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Pacira v. eVenus & Fresenius Kabi: EXPAREL Liposome Patent Dispute | PatSnap
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Case ID2:24-cv-06294
FiledMay 2024
ClosedApr 2025
Patent Litigation

Pacira v. eVenus & Fresenius Kabi: EXPAREL Liposome Patent Action Dismissed With Prejudice

Pacira Pharmaceuticals and Pacira Biosciences brought a patent infringement action in the District of New Jersey against three defendants — eVenus Pharmaceutical Laboratories, Jiangsu Hengrui Pharmaceuticals, and Fresenius Kabi USA — asserting US11819574B2 covering their EXPAREL bupivacaine liposome injectable suspension. All claims and counterclaims were dismissed with prejudice by joint stipulation after 330 days, with no costs or attorneys’ fees awarded to any party.

Resolution time
330days
330 days — resolved well within the median ANDA/Hatch-Waxman district court lifecycle
Patents asserted
1
US11819574B2 — EXPAREL bupivacaine liposome injectable suspension, 266 mg/20 mL
Outcome
Case Dismissed
With prejudice by joint stipulation — claims cannot be refiled; no costs awarded to any party
Cost ruling
No Costs
Stipulated dismissal explicitly bars costs, disbursements, and attorneys’ fees to all parties
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

A three-defendant liposomal anesthetic dispute ends by mutual agreement

On 20 May 2024, Pacira Pharmaceuticals, Inc. and Pacira Biosciences, Inc. filed a patent infringement action in the United States District Court for the District of New Jersey, case number 2:24-cv-06294, asserting US11819574B2 against eVenus Pharmaceutical Laboratories, Inc., Jiangsu Hengrui Pharmaceuticals Co., Ltd., and Fresenius Kabi USA, LLC. The patent at issue relates to EXPAREL® — Pacira’s branded bupivacaine liposome injectable suspension indicated for postsurgical pain management — marketed at a concentration of 266 mg/20 mL (13.3 mg/mL). The involvement of a Chinese API manufacturer and a major U.S. generic injectable company alongside eVenus suggests the dispute likely arose in the context of an abbreviated new drug application (ANDA) or a biosimilar-adjacent regulatory pathway.

The case closed on 15 April 2025 after 330 days when all five parties filed a joint stipulation of dismissal under Federal Rules of Civil Procedure 41(a)(1) and 41(c). All claims, counterclaims, and affirmative defenses were dismissed with prejudice, meaning neither side may relitigate the same claims arising from this action. Notably, each party bears its own costs, with no disbursements or attorneys’ fees shifting to any party — a hallmark of negotiated resolution rather than adjudicated defeat.

A 330-day resolution without a merits ruling is consistent with an out-of-court settlement, potentially including a licensing arrangement, an agreed entry date for a generic or competing product, or a covenant not to sue — though the public record is silent on specific terms. The with-prejudice designation is consequential: it forecloses any future identical action between these parties on this patent without fresh cause. What drove the resolution — whether commercial, regulatory, or clinical developments — remains undisclosed, as is typical for pharmaceutical IP settlements of this nature.

Case at a glance
Case no.2:24-cv-06294
CourtNew Jersey
JudgeN/A
FiledMay 20, 2024
ClosedApril 15, 2025
Duration330 days
OutcomeCase Dismissed
Verdict causeInfringement Action
BasisCase Dismissed
Prior Art Intelligence
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Case Dismissed in 330 days

330 days — resolved well within the median ANDA/Hatch-Waxman district court lifecycle

Case timeline: Complaint filed MAY 20 2024, NOV–DEC — 330 days total Horizontal timeline showing the three key events in Pacira Pharmaceuticals, Inc. v Evenus Pharmaceuticals Laboratories, Inc. from filing to resolution. Source: PACER, New Jersey District Court. MAY 20 2024 Complaint filed Pre-trial proceedings APR 15 2025 Case Dismissed 330 DAYS TOTAL
Dismissal terms

Dismissed with prejudice by stipulation: what the joint filing means for both sides

Legal mechanism

Rule 41 dismissal with prejudice: a final, court-closing event

A stipulated dismissal under FRCP 41(a)(1) and 41(c) is a jointly agreed procedural filing that terminates an action without a merits adjudication. When designated ‘with prejudice,’ the dismissal has the force of a final judgment — precluding any party from re-asserting the same claims between the same parties in a future action. This is the dominant mechanism for pharmaceutical IP settlements where parties reach commercial resolution before trial.

