Cubist told of Teva ANDA submission for Cubicin

16 February 2009

Massachusetts, USA-based Cubist Pharmaceuticals says that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral  Medicines, a part of Israel Teva group, notifying it that TPM had  submitted an Abbreviated New Drug Application to the US Food and Drug  Administration for approval to market a generic version of Cubicin  (daptomycin for injection). TPM's notice letter advised that it is  seeking FDA approval to market daptomycin for injection prior to the  expiration of US patent nos 6,468,967 and 6,852,689, which lapse on  September 24, 2019, and US patent  RE39,071, which expires on June 15,  2016. The notice letter further stated that TPM is asserting that claims  in the referenced patents are not infringed and/or invalid.

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