patent extends SOLOSEC's market exclusivity to 2041, strengthening their commercial position for this single-dose treatment.
The newly listed patent (No. 12,280,037) for SOLOSEC represents a significant intellectual property development for Evofem. This patent specifically covers the method, pharmaceutical composition, and use in treating trichomoniasis, extending market exclusivity until December 2041. This considerably lengthens Evofem's commercial runway for their single-dose oral antimicrobial.
Orange Book listings carry substantial weight in the pharmaceutical industry as they effectively block generic competition. With eleven Orange Book-listed patents now covering SOLOSEC, Evofem has built a robust protective barrier around their product. The patent's broad claims centered on pharmacokinetics and formulation features provide comprehensive protection against potential competitors.
SOLOSEC's single-dose administration offers a meaningful advantage over the current standard treatment (metronidazole, taken twice daily for seven days) for trichomoniasis, which affects an estimated 6.9 million new patients annually in the US alone. The ongoing NIH-funded Phase 4 trial comparing SOLOSEC to metronidazole could potentially strengthen SOLOSEC's market position if it demonstrates superior effectiveness and cost-efficiency as hypothesized.
For a company trading on the OTC markets (OTCID: EVFM), securing long-term patent protection is particularly valuable as it provides stability and predictable revenue potential, which could support efforts to eventually uplist to major exchanges. This patent extension essentially gives Evofem nearly 16 more years of market exclusivity for SOLOSEC's trichomoniasis indication.
-- Evofem now holds eleven Orange Book - listed patents covering SOLOSEC into late 2041 --
"The Orange Book listing of this patent covering SOLOSEC's method, pharmaceutical composition, and use in trichomoniasis is an important step in further strengthening our patent portfolio," said Evofem Biosciences CEO Saundra Pelletier. "The patent itself extends SOLOSEC's intellectual property and market exclusivity into December 2041, which significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand – the first and only single-dose oral treatment FDA-approved to treat BV as well as trichomoniasis – in the
The newly listed
Trichomoniasis is the most common non-viral sexually transmitted infection in the world. There are an estimated 6.9 million new infections with T. vaginalis in the
Patient recruitment is underway in an investigator-led, NIH-funded Phase 4 clinical trial evaluating the effectiveness and cost-effectiveness of SOLOSEC (single-dose, one time) versus metronidazole (twice daily for seven days) for the treatment of T. vaginalis in men and women. Study investigators hypothesize that the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. 2
About Evofem Biosciences
Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company generates revenue from the sale of two FDA-approved products.
- PHEXXI® (lactic acid, citric acid, and potassium bitartrate), is the first and only hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Visit phexxi.com to learn more and for important safety information.
- SOLOSEC® (secnidazole) 2g oral granules is an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Visit solosec.com to learn more and for important safety information.
Evofem filed a preliminary proxy on July 24, 2025 regarding its planned Special Meeting of Stockholders at which stockholders of record may vote on a proposal to approve the transactions contemplated under the A&R Merger Agreement between the Company, Aditxt, Inc. (NASDAQ: ADTX) and Adifem, Inc., a wholly owned subsidiary of Aditxt. Under the A&R Merger Agreement, Adifem will merge with and into the Company, with Evofem surviving as a wholly owned subsidiary of Aditxt. A definitive proxy filing is expected in a few weeks.
PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
Sources
- Kreisel KM et al. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018. Sex Transm Dis. 2021 Apr 1;48(4):208-214. doi: 10.1097/OLQ.0000000000001355. PMID: 33492089; PMCID: PMC10245608.
- National Institute of Allergy & Infectious Diseases (NIAID) of the National Institutes of Health. Award number R01AI183266: Refining Trichomonas vaginalis treatment in women and men.
Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "anticipate," "aim," "believe," "contemplate," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to anticipated timing of the definitive proxy filing regarding the planned Special Meeting of Stockholders. The closing of the transactions with Evofem, Aditxt and Adifem, Inc., contemplated by the A&R Merger Agreement are subject to several conditions including, but not limited to, 1) approval of the transactions by a majority of the combined voting power of Evofem's E-1 and Common Stock, voting together as a single class, at a meeting where quorum is present, and 2) Aditxt raising sufficient capital to fund its closing obligations, notably a cash payment of approximately
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FAQ
When does Evofem's new SOLOSEC patent expire?
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