American Regent v. SterIScience: Consent Judgment in 58 Days Over Selenious Acid Patent
American Regent, Inc. filed suit against SterIScience Pte. Ltd in the District of New Jersey alleging infringement of US11998565, covering selenious acid injectable products, in connection with SterIScience’s ANDA No. 219492. The case resolved in just 58 days via a negotiated consent judgment that permanently enjoins SterIScience from commercialising its generic product in the United States.
ANDA Infringement Action Ends in Swift Injunction for American Regent
American Regent, Inc. (ARI), a pharmaceutical company and holder of US11998565, filed suit on 16 July 2024 in the United States District Court for the District of New Jersey against SterIScience Pte. Ltd, a Singapore-based entity that had filed ANDA No. 219492 seeking approval to market a generic version of ARI’s selenious acid injectable product (600 mcg Selenium/10 mL). The asserted patent covers the selenious acid formulation at the heart of ARI’s branded product line.
The case closed on 12 September 2024 — just 58 days after filing — through a consent judgment entered by the court. Under the judgment, SterIScience and its affiliates, successors and assigns are permanently enjoined from making, using, selling, offering to sell, importing or distributing the ANDA product in the United States. All claims, counterclaims and affirmative defenses were dismissed without prejudice, and no costs or attorneys’ fees were awarded to either party, consistent with a negotiated resolution rather than a contested merits ruling.
The 58-day resolution is notably fast for ANDA patent litigation, which typically extends well beyond a year when contested. The speed suggests the parties reached agreement shortly after service and before substantive motion practice, consistent with SterIScience accepting the injunction in exchange for confidential settlement terms referenced in the consent judgment. The underlying settlement agreement is not public, leaving open questions about whether any licence period, launch date, or royalty arrangement was privately agreed.
Filing to Consent Judgment in 58 days
58 days — well below the median ANDA patent litigation duration, suggesting early settlement pressure
Consent judgment entered: injunction, no costs, claims dismissed without prejudice
Consent judgment is a court-enforceable settlement
A consent judgment is a formal court order entered by agreement of the parties. It carries full judicial authority — meaning SterIScience’s compliance can be enforced by the court, not merely pursued through contract claims. Here, the court retained jurisdiction to supervise performance under both the judgment and the underlying settlement agreement, giving ARI a direct enforcement pathway if SterIScience violates the injunction.
Court-ordered settlementClaims dismissed without prejudice — with an injunction in place
The dismissal is ‘without prejudice,’ meaning claims are not extinguished on the merits and could theoretically be refiled. However, the simultaneous injunction makes this distinction largely academic for the current ANDA product: SterIScience is already barred from commercialising it. Without prejudice language in consent judgments typically preserves ARI’s ability to return to court for enforcement or to address future ANDA amendments or new products not covered by the current order.
Without prejudice + injunctionSterIScience enjoined; ANDA product blocked from US market
SterIScience, including all affiliates, successors and assigns, is permanently enjoined from any commercialisation activity relating to ANDA No. 219492 in the United States. The broad scope — covering making, having made, using, selling, offering to sell, importing and distributing — forecloses all near-term routes to market for the generic product. Any confidential licence or entry date agreed in the settlement agreement would be the only pathway to eventual US market access.
US market access blockedARI’s selenious acid exclusivity reinforced through patent lifecycle
The consent judgment effectively extends ARI’s market exclusivity for its selenious acid injectable line for as long as US11998565 remains enforceable. The swift resolution limits litigation costs and sets a precedent signal to other potential ANDA filers in this product space. Companies holding or monitoring competing formulation patents in the parenteral nutrition and trace element sector should note that ARI has demonstrated willingness to litigate rapidly and secure injunctive relief early in the ANDA challenge process.
Exclusivity maintainedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | American Regent, Inc. | Company | Pharmaceutical company — holder of US11998565 covering selenious acid injectablesSearch in Eureka ↗ |
| Defendant | STERISCIENCE PTE. LTD | Company | Singapore-based generic pharmaceutical company; ANDA filer for selenious acid injectionSearch in Eureka ↗ |
| Plaintiff counsel | Charles H. Chevalier | Attorney | Counsel for American Regent, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Christine A. Gaddis | Attorney | Counsel for American Regent, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Dennies Varughese | Attorney | Counsel for American Regent, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing American Regent, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Sterne Kessler Goldstein & Fox | Law Firm | Representing American Regent, Inc.Search in Eureka ↗ |
| Defendant counsel | Melissa Ellen Flax | Attorney | Counsel for STERISCIENCE PTE. LTDSearch in Eureka ↗ |
| Defendant law firm | Carella Byrne Cecchi Olstein Brody & Agnello, PC | Law Firm | Representing STERISCIENCE PTE. LTDSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consent judgment’s language is notably comprehensive: it defines ‘Steriscience Product’ by reference to the specific ANDA number (including future supplements, modifications and amendments), ensuring the injunction cannot be circumvented through minor product reformulations filed under the same ANDA. The phrase ‘good cause and valuable consideration’ signals a negotiated quid pro quo, though the consideration provided to SterIScience remains confidential. ARI’s enforcement and assignment rights are expressly preserved, suggesting the patent may be monetised or licensed to third parties in future.
