Shire plc, announces that it has received Paragraph IV Notice letters from Barr Laboratories, Inc. (Barr) and Mylan, Inc. (Mylan) dated 2 and 4 February 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of 500mg, 750mg and 1gm Fosrenol, (lanthanum carbonate).
Fosrenol is protected by three FDA Orange Book listed patents: US patent No. 5,968,976, Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates; US patent No. 7,381,428, Stabilized Lanthanum Carbonate Compositions; and US patent No. 7,465,465, Pharmaceutical Formulation Comprising Lanthanum Compounds which expire in 2018, 2024 and 2024 respectively. Shire believes these patents provide a robust and sustainable proprietary position for Fosrenol under US patent laws.
Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act, has 45 days from the date of each notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Barr's and Mylan's ANDA, which will commence on 26 October 2009.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.