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Cosmo Pharmaceuticals SpA Announces that Shire Wins Patent Trial against Actavis Inc Concerning LIALDA

Monday, 13 May 2013 11:31am EDT 

Cosmo Pharmaceuticals SpA announced that Shire plc prevailed in its litigation against the Watson Pharmaceuticals Group (now Actavis Inc) in connection with their Abbreviated New Drug Application (ANDA) for a generic version of LIALDA. The Southern District Court of Florida upheld the validity of the patent covering LIALDA and ruled that the proposed ANDA formulation infringes the claims of the patent and that the FDA is prohibited from approving the ANDA formulation until the patent expires in 2020. No ANDA's have been approved for generic versions of LIALDA. Cosmo invented the formulation (the active pharmaceutical ingredient mesalamine is off-patent) and licensed it to Giuliani in 2001 who further licensed it to Shire in 2002. 

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