A patent infringement lawsuit filed against drug maker Lipocine Inc. by Clarus Therapeutics was dismissed by the U.S. District Court in Delaware. Clarus was suing Lipocine over claims that Lipocine’s key drug candidate, LPCN 1021, infringed Clarus’ patent of Clarus’ similar drug JATENZO.
LPCN 1021 and JATENZO are experimental oral testosterone replacement therapy currently in Phase III clinical trials. They are designed for boost levels of the male hormone in men with hypogonadism, a deficiency of testosterone due to disease or defect.
Testosterone treatments are generally administered by injection, topical gel, or nasal spray. Both LPCN 1021 and JATENZO aim to be the first oral testosterone treatment in an already saturated market of testosterone products.
Clarus says that the court made the decision solely on the fact that Lipocine’s testosterone product does not have FDA approval, which made the validity of Clarus’ case moot. Because of this, the drug company says it believes its patent infringement claim still holds true. Clarus does not plan to take further action unless LPCN 1021 is granted FDA approval.
Testosterone replacement therapies have enjoyed booming sales in recent years, but the trend is waning as the first personal injury and wrongful death lawsuits near trial dates. People who have filed lawsuits against testosterone manufacturers claim that the makers did not warn the public that taking the hormone supplements could lead to cardiovascular risks including heart attacks, strokes and death.
The drug companies are also being blamed for jacking up sales through aggressive marketing campaigns resulting in overprescribing to many men who do not suffer from hypogonadism.