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American Regent v. Amneal Pharmaceuticals — Selenious Acid Patent Litigation | PatSnap
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Case ID2:24-cv-11503
FiledDec 2024
ClosedFeb 2025
Patent Litigation

American Regent v. Amneal: Selenious Acid ANDA Dispute Resolved by Consent Judgment in 57 Days

American Regent, Inc. filed suit against Amneal Pharmaceuticals in the District of New Jersey over two patents covering its selenious acid injection product (600 mcg Selenium/10 mL). The parties reached a negotiated consent judgment — including a permanent injunction against Amneal — in just 57 days, one of the fastest resolutions in recent Hatch-Waxman ANDA litigation.

Resolution time
57days
57-day resolution — well below the typical 12–30 month Hatch-Waxman litigation window
Patents asserted
2
US11998565B2 and US12150957B2 — selenious acid injection, intravenous selenium formulation patents
Outcome
Consent Judgment
Settled via agreed injunction; all claims dismissed without prejudice, no costs awarded
Cost ruling
No Costs Awarded
Consent judgment explicitly excludes attorneys’ fees and disbursements to either party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Swift Hatch-Waxman Consent Judgment Locks Out Amneal’s Generic Selenium Injection

American Regent, Inc. (ARI) filed this Hatch-Waxman patent infringement action in the District of New Jersey on December 30, 2024, asserting two patents — US11998565B2 and US12150957B2 — against Amneal Pharmaceuticals’ abbreviated new drug application (ANDA No. 219069) for a generic selenious acid injection (600 mcg Selenium/10 mL). ARI’s branded product delivers intravenous selenium, a critical trace element used in parenteral nutrition, and the asserted patents protect the formulation and methods associated with that product.

The case concluded on February 25, 2025 — just 57 days after filing — through a consent judgment entered by the District Court. The consent judgment enjoins Amneal and its affiliates from making, using, selling, offering to sell, importing, or distributing the ANDA product in the United States unless specifically authorized by ARI or by 35 U.S.C. § 271(e)(1). Critically, the FDA retains authority to grant final approval to Amneal’s ANDA, and Amneal may maintain its Paragraph IV certification — signalling that a licensing arrangement, rather than outright capitulation, likely underlies the settlement agreement.

The 57-day timeline suggests the parties entered negotiations almost immediately after service, consistent with a pre-existing licensing framework or rapid commercial resolution rather than hard-fought litigation. The underlying settlement agreement is not public, so the specific royalty terms, licensed entry date, or any market exclusivity provisions remain unknown from the public record. What is clear is that ARI has secured court-enforced protection for both patents across Amneal’s entire ANDA product line, with the court retaining jurisdiction to supervise ongoing compliance.

Case at a glance
Case no.2:24-cv-11503
CourtNew Jersey
JudgeN/A
FiledDecember 30, 2024
ClosedFebruary 25, 2025
Duration57 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 57 days

57-day resolution — well below the typical 12–30 month Hatch-Waxman litigation window

Case timeline: Complaint filed DEC 30 2024, JAN–FEB — 57 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. DEC 30 2024 Complaint filed Pre-trial proceedings FEB 25 2025 Consent Judgment 57 DAYS TOTAL
Dismissal terms

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

Legal mechanism

Consent judgment is a court order, not just a settlement

A consent judgment is entered by the court and carries the full force of a judicial order. Unlike a private settlement agreement, it is directly enforceable through contempt proceedings. Here, the District of New Jersey retains jurisdiction to supervise compliance, giving ARI a powerful enforcement tool if Amneal launches outside the agreed terms. The underlying settlement agreement governs the commercial details, but the injunction is the court-backed mechanism.

Court-enforceable injunction
Patent holder outcome

ARI secures injunction over both patents without trial risk

American Regent obtained a permanent injunction covering both US11998565B2 and US12150957B2 against Amneal’s ANDA product — without the cost or uncertainty of a full Hatch-Waxman trial. The dismissal is without prejudice, preserving ARI’s ability to re-file if Amneal were to breach the settlement agreement. ARI’s selenium injection franchise is protected while the FDA process for Amneal’s ANDA continues, suggesting a negotiated licensed-entry date may govern future market access.

Dual-patent injunction secured
Generic challenger outcome

Amneal enjoined but ANDA and Paragraph IV certification preserved

Amneal cannot launch its generic selenious acid injection in the U.S. without ARI’s authorisation, but critically retains its ANDA approval pathway and Paragraph IV certification rights. This is consistent with a negotiated licensed-entry arrangement — Amneal likely agreed to a future market entry date or royalty structure rather than abandoning its generic entirely. The without-prejudice dismissal also means Amneal faces no res judicata bar on the underlying patent validity questions.

ANDA preserved; launch deferred
Commercial implications

Rapid resolution pattern signals ARI’s Hatch-Waxman enforcement posture

A 57-day consent judgment in an ANDA case is unusually fast and suggests ARI entered the litigation with a clear licensing strategy rather than seeking a merits verdict. For competing generic manufacturers watching this space, the dual-patent assertion across formulation and method claims — combined with rapid enforcement — raises the cost of any non-licensed ANDA challenge to ARI’s selenium franchise. Other ANDA filers for selenious acid products should anticipate similar early-stage enforcement action.