US11998565 — Selenious Acid Injectable Formulation
US11998565 (application no. US18/124391) covers ARI’s selenious acid injectable product — a parenteral formulation delivering 60 mcg selenium per mL (600 mcg/10 mL vial). Selenium is an essential trace element administered intravenously to patients who cannot receive adequate nutrition orally, making this formulation clinically significant in critical care and long-term parenteral nutrition settings. The patent’s relatively recent grant date places it well within its enforcement lifecycle, giving ARI a substantial remaining exclusivity runway.
For generic pharmaceutical companies, US11998565 represents a direct barrier to ANDA-based entry into the selenious acid injectable market. The swift enforcement action and resulting injunction demonstrate ARI’s intent to defend this asset aggressively. Companies active in the parenteral nutrition, trace element, or IV micronutrient space — particularly those with pending ANDAs or 505(b)(2) applications — should assess whether their formulations fall within the claims of this patent before committing to regulatory timelines or manufacturing investment.
Should your ANDA team run an FTO against US11998565?
Any pharmaceutical company developing, manufacturing or planning to commercialise a selenious acid injectable product in the United States should treat US11998565 as a priority FTO target. The SterIScience case demonstrates that ARI will litigate immediately upon ANDA notification and seek injunctive relief. Given the patent’s application number (US18/124391), R&D and regulatory teams should also examine the prosecution history and any continuation or divisional applications that may broaden the claim landscape.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US11998565 against your product specifications, identify prior art that may support invalidity arguments, and surface any related ARI family patents that could create additional infringement exposure. Eureka also monitors new ANDA filings and litigation activity in the parenteral nutrition space, enabling your IP team to stay ahead of enforcement risk before regulatory investment is locked in.
Run a freedom-to-operate analysis on US11998565B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA Patent Cases: Selenious Acid and Parenteral Nutrition Formulations
Related ANDA infringement actions involving parenteral nutrition formulation patents litigated in the District of New Jersey and comparable Hatch-Waxman venues.
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 a generic version of ARI’s Selenious Acid products-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.
DecidedAmerican Regent, Inc.’s broader IP enforcement history
American Regent, Inc.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat this case signals for the parenteral nutrition IP landscape
ARI’s rapid enforcement of US11998565 via consent judgment sends a clear signal to generic filers in the selenious acid injectable space.
ANDA filers should treat this patent as an active enforcement risk
ARI filed suit within the standard 45-day Hatch-Waxman window and secured an injunction in under two months. Any company with a pending or planned ANDA referencing selenious acid products should conduct a thorough FTO analysis against US11998565 before investing further in development or regulatory preparation.
Consent judgments with retained jurisdiction amplify post-settlement risk
The court’s retained jurisdiction to enforce the settlement agreement means SterIScience faces contempt exposure — not merely breach of contract liability — for any future violation. Companies negotiating consent judgments in ANDA cases should scrutinise scope language covering affiliates, successors and ANDA amendments before execution.
Confidential settlement terms may include a future entry date
The consent judgment references a private settlement agreement not in the public record. In ANDA litigation, such agreements frequently contain a licensed entry date tied to patent expiry or negotiated royalty terms. Competitors should monitor both parties’ regulatory filings for any ANDA amendment or approval notice that could signal a future generic launch window.
Affiliate and successor language broadens injunction scope significantly
The injunction expressly extends to SterIScience’s affiliates, successors and assigns, covering entities with 50%+ ownership or board control. This structuring forecloses common workarounds such as corporate spin-offs or licensing to a related entity. IP teams advising on generic strategy in this space should model the full corporate group exposure before any product development commitment.
American v STERISCIENCE — key questions answered
The case was resolved by a consent judgment entered 12 September 2024. SterIScience is permanently enjoined from making, selling, offering to sell, importing or distributing its ANDA No. 219492 selenious acid product in the United States. All claims were dismissed without prejudice and no costs were awarded.
US11998565 covers a selenious acid injectable formulation delivering 60 mcg selenium per mL, used in parenteral nutrition. ARI asserted this patent against SterIScience because SterIScience filed ANDA No. 219492 seeking FDA approval to market a generic version of ARI’s selenious acid product, triggering Hatch-Waxman infringement liability under 35 U.S.C. § 271(e)(2).
No. The injunction is a separate court order that stands independently of the dismissal. The without-prejudice dismissal of claims relates to the formal pleadings; the injunction barring SterIScience from commercialising ANDA No. 219492 in the US remains fully enforceable, backed by the court’s retained jurisdiction over both the judgment and the underlying settlement agreement.
The case closed in 58 days from filing, which is substantially faster than the typical ANDA patent litigation timeline. Hatch-Waxman cases are frequently stayed pending PTAB proceedings or litigated for 18–30 months. The 58-day resolution suggests the parties reached a commercial agreement very shortly after the complaint was served, likely before any substantive court proceedings began.
The consent judgment signals that ARI actively enforces US11998565 and is willing to litigate promptly after ANDA notification. Any company with a pending or planned selenious acid injectable ANDA should conduct an FTO analysis against US11998565 and monitor ARI’s patent family for related continuations. The broad injunction scope — including affiliates, successors and ANDA amendments — suggests ARI will seek similarly comprehensive relief in future actions.
Monitor selenious acid patent risk before your next ANDA filing
PatSnap Eureka tracks US11998565 and related ARI family patents in real time. Run an FTO analysis against your injectable selenium formulation and receive enforcement alerts before your ANDA investment is committed.
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