Clarus Therapeutics, Lipocine endocrine/metabolic, drug delivery news
Clarus said the U.S. District Court for the District of Delaware dismissed a patent infringement lawsuit the company filed against Lipocine. The case argued that Lipocine’s LPCN 1021 testosterone replacement therapy infringed U.S. Patent No. 8,828,428 that is related to its Jatenzo testosterone therapy. Clarus said that the court found no immediate reason to hear the case after Lipocine failed to secure FDA approval for LPCN 1021 this summer. Both products are twice-daily oral formulations of testosterone undecanoate designed to prolong and promote systemic absorption in men with hypogonadism.
In late June, FDA issued a complete response letter for LPCN 1021. At the time, Lipocine said that FDA identified problems with the company’s proposed dose titration scheme for clinical practice, which “significantly differed” from the scheme used in a Phase III trial. ...