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.

Shire is currently reviewing the detail of the letters from Barr and  Mylan and, under the Hatch Waxman Act, has 45 days from the date of each  to determine if it will file a patent infringement suit. If Shire brings  suit, a 30-month stay of approval will be imposed by the FDA on each of  the generic firms ANDA, which will commence on October 26 this year.