In its continued bid to waylay the launch of MSN Pharmaceuticals’ proposed Entresto generic, Novartis has told a federal judge in Delaware that time is of the essence.
Novartis has submitted a request in Delaware federal court urging the judge who oversaw a December patent litigation trial to issue a final decision and verdict on the case before July 15. In its lawsuit, Novartis alleged that MSN’s efforts to launch an Entresto generic violate its '918 patent, which covers the amorphous solid form of a compound used in the lucrative heart failure drug.
Securing a decision in its favor before the July deadline would allow Novartis to further delay the rollout of MSN’s Entresto copycat, which is already blocked from launching until at least July 16, the day after a pediatric exclusivity period linked to a separate Entresto patent is set to expire, Novartis’ legal team argued in a filing this week.
MSN’s Entresto generic secured FDA approval last summer, though Novartis was quick to hit back at the decision, even suing the regulatory agency over claims that the generic green light “inappropriately rewrites Entresto’s approved indication” and omits key safety data.
While there have been multiple twists and turns in the patent feud in the months that followed MSN’s approval, Novartis did prevail, in part, when the Delaware court recently ruled in its favor in the case concerning the pediatric exclusivity patent. That verdict, which came down on April 1, resulted in an order for the FDA to reset the effective approval date of MSN’s application to “no earlier than July 16, 2025,” Novartis’ legal filing states.
Now, Novartis wants to further reset that effective approval date until November 9 of next year.
Novartis argues that it needs the court to issue its decision on the ‘918 patent case quickly because MSN has indicated it’s willing to launch at risk as soon as it has approval and isn’t enjoined from doing so.
First approved in 2015, Entresto remains Novartis’ top-selling medication, bringing home roughly $7.8 billion in net sales last year. Aside from the threat of generics, Entresto is also among the first high-spend drugs that will be subject to government-negotiated pricing for Medicare patients starting in 2026 under the Inflation Reduction Act.
Though Novartis stumbled several times in its attempts to block MSN’s generic last year, the chips have fallen more in the Swiss pharma’s favor this year.
Aside from the approval reset order handed down in April, the U.S. Court of Appeals for the Federal Circuit in January ordered MSN to delay its generic Entresto launch “until further notice” as the court reviewed Novartis’ arguments.