NORTHBROOK, Ill – April 3, 2019 – Clarus Therapeutics, Inc. today announced that it will vigorously defend itself against an action brought by Lipocine, Inc. for patent infringement. Based on a complaint filed in the U. S. District Court for the District of Delaware, Lipocine asserts that Clarus’s intent to market and sell JATENZO®, its oral testosterone replacement therapy recently approved by the U. S. Food and Drug Administration, infringes U.S. Patent Nos. 9,034,858; 9,025,057; 9,480,690; 9,757,390; 6,569,463; and 6,923,988.

“Clarus firmly believes that its actions related to JATENZO® do not infringe any of the Lipocine patents,” said Dr. Robert E. Dudley, President and Chief Executive Officer. “When the facts are brought before the court, we are confident that Lipocine’s assertions will be found to be without merit.”


JATENZO®, a first-in-class proprietary softgel oral formulation of testosterone undecanoate for testosterone replacement therapy in certain adult males, is protected by patents issued in the United States and in other major pharmaceutical markets around the world. JATENZO® is the first oral testosterone pro-drug approved by FDA to treat men diagnosed with hypogonadism associated with structural and genetic etiologies. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO®. For more information, please visit:

About Clarus Therapeutics, Inc.

Clarus is a men’s specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO®.