Esperion v. Accord Healthcare: NEXLETOL® Patent Claims Dismissed Without Prejudice
Esperion Therapeutics filed suit against Accord Healthcare and Intas Pharmaceuticals in May 2024 over three patents protecting NEXLETOL® (bempedoic acid), a cholesterol-lowering therapy. Claims against Accord were dismissed without prejudice after 424 days — but litigation against remaining defendants continues in the consolidated action.
Partial Dismissal in Bempedoic Acid ANDA Battle Leaves Door Open
Esperion Therapeutics, Inc. — the originator of NEXLETOL® (bempedoic acid), an ATP-citrate lyase inhibitor approved for LDL-C reduction — filed this Hatch-Waxman infringement action in the District of New Jersey on May 16, 2024. The suit named Accord Healthcare, Ltd. and Intas Pharmaceuticals Limited as defendants, asserting three patents: US11760714B2, US11926584B2, and US11613511B2, each directed to bempedoic acid compositions and methods of use.
On July 14, 2025, Esperion and Accord Healthcare filed a Rule 41(a)(1)(A)(ii) stipulated dismissal, extinguishing all claims and counterclaims between those two parties without prejudice and with each side absorbing its own costs. The dismissal was entered in the context of the consolidated action under Case No. 24-05921, meaning the partial resolution was formally recorded within that broader proceeding. Critically, claims against co-defendant Intas Pharmaceuticals remain pending.
A without-prejudice dismissal after 424 days — without any reported settlement payment or consent judgment — suggests the parties may have reached a private licensing arrangement or agreed to a covenant not to sue, though the public record is silent on the specific terms. The consolidation with Case No. 24-05921 and the continued litigation against Intas signals that Esperion’s NEXLETOL® patent portfolio remains actively enforced, and the Accord resolution should not be read as a concession on patent validity or infringement.
Filing to Dismissed without Prejudice in 424 days
424 days from filing to partial dismissal — longer than many Hatch-Waxman ANDA resolutions at this stage
Dismissed without prejudice: what the Accord stipulation means for both parties
Rule 41(a)(1)(A)(ii) stipulated dismissal — no merits adjudication
A dismissal under Fed. R. Civ. P. 41(a)(1)(A)(ii) requires the consent of all parties who have appeared and filed an answer. It carries no judgment on the merits — the court makes no ruling on infringement, validity, or enforceability of the three asserted patents. The dismissal is purely a procedural exit agreed to by both sides.
No merits rulingEsperion can refile against Accord if circumstances change
A without-prejudice dismissal preserves Esperion’s right to bring future infringement claims against Accord over the same patents and product. This contrasts sharply with a with-prejudice dismissal, which would bar refiling. The public record does not disclose whether a private licensing agreement, covenant not to sue, or other arrangement underlies this dismissal — only that neither party obtained a judgment.
Refiling right preservedAccord exits this action but patent cloud remains
Accord Healthcare secured dismissal of all claims and counterclaims against it, including any invalidity counterclaims it may have filed. With each party bearing its own costs, Accord avoids an adverse cost order. However, the without-prejudice nature means Accord cannot treat this as a cleared path — Esperion retains the ability to reassert these three patents should Accord proceed toward commercial ANDA launch.
No cost award; patent cloud persistsIntas Pharmaceuticals litigation continues — NEXLETOL® patents actively enforced
The stipulation is explicit that all claims against Intas Pharmaceuticals in the consolidated action under CA No. 24-05921 remain pending. This partial resolution does not signal weakness in Esperion’s patent position. Other generic manufacturers considering NEXLETOL® ANDAs should note that three bempedoic acid patents are still being actively litigated in New Jersey federal court.
Litigation ongoing vs. IntasFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Esperion Therapeutics, Inc. | Company | Pharmaceutical innovator — originator and patent holder of NEXLETOL® bempedoic acidSearch in Eureka ↗ |
| Defendant | Accord Healthcare, Ltd. | Company | Generic pharmaceutical manufacturer seeking ANDA approval for bempedoic acidSearch in Eureka ↗ |
| Co-Defendant | INTAS PHARMACEUTICALS, LIMITED | Individual | Search in Eureka ↗ |
| Plaintiff counsel | Jessica K. Formichella | Attorney | Counsel for Esperion Therapeutics, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Katelyn O’Reilly | Attorney | Counsel for Esperion Therapeutics, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Liza M. Walsh | Attorney | Counsel for Esperion Therapeutics, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Walsh Pizzi O’Reilly Falanga LLP | Law Firm | Representing Esperion Therapeutics, Inc.Search in Eureka ↗ |
| Defendant counsel | KEVIN M. CAPUZZI | Attorney | Counsel for Accord Healthcare, Ltd.Search in Eureka ↗ |
| Defendant counsel | KRISTEN HEALEY CRAMER | Attorney | Counsel for Accord Healthcare, Ltd.Search in Eureka ↗ |
| Defendant counsel | NOELLE TORRICE | Attorney | Counsel for Accord Healthcare, Ltd.Search in Eureka ↗ |
| Defendant law firm | BENESCH FRIEDLANDER COPLAN & ARNOFF | Law Firm | Representing Accord Healthcare, Ltd.Search in Eureka ↗ |
| Defendant law firm | BENESCH FRIEDLANDER COPLAN & ARONOFF LLP | Law Firm | Representing Accord Healthcare, Ltd.Search in Eureka ↗ |
| Defendant law firm | BENESCH, FRIEDLANDER, COPLAN, AND ARONOFF LLP | Law Firm | Representing Accord Healthcare, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated dismissal is narrow and surgical: it extinguishes only the Esperion–Accord bilateral claims within the consolidated action, explicitly preserving all claims against Intas Pharmaceuticals. The ‘without prejudice’ designation and mutual cost-bearing clause are consistent with a negotiated exit rather than a litigated outcome. No court finding on infringement, validity, or claim scope of the three asserted patents was made — meaning the legal strength of US11760714B2, US11926584B2, and US11613511B2 remains formally untested as against Accord.
