If a final decision finding MSN’s generic version infringes US Patent No. 11,096,918 is issued before July 15—when Entresto’s pediatric exclusivity on another patent ends—the US Food and Drug Administration will have to push back its final approval for MSN’s generic to Nov. 9, 2026, according to Novartis’ request filed Wednesday in the US District Court for the District of Delaware.
Novartis ...
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