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Lipocine Announces Outcome of Markman Hearing in Patent Infringement Suit Against Clarus
SALT LAKE CITY, March 26, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":" SALT LAKE CITY, March 26, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware has issued a Claim Construction Order post the claim construction hearing (commonly referred to as a \"Markman Hearing\") related to Lipocine's patent infringement lawsuit against Clarus Therapeutics, Inc. (\"Clarus\"). The purpose of a Markman Hearing is to determine the precise meaning of words from patent claims that are in dispute in a patent infringement lawsuit. No ultimate determination of infringement or validity of the patents has been determined at this point. \n\n \n \n \n \n \n \n\n \nThe Markman Hearing Order, issued by the United States District Court of Delaware, has been posted on Lipocine's website at: https://ir.lipocine.com/presentations. \nLipocine has a pending suit against Clarus in the United States District Court of Delaware alleging that Clarus's JATENZO® product infringes Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690; and 9,757,390. \nAbout LipocineLipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, w...