US11760714B2, US11926584B2 & US11613511B2 — NEXLETOL® bempedoic acid patents
The three asserted patents — US11760714B2, US11926584B2, and US11613511B2 — protect bempedoic acid (ETC-1002), an ATP-citrate lyase (ACL) inhibitor approved as NEXLETOL® for adjunct LDL-C lowering in adults with heterozygous familial hypercholesterolemia or established cardiovascular disease. The patents cover compositions, formulations, and methods of use, filed across application numbers US17/577829, US18/297846, and US17/742728, placing them squarely within Esperion’s post-approval patent portfolio protecting the commercial product.
Bempedoic acid represents a differentiated mechanism in the cardiovascular lipid-lowering space, competing alongside statins and PCSK9 inhibitors. Esperion’s multi-patent filing strategy — spanning compound, formulation, and method claims across three patents — creates overlapping layers of protection typical of a branded pharmaceutical defending against ANDA-driven generic entry. For generic manufacturers, designing around all three patents simultaneously is a materially higher bar than challenging a single patent, reinforcing Esperion’s enforcement leverage in the NJ consolidated action.
Should you run an FTO against NEXLETOL®’s bempedoic acid patent estate?
Any pharmaceutical company, contract manufacturer, or formulator considering generic, biosimilar-adjacent, or combination-product development involving bempedoic acid or ACL inhibitor mechanisms should conduct a formal freedom-to-operate analysis against US11760714B2, US11926584B2, and US11613511B2. The Accord dismissal without prejudice provides no safe harbour — these patents are actively litigated and their claim scope remains judicially untested. Formulary and procurement teams at payers should also flag NEXLETOL® as subject to ongoing exclusivity risk.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of all three bempedoic acid patents, identify cited prior art, surface related prosecution history, and flag continuations or divisionals that may extend coverage. Eureka also monitors the consolidated NJ litigation docket in real time, alerting IP teams to claim construction orders, invalidity rulings against Intas, or any new ANDA defendants added to the action — intelligence that directly informs go/no-go decisions on generic bempedoic acid development timelines.
Run a freedom-to-operate analysis on US11760714B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ANDA patent cases in NJ District Court
Browse comparable cardiovascular drug ANDA infringement actions filed in the District of New Jersey, including multi-defendant consolidations and without-prejudice dismissals.
What this case signals for the bempedoic acid and cardiovascular drug IP landscape
A partial, without-prejudice exit in a multi-defendant ANDA case rarely ends the story — here is what IP teams and generic manufacturers need to watch.
Without-prejudice exits in Hatch-Waxman cases often signal private deal terms
When an ANDA infringement case resolves without prejudice and without a reported settlement payment, the most common explanation is a private licensing or entry-date agreement. IP teams monitoring the NEXLETOL® competitive landscape should track Accord’s ANDA approval status and any commercial launch activity as a leading indicator of deal structure.
Three patents remain live — NEXLETOL® exclusivity window is still contested
US11760714B2, US11926584B2, and US11613511B2 are all actively asserted against Intas Pharmaceuticals in the consolidated NJ action. Generic manufacturers and formulary decision-makers should treat NEXLETOL® as patent-protected until the Intas litigation resolves or patents expire — the Accord dismissal provides no validity signal.
Esperion v Accord — key questions answered
The without-prejudice dismissal means all claims between Esperion and Accord were dropped with no court ruling on infringement or validity of the three NEXLETOL® patents. Esperion retains the right to refile against Accord. This does not clear a path for Accord to commercially launch a generic bempedoic acid product — the patent cloud over NEXLETOL® remains, and litigation against Intas Pharmaceuticals is ongoing.
Esperion asserted three patents: US11760714B2 (application US17/577829), US11926584B2 (application US18/297846), and US11613511B2 (application US17/742728). All three protect aspects of bempedoic acid, the active ingredient in NEXLETOL®, including compositions and methods of use for LDL-C reduction.
No. The stipulated dismissal explicitly states that all claims asserted by Esperion against all other defendants — including Intas Pharmaceuticals — in the consolidated actions remain pending. The Accord resolution is bilateral only and has no legal effect on the Intas proceedings.
Rule 41(a)(1)(A)(ii) allows voluntary dismissal by stipulation of all parties who have appeared. It requires no court order and carries no judgment on the merits. The use of this mechanism, combined with a without-prejudice designation and mutual cost-bearing, is procedurally neutral — it closes the Accord docket entry without any finding on patent validity, enforceability, or infringement.
The public record is silent on the underlying reasons. Common explanations in Hatch-Waxman ANDA litigation include: a private patent licensing agreement with a negotiated generic entry date, a covenant not to sue tied to Accord’s commercial plans, or an agreement to defer litigation pending resolution of the Intas action. The without-prejudice structure suggests Esperion was unwilling to permanently relinquish enforcement rights against Accord.
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