The Entresto antitrust lawsuit was dismissed with prejudice, so there is no settlement and no claim to file right now. The only route to revive the claims is an appeal to the Second Circuit. Entresto is sacubitril/valsartan, a heart-failure drug at the center of the pricing dispute. Iron Workers Local 580 Insurance Fund sued Novartis on behalf of Entresto purchasers over alleged inflated prices.
According to analysis from Latham & Watkins, Judge Lewis J. Liman of the Southern District of New York dismissed the case in Iron Workers Local 580 Insurance Fund v. Novartis, No. 1:25-cv-07230, on September 23, 2026 (Latham & Watkins analysis of the dismissal).
Official resources:
- Read the official notice from Lw — Use this primary source to verify the official announcement.
- Read the official guidance from Bloomberglaw — Use this primary source to verify the official guidance.
Table of Contents
- Why was the case dismissed?
- Is there a settlement or claim form?
- Could an appeal revive the case?
- What should Entresto purchasers do now?
Why was the case dismissed?
Purchasers alleged Novartis improperly listed U.S. Patent No. 8,101,659 in the FDA Orange Book. The Orange Book is the federal list where brand drug makers identify patents covering an approved drug.
As reported by MedPath Trial, purchasers said the listing extended monopoly pricing by more than five months and delayed generics by at least six months (MedPath Trial report on the ruling). The court rejected that theory. It held the '659 patent was properly listed as a drug-product patent because it claims the active ingredients, valsartan and sacubitril. The court said the patent did not need to claim their specific combined complex form. That finding removed the basis for the antitrust overcharge claim.
Is there a settlement or claim form?
No. Dismissal ended the district-court case without payment, eligibility rules, or filing deadlines. There is nothing for consumers, health plans, or third-party payors to submit.
The CourtListener docket shows the clerk entered judgment for Novartis on the Rule 12(b)(6) motion, dismissed the Second Amended Complaint, and closed the case on September 25, 2026 (docket entry closing the case). A Rule 12(b)(6) dismissal means the judge found the complaint legally insufficient even if its factual allegations were true. Because dismissal was with prejudice, the same purchasers cannot refile the same listing-based antitrust claims. A new case based on the same Orange Book theory would face prompt dismissal.
Could an appeal revive the case?
Yes, appeal is the remaining path. The plaintiff can ask the U.S. Court of Appeals for the Second Circuit to reverse the dismissal. An appeal would focus on whether the patent qualified for Orange Book listing and whether dismissal before discovery was correct.
Reversal is possible but not assured. The decision was a first-impression district ruling. It supports how drug makers have listed similar patents and gives innovators a defense framework, but it does not bind other courts. If the Second Circuit reverses, the case would return to the district court for further proceedings. If it affirms, or if no appeal is filed, the dismissal stands and the listing claims end.
What should Entresto purchasers do now?
Do not pay anyone to file an Entresto antitrust claim. No claims administrator, filing portal, or deadline exists.
Paid filing offers tied to this dismissal are a warning sign. Those records will matter if an appeal revives the case or a separate qualifying case appears. They also help a health plan or insurer answer coverage questions.
- Keep pharmacy receipts, explanation-of-benefits forms, and plan records for Entresto purchases
- Note whether you paid full price, a copay, or coinsurance, and the purchase dates
- Watch for a Second Circuit appeal filing in the same case name and number
- Check for a new lawsuit only if it alleges a different legal theory, not the same Orange Book claim