Entresto (Sacubitril/Valsartan) Patent Litigation
Entresto (Sacubitril/Valsartan) is a combination drug used to treat heart failure with reduced ejection fraction (HFrEF). Its mechanism involves sacubitril, a neprilysin inhibitor that increases endogenous natriuretic peptides, leading to vasodilation, natriuresis, and diuresis, and valsartan, an angiotensin II receptor blocker (ARB) that inhibits the renin-angiotensin-aldosterone system (RAAS). This dual action reduces cardiac preload and afterload, mitigates myocardial remodeling, and improves clinical outcomes. Approved by the FDA based on clinical trials showing reductions in cardiovascular mortality and hospitalizations, Entresto is a significant advancement in heart failure management, emphasizing neurohormonal modulation to improve prognosis and quality of life.
1
Pending actions
28
Total actions filed
Active
Status
03/27/2020
Established
Filing deadline
The primary procedural deadline for generic manufacturers to file ANDA challenges is within 45 days of receipt of paragraph IV certifications. No additional specific deadlines or statutes of limitations beyond the general 6-year patent infringement limit are explicitly detailed in recent court documents.
Who qualifies
Plaintiffs in this patent litigation are typically generic drug manufacturers who have filed ANDA applications challenging the validity or infringement of Novartis's patents related to Entresto. To qualify as a plaintiff, a generic manufacturer must have filed a detailed ANDA with a paragraph IV certification asserting patent invalidity or non-infringement, demonstrating a commercial interest in market entry, and complying with procedural requirements. The case involves claims of patent infringement or invalidity, with plaintiffs often seeking to market biosimilar or generic versions of Entresto.
Products involved
- Entresto (Sacubitril/Valsartan)
Alleged injuries
- Patent infringement
Bellwether trials
No bellwether trials have been scheduled or occurred in MDL-2930 Entresto Patent Litigation. The litigation has progressed primarily through court motions, summary judgments, and appeals, with ongoing procedural activity as of early 2026.
Settlement landscape
As of March 2026, specific settlement amounts or damages awards related to MDL-2930 are not publicly disclosed. Recent legal rulings, including summary judgments, suggest ongoing disputes, but no publicly available figures on settlement sums or damages have been reported.
Lead counsel
- Not explicitly identified in the research; specific lead counsel information is not available in the sources reviewed.
This page is generated from the official JPML pending-MDL report and public court records, refreshed monthly. It is provided for attorney reference and is not legal advice.
