Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

 As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto.

In a court decision filed this week in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s July approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld MSN’s generic green light.

Novartis’ complaint largely came down to issues around labeling and the active ingredients in MSN’s generic. However, MSN’s product is “consistent with FDA regulatory and statutory requirements” on both of those issues, Friedrich wrote in the order denying Novartis’ motion for summary judgment.

The case is the latest in a string of challenges around the so-called practice of skinny labeling, which allows drugmakers to get their generic medicines approved for one or several—but not all—approved indications of their brand-name counterparts.

Novartis disagrees with the decision and has appealed the ruling, a spokesperson said.

MSN’s generic version of Entresto is still barred from launching at risk thanks to separate stays put in place by the U.S. Court of Appeals for the D.C. Circuit and the U.S. Court of Appeals for the Federal Circuit, the Novartis spokesperson added.

Entresto—which combines the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker Valsartan—was first approved by the FDA in 2015. Originally cleared to curb 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.

In patients who with HFrEF, the heart’s left ventricle loses its ability to contract normally. For patients with HFpEF, the heart muscle contracts properly but the ventricles don’t relax, causing diminished blood flow.

According to FDA records, Novartis holds multiple patents on the drug, with some set to expire in 2025, 2026 and 2027. Novartis executives said during the company's second-quarter earnings call in July that they expect Entresto generics to hit the scene in mid-2025.

In order to get its generic approved with a skinny label, MSN only included the non-patent-protected HFrEF use in its filing, according to Novartis. The Swiss drugmaker took issue with the fact that MSN and the FDA allegedly reverted to an older label that had been suspended and replaced.

“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,” Friedrich wrote in her decision.

Novartis additionally argued that MSN’s product is not a one-to-one generic of Entresto given the way the copycat product’s 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.”

But, to hear Friedrich tell it, drug ingredients “need not have the same solid state physical form to have the same chemical identity.”

The judge issued her decision after Novartis filed suit against the FDA in D.C. federal court in late July.

Elsewhere, the Swiss pharma had separate infringement claims against MSN shot down in Delaware district court in mid-August. The judge in that decision also denied Novartis’ request for an injunction barring a potential generic launch.

Novartis first sued MSN in 2022 in a complaint that also named Viatris, Alembic, Crystal and Nanjing Noratech as defendants.

Multiple drugmakers, including Alembic and Crystal, have managed to eke out generic Entresto approvals in 2024, though none of the copycat products have launched.

Aside from looming exclusivity challenges, Entresto is one of 10 drugs that will face government-negotiated prices in 2026 as part of the Inflation Reduction Act. Entresto will be subject to a 53% cut in its list price for Medicare patients, according to a list of negotiated prices published over the summer.

Entresto is Novartis’ bestselling drug: For all of 2023, the heart failure blockbuster brought home a little more than $6 billion in sales. 

https://www.fiercepharma.com/pharma/judge-upholds-msns-generic-entresto-approval-novartis-continues-attempts-defend-heart