Judge Dismissed Novartis Patent Lawsuit
A federal judge ruled that Novartis properly listed its Entresto patent in the FDA Orange Book.
Updated on Sept. 23, 2026 in Healthcare
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A federal judge in Manhattan has dismissed a class action lawsuit against Novartis regarding its heart medication, Entresto. The court determined the company acted appropriately when listing its patent in the FDA Orange Book.
Why it matters
The lawsuit alleged that Novartis misused patent listings to prevent generic competition and maintain market exclusivity. This ruling supports the company's legal standing regarding its regulatory filings for the drug.
Entresto accounted for 14% of Novartis sales in 2025, though revenue dropped 42% to $1.31 billion in Q1 2026. The lawsuit claimed these patent maneuvers delayed lower-cost generics for at least six months.
The players
Novartis
This Switzerland-based multinational pharmaceutical company is one of the largest drug manufacturers in the world.
Lewis Liman
He is a United States District Judge presiding over federal cases in Manhattan.
Iron Workers Local 580 Insurance Fund
This is a labor union-affiliated benefit fund that acts as a plaintiff in drug pricing litigation.
The details
The class action, brought by the Iron Workers Local 580 Insurance Fund, challenged whether Novartis appropriately registered patents for the drug's components or combined form. Judge Lewis Liman ultimately found no misconduct in the company's compliance with FDA listing requirements.
Timeline
The Iron Workers Local 580 Insurance Fund filed the lawsuit in 2025.
Entresto sales fell 42% to $1.31 billion during Q1 2026.
Judge Lewis Liman dismissed the case on September 23, 2026.
Market Landscape
The ruling reinforces the existing regulatory precedent set by the FDA Orange Book patent listing requirements. This decision validates how major pharmaceutical firms structure their intellectual property to maintain market exclusivity.
The dismissal of this lawsuit preserves the current market status of Entresto for patients and healthcare providers. It indicates no immediate changes to retail pricing or drug availability as a result of the legal challenge.
The takeaway
This case highlights the intense legal scrutiny pharmaceutical companies face regarding patent listings and market exclusivity periods. Patients and providers should continue to monitor generic drug entry timelines as court rulings shape the availability of lower-cost alternatives.
Further reading
For broader context on current pharmaceutical industry legal challenges, visit the Healthcare section.
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Should pharmaceutical companies face legal penalties for strategies that delay generic drug entry?
