SHIPMENTS: AbbVie (NYSE: ABBV) announced that it has begun shipping testosterone gel 1%. The U.S. Food and Drug Administration previously approved Par’s Abbreviated New Drug Application for the product.
Testosterone gel 1% is the generic version of AbbVie’s (NYSE: ABBV) AndroGel 1% and is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Par previously entered into a settlement and license agreement and consent decree that permit Par to launch the product at this time, which is five years earlier than the expiration of the relevant patent.
Testosterone gel 1% is available in 2.5 g and 5 g aluminum foil packets containing 25 mg or 50 mg testosterone, respectively. According to IMS Health data, annual U.S. sales of testosterone gel 1% packets are approximately $206 million.