Evofem Strengthens SOLOSEC Intellectual Property with New U.S. Patent from USPTO
Evofem Biosciences (OTCQB: EVFM) has received a Notice of Allowance from the USPTO for a new patent application related to SOLOSEC®, extending its intellectual property protection until 2040. The patent covers the treatment of trichomoniasis with SOLOSEC® 2g oral granules, focusing on pharmacokinetics and formulation features.
SOLOSEC® is the first and only single-dose oral antibiotic FDA-approved for treating both bacterial vaginosis in females and trichomoniasis in people 12 years and older. The company acquired global rights to the product in July 2024 and relaunched it in the U.S. in November 2024.
The patent extension provides an additional five years of protection beyond the previous 2035 expiration. Trichomoniasis, affecting an estimated 6.9 million new cases annually in the U.S., is the most common non-viral sexually transmitted infection globally.
Evofem Biosciences (OTCQB: EVFM) ha ricevuto un Avviso di Concessione dall'USPTO per una nuova domanda di brevetto relativa a SOLOSEC®, estendendo la protezione della sua proprietà intellettuale fino al 2040. Il brevetto copre il trattamento della trichomoniasi con le granule orali SOLOSEC® 2g, concentrandosi sulle caratteristiche farmacocinetiche e di formulazione.
SOLOSEC® è il primo e unico antibiotico orale a dose singola approvato dalla FDA per il trattamento sia della vaginosi batterica nelle donne che della trichomoniasi nelle persone di 12 anni e oltre. L'azienda ha acquisito i diritti globali sul prodotto nel luglio 2024 e lo ha rilanciato negli Stati Uniti nel novembre 2024.
L'estensione del brevetto fornisce cinque anni aggiuntivi di protezione oltre alla scadenza precedente del 2035. La trichomoniasi, che colpisce circa 6,9 milioni di nuovi casi ogni anno negli Stati Uniti, è l'infezione sessualmente trasmissibile non virale più comune a livello globale.
Evofem Biosciences (OTCQB: EVFM) ha recibido un Aviso de Concesión de la USPTO para una nueva solicitud de patente relacionada con SOLOSEC®, extendiendo su protección de propiedad intelectual hasta 2040. La patente cubre el tratamiento de la tricomoniasis con gránulos orales de SOLOSEC® 2g, enfocándose en las características farmacocinéticas y de formulación.
SOLOSEC® es el primer y único antibiótico oral de dosis única aprobado por la FDA para tratar tanto la vaginosis bacteriana en mujeres como la tricomoniasis en personas de 12 años o más. La compañía adquirió los derechos globales sobre el producto en julio de 2024 y lo relanzó en EE.UU. en noviembre de 2024.
La extensión de la patente proporciona cinco años adicionales de protección más allá de la fecha de caducidad anterior de 2035. La tricomoniasis, que afecta a aproximadamente 6,9 millones de nuevos casos anuales en EE.UU., es la infección de transmisión sexual no viral más común a nivel mundial.
에보펨 바이오사이언스 (OTCQB: EVFM)는 SOLOSEC®와 관련된 새로운 특허 출원에 대해 USPTO로부터 허가 통지를 받았으며, 이는 지적 재산 보호를 2040년까지 연장합니다. 이 특허는 SOLOSEC® 2g 경구용 과립을 사용한 트리코모나스증 치료를 다루며, 약리학적 특성과 제형 특징에 중점을 두고 있습니다.
SOLOSEC®는 여성의 세균성 질염과 12세 이상의 사람의 트리코모나스증을 치료하기 위해 FDA에서 승인된 유일한 단일 복용량 경구 항생제입니다. 이 회사는 2024년 7월에 이 제품의 전 세계 권리를 인수하였고, 2024년 11월에 미국에서 재출시했습니다.
특허 연장은 이전의 2035년 만료일에서 5년 추가 보호를 제공합니다. 트리코모나스증은 미국에서 매년 약 690만 건의 새로운 사례에 영향을 미치며, 전 세계에서 가장 흔한 비바이러스 성 성병입니다.
