Novartis v. Lupin: ENTRESTO® Patent Dispute Dismissed Without Prejudice
Novartis AG brought a patent infringement action against Lupin Limited and its affiliates in the Delaware District Court, asserting two patents covering ENTRESTO® tablets — a blockbuster heart failure therapy. The case resolved by stipulated dismissal without prejudice just 69 days after filing, consistent with an out-of-court settlement agreement.
ENTRESTO® ANDA battle resolved before Lupin answered the complaint
On 18 September 2024, Novartis AG filed a complaint for patent infringement against Lupin Limited, Lupin Pharmaceuticals, Inc., and Lupin Atlantis Holdings, S.A. in the Delaware District Court before Judge Richard G. Andrews (Case No. 1:24-cv-01045). The action asserted two patents — US8101659B2 and US11096918B2 — covering ENTRESTO® tablets in three commercially marketed dosage strengths: 24/26 mg, 49/51 mg, and 97/103 mg. ENTRESTO® (sacubitril/valsartan) is one of the highest-revenue cardiovascular drugs globally, making generic entry commercially consequential.
The case closed on 26 November 2024, just 69 days after filing, through a joint stipulation of dismissal without prejudice under Federal Rule of Civil Procedure 41(a)(2). Critically, Lupin had not yet filed an answer to Novartis’s complaint at the time of dismissal. The stipulation states that the parties ‘entered into an agreement resolving their disputes,’ strongly suggesting a private licensing or settlement arrangement governs the terms of any future generic entry, though those terms remain confidential on the public record.
A 69-day resolution in ANDA-related Hatch-Waxman litigation is notably fast and consistent with a negotiated settlement reached before substantive litigation began. The without-prejudice dismissal means Novartis retains the right to refile on the same patents if the settlement conditions are breached, preserving leverage over Lupin’s commercialisation timeline. The specific terms — including any authorised generic provisions, royalty structures, or launch date restrictions — are not disclosed in the public court record.
Filing to Dismissed without Prejudice in 69 days
69 days — resolved before Lupin filed its first answer
Dismissed without prejudice: what the stipulation means for both parties
Rule 41(a)(2) dismissal without prejudice — the case can be refiled
A dismissal without prejudice under Fed. R. Civ. P. 41(a)(2) terminates the action without adjudicating the merits. Critically, it does not bar Novartis from refiling the same patent infringement claims against Lupin in the future. This mechanism is the standard vehicle for court-approved termination of Hatch-Waxman suits following a private settlement, leaving the underlying patent rights fully intact.
No merits adjudicationStipulation language confirms a private agreement — terms undisclosed
The dismissal stipulation explicitly states the parties ‘entered into an agreement resolving their disputes.’ This language is a strong indicator of a confidential settlement, potentially including a licensed launch date for Lupin’s generic, royalty obligations, or authorised generic rights. The public record does not disclose the substantive terms. The without-prejudice dismissal also preserves Novartis’s ability to enforce compliance with any settlement conditions through renewed litigation.
Confidential settlement likelyNovartis retains full enforcement rights over both ENTRESTO® patents
Because the case was dismissed without prejudice and no invalidity or non-infringement ruling was made, US8101659B2 and US11096918B2 remain fully enforceable. Novartis’s IP position over the sacubitril/valsartan franchise is unchanged. Any settlement-controlled entry date for Lupin’s generic preserves Novartis’s exclusivity window, and the without-prejudice structure gives Novartis a litigation backstop if Lupin deviates from agreed terms.
Patents remain enforceableLupin’s generic launch timeline now governed by private agreement
Lupin avoided a full Hatch-Waxman trial and any adverse patent ruling, but its path to market for ENTRESTO® generics is now controlled by the undisclosed settlement terms rather than a court-determined patent expiry. Other generic manufacturers watching this case receive no public invalidity or non-infringement precedent they can rely upon, sustaining the deterrent value of Novartis’s patent portfolio for the ENTRESTO® franchise.
Market entry terms undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Novartis, AG | Company | Novartis AG — global pharmaceutical innovator, holder of ENTRESTO® patents US8101659B2 and US11096918B2Search in Eureka ↗ |
| Defendant | Lupin Limited | Individual | Lupin Limited and affiliates — Indian generics manufacturer seeking ENTRESTO® ANDA approvalSearch in Eureka ↗ |
| Co-Defendant | Lupin Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Lupin Atlantis Holdings, S.A. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Alexandra M. Joyce | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff counsel | Daniel M. Silver | Attorney | Counsel for Novartis, AGSearch in Eureka ↗ |
| Plaintiff law firm | McCarter & English LLP | Law Firm | Representing Novartis, AGSearch in Eureka ↗ |
| Defendant counsel | Alexandra M. Ewing | Attorney | Counsel for Lupin LimitedSearch in Eureka ↗ |
| Defendant counsel | Frederick L. Cottrell , III | Attorney | Counsel for Lupin LimitedSearch in Eureka ↗ |
| Defendant law firm | Richards Layton & Finger PA | Law Firm | Representing Lupin LimitedSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation’s operative language — dismissal ‘without prejudice pursuant to Fed. R. Civ. P. 41(a)(2)’ combined with the recital that parties ‘entered into an agreement resolving their disputes’ — is the standard Hatch-Waxman settlement formulation. No infringement, validity, or enforceability finding was made on either patent. The each-party-bears-own-costs provision is customary in consensual dismissals and does not indicate relative bargaining strength. The absence of Lupin’s answer from the record confirms the case ended entirely at the pleadings stage, with zero substantive merits development on the public docket.
