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.
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.
Filing to Case Dismissed in 330 days
330 days — resolved well within the median ANDA/Hatch-Waxman district court lifecycle
Dismissed with prejudice by stipulation: what the joint filing means for both sides
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 signedPacira 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 recordDefendants’ 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 extinguishedEXPAREL’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 setFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Pacira Pharmaceuticals, Inc. | Company | Specialty pharmaceutical company — holder of US11819574B2 covering EXPAREL bupivacaine liposome injectable suspensionSearch in Eureka ↗ |
| Co-Plaintiff | Pacira Biosciences, Inc. | Company | Search in Eureka ↗ |
| Defendant | Evenus Pharmaceuticals Laboratories, Inc. | Company | Generic pharmaceutical developer (eVenus), Chinese API manufacturer (Jiangsu Hengrui), and U.S. generic injectable specialist (Fresenius Kabi USA)Search in Eureka ↗ |
| Co-Defendant | JIANGSU HENGRUI PARMACEUTICALS CO., LTD. | Company | Search in Eureka ↗ |
| Co-Defendant | Fresenius Kabi USA, LLC | Company | Search in Eureka ↗ |
| Plaintiff counsel | Cynthia Stencel Betz | Attorney | Counsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Mark M. Makhail | Attorney | Counsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Michael Theodore Zoppo | Attorney | Counsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | THOMAS P. SCRIVO | Attorney | Counsel for Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Fish & Richardson, PC | Law Firm | Representing Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Mccarter & English, LLP | Law Firm | Representing Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | O’Toole Scrivo, LLC | Law Firm | Representing Pacira Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Eric I. Abraham | Attorney | Counsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗ |
| Defendant counsel | Kristine L. Butler | Attorney | Counsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗ |
| Defendant counsel | William Murtha | Attorney | Counsel for Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗ |
| Defendant law firm | Hill Wallack LLP | Law Firm | Representing Evenus Pharmaceuticals Laboratories, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US11819574B2 — bupivacaine liposome injectable suspension for postsurgical pain
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.
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.
Run a freedom-to-operate analysis on US11819574B2 to assess your product’s exposure
Run FTO in Eureka →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.
Related patent case — similar technology
Comparable case in the same technology domain. Patent holder and defendant reached resolution after proceedings.
SettledRelated infringement action — same court
Comparable EXPAREL® bupivacaine liposome injectable suspension, 266 mg/20 mL (13.3 mg/mL)-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedPacira Pharmaceuticals, Inc.’s broader IP enforcement history
Pacira Pharmaceuticals, Inc.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
Settlement timing suggests a negotiated entry date or licensing window may exist
Resolution at 330 days — before claim construction or any substantive ruling — is strongly consistent with a confidential settlement containing an agreed generic or biosimilar entry date. If a licensing arrangement is embedded in the resolution, it may not appear on the public docket. Competitors should monitor FDA Orange Book patent listings for US11819574B2 and any paragraph IV certification filings to detect shifts in Pacira’s enforcement posture.
IPR remains the viable validity challenge route for future entrants
With district court invalidity challenges foreclosed for these defendants, the USPTO’s inter partes review process is the primary remaining mechanism for third parties to challenge US11819574B2. The patent’s application number (US17/719716) and grant date should be assessed against the IPR one-year bar from service of a complaint. New ANDA filers entering the bupivacaine liposome space would be advised to conduct a dedicated prior art search before any paragraph IV filing triggers litigation.
Pacira v Evenus — key questions answered
Pacira asserted US11819574B2, covering their EXPAREL® bupivacaine liposome injectable suspension (266 mg/20 mL, 13.3 mg/mL), in the District of New Jersey. The application number on record is US17/719716.
The case was dismissed with prejudice by joint stipulation under FRCP 41(a)(1) and 41(c). All claims, counterclaims, and affirmative defenses were extinguished, and no costs, disbursements, or attorneys’ fees were awarded to any party. The with-prejudice designation means these parties cannot relitigate the same claims in a future action.
Jiangsu Hengrui Pharmaceuticals Co., Ltd. was named alongside eVenus and Fresenius Kabi as a co-defendant. Their involvement is consistent with a supply-chain role — typically as an API manufacturer or development partner — in an ANDA or competing injectable product development program targeting EXPAREL’s market. The public record does not specify the precise basis for their inclusion.
No. The stipulated dismissal contains no merits ruling, claim construction, or validity finding. US11819574B2 remains fully in force against all third parties. Only the specific claims and counterclaims between these named parties are extinguished. The patent’s enforceability and scope are unchanged by the dismissal.
District court invalidity challenges are foreclosed for these defendants by the with-prejudice dismissal. However, inter partes review (IPR) at the USPTO is a separate proceeding and is not directly barred by a Rule 41 dismissal, subject to applicable statutory time bars. Defendants would need independent grounds and to satisfy IPR standing and timing requirements to pursue that route.
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.
PatSnap Eureka searches patents and litigation data to answer instantly.