Padagis will not seek FDA approval for generic Phexxi until Evofem's patents expire
Evofem Biosciences announced that Padagis has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application for a generic version of Phexxi (lactic acid, citric acid and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 Food and Drug Administration 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.
Padagis 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.
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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.
Phexxi s a hormone free birth control prescription vaginal gel that is FDA approved to prevent pregnancy.
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