Novartis' attempts to prevent MSN Pharmaceuticals from launching a generic version of its blockbuster heart failure drug, Entresto, have once again failed.
First approved in 2015, Entresto is a heart failure medication that improves heart function in people with specific heart conditions. The drug generated $4.64 billion in 2022. Its exclusivity was extended with an approval for HFpEF in 2021, and there are still no approved generic versions available.
This week, a Delaware judge dismissed Novartis' patent infringement claims and denied their request to block MSN's generic from entering the market. While Novartis argued that MSN's generic infringes on its patent, the judge ruled that Novartis did not demonstrate a strong likelihood of success in proving this. The court also found that Novartis had not shown it would suffer "irreparable harm" if the generic launched.
The court dismissed MSN's request to strike some of Novartis' evidence since it wasn't necessary to rule on it. However, the judge gave Novartis 72 hours to appeal the decision before any changes take effect.
Despite this challenge, Novartis is exploring its legal options and has also filed a lawsuit against the FDA, arguing that the approval of MSN's generic was unlawful. The agency responded last month, explaining that its decision centers on the balance between fostering pharmaceutical innovation and ensuring the availability of affordable generic drugs.
In its statement, the FDA outlined drug approval pathways under the FD&C Act, highlighting the 505(b)(1) NDA, which requires full safety and efficacy reports, and the 505(j) ANDA, which facilitates generic approvals based on existing data. The FDA rejected Novartis' request to block ANDA approvals for Entresto during its exclusivity period, clarifying that exclusivity does not indefinitely prevent generic competition. Additionally, the FDA addressed labeling carve-outs, allowing generics to omit patented uses while ensuring the drug remains safe and effective for non-patented indications.