Bilateral — all five parties signed
Patent holder outcome

Pacira retains US11819574B2 without adverse validity ruling

Because the case was dismissed before any merits ruling, no court has invalidated or construed US11819574B2 in this proceeding. Pacira’s patent survives fully intact against the public, and the with-prejudice bar runs only as between these specific parties. The absence of a cost-shifting award and the mutual dismissal of counterclaims — which typically assert invalidity or non-infringement — suggests Pacira secured at least a neutral, and possibly favourable, commercial outcome.

Patent validity unchallenged on record
Challenger outcome

Defendants’ invalidity counterclaims also dismissed with prejudice

eVenus, Jiangsu Hengrui, and Fresenius Kabi each had counterclaims and affirmative defenses — almost certainly including invalidity and non-infringement arguments — that were likewise extinguished with prejudice. These defendants cannot revive the same invalidity theories in a new district court action against Pacira on this patent. Their path to market for a competing bupivacaine liposome product now likely depends on negotiated terms or a separate IPR/PGR strategy at the USPTO.

Counterclaims extinguished
Commercial implications

EXPAREL’s IP moat strengthened by absence of any adverse record

For the broader liposomal drug delivery sector, this resolution leaves US11819574B2 unchallenged on its merits in federal court. Companies developing competing long-acting local anesthetics or liposomal injectable formulations must still design around or license this patent. The presence of Jiangsu Hengrui — a major Chinese pharma player — among the defendants signals international interest in the EXPAREL space, raising the competitive stakes for Pacira’s IP enforcement posture globally.

No validity precedent set
Legal analysis based on PACER docket records for case 2:24-cv-06294 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffPacira Pharmaceuticals, Inc.CompanySpecialty pharmaceutical company — holder of US11819574B2 covering EXPAREL bupivacaine liposome injectable suspensionSearch in Eureka ↗
Co-PlaintiffPacira Biosciences, Inc.CompanySearch in Eureka ↗
DefendantEvenus Pharmaceuticals Laboratories, Inc.CompanyGeneric pharmaceutical developer (eVenus), Chinese API manufacturer (Jiangsu Hengrui), and U.S. generic injectable specialist (Fresenius Kabi USA)Search in Eureka ↗
Co-DefendantJIANGSU HENGRUI PARMACEUTICALS CO., LTD.CompanySearch in Eureka ↗
Co-DefendantFresenius Kabi USA, LLCCompanySearch in Eureka ↗
Plaintiff counselCynthia Stencel BetzAttorneyCounsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselMark M. MakhailAttorneyCounsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselMichael Theodore ZoppoAttorneyCounsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff counselTHOMAS P. SCRIVOAttorneyCounsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmFish & Richardson, PCLaw FirmRepresenting Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmMccarter & English, LLPLaw FirmRepresenting Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Plaintiff law firmO’Toole Scrivo, LLCLaw FirmRepresenting Pacira Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselEric I. AbrahamAttorneyCounsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗
Defendant counselKristine L. ButlerAttorneyCounsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗
Defendant counselWilliam MurthaAttorneyCounsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗
Defendant law firmHill Wallack LLPLaw FirmRepresenting Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, Pacira Pharmaceuticals, Inc. and Pacira Biosciences, Inc. (collectively, “Plaintiffs”) and eVenus Pharmaceutical Laboratories, Inc., Jiangsu Hengrui Pharmaceuticals Co., Ltd., and Fresenius Kabi USA, LLC (collectively, “Defendants”) hereby stipulate and agree that all claims, counterclaims, and affirmative defenses asserted by Plaintiffs and Defendants against each other in the abovecaptioned action are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.”
Source: PACER Docket, Case 2:24-cv-06294, New Jersey District Court

The stipulation explicitly invokes FRCP 41(a)(1) and 41(c) — the joint dismissal rule applicable to actions involving claims and counterclaims — and designates the dismissal ‘with prejudice and without costs, disbursements, or attorneys’ fees to any party.’ The with-prejudice language is the operative term: it extinguishes all claims and counterclaims between these parties as a matter of res judicata, while the mutual cost waiver signals a negotiated outcome rather than capitulation. No merits findings, claim constructions, or validity determinations appear on the record.