US8101659B2 & US11096918B2 — ENTRESTO® sacubitril/valsartan formulations
US8101659B2 (Application No. 12/147570) and US11096918B2 (Application No. 16/579581) both protect aspects of the sacubitril/valsartan combination that constitutes ENTRESTO®, Novartis’s angiotensin receptor–neprilysin inhibitor (ARNi) therapy approved for heart failure with reduced ejection fraction. The patents cover formulation and composition elements across the three commercial dose strengths (24/26 mg, 49/51 mg, and 97/103 mg). US11096918B2, with its later application date, is a continuation-type asset suggesting Novartis built layered IP coverage over successive prosecution cycles.
ENTRESTO® generated approximately $6 billion in global net sales in 2023, making the protection of these patents commercially critical for Novartis’s cardiovascular franchise. The assertion of two patents with different application vintages against a single ANDA filer is consistent with a layered exclusivity strategy designed to maximise the window within which generic entry can be delayed or licensed on favourable terms. Generic manufacturers developing sacubitril/valsartan formulations must independently assess both patents to determine freedom-to-operate before any US commercial launch.
Should you run an FTO analysis against US8101659B2 and US11096918B2?
Any company developing a generic, biosimilar-adjacent, or reformulated sacubitril/valsartan product targeting the US market should treat US8101659B2 and US11096918B2 as active blocking patents until their expiry dates pass or a public invalidity ruling is obtained. This case’s without-prejudice dismissal means no court has weakened either patent. R&D teams formulating ENTRESTO® alternatives, and business development professionals modelling generic launch windows, face live infringement risk on both assets.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US8101659B2 and US11096918B2, identify related family members and continuation patents in Novartis’s ENTRESTO® portfolio, surface prior art landscapes that could support future IPR petitions, and benchmark expiry timelines against any patent term extensions. This gives IP and product teams an evidence-based foundation for launch timing decisions and design-around strategies before committing R&D resources.
Run a freedom-to-operate analysis on US8101659B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman patent cases in Delaware District Court
Explore comparable ANDA patent infringement cases involving cardiovascular and fixed-dose combination drugs filed in the Delaware District Court.
What this case signals for the ENTRESTO® and cardiovascular IP landscape
A pre-answer settlement in a high-value Hatch-Waxman case signals patent strength — and raises the bar for other generic challengers.
Pre-answer resolution typically signals strong patent confidence
When an ANDA defendant settles before filing its answer, it typically suggests the patentee’s IP position was sufficiently robust that early resolution was commercially preferable to litigation risk. For Novartis, the rapid settlement of this ENTRESTO® suit is consistent with a well-maintained and defensible patent estate covering one of its most commercially critical products.
Without-prejudice structure preserves Novartis’s enforcement leverage
The dismissal without prejudice is a deliberate strategic choice: Novartis can refile if Lupin breaches any settlement condition, including an agreed launch date restriction. For in-house IP teams monitoring the ENTRESTO® generic pipeline, this structure means the litigation threat remains live as a compliance mechanism, not just a historical filing.
Novartis v Lupin — key questions answered
Novartis asserted two patents: US8101659B2 (Application No. 12/147570) and US11096918B2 (Application No. 16/579581), both covering ENTRESTO® (sacubitril/valsartan) tablet formulations in 24/26 mg, 49/51 mg, and 97/103 mg dosage strengths.
The parties filed a joint stipulation of dismissal under Fed. R. Civ. P. 41(a)(2), stating they had entered into an agreement resolving their disputes. A without-prejudice dismissal means no merits ruling was made and Novartis retains the right to refile on the same patents if the settlement agreement is breached.
The public record does not disclose settlement terms. However, it is consistent with a licensed entry date arrangement. The without-prejudice structure means Lupin’s commercial launch timeline is likely governed by the private agreement, not a court-determined patent expiry, and Novartis can litigate again if Lupin deviates from those terms.
No. Because the case was dismissed without any merits adjudication on validity, infringement, or enforceability of US8101659B2 or US11096918B2, competing generic filers receive no favourable precedent from this case. Each Hatch-Waxman challenger must independently litigate or license Novartis’s patents.
The case was filed on 18 September 2024 and dismissed on 26 November 2024 — a span of 69 days. Lupin had not yet filed its answer when the stipulation was entered, indicating the parties reached agreement entirely at the pre-answer pleadings stage, which is unusually fast for Hatch-Waxman patent litigation.
PatSnap Eureka searches patents and litigation data to answer instantly.