Entresto (Sacubitril/Valsartan) Patent
This MDL consolidates Hatch-Waxman patent litigation brought by the branded manufacturer of Entresto, a heart-failure medication combining sacubitril and valsartan, against generic drug companies that filed abbreviated new drug applications to market generic versions ahead of patent expiration. Centralized in the District of Delaware in 2020, the litigation originally involved patents covering the fixed-dose combination, its pharmaceutical composition, and methods of treating heart failure. Over more than six years of litigation, the large majority of the original generic defendants settled or exited the case, leaving a single generic manufacturer as the primary remaining party, and generic competition has since entered the market.
What drove the docket's resolution timeline was a sequence of claim-construction rulings, a bench trial addressing the validity of the earliest-expiring patent (which the court found invalid for lack of written description on one key claim set while rejecting other invalidity theories), and parallel Federal Circuit appellate review, all layered against a regulatory backdrop in which FDA approval timing for each generic applicant independently affected when that defendant could actually enter the market. That combination, patent validity litigation running alongside regulatory approval timing, is characteristic of how Hatch-Waxman pharmaceutical patent MDLs resolve differently than a typical commercial patent dispute.
For anyone studying how branded-generic pharmaceutical patent litigation moves through the federal MDL system, this docket is a clear example of a multi-defendant, multi-patent fight narrowing over years to a single contested claim while the underlying product nonetheless reaches the generic market. Criterica Intelligence's platform tracks this Hatch-Waxman-specific resolution pattern, regulatory approval timing interacting with parallel patent litigation, separately from ordinary commercial or consumer IP disputes.
A Hatch-Waxman pharmaceutical patent dispute in which the branded manufacturer of Entresto sued generic drug companies that sought FDA approval to market generic sacubitril/valsartan before the branded patents expire.
It addressed the validity of the earliest-expiring patent at issue, with the court finding certain claims invalid for lack of written description while rejecting other invalidity theories, narrowing the scope of the remaining dispute.
FDA approval timing for each generic applicant operates on its own regulatory track that runs alongside, rather than strictly after, the patent litigation, so a generic product can reach the market even while narrower patent questions remain contested for other applicants.
That a multi-defendant, multi-patent branded-generic fight can run for years through district court and appellate proceedings, narrowing sharply as defendants settle, while regulatory approval and patent litigation timelines move independently of each other, a pattern Criterica Intelligence tracks specifically for this category of IP dispute.
Statistics shown reflect historical or illustrative model outputs derived from real case data. They are not predictions or guarantees of any individual outcome. Litigation results depend on facts, jurisdiction, judge, and counsel, and vary case by case. Model accuracy is subject to selection effects and changing legal dynamics.