Our once-daily transdermal testosterone gel has been developed for the treatment of male hypogonadism, or low testosterone levels. Male hypogonadism generally is characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. In 2010, the transdermal testosterone market for men in the U.S. was over $1.6 billion.
Our testosterone gel for men is licensed to Teva Pharmaceuticals, USA. Our testosterone gel for men NDA was approved by the FDA on February 14, 2012. Teva is responsible for all regulatory and marketing activities.
Shortly after submission of our testosterone gel for men NDA by Teva, Teva was sued by Abbott Pharmaceuticals for patent infringement. The patent litigation was settled in December, 2011. Terms of the settlement are not disclosed.
Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone can be caused by a signaling problem that occurs between the brain and the testes that causes the production of testosterone to drop below normal. Low testosterone also can occur when the body can't make normal levels of testosterone and can lead to a medical condition known as hypogonadism that has many symptoms including fatigue, decreased energy, reduced sexual desire and depressed mood.
It is estimated that low testosterone affects more than 4 to 5 million men in the U.S. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.