Early enforcement precedent set
Legal analysis based on PACER docket records for case 2:24-cv-11503 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAmerican Regent, Inc.CompanyPharmaceutical company — holder of US11998565B2 and US12150957B2 (selenious acid injection)Search in Eureka ↗
DefendantAmneal Pharmaceuticals, Inc.CompanyGeneric pharmaceutical manufacturer seeking ANDA approval for selenious acid injection, USPSearch 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 counselDennies VarugheseAttorneyCounsel for American Regent, Inc.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting American Regent, Inc.Search in Eureka ↗
Plaintiff law firmSterne Kessler Goldstein & FoxLaw 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 (collectively, "Amneal"), parties in the above-captioned action, specifically in the action initiated by Plaintiff. ARI, against Amneal in Civil Action No. 2:2411503 (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 action, as follows:IT IS this 24th day of February 2025.ORDERED, ADJUDGED AND DECREED as follows: This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, (i) the term "Amneal Product" shall mean the drug product manufactured, sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 219069 (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 Nos. 11,998,565 ("the ‘565 patent") and 3. 4. 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. 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 in the United States. 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. 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 this action are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party. 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, or maintaining with the FDA any Paragraph IV Certification for the Amneal Product pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).”
Source: PACER Docket, Case 2:24-cv-11503, New Jersey District Court

The consent judgment language is precise in scope: Amneal and all affiliates are enjoined from any commercial act involving ANDA No. 219069’s product in the U.S., but the FDA approval pathway and Paragraph IV certification are explicitly preserved. This dual construct — injunction plus preserved ANDA — is the hallmark of a Hatch-Waxman licensed-entry settlement. The dismissal of all claims ‘without prejudice and without costs’ means neither party acknowledged liability, and ARI retains the right to reassert infringement if the private settlement agreement is breached.

PACER case 2:24-cv-11503 · Public docket record Explore in Eureka ↗
Patent at issue

US11998565B2 & US12150957B2 — Selenious Acid Injection Formulation Patents

Publication No.US12150957B2
Application No.US18/672876
Patent details
ProductSelenious acid injection formulations and methods — 600 mcg Selenium/10 mL parenteral product
Cited in actionDecember 30, 2024

Publication No.US11998565B2
Application No.US18/124391
Patent details
ProductIntravenous selenious acid compositions and use for selenium supplementation in parenteral nutrition
Cited in actionDecember 30, 2024

US11998565B2 and US12150957B2 both protect aspects of ARI’s selenious acid injection product — a sterile intravenous formulation delivering 600 mcg of selenium per 10 mL (60 mcg/mL), used in parenteral nutrition regimens. The applications (US18/124391 and US18/672876) are relatively recent filings, suggesting ARI has been actively building and refreshing its patent portfolio around this established trace element therapy. Selenium deficiency in critically ill and long-term parenteral nutrition patients is a documented clinical concern, giving these formulations significant therapeutic and commercial value.

From a competitive intelligence standpoint, ARI’s dual-patent strategy — covering both the formulation and likely related method claims — creates overlapping protection that complicates any design-around effort by generic manufacturers. The rapid enforcement against Amneal’s ANDA demonstrates that ARI treats these patents as commercially active enforcement assets, not defensive filings. Any company with a pending or planned ANDA for selenious acid injectable products should treat both patents as live blocking assets requiring FTO clearance before committing to development expenditure.

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

Should you run an FTO analysis against US11998565B2 and US12150957B2?

If your organisation is developing, manufacturing, or seeking ANDA approval for any selenious acid injection product — or any parenteral trace element formulation in the selenium category — both US11998565B2 and US12150957B2 should be assessed as part of your freedom-to-operate review. ARI has demonstrated a willingness to file suit rapidly and enforce both patents simultaneously. The scope of the consent judgment covers making, using, selling, offering for sale, importing, and distribution, meaning the risk window extends beyond U.S. commercial launch.

PatSnap Eureka’s FTO Search Agent can map the claim scope of both patents against your product specifications, identify prior art that may bear on validity, and surface related ARI portfolio filings that could present additional risk vectors. Eureka also tracks ANDA litigation dockets in real time, so your team receives early signals of enforcement activity before it affects your product pipeline. Run your FTO analysis now to inform go/no-go decisions on selenious acid development programmes.

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Run a freedom-to-operate analysis on US12150957B2 to assess your product’s exposure

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Related litigation

Similar Hatch-Waxman ANDA Cases Involving Parenteral Nutrition Patents in D.N.J.

Cases involving ANDA challenges to parenteral nutrition and injectable pharmaceutical patents in the District of New Jersey with consent judgment or early settlement outcomes.

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Strategic implications

What this case signals for the parenteral nutrition IP landscape

ARI’s swift enforcement of two selenium injection patents illustrates how branded pharma can use Hatch-Waxman litigation as a rapid licensing lever.

Dual-patent ANDA filings enable broader injunctive coverage with less trial risk

By asserting both a formulation patent (US11998565) and a related method/use patent (US12150957) together, ARI created a wider infringement net. Even if one patent faced validity challenges, Amneal would need to design around both — a significant barrier that likely accelerated the consent judgment outcome.

Consent judgment with retained jurisdiction is stronger than a private settlement

ARI’s insistence on a court-entered consent judgment — rather than a simple voluntary dismissal — means any breach by Amneal is immediately actionable as contempt. For IP teams monitoring this space, this enforcement structure is increasingly common in pharmaceutical ANDA disputes and should be factored into generic launch risk assessments.

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Unlock gated intelligence on licensed-entry timing, exclusivity implications, and ANDA risk in the parenteral pharmaceutical sector from this District of New Jersey consent judgment.
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Frequently asked questions

American v Amneal — key questions answered

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Stay ahead of parenteral pharma patent enforcement — run your FTO now

ARI’s 57-day enforcement playbook signals active monitoring of the selenious acid ANDA space. Use PatSnap Eureka to screen US11998565B2 and US12150957B2 against your pipeline and track new enforcement actions before they affect your launch timeline.

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