Women’s Productive Health Innovator Fends off Generic ANDA Challenge
Congratulations to client Evofem Biosciences on successfully fending off a generic company’s challenge to key patents, ensuring continued patent protection for its hormone-free prescription birth control gel Phexxi® until 2033. Padagis Israel Pharmaceuticals Ltd. has withdrawn its Abbreviated New Drug Application (ANDA) for a generic version of FDA-approved Phexxi and has instead converted to a Paragraph III certification, meaning it won’t challenge Evofem’s patents and will ask the U.S. Food and Drug Administration to wait until all Phexxi patents expire before issuing final ANDA approval.
Procopio IP Litigation Partners Jeremy Edwards and Steve Maddox served as litigation counsel for Evofem’s patent litigation. IP Partner Xiaofan “Frank” Yang, PhD, performs the strategic planning and implementation of Evofem’s Orange Book patent portfolio covering Phexxi and counseled Evofem during its successful patent defense, and Partner Dennis Doucette provides corporate law services.
Phexxi is currently protected by four patents, each of which are listed in the FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.” All four patents would need to expire or be deemed invalid or not infringed before a generic version of Phexxi could be marketed.
Evofem is commercializing innovative products to address unmet needs in women’s sexual and reproductive health. Phexxi, is a hormone-free, on-demand prescription contraceptive vaginal gel. Learn more in Evofem’s press release.