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Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire
Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire.
About this update from Evofem Biosciences, Inc.
[{"type":"text","content":"\n\n\n\nEvofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\nEvofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire\nPR Newswire\nSAN DIEGO, Sept. 27, 2023\n\n\n\n-- Padagis Determined They Will Not Challenge the Phexxi Patents -- \n -- Evofem Has Phexxi Patent Protection Through 2033 -- \nSAN DIEGO, Sept. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that Padagis Israel Pharmaceuticals Ltd. (Padagis) has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application (ANDA) for a generic version of Phexxi® (lactic acid, citric acid and potassium bitartrate) and has instead converted to a Paragraph III certification. With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA. The latest-expiring Phexxi patents do not expire until 2033.\n\n \n \n \n \n \n \n\n \nPadagis previously submitted its ANDA in April 2023 requesting permission to manufacture and market a generic version of Phexxi. That ANDA contained a Paragraph IV certification, in response to which Evofem initiated patent infringement litigation against Padagis. As a result of its conversion to a Paragraph III certification, Padagis is effectively no longer challenging the Phexxi Patents; accordingly, the parties have submitted a stipulation to dismiss the case.\nPhexxi 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 ex...