Axsome Malta v. Aurobindo Pharma: Solriamfetol Patent Case Consolidated in New Jersey

Introduction

A pharmaceutical patent infringement dispute between Axsome Malta, Ltd. and Aurobindo Pharma, Ltd. has been resolved through consolidation in the U.S. District Court for the District of New Jersey, closing Civil Action No. 2:25-cv-00643 after 140 days. At the center of the dispute is U.S. Patent No. 12,102,609 B2, covering solriamfetol oral tablets — a wakefulness-promoting agent used in treating excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.

Rather than reaching a merits-based verdict, the case was administratively terminated and folded into a broader consolidated action encompassing related civil matters. For patent attorneys, IP professionals, and pharmaceutical R&D teams, this outcome signals an increasingly common procedural strategy in ANDA-related pharmaceutical patent litigation: consolidating parallel Hatch-Waxman cases to streamline discovery, manage judicial resources, and accelerate resolution timelines. Understanding how and why consolidation occurred here offers strategic value for anyone navigating multi-case pharmaceutical patent disputes.

Case Overview

The Parties

The Patent at Issue

This case involves U.S. Patent No. 12,102,609 B2, covering solriamfetol oral tablets:

• • **Patent Number:** U.S. 12,102,609 B2 (Application No. 18/491,319)
• • **Technology Area:** Central nervous system (CNS) pharmacology; wakefulness-promoting compounds
• • **Subject Matter:** Formulations and/or methods related to solriamfetol oral tablet dosing, specifically equivalent to 75 mg base and 150 mg base strengths

The Accused Products

Aurobindo’s accused products are generic solriamfetol oral tablets, equivalent to 75 mg base and 150 mg base — the same strengths as the branded Sunosi® product. The infringement action follows a standard Hatch-Waxman pathway, wherein Aurobindo’s ANDA filing triggered a 30-month stay and corresponding litigation.

Legal Representation

Plaintiff (Axsome Malta): Saul Ewing LLP, represented by Alexander Lee Callo, Charles Michael Lizza, Sarah Ann Sullivan, and William C. Baton.

Defendant (Aurobindo Pharma): McNeely, Hare & War LLP, represented by William Hare.

Litigation Timeline & Procedural History

Filed on January 21, 2025, this case moved with notable speed — closing in fewer than five months. The venue selection of the District of New Jersey is strategically significant: New Jersey is the preeminent forum for Hatch-Waxman pharmaceutical patent litigation, home to the largest concentration of branded and generic pharmaceutical companies in the United States and a judiciary deeply experienced in complex pharmaceutical IP disputes.

The case did not proceed to trial or substantive merits adjudication. Instead, the court ordered administrative termination through consolidation with Civil Action No. 24-10617, the lead consolidated action, which also absorbed related cases Nos. 24-10619 and 25-3721. Going forward, all filings are directed to the Consolidated Action, which will proceed on the schedule previously entered in Civil Action No. 24-10617. This consolidation order is the defining procedural event of this case’s lifecycle.

No information was disclosed regarding specific claim construction hearings, summary judgment motions, or damages proceedings within this individual docket prior to consolidation.

The Verdict & Legal Analysis

Outcome

Civil Action No. 2:25-cv-00643 was administratively terminated by order of the New Jersey District Court. The case was not dismissed on the merits, nor was a settlement announced. Instead, it was consolidated with three related Axsome Malta cases into a single coordinated proceeding. The consolidated action will continue under the schedule established in the lead case, Civil Action No. 24-10617.

No damages were awarded, and no injunctive relief was separately ordered within this docket. Any such relief would be addressed within the consolidated proceeding.

Verdict Cause Analysis

The underlying cause of action is a patent infringement claim — consistent with the Hatch-Waxman Act framework, under which a brand-name drug patent holder may sue a generic ANDA applicant upon receiving a Paragraph IV certification. Aurobindo’s ANDA filing, asserting that U.S. Patent No. 12,102,609 B2 is either invalid or would not be infringed by their generic product, triggered Axsome Malta’s obligation to file suit within 45 days to preserve the 30-month stay of FDA approval.

The decision to consolidate suggests that Axsome Malta pursued coordinated litigation strategy across multiple ANDA filers targeting solriamfetol, a common approach that reduces duplicative discovery, ensures consistent claim construction rulings, and concentrates resources before a single judicial officer familiar with the technology.

Legal Significance

Consolidation as Strategic Tool: The consolidation of four related pharmaceutical patent cases reflects a growing judicial preference for efficiency in Hatch-Waxman litigation. When multiple generics file ANDAs against the same branded product, brand-name holders often file separate suits within the 45-day window — which courts then consolidate. Practitioners should recognize that administrative termination through consolidation does not represent a merits ruling and preserves all claims for adjudication in the lead case.

Patent Prosecution Timing: U.S. Patent No. 12,102,609 B2, issued on a continuation application (App. No. 18/491,319), reflects Axsome’s ongoing prosecution strategy to maintain patent coverage over solriamfetol formulations. The issuance of continuation patents timed to ANDA filings is a well-established lifecycle management technique with significant litigation implications.