NORTHBROOK, Illinois, Nov 2, 2015 — Clarus Therapeutics, Inc. today filed a lawsuit against Lipocine, Inc. for infringing a Clarus patent, namely U.S. Patent 8,828,428 (“the ‘428 patent”) entitled “Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same.”

This lawsuit, filed in the U.S. District Court in Delaware, asserts that the ‘428 patent covers Lipocine’s LPCN 1021 product, an oral product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

Lipocine announced on October 29, 2015, that the U.S. Food and Drug Administration had accepted for filing Lipocine’s NDA which seeks FDA approval of LPCN 1021. Clarus seeks an injunction to prevent the commercial manufacture, use and sale of Lipocine’s LPCN 1021 product.

About Clarus Therapeutics, Inc.

Clarus is a privately held men’s specialty pharmaceutical company focused on the development and commercialization an oral testosterone replacement therapy and has a pending NDA on file with the FDA seeking approval to market its own oral testosterone replacement product. If approved, the Clarus product will offer patients and prescribing physicians a novel oral testosterone replacement option to restore testosterone levels.

The company is headquartered in Northbrook, Ill. For more information, please visit