Court clears Lupin's generic Kalydeco in Vertex patent fight

A Delaware federal court ruled on August 24 that Lupin's proposed generic version of Vertex's cystic fibrosis drug Kalydeco does not infringe Vertex's patents, finding Lupin's 74% ivacaftor formulation falls outside the patents' claimed 80% concentration range. The ruling clears a path for Lupin, which already holds tentative FDA approval, to launch the first generic challenger to a Vertex CF modulator pending final FDA approval.