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American Regent v. Amneal: Multrys Trace Elements Injection Patent Litigation | PatSnap
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Case ID2:25-cv-12169
FiledJun 2025
ClosedAug 2025
Patent Litigation

American Regent v. Amneal: Multrys® Patent Infringement Resolved by Consent Judgment

American Regent, Inc. sued Amneal Pharmaceuticals over five patents protecting Multrys® (trace elements injection 4*, USP) in 1 mL single-dose vials. The New Jersey District Court case closed in just 36 days via a consent judgment that enjoins Amneal from infringing the asserted patents unless specifically authorized under the parties’ settlement agreement.

Resolution time
36days
36-day resolution — well below the median ANDA patent litigation timeline of several years
Patents asserted
5
US11786548B2 and 4 further patents asserted covering trace elements injection formulations
Outcome
Consent Judgment
Dismissed without prejudice; injunction entered by court order under settlement agreement
Cost ruling
No Costs Awarded
Parties agreed no costs, disbursements or attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Rapid ANDA settlement injects an injunction into Amneal’s generic path

American Regent, Inc. (ARI) filed suit against Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited in the District of New Jersey on 26 June 2025, asserting five patents — US11786548B2, US11975022B2, US11998565B2, US12150956B2 and US12150957B2 — covering its Multrys® (trace elements injection 4*, USP) product. Amneal had filed Abbreviated New Drug Application No. 219027 seeking FDA approval for a generic trace elements injection (1000 mcg Zn/mL, 60 mcg Cu/mL, 3 mcg Mn/mL and 6 mcg Se/mL in 1 mL single-dose vials), triggering the Hatch-Waxman litigation.

The case closed on 1 August 2025 — just 36 days after filing — through a court-entered consent judgment. The judgment enjoins Amneal and its affiliates from making, using, selling, offering to sell, importing or distributing the ANDA products in the United States unless specifically authorised by ARI or by 35 U.S.C. § 271(e)(1). All claims, counterclaims and affirmative defenses were dismissed without prejudice and without costs. The court retained jurisdiction to enforce the consent judgment and the underlying settlement agreement.

The 36-day resolution is strikingly fast for ANDA litigation, which typically extends years through claim construction and trial. The consent judgment’s explicit injunction — rather than a simple dismissal — suggests the parties reached a negotiated commercial arrangement, likely a licensed market entry date, the financial terms of which are not disclosed in the public record. The FDA retains authority to grant final ANDA approval, and Amneal may continue to maintain or file Paragraph IV certifications, signalling that a future licensed entry date has been agreed rather than a permanent bar.

Case at a glance
Case no.2:25-cv-12169
CourtNew Jersey
JudgeN/A
FiledJune 26, 2025
ClosedAugust 1, 2025
Duration36 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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 Consent Judgment in 36 days

36-day resolution — well below the median ANDA patent litigation timeline of several years

Case timeline: Complaint filed JUN 26 2025, JUL–AUG — 36 days total Horizontal timeline showing the three key events in American Regent, Inc. v Amneal Pharmaceuticals, Inc. from filing to resolution. Source: PACER, New Jersey District Court. JUN 26 2025 Complaint filed Pre-trial proceedings AUG 1 2025 Consent Judgment 36 DAYS TOTAL
Dismissal terms

Consent judgment with injunction: what the settlement means for both parties

Legal mechanism

Consent judgment is not a merits ruling — it is a binding court order by agreement

A consent judgment combines a negotiated settlement with judicial enforcement. The court entered a formal order enjoining Amneal without adjudicating patent validity or infringement on the merits. Dismissal without prejudice means neither side is collaterally estopped from future litigation, but the injunction itself is immediately enforceable and survives the case’s closure. The court retains jurisdiction to police compliance.

Enforceable injunction entered
Dismissal without prejudice

No prejudice finding: what the public record does — and does not — tell us

Dismissal without prejudice preserves both parties’ rights to re-litigate if the settlement agreement is breached or a licensing dispute arises. Unlike a dismissal with prejudice, ARI could theoretically refile on the same patents if Amneal were to act outside the settlement’s authorised scope. The financial terms of the settlement — including any licensed entry date — are not publicly disclosed and cannot be inferred from the consent judgment alone.

No merits adjudication
Patent holder outcome

ARI secures injunction across all five patents and retains enforcement rights

The consent judgment confirms that all five Licensed ARI Patents remain in force and enforceable against Amneal without any validity concession. ARI retains the unilateral right to authorise market entry under the settlement agreement, and compliance can be enforced directly by ARI or its successors. This outcome is broadly favourable for the patent holder, preserving both the IP estate and commercial control over Multrys®.

