The lawsuit was filed in response to an abbreviated new drug applications (ANDA) filed by Barr seeking the FDA approval to market and sell generic versions of Shire’s 500mg, 750mg, and 1gm Fosrenol products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement lawsuit within 45 days of receiving Barr’s paragraph IV notification letter, the FDA must refrain from approving Barr’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 is confident in its intellectual property portfolio protecting Fosrenol, and will enforce its patents against infringers to the fullest extent allowed by law.