Novartis petitions FDA to block 18 generic competitors for its megablockbuster heart drug until 2024
Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.
In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.
Under Novartis’ reading of FDA’s “same labeling” regulations, the company contends that “the agency cannot approve an ANDA [generic drug] seeking to omit the patent- and exclusivity-protected use until expiration of the exclusivity in February 2024 – and even then, only if the ANDA applicants submit a paragraph IV certification to each of the HFpEF Patents.”
While such petitions to FDA are often denied, and Novartis understands that generics will eat away at its massive sales for Entresto soon-ish, many companies often file the FDA petitions anyway in an attempt to further delay generics.
Novartis has already sued generic drugmakers looking to bring copycats of Entresto to market in July 2023, which is when a regulatory stay on FDA’s authority to grant final approval to these ANDAs will lift. Other lawsuits are also currently pending, and a trial in the Delaware district court has been scheduled to start on Sept. 8, 2022. Novartis also filed other lawsuits against certain generic companies in September and October that were targeting three other patents, one of which doesn’t expire until 2036.
Entresto won its first FDA approval in the HFrEF population in July 2015 and hauled in almost $2.5 billion in sales in 2020, and another $2.6 billion in the first nine months of 2021.
Back in February, the FDA also approved Entresto as the first and only therapy in the US to treat patients diagnosed with heart failure, including both those with heart failure with reduced ejection fraction (HFrEF) and with heart failure with preserved ejection fraction (HFpEF). That means that of the more than 6 million Americans suffering from chronic heart failure, about 5 million may be appropriate for treatment with Entresto, the company contended.
That new use for Entresto is also protected by three more years of exclusivity, which could amount to billions more for the company.
Novartis told FDA that a generic competitor seeking approval before the expiration of Entresto’s exclusivity must propose labeling that omits the exclusivity-protected conditions of approval and does not disclose the patented use, adding:
An ANDA applicant may only seek approval for the conditions of use that existed in the Entresto labeling prior to February 2021, i.e., to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction. However, there is no permissible way for ANDA applicants to draft an indication statement for use in patients with reduced ejection fraction by deleting words or making de minimis changes to the existing indication statement.