Cubist Pharma announced that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral Medicines notifying Cubist that TPM had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market a generic version of CUBICIN® (Daptomycin for injection). Teva'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 expire on September 24, 2019, and US Patent No. 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. Cubist also announced that it plans to file a patent infringement lawsuit against TPM in response to the ANDA filing. Cubist continues to be confident in its intellectual property portfolio protecting CUBICIN, including the patents listed in the FDA Orange Book.
(Source: Pharmalive)
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