Evofem Biosciences (OTCQB: EVFM) a reçu un Avis de Concession de l'USPTO pour une nouvelle demande de brevet liée à SOLOSEC®, prolongeant ainsi sa protection de propriété intellectuelle jusqu'en 2040. Le brevet couvre le traitement de la trichomonase avec des granules oraux SOLOSEC® 2g, en mettant l'accent sur les caractéristiques pharmacocinétiques et de formulation.
SOLOSEC® est le premier et unique antibiotique oral à dose unique approuvé par la FDA pour traiter à la fois la vaginose bactérienne chez les femmes et la trichomonase chez les personnes de 12 ans et plus. L'entreprise a acquis les droits mondiaux sur le produit en juillet 2024 et l'a relancé aux États-Unis en novembre 2024.
L'extension du brevet offre cinq années supplémentaires de protection au-delà de l'expiration précédente de 2035. La trichomonase, touchant environ 6,9 millions de nouveaux cas chaque année aux États-Unis, est l'infection sexuellement transmissible non virale la plus courante au monde.
Evofem Biosciences (OTCQB: EVFM) hat eine Erlaubnisbenachrichtigung vom USPTO für einen neuen Patentantrag in Bezug auf SOLOSEC® erhalten, wodurch der Schutz des geistigen Eigentums bis 2040 verlängert wird. Das Patent umfasst die Behandlung von Trichomoniasis mit SOLOSEC® 2g Granulat, wobei der Fokus auf den pharmakokinetischen Eigenschaften und der Formulierung liegt.
SOLOSEC® ist das erste und einzige einmalige orale Antibiotikum, das von der FDA zur Behandlung von bakterieller Vaginose bei Frauen und Trichomoniasis bei Personen ab 12 Jahren zugelassen wurde. Das Unternehmen erwarb im Juli 2024 die globalen Rechte an dem Produkt und brachte es im November 2024 erneut auf den Markt.
Die Patenterweiterung bietet fünf zusätzliche Jahre Schutz über das vorherige Ablaufdatum von 2035 hinaus. Trichomoniasis, die schätzungsweise 6,9 Millionen neue Fälle jährlich in den USA betrifft, ist die häufigste nicht-virale sexuell übertragbare Infektion weltweit.
- Patent protection for SOLOSEC extended by 5 years to 2040
- Patent is Orange Book-listable
- Single-dose treatment advantage in a market with compliance challenges
- Large market potential with 6.9M new trichomoniasis cases annually in the U.S.
- None.
-- Allowed Patent Extends SOLOSEC IP to 2040 with Broad Claims that are Orange Book-listable --
"This new
The allowed patent application is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC® (secnidazole) 2 g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Evofem expects the resulting patent will be Orange Book-listable.
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
SOLOSEC is the first and only single-dose oral antibiotic FDA-approved to treat bacterial vaginosis (BV) in females 12 years of age and older as well as trichomoniasis in people 12 years of age and older. Evofem acquired global rights to the product in July 2024 and relaunched SOLOSEC in the
About Trichomoniasis
Trichomoniasis (or "Trich") is a sexually transmitted infection (STI) caused by infection with Trichomonas vaginalis, a protozoan parasite. It is the most common nonviral STI globally. Up to
In women, Trich can cause a foul-smelling vaginal discharge, genital itching, and pain with urination or sex. Trich is also associated with an increased risk for cervical cancer, HIV acquisition, and, among women with HIV infection, pelvic inflammatory disease (PID). Pregnant women who have Trich may be at higher risk of delivering their babies prematurely.
Men who have Trich typically have no symptoms, however when men do have symptoms these may include itching or irritation inside the penis, burning with urination or after ejaculation, and discharge from the penis.2
About Evofem Biosciences
Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, PHEXXI® (lactic acid, citric acid, and potassium bitartrate), is a 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.
In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, 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.
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PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
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. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended September 30, 2024 filed with the SEC on November 14, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.
Contact
Amy Raskopf, Chief Business Development Officer
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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.
- Mayo Clinic. Diseases & Conditions: Trichomoniasis. 17 May 2022. Accessed 5 Nov 2024 at https://www.mayoclinic.org/diseases-conditions/trichomoniasis/symptoms-causes/syc-20378609.
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SOURCE Evofem Biosciences, Inc.
FAQ
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