Full Breakdown
Novartis Defeats Antitrust Lawsuit Over Entresto Patent Listing
By Drooid · · How we work
Court Ruling
On September 23, U.S. District Judge Lewis Liman dismissed the antitrust suit filed by the Iron Workers Local 580 Insurance Fund on behalf of Entresto purchasers. The judge held that Novartis Pharmaceuticals Corp.’s listing of U.S. Patent No. 8,101,659 in the Food and Drug Administration (FDA)’s Orange Book was proper, rejecting the plaintiffs’ argument that the patent covered only the individual ingredients of Entresto rather than the specific combined formulation.
Background & Context
The Orange Book is the FDA’s official list of approved drugs and the patents manufacturers claim cover those products. A patent’s inclusion can extend market exclusivity by delaying generic entry, making Orange Book listings a frequent focus of competition-law disputes. Entresto, a fixed-dose combination of sacubitril and valsartan for heart-failure treatment, is Novartis’s best-selling medicine worldwide.
Data & Statistics
- The lawsuit alleged that the Orange Book listing delayed generic competition by at least six months, during which Novartis earned more than $2 billion in U.S. sales of Entresto.
- According to a company report, Entresto accounted for 14 % of Novartis’s total sales in the prior year.
- Following the expiration of U.S. patents and the entry of generics, Entresto sales fell 42 % to $1.31 billion in the first quarter of 2026.
Official Statements & Responses
Novartis attorneys declined to comment on the ruling. The plaintiffs’ counsel did not provide an immediate response either. The court’s decision therefore rests on the legal interpretation of the patent’s scope rather than on any public statements from the parties.
Criticism & Opposition
The Iron Workers Local 580 Insurance Fund argued that the Orange Book entry was an improper patent-listing strategy that artificially prolonged monopoly pricing, causing purchasers to overpay for Entresto. The fund’s complaint framed the listing as an anticompetitive maneuver rather than a legitimate protection of intellectual property.
Conflicting Reports & Gaps
All cited sources (Reuters, Lawyer Monthly) present the same figures for Entresto’s sales share, revenue impact, and the alleged six-month delay. No alternative numbers or contradictory evidence were reported, leaving the factual basis of the plaintiffs’ claim unchallenged beyond the court’s legal finding.
What’s Next
The dismissal resolves the specific class-action claim concerning the Orange Book listing. Future litigation could arise if purchasers pursue other antitrust theories, but no further proceedings were identified in the available reports.