Novartis (NOVN.S) has encountered a legal hurdle in its ongoing efforts to prevent the release of a generic version of its blockbuster heart failure drug, Entresto. A U.S. District Court ruling, made public on Tuesday, denied the pharmaceutical giant’s attempt to block regulators from approving the generic version developed by MSN Pharmaceuticals.
The ruling, delivered by U.S. District Judge Dabney Friedrich in Washington, D.C., concluded that the U.S. Food and Drug Administration (FDA) did not exceed its authority when it granted approval to MSN’s generic version of Entresto, despite differences in the labeling and formulation. The court dismissed Novartis’ claims that these differences should have prevented the approval.
In response to the ruling, Novartis expressed disagreement and confirmed its plans to appeal the decision. While the FDA and MSN Pharmaceuticals have yet to comment, this legal development is a major turning point in the battle over the future of Entresto, Novartis’ highest-selling drug, which generated more than $6 billion in revenue last year.
Although MSN’s version of the drug was approved by the FDA last month, its launch is still delayed due to separate patent infringement litigation filed by Novartis. The Swiss-based pharmaceutical company has been actively trying to delay the release of MSN’s generic drug while it appeals a court decision made in August that also ruled against its efforts to block the competitor’s version. For now, MSN remains barred from launching its product until the appeal process is resolved.
Novartis initially filed suit against the FDA in July, shortly after MSN received approval for its generic version of Entresto. The pharmaceutical company argued that the FDA’s decision was “arbitrary and capricious,” and claimed it violated the Food, Drug, and Cosmetic Act (FDCA). Novartis pointed to discrepancies between the labeling of the generic drug and Entresto, insisting that these distinctions warranted further scrutiny.
Originally approved by the FDA in 2015, Entresto is prescribed to reduce the risk of death and hospitalization for heart failure patients with reduced ejection fraction. Following its initial approval, Novartis expanded its use after a clinical trial demonstrated its effectiveness in patients without reduced ejection fraction, and subsequently secured patents for this broader application.
The outcome of this legal battle holds significant implications for both Novartis and patients. With billions at stake, Novartis is determined to fight against the generic competition, while healthcare providers and patients anticipate potential cost reductions should a generic version of Entresto become widely available.
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