American Regent v. Gland Pharma: Selenious Acid Patent Suit Consolidated Into 13-Defendant Action
American Regent, Inc. filed suit against Gland Pharma, Ltd. in the District of New Jersey asserting US11998565B2 covering selenious acid injectable formulations used in parenteral nutrition. Within 128 days, the case was consolidated with 12 parallel ANDA actions — one of the largest multi-defendant Hatch-Waxman consolidations in New Jersey in 2024.
A 13-Front Hatch-Waxman Battle Over IV Selenium Therapy
American Regent, Inc., a specialty pharmaceutical company and holder of US11998565B2, filed Civil Action No. 2:24-cv-07802 against Gland Pharma, Ltd. in the United States District Court for the District of New Jersey on 16 July 2024. The suit alleged infringement of a patent covering selenious acid injectable formulations — specifically products providing equivalent selenium concentrations of 60 mcg/mL and 6 mcg/mL — used in intravenous parenteral nutrition regimens. The action is consistent with a standard Hatch-Waxman paragraph IV certification dispute triggered by Gland Pharma’s ANDA filing.
On 21 November 2024 — 128 days after filing — the court entered a consolidation order merging this action with 12 substantially identical suits American Regent had filed against other generic pharmaceutical defendants, including Accord Healthcare, Cipla, Dr. Reddy’s Laboratories, Hikma, Sun Pharmaceutical, Zydus, and others. All consolidated cases are now maintained under the lead docket Civil Action No. 2:24-cv-07791. The individual case against Gland Pharma was therefore terminated as a standalone docket, but the underlying infringement claims remain live in the consolidated proceeding.
The speed of consolidation — under four months — suggests coordinated case management rather than any substantive merits resolution. The breadth of defendants (13 in total) is consistent with a wave of near-simultaneous ANDA filings by generic manufacturers seeking to enter the IV selenium market. What drove the specific timing of each individual ANDA submission, and whether any defendant has negotiated an early settlement or consent judgment, remains undisclosed in the public record at this stage.
Filing to Case Consolidated in 128 days
128 days from filing to consolidation order — faster than the median ANDA case disposition in D.N.J.
Case consolidated: what the merger of 13 actions means for both parties
Consolidation under Rule 42: one docket, 13 defendants
Federal Rule of Civil Procedure 42(a) allows a court to consolidate actions sharing common questions of law or fact. Here, all 13 cases assert the same patent against different ANDA filers for the same product category. Consolidation streamlines discovery and claim construction, but does not merge the defendants’ liability — each defendant’s ANDA and infringement position is evaluated separately. All filings now proceed under lead docket 2:24-cv-07791.
Procedural consolidationAmerican Regent retains all infringement claims against Gland Pharma
Consolidation does not dismiss or weaken American Regent’s infringement claims. ARI continues to assert US11998565B2 against Gland Pharma within the consolidated action. The move may benefit ARI by reducing duplicative litigation costs and enabling a single claim construction ruling that applies across all defendants. The 30-month stay typical in Hatch-Waxman paragraph IV cases may still be in effect, potentially blocking Gland Pharma’s ANDA approval during litigation.
Claims remain activeGland Pharma now litigates alongside 12 other generic challengers
Gland Pharma’s standalone case being subsumed into a 13-defendant consolidated action creates a mixed dynamic. Shared discovery and claim construction may reduce individual litigation costs, but Gland Pharma’s specific ANDA formulation and invalidity arguments must still be independently proven. Co-defendants with stronger invalidity arguments could benefit all generics if a finding of invalidity or non-infringement is reached — though any settlement by one defendant does not bind the others.
Co-defendant dynamicsIV selenium market entry blocked pending consolidated outcome
The parenteral selenium market — selenious acid injectables used in hospital nutrition protocols — remains protected by ARI’s patent for the duration of this consolidated litigation. With 13 generic filers all held at bay, the commercial exclusivity window for American Regent could extend several years depending on litigation pace in D.N.J. Generic manufacturers monitoring this space should track claim construction rulings in the lead docket, as those determinations will set the scope of protection across all defendants.
Market exclusivity at stakeFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | American Regent, Inc. | Company | Specialty injectable pharmaceutical company — holder of US11998565B2 covering selenious acid IV formulationsSearch in Eureka ↗ |
| Defendant | Gland Pharma, Ltd. | Company | Hyderabad-based generic injectable manufacturer and ANDA filer seeking U.S. market entry for selenious acid productsSearch 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 | R. Touhey Myer | Attorney | Counsel for Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | Kratz & Barry, LLP | Law Firm | Representing Gland Pharma, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consolidation order is purely administrative and carries no merits determination. The stipulated language confirms all parties consented to consolidation into lead docket 24-7791, preserving each defendant’s individual liability posture. For Gland Pharma specifically, no infringement finding, invalidity ruling, or consent judgment has been entered. The case remains substantively open — the order signals judicial efficiency management, not any resolution of the underlying patent dispute over US11998565B2.
