Court dismissed lawsuit due to lack of FDA approval for LPCN-1021 and not on merits of case

Clarus will be allowed to refile its lawsuit, if necessary

NORTHBROOK, Ill. – October 13, 2016 Clarus Therapeutics, Inc. (“Clarus” or the “Company”) today reported that its patent infringement lawsuit against Lipocine, Inc. (NASDAQ: LPCN) that had been filed in U.S. District Court in Delaware has been dismissed. The court found that there was not an immediate reason to hear the case given Lipocine’s failure to receive FDA market approval for LPCN-1021. Importantly, the decision was made without ruling on the validity of Clarus’s U.S. Patent 8,828,428 and other merits of the case. While Clarus disagrees with the court’s ruling, no further action will be taken unless LPCN-1021 is approved by the FDA, at which time Clarus will have the option to refile its patent infringement lawsuit.

Dr. Robert Dudley, President and CEO of Clarus and co-inventor of the patent in question, stated, “We remain strong in our belief that LPCN-1021 infringes Clarus’s ‘428 patent and it is particularly noteworthy that the court did not rule on this central fact. If LPCN-1021 were to be approved by the FDA, our plan would be to vigorously pursue all avenues to keep Lipocine’s LPCN 1021 from entering the market and protect the intellectual property, accompanying financial investment and years of work we have invested in JATENZO® – our oral TRT product. We continue to advance the development of JATENZO® which is being evaluated in a new Phase 3 study that is near completion.”

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