Novartis Loses Bid to Delay Generic Rival to Best-Selling Heart Drug

Swiss pharmaceutical giant Novartis has encountered a setback in its efforts to prevent the U.S. market entry of a generic version of its blockbuster heart failure drug, Entresto. US District Judge Dabney Friedrich, in a ruling made public on Tuesday, rejected Novartis’ bid to stop the U.S. Food and Drug Administration (FDA) from approving a generic version of the drug produced by MSN Pharmaceuticals. This decision paves the way for the eventual release of the first U.S. generic of Entresto, although its launch still faces hurdles due to other legal challenges.

According to Reuters, Novartis had sued the FDA earlier this year, arguing that the agency’s approval of MSN’s generic version was “arbitrary and capricious,” and violated the Food, Drug, and Cosmetic Act (FDCA). Novartis contended that MSN’s version featured a slightly different label, and that the FDA had overstepped its regulatory boundaries by approving the generic. However, Judge Friedrich ruled that the FDA had acted within its authority, despite the labeling differences between the two drugs.

Entresto, which was originally approved in 2015, has been a top-selling medication for Novartis, generating over $6 billion in revenue last year. The drug is used to reduce the risk of death and hospitalization in heart failure patients with reduced ejection fraction — a condition where the heart’s left ventricle does not pump out enough blood with each contraction. Following its initial approval, Novartis expanded the drug’s label to include patients without reduced ejection fraction, supported by additional clinical trials. This label expansion has been at the heart of the company’s argument for maintaining exclusive rights to the drug.

Read more: Novartis Cleared of Wrongdoing in Swiss Competition Commission Investigation

Despite the recent ruling, Novartis is continuing to fight back. The company has already stated its intention to appeal the decision, arguing that the FDA’s approval process for MSN’s generic was flawed. According to Reuters, the drugmaker had also sought to block the generic on the grounds of patent infringement, but in August, it lost a key motion in that separate lawsuit. Although Novartis is appealing that decision as well, MSN remains barred from launching its version of the drug until the legal proceedings are resolved.

MSN Pharmaceuticals, a key player in the generic drug industry, had its version of Entresto approved by the FDA in September. However, while the court’s decision clears one major obstacle, Novartis’ ongoing patent infringement case means that the generic’s launch could still be delayed for months or even years, depending on the outcome of further litigation.

The legal battle underscores the high stakes surrounding the market for heart failure medications. With Entresto being one of Novartis’ top earners, the introduction of a lower-cost generic could significantly impact the company’s revenues. At the same time, the availability of a generic version would likely reduce costs for patients and insurers, particularly in the U.S. market, where drug pricing is a major concern.

Source: Reuters