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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