Judge Delays Novartis Move That Could Block MSN’s Entresto Copy

A federal judge temporarily blocked Novartis AG from sending the FDA his final judgment delaying until July approval of MSN Laboratories Pvt. Ltd.'s Entresto copy, preserving MSN’s chance to launch earlier if it convinces the judge to order a key patent be pulled from a registry of approved drugs.

Sending the judgment to the US Food and Drug Administration would reset the approval date for MSN’s generic version of the blockbuster heart drug to after July 15, when Novartis’ pediatric exclusivity ends.

That reset would eliminate any opportunity to launch earlier if MSN wins its bid to remove US Patent ...