Datapoint: Novartis Asks FDA to Stave Off Early Entresto Copies

Novartis last week asked the FDA not to approve any generic copies of its heart failure drug Entresto before its exclusivity period ends in February 2024, citing labeling concerns. The agency denied a similar request from the drugmaker in April. For the treatment of heart failure, Entresto holds covered or better status for virtually all covered lives (99%) under the pharmacy benefit. 66.3% of insured lives have preferred access to Entresto without utilization management restrictions. The drug will likely face heavy competition, with at least 18 generic versions in development.

SOURCE: MMIT Analytics, as of 9/19/22

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