Shire told Mylan and Barr seeking generic Fosrenol appro
Drugmaker Shire says that it has received Paragraph IV Notice letters from two US generics companies, Barr Laboratories and Mylan, dated February 2 and 4, respectively, advising in each case of the filing of an Abbreviated New Drug Application for a generic version of 500mg, 750mg and 1gm Fosrenol (lanthanum carbonate) in the USA.
Shire claims Fosrenol is protected by three Food and Drug Administration 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 the product under US patent laws.
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