Novartis Sues FDA Over Approval of Entresto Generic After Petition Rejection

1. Novartis' Legal Action: Novartis has filed a lawsuit against the FDA over the approval of a generic version of its heart failure drug Entresto, following the FDA's rejection of its citizen petition to block the generic drug's approval.
2. FDA's Decision: The FDA denied Novartis' petition, which sought to block the approval of generic versions of Entresto until its exclusivity period expired. The FDA argued that the exclusivity period had already expired and that generic drug companies could tweak their labeling to avoid patent violations.
3. Generic Approval: The FDA approved a generic version of Entresto from MSN Laboratories on July 25, 2024, prompting Novartis to sue the agency.
4. Financial Impact: Entresto is a significant revenue generator for Novartis, with net sales of $3.77 billion in the first six months of 2024. The drug is also listed under the Inflation Reduction Act’s Medicare Drug Price Negotiation Program.
5. Patent Exclusivity: Novartis argued that the FDA should not allow generic versions of Entresto because the drug's patents, which expire between 2023 and 2036, protect specific uses that cannot be carved out by generic drug companies.
6. Litigation Background: Novartis has been involved in extensive litigation against multiple generic drug manufacturers, including Alembic Pharmaceuticals, Alkem Laboratories, and Teva Pharmaceuticals, among others.