Novartis Aims to Block MSN’s Entresto Copy Launch Until 2026

June 5, 2025, 6:31 PM UTC

Novartis AG urged a federal judge to issue a final ruling before mid-July blocking MSN Laboratories Pvt. Ltd. from launching its Entresto copy until late 2026, as the FDA separately confirmed MSN’s approval bid is now on hold.

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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