Novartis is seeking to prevent the entry of generics for its blockbuster heart failure drug Entresto, its top-selling asset that brought in more than $6 billion in net global sales last year.
An appeals court on Wednesday ruled against Novartis in its bid to block the entry of MSN Pharmaceuticals’ generic competitor to the blockbuster heart failure drug Entresto (sacubitril/valsartan), according to Reuters and other outlets.
First approved in 2015, Entresto is an oral drug indicated for the treatment of heart failure in adults. It combines the neprilysin blocker sacubitril with the angiotensin receptor inhibitor valsartan to lower blood pressure and vascular resistance. Since hitting the market, Entresto has become Novartis’ top-selling asset, raking in more than $6 billion in net sales globally last year.
In its decision on Wednesday, the U.S. Court of Appeals for the Federal Circuit agreed with a lower court’s verdict that Novartis had not sufficiently proven that it could win a patent suit against MSN. The appellate judges saw “no clear error in the district court’s analysis,” as reported by Reuters.
The tussle over Entresto’s market exclusivity began in September 2022, when Novartis filed a citizen petition with the FDA, asking the regulator not to approve any drug application that referenced the heart failure drug until after Feb. 16, 2024—the date when its three-year exclusivity period under the Orange Book expires.
The pharma also asked the FDA to refrain from approving drug applications that referenced two specific Entresto-related patents, which are set to expire on August 22, 2033 and May 9, 2036, respectively.
In July 2024, the FDA rejected the petition, calling the first request moot—given that the exclusivity period had already lapsed—while noting that the two patent-specific requests can easily be avoided by tweaking the labelling of generics applicants.
“In accordance with our statutory and regulatory authority, we have determined that in this instance, an [abbreviated New Drug Application] may propose labeling for a generic sacubitril and valsartan product that does not seek approval for the purported use protected” by the patents in question, the FDA wrote in its letter.
A month later, in August, Judge Richard Andrews of the United States District Court for the District of Delaware blocked Novartis’ bid for a preliminary injunction against MSN. The pharma alleged that MSN had violated patent protection of TVS, a specific compound found in Entresto that is protected until November 2026. MSN shot back and argued that Novartis had provided incomplete information to substantiate its claims.
Andrews sided with MSN, noting that Novartis “bears the burden of proof, both on infringement and showing likelihood of success.” Andrews also said that he was “skeptical” of Novartis’ “characterizations of many of its potential harms” if the injunction is not granted.
Aside from generic competition, Entresto’s sales are also threatened by the Inflation Reduction Act’s drug price negotiation program. The Centers for Medicare and Medicaid Services in August 2024 revealed the final maximum fair prices for the first 10 drugs in the program, which include Entresto. The prices are set to take effect in 2026. In October 2024, Novartis lost its court case against the IRA.
