Evofem Biosciences, Inc., announced that two US patents which cover Phexxi (lactic acid, citric acid and potassium bitartrate) and its labeled indication are now listed in the US Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.Phexxi is the first and only FDA-approved, non-hormonal contraceptive vaginal gel that is designed to be used immediately before or up to an hour before intercourse. It was approved in May 2020 and is now available in the US by prescription. Phexxi works to maintain vaginal pH, which reduces sperm mobility, lowering the chance of sperm reaching the egg."The Orange Book listing of these two patents covering Phexxi's composition of matter and its method of use in prevention of pregnancy is an important step in the ongoing development of our patent portfolio, which currently covers Phexxi into 2033," said Evofem Biosciences CEO Saundra Pelletier. "We plan to further expand our intellectual property estate as we continue to develop and iterate our vaginal pH modulator platform for additional unmet medical needs, including the prevention of chlamydia and gonorrhea in women and other potential indications."The newly listed method of use patent, number 10,568,855 (the '855 patent), covers contraception using the L-Lactic Acid Phexxi formulation. The '855 patent was issued by the US Patent and Trademark Office (USPTO) on February 25, 2020 and is expected to expire in March 2033.The newly listed patent number 6,706,276 (the '276 patent) is a composition of matter patent covering Phexxi. Evofem has an exclusive license to this patent, which is held by Rush University. The '276 patent was issued by the USPTO on March 16, 2004, and is expected to expire in March 2026 based on the five-year patent term extension application that was timely filed by the patent owner.Phexxi (lactic acid, citric acid, and potassium bitartrate) is a prescription vaginal gel used to prevent pregnancy in females who choose to use an on-demand method of birth control. Phexxi is only effective when used immediately before (or up to one hour before) each act of vaginal sex. Phexxi is not effective when used after vaginal sex.Evofem Biosciences, Inc., is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs).
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