PACER case 2:24-cv-06294 · Public docket record Explore in Eureka ↗
Patent at issue

US11819574B2 — bupivacaine liposome injectable suspension for postsurgical pain

Publication No.US11819574B2
Application No.US17/719716
Patent details
ProductBupivacaine liposome injectable suspension for extended postsurgical pain management
Cited in actionMay 20, 2024

US11819574B2, filed under application number US17/719716, protects formulations and related aspects of bupivacaine encapsulated within liposomal drug delivery systems — the core technology behind EXPAREL®, Pacira’s flagship postsurgical analgesic. Liposomal encapsulation of bupivacaine enables a sustained-release pharmacokinetic profile that extends local anesthetic effect well beyond conventional bupivacaine formulations, reducing opioid requirements in the perioperative setting. The patent’s grant reflects a sophisticated claim architecture in a crowded and commercially high-value space within injectable pharmaceutical formulation.

EXPAREL® commands a significant share of the U.S. postsurgical non-opioid analgesia market, making US11819574B2 a commercially strategic asset. The fact that three parties — including a Chinese API manufacturer and a major U.S. generic injectable company — jointly challenged this patent underscores the market’s attractiveness to generic entrants. For pharmaceutical IP teams, this patent represents a critical watch asset: any company developing liposomal bupivacaine formulations, long-acting local anesthetics, or competing non-opioid perioperative analgesics should assess their exposure against its claim scope before entering clinical or regulatory development.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should you run an FTO against US11819574B2?

Any company developing liposomal bupivacaine formulations, long-acting injectable local anesthetics, or non-opioid postsurgical analgesics in liposomal delivery systems should treat US11819574B2 as a priority FTO target. This patent has already attracted ANDA-related litigation from multiple sophisticated entrants, confirming that Pacira actively enforces it. R&D and regulatory teams planning an ANDA or 505(b)(2) submission for a competing product should conduct FTO analysis before paragraph IV certification — not after receiving a complaint.

PatSnap Eureka’s FTO Search Agent can map the claim landscape of US11819574B2, identify prior art publications and related family members, and flag design-around opportunities in liposomal formulation or dosing parameters. Eureka’s portfolio monitoring tools can also track new Pacira filings in the bupivacaine space, detect continuation applications, and alert you to Orange Book listing changes — giving your IP and regulatory teams the intelligence needed to time market entry with minimised litigation risk.

PatSnap Eureka FTO Search

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Related litigation

Similar liposomal drug delivery patent cases in U.S. District Courts

Cases involving liposomal injectable formulation patents litigated in U.S. district courts, including ANDA-related pharmaceutical IP disputes comparable to Pacira v. eVenus.

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Strategic implications

What this case signals for the liposomal drug delivery IP landscape

A three-defendant dismissal with prejudice in a high-value injectable anesthetic case rewards close reading for drug delivery and generic pharmaceutical IP teams.

With-prejudice bar cuts both ways — Pacira’s invalidity exposure is frozen here

Defendants’ invalidity counterclaims were dismissed with prejudice, meaning these specific parties cannot mount a fresh federal district court challenge to US11819574B2 on the same grounds. For Pacira, this is tactically significant: three well-resourced opponents have effectively stepped back from the patent’s validity battlefield in New Jersey. Competitors watching this space should note that any invalidity strategy may need to route through IPR proceedings at the USPTO rather than district court.

Fresenius Kabi and Jiangsu Hengrui’s involvement signals commercial ANDA dynamics

The pairing of a U.S.-based generic injectable company (Fresenius Kabi) with a major Chinese pharmaceutical manufacturer (Jiangsu Hengrui) alongside eVenus is consistent with an ANDA-driven supply chain dispute. This structure — where a domestic filer partners with an offshore API supplier — is a recurring pattern in complex injectable patent litigation. Companies developing competing liposomal products should map these relationships when assessing FTO risk for bupivacaine liposome formulations.

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Frequently asked questions

Pacira v Evenus — key questions answered

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Track liposomal pharmaceutical patent enforcement before it reaches your pipeline

US11819574B2 remains in force and Pacira has demonstrated willingness to pursue multi-defendant litigation. Use PatSnap Eureka to run FTO analysis, monitor continuation filings, and benchmark your bupivacaine liposome development program against the current IP landscape.

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