As blockbuster heart failure drug Entresto inches toward a patent cliff, Novartis is calling on the FDA—again—to keep early-bird generics at bay.
Novartis has petitioned the U.S. regulator not to approve any Entresto copycats until the end of a three-year exclusivity period in February 2024. The move follows a similar appeal by the Swiss pharma juggernaut last November.
At the time, Novartis argued greenlighting any generic before 2024 would violate the FDA’s “same labeling” standards for copycat drugs. The FDA slapped down Novartis’ prior bid in April, stating it had “not made a final determination on whether to approve or not approve any [Abbreviated New Drug Application] referencing Entresto.”
Entresto, which has patents protecting various aspects of its formulation into 2036, won an extra three years of intellectual property breathing room in Feb. 2021, courtesy of an expanded approval in heart failure with preserved ejection fraction (HFpEF).
In its latest appeal to FDA, Novartis argues early Entresto generic approvals could create labeling inconsistencies.
The company's issue comes down to so-called skinny labeling, which enables generic drugmakers to get their copycats approved for one of several—but not necessarily all—indications of their brand-name counterparts. A label is “skinny” when the generic doesn’t cover all the indications of its reference product.
Under FDA’s generic labeling guidelines, generic applicants looking to avoid approvals for a drug’s patent-protected uses must “start with the currently approved [reference listed drug] and may omit sections, or specific words and phrases, to avoid disclosing the protected use," Novartis says.
Problem is, as Novartis sees it, Entresto’s HFpEF nod in 2021 “precludes such an approach” by generic drugmakers.
At least 18 drugmakers are circling the gates with potential Entresto copycats, Novartis said in its latest FDA filing. Those companies—which include Teva, Viatris, Aurobindo and Lupin, among others—are angling to bring their generic versions of the heart med to market in July 2023, when a regulatory stay that prevents the FDA from granting final generic approvals lifts.
Novartis has long held that Entresto—a combination of sacubitril and valsartan first approved in 2015—could deliver peak sales of $5 billion. In 2021, the therapy pulled down nearly $3.55 billion in global sales, Novartis said in its most recent annual report.
FDA plea aside, Novartis is involved in litigation with several generic drugmakers in a bid to delay Entresto copycats.
Last month, however, Novartis found itself on the receiving end of Entresto litigation when it was sued by the University of Michigan and the University of South Florida, which alleged the company’s heart drug infringes a co-crystal patent held by the two institutions. The schools are pursuing a jury trial and damages to make up for the alleged infringement.