Shire files Fosrenol law suit against Natco Pharma
UK drugmaker Shire has filed a law suit in the US District Court for the Southern District of New York against Natco Pharma for infringement of two of its US patents, numbers 5,968,976 and 7,381,428.
The case was filed in response to an Abbreviated New Drug Application filed by Natco seeking US Food and Drug Administration approval to market and sell generic versions of Shire's 500mg, 750mg, and 1g Fosrenol (lanthanum carbonate) products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement law suit within 45 days of receiving Natco's Paragraph IV notification letter, the FDA must refrain from approving the 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, according to Shire.
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