Cubist takes exception to generic threat

|By:, SA News Editor

Fresenius Kabi USA sends Cubist Pharmaceuticals (CBST +0.1%) a letter notifying it that it has submitted an ANDA for a generic version of Cubicin (daptomycin for injection) which, according to Cubist, is protected by six Orange Book-listed patents expiring between 2016 and 2028. Fresenius alleges that five of the patents are invalid and unenforceable. Cubist intends to file a complaint with the FDA within 45 days. Once it files its lawsuit, the FDA will institute an automatic 30-month stay on its approval decision.