Novartis Battles MSN, FDA to Block Launch of Entresto Drug Copy

Novartis AG asked two federal courts to block MSN Laboratories Pvt. Ltd.’s generic Entresto after a key patent’s revival and to require the FDA to enforce pediatric-exclusivity rights for the blockbuster heart drug.

Novartis’ injunction motion seeks to prevent MSN from launching its copy until at least July 16, one day after Entresto’s six-month pediatric exclusivity period expires, the Monday filing in the US District Court for the District of Delaware said. It cited the US Court of Appeals for the Federal Circuit’s Jan. 10 decision reviving US Patent No. 8,101,659, which is related to the composition of the ...