IP estate intact
Generic challenger outcome

Amneal’s ANDA survives — but launch is subject to ARI’s authorisation

Amneal’s ANDA No. 219027 is not withdrawn. The FDA may still grant final approval, and Amneal retains the right to maintain or file Paragraph IV certifications. This strongly suggests a negotiated future launch date rather than a permanent exclusion. Amneal avoided an adverse merits ruling on patent validity, preserving litigation optionality — but is enjoined from launching without ARI’s sign-off until the settlement’s conditions are met.

Conditional future entry preserved
Legal analysis based on PACER docket records for case 2:25-cv-12169 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAmerican Regent, Inc.CompanyPharmaceutical manufacturer — holder of US11786548B2 and four related Multrys® patentsSearch in Eureka ↗
DefendantAmneal Pharmaceuticals, Inc.CompanyGeneric pharmaceutical company seeking FDA approval via ANDA No. 219027 for trace elements injectionSearch in Eureka ↗
Plaintiff counselCharles H. ChevalierAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff counselChristine A. GaddisAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting American Regent, Inc.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“American Regent, Inc. (“ARI”), and Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited (together “AMNEAL”), parties in the above-captioned Actions, specifically in the Action initiated by Plaintiff, ARI, against AMNEAL in Civil Action Nos. 2:25-cv-02642-BRM-CLW and 2:25-cv-12169-BRM-CLW, have resolved this litigation for good cause and valuable consideration recognized by ARI and AMNEAL. Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in the Actions, as follows: IT IS this _____ day of ___________, 2025: ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above Actions and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, (i) the term “AMNEAL Product(s)” shall mean the drug product(s) manufactured, sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 219027 (including any supplements, or modification or amendments thereto or replacements thereof) (“AMNEAL’s ANDA”); (ii) the term “Licensed ARI Patents” shall mean United States Patent United States Patent Nos.: AMERICAN REGENT, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC AND AMNEAL EU, LIMITED 1st August Case 2:25-cv-12169-BRM-CLW Document 8 Filed 08/01/25 Page 1 of 4 PageID: 515 11,786,548 (“the ‘548 Patent”); 11,975,022 (“the ‘022 Patent”); 11,998,565 (“the ’565 Patent”); 12,150,956 (“the ‘956 Patent”) and 12,150,957 (“the ’957 Patent”); and (iii) the term “Affiliate” shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with AMNEAL; for purposes of this definition, “control” means: (a) ownership, directly or through one or more intermediaries, of: (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership; or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. 3. Unless otherwise specifically authorized by ARI pursuant to the Settlement Agreement or by 35 U.S.C. § 271(e)(1), AMNEAL, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed ARI Patents, on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the AMNEAL Product(s) in the United States. 4. Compliance with this Consent Judgment may be enforced by ARI, its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. 5. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. 6. All claims, counterclaims, affirmative defenses and demands in these Actions are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party. Case 2:25-cv-12169-BRM-CLW Document 8 Filed 08/01/25 Page 2 of 4 PageID: 516 7. Nothing herein shall preclude the U.S. Food & Drug Administration from granting final approval to AMNEAL’s ANDA or shall preclude AMNEAL from filing, modifying, amending, recertifying or maintaining with the FDA any Paragraph IV Certification for the AMNEAL Product(s) pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).”
Source: PACER Docket, Case 2:25-cv-12169, New Jersey District Court

The consent judgment’s operative language — enjoining Amneal from any commercialisation of ANDA No. 219027 products ‘unless otherwise specifically authorized by ARI’ — signals that the real substance of the resolution lies in the non-public settlement agreement, which governs the scope and timing of any licensed entry. The dismissal without prejudice and the explicit FDA carve-out in paragraph 7 are characteristic of a negotiated entry-date settlement rather than a capitulation, and no patent was adjudicated invalid or not infringed.

