The introduction of the generic form of Novartis’ bestselling heart-failure medicine Entresto by the pharmaceutical company MSN Pharmaceuticals was temporarily halted by a federal appeals court.
While it is considering Novartis’ urgent plea for a lengthier stay, the U.S. Court of Appeals for the District of Columbia Circuit has put a hold on the launch, which was scheduled to begin soon.
A second order issued on Wednesday by U.S. District Judge Dabney Friedrich in Washington had removed a barrier that had been preventing MSN from introducing the first generic version of Novartis’ best-selling medicine in the country. This drug delivered the firm nearly $6 billion in income in 2023 with its introduction.
With regard to the rulings, a counsel representing MSN refused to comment. Requests for reaction from Novartis were not immediately met with a response from either an attorney or a spokesperson for the company.
Last year, the U.S FDA gave its approval to the version of Entresto developed by MSN.
Novartis filed a lawsuit against MSN and other companies who were planning to produce generic versions of Entresto, alleging that they had violated their patent. Last Thursday, the U.S. Court of Appeals for the Federal Circuit overturned a judgment made in 2023 by a judge in Delaware that deemed invalid one of the patents.
The verdict of the appeals court, according to Novartis’s argument in a court filing, ensured that the firm would continue to have exclusive rights to market Entresto until July.
The Federal Circuit Court of Appeals denied Novartis’ proposal for a rule that would instantly prevent the generic from being prescribed.
To prevent the launch, Novartis filed a second lawsuit against the FDA in an appellate court in Washington on Monday. During the hearing that took place late on Wednesday, Friedrich was quoted as saying that she was not going to approve Novartis’ recommendation.
At the JP Morgan Healthcare meeting in San Francisco, Vas Narasimhan, CEO of Novartis, presented the company’s future ambitions. He noted that Novartis anticipates peak sales of more than $3 billion for its eight top branded products, which, coupled with encouraging development in Japan and China, will drive the company’s revenues for the next ten years.
Novartis plans to keep making money even after the patents on its current blockbuster pharmaceuticals expire, according to Narasimhan. The firm anticipates 15 submission-enabling data readings from their key assets in the next two years.