US11998565B2 — Selenious Acid Injectable Formulations for Parenteral Nutrition
US11998565B2, filed under application number US18/124391, protects selenious acid injectable formulations delivered at specific selenium-equivalent concentrations — including 60 mcg selenium/mL (in 10 mL and 2 mL vial presentations) and 6 mcg selenium/mL. Selenious acid is the standard IV source of selenium in parenteral nutrition, an essential trace element for patients who cannot tolerate oral or enteral feeding. The patent’s protection of precise concentration formulations suggests claims directed at the specific compounding and stability profile of these hospital-grade injectables.
For the branded injectable nutrition market, a formulation patent covering multiple concentration presentations creates layered barriers to generic entry — each ANDA filer must demonstrate non-infringement or invalidity for every claimed concentration. With 13 ANDAs challenged simultaneously, the commercial significance of US11998565B2 is considerable: it potentially controls a product used in critical care and long-term nutritional support across U.S. hospitals. Competitors, formulary decision-makers, and CMC teams at generic manufacturers should closely monitor claim construction proceedings in the consolidated action.
Should you run an FTO against US11998565B2 for selenious acid injectables?
Any pharmaceutical company developing, reformulating, or filing an ANDA for a selenious acid injectable product — particularly at selenium concentrations of 60 mcg/mL or 6 mcg/mL — faces direct exposure to US11998565B2. With 13 defendants already in active litigation, the risk landscape is well-established. R&D and regulatory teams planning IV trace element formulations for the U.S. market should conduct an FTO analysis before committing to a specific concentration, excipient profile, or vial presentation that could fall within the patent’s claim scope.
PatSnap Eureka’s FTO Search Agent can map US11998565B2’s claim language against your specific formulation parameters, identify relevant prior art that defendants in the consolidated action may already be leveraging, and surface continuations or related applications in American Regent’s portfolio that could present additional risk. Eureka’s landscape view also identifies whether any of the 13 co-defendants have published IPR petitions or inter partes review filings that could affect the patent’s validity status — intelligence critical to any go/no-go decision on U.S. ANDA filing.
Run a freedom-to-operate analysis on US11998565B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ANDA Cases Involving Injectable Formulation Patents in D.N.J.
Cases below involve comparable Hatch-Waxman paragraph IV infringement actions over injectable pharmaceutical formulation patents litigated in the District of New Jersey.
What this case signals for the IV pharmaceutical patent IP landscape
A 13-defendant ANDA consolidation over a single injectable formulation patent signals aggressive exclusivity defence in the parenteral nutrition sector.
Multi-defendant ANDA waves require coordinated IP monitoring from day one
When 13 generic manufacturers file ANDAs near-simultaneously, the originator’s litigation strategy shifts from bilateral to multi-front. IP teams at branded injectable manufacturers should implement portfolio monitoring systems that flag paragraph IV certifications in real time, enabling coordinated filing of suits within the 45-day statutory window to preserve Hatch-Waxman 30-month stay benefits.
Consolidation orders create shared claim construction risk for all ANDA defendants
In a consolidated Hatch-Waxman action, a single Markman ruling governs all defendants. A claim construction adverse to one defendant affects all. Generic manufacturers co-defending should align on claim construction strategy early — divergent positions among defendants can weaken the collective case and signal vulnerability to the patent holder.
American v Gland — key questions answered
The case was not decided on the merits. On 21 November 2024, it was consolidated with 12 parallel actions into lead docket Civil Action No. 2:24-cv-07791 in the District of New Jersey. American Regent’s infringement claims against Gland Pharma under US11998565B2 remain active within the consolidated proceeding.
The asserted patent is US11998565B2 (application no. US18/124391). It covers selenious acid injectable formulations for intravenous parenteral nutrition, specifically at selenium-equivalent concentrations of 60 mcg/mL (in 10 mL and 2 mL presentations) and 6 mcg/mL. These formulations provide essential trace element supplementation for patients dependent on IV nutrition.
All 13 actions filed by American Regent assert the same patent — US11998565B2 — against different generic pharmaceutical manufacturers who filed ANDAs for selenious acid injectable products. Federal Rule of Civil Procedure 42(a) permits consolidation of actions sharing common legal and factual questions. Consolidation reduces duplicative proceedings and allows a single claim construction ruling to apply across all defendants.
No. Consolidation is a case management procedure. American Regent’s infringement claims against Gland Pharma under US11998565B2 are preserved within the consolidated action under lead docket 2:24-cv-07791. No merits ruling, consent judgment, or settlement has been recorded in relation to Gland Pharma as of the consolidation order date.
The consolidated action includes 13 defendants: Accord Healthcare, Aspiro Pharma, Cipla USA and Cipla Limited, Dr. Reddy’s Laboratories (US and India), Eugia Pharma Specialities and Eugia US, Gland Pharma, Hikma Pharmaceuticals USA, Long Grove Pharmaceuticals, RK Pharma, Somerset Therapeutics/Somerset Pharma/Odin Pharmaceuticals, Sun Pharmaceutical Industries (US and India), Xiromed LLC and Xiromed Pharma España, and Zydus Pharmaceuticals (USA).
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