PACER case 2:25-cv-12169 · Public docket record Explore in Eureka ↗
Patent at issue

US11786548B2 and four related patents — Multrys® trace elements injection formulations

Publication No.US12150956B2
Application No.US18/653608
Patent details
ProductTrace elements injection formulations for parenteral nutrition — ‘956 Patent
Cited in actionJune 26, 2025

Publication No.US12150957B2
Application No.US18/672876
Patent details
ProductTrace elements injection formulations for parenteral nutrition — ‘957 Patent
Cited in actionJune 26, 2025

Publication No.US11975022B2
Application No.US18/482612
Patent details
ProductTrace elements injection compositions and methods — ‘022 Patent
Cited in actionJune 26, 2025

Publication No.US11998565B2
Application No.US18/124391
Patent details
ProductTrace elements injection compositions and methods — ‘565 Patent
Cited in actionJune 26, 2025

Publication No.US11786548B2
Application No.US17/365695
Patent details
ProductTrace elements injection 4* USP formulations in single-dose vials — ‘548 Patent
Cited in actionJune 26, 2025

The five asserted patents — US11786548B2, US11975022B2, US11998565B2, US12150956B2 and US12150957B2 — collectively cover formulations and methods relating to ARI’s Multrys® product, a four-element trace elements injection (zinc, copper, manganese, selenium) indicated for parenteral nutrition. The application numbers span filing dates from US17/365695 through US18/672876, consistent with an active continuation prosecution strategy building a layered patent estate around a single commercial product.

Multrys® holds a significant position in the parenteral nutrition market as an FDA-approved trace elements injection meeting updated nutritional guidelines. A five-patent assertion strategy against a single ANDA makes invalidity challenges disproportionately expensive for generic filers, and the rapid settlement suggests Amneal assessed the litigation cost-benefit as unfavourable to a full contest. For competitors developing trace element injectable products, this portfolio signals meaningful freedom-to-operate risk that extends well beyond any single claim.

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

Should your product team run an FTO against ARI’s Multrys® patent family?

Any company developing, manufacturing or seeking ANDA approval for a trace elements injection product containing zinc, copper, manganese and selenium in single-dose vials should treat this five-patent family as a priority FTO target. The consent judgment confirms all five patents are active and enforceable. Given ARI’s continuation filing activity across application numbers US17/365695 to US18/672876, additional patents from this family may issue — meaning an FTO conducted today could be incomplete within 12–18 months.

PatSnap Eureka’s FTO Search Agent can map your formulation parameters against all five asserted patents and their prosecution histories simultaneously, flag continuation applications still pending at the USPTO, and identify claim elements most likely to capture competing trace element injectable formulations. Running a structured FTO now — before FDA submission — substantially reduces the risk of a consent judgment scenario that forecloses a commercial launch.

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Related litigation

Similar ANDA patent infringement cases: trace elements and parenteral nutrition injectables

Explore comparable Hatch-Waxman ANDA patent infringement cases involving parenteral nutrition and specialty injectable formulations in New Jersey District Court.

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American Regent, Inc. patent enforcement history, New Jersey case history, American Regent, Inc.’s full IP portfolio, and comparable case analysis
Comparable ANDA settlementsTrace element injection casesNJ District Court ANDA outcomesARI patent enforcement history
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Strategic implications

What this case signals for the parenteral nutrition and ANDA patent IP landscape

A 36-day consent judgment with injunction in an ANDA case is a rare and instructive outcome for pharmaceutical IP teams.

Early ANDA settlements with injunctions are increasingly preferred by branded firms

By securing a court-entered injunction rather than relying solely on contractual terms, ARI ensured that any breach by Amneal exposes it to contempt proceedings — a stronger enforcement posture than a private settlement alone. IP teams protecting specialty injectables should consider whether consent judgments offer better enforcement leverage than pure settlement agreements.

Five-patent portfolios around specialty injectables raise the ANDA litigation cost calculus

ARI’s assertion of five overlapping patents covering Multrys® formulations illustrates a layered prosecution strategy that makes invalidity challenges more costly for generic filers. R&D and IP teams developing competing trace element injectable products should conduct FTO assessments against the entire ARI patent family, not just the earliest-filed patent.

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Full strategic analysis in PatSnap Eureka
Full strategic analysis of ARI’s trace elements injection IP portfolio and ANDA litigation strategy at New Jersey District Court level.
Licensed entry date signalsContinuation patent riskANDA No. 219027 FDA timeline
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Analysis powered by PatSnap Eureka Litigation Intelligence Explore in Eureka ↗
Frequently asked questions

American v Amneal — key questions answered

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Track ANDA patent risk before your next FDA submission

PatSnap Eureka maps active patent estates like ARI’s five-patent Multrys® portfolio against your pipeline formulations, flags continuation risk, and monitors new ANDA filings in your therapeutic area. Start your FTO before the litigation clock starts.

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