Novartis’s latest attempt to block the US Food and Drug Administration (FDA) from approving a generic version of its blockbuster heart failure drug, Entresto (sacubitril/valsartan), has been shot down by a federal court.
The court ruled against Novartis’ argument that the generic in question, developed by MSN Pharmaceuticals, infringes on its patents, particularly with respect to a compound used in the drug.
In its complaint, Novartis claimed that the FDA’s approval of MSN’s Ernesto generic in July was unlawful.
Novartis’ lawsuit centered on concerns regarding the labeling and active ingredients in MSN’s generic version of Entresto. However, in the ruling denying Novartis’ motion for summary judgment, Washington, DC, US District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of Entresto was unlawful. In issuing the decision, the judge upheld MSN’s generic green light.
Judge Friedrich stated that MSN’s product complies with FDA regulatory and statutory requirements on both counts.
She also noted that “Simply because the language of the generic label tracks Entresto’s original superseded label, it does not follow that the FDA ‘reverted back’ to Entresto’s original label.”
This follows the FDA’s earlier denial of Novartis’ petition to delay the approval. Novartis plans to continue its legal battle.
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Novartis also argued that the MSN generic is not a one-to-one generic of Entresto, given the way its active ingredients are a physical mixture of “two independent salts” versus the brand-name product, in which the ingredients take the form of a “co-crystal.”
However, Friedrich countered that the ingredients “need not have the same solid state physical form to have the same chemical identity.”
MSN’s Entresto generic is the first generic of the heart failure drug to be approved in the US. Shortly after its approval, Novartis filed a lawsuit against the FDA in DC federal court towards the end of July.
Entresto remains Novartis’ best-seller, having generated over $6 billion in revenue last year for the Switzerland-based pharma company.
The drug was first approved by the FDA in 2015. The drug, a combo of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan, was originally approved to reduce the risk of death and hospitalization risks in heart failure patients with reduced ejection fraction (HFrEF). Entresto eventually gained approval in heart failure patients with preserved ejection fraction (HFpEF) as well.
Ernesto is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
Novartis had first filed a lawsuit against MSN in 2022 in which it also named Viatris, Alembic, Crystal and Nanjing Noratech as co-defendants in the complaint.
FDA records show that Novartis holds several patents on Entresto, with expirations scheduled for 2025, 2026 and 2027. During the company’s second-quarter earnings call in July, Novartis executives indicated that they anticipate generic versions of Entresto to enter the market by mid-2025.
In addition to facing challenges around exclusivity, Entresto is among the ten drugs selected for government-negotiated prices under the Inflation Reduction Act. Starting in 2026, the list price of Entresto for Medicare patients will be reduced by 53 percent, as outlined in a list of negotiated drug prices published earlier this year.
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