The lawsuit was filed in response to an abbreviated new drug application (ANDA) filed by Natco seeking FDA approval to market and sell generic versions of Shire’s 500mg, 750mg, and 1g Fosrenol products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Natco’s paragraph IV notification letter, the FDA must refrain from approving Natco’s ANDA for 30 months, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier. The stay on generic approval will expire on April 26, 2012 unless terminated earlier.
Shire has asserted the patents based upon information provided to it by Natco. Shire will continue to evaluate the situation throughout the litigation and will take all necessary actions to protect its rights to the fullest extent possible.