Hospira challenges Cubist patents on Cubicin

10 February 2012

US drugmaker Cubist Pharmaceuticals (Nasdaq: CBST) says that it has received a Paragraph IV Notice Letter from Hospira (NYSE: HSP), a US provider of generic injectable drugs and infusion technologies, advising of the filing of an Abbreviated New Drug Application for a generic version of the antibiotic Cubicin (daptomycin for injection).

Cubicin is currently protected by five Food and Drug Administration Orange Book-listed patents, which expire between 2016 and 2028. Hospira’s Notice Letter is directed to all of the patents listed in the Orange Book.

Cubist intends to vigorously enforce its extensive intellectual property rights for Cubicin and plans to file a complaint alleging infringement within the required 45-day response period of the Hatch-Waxman Act. Once a suit is filed, a 30-month stay of approval will be imposed by the FDA on Hospira's ANDA.

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