Axsome Therapeutics & Antecip Bioventures v. Teva: Auvelity® Patent Dispute Dismissed Without Prejudice
Axsome Therapeutics and Antecip Bioventures II filed a five-patent infringement action against Teva in the District of New Jersey, asserting rights over Auvelity® — a novel dextromethorphan/bupropion combination targeting NMDA receptor pathways for major depressive disorder. All claims were dismissed without prejudice by stipulation after 259 days, with no costs awarded to either side.
Five-Patent Auvelity® ANDA Battle Ends in Stipulated Dismissal
Filed on 28 May 2024 in the U.S. District Court for the District of New Jersey, this infringement action was brought by Axsome Therapeutics, Inc. and its licensing partner Antecip Bioventures II, LLC against Teva Pharmaceutical Industries, Ltd. The complaint asserted five U.S. patents — US11925636B2, US11844797B1, US11839612B1, US11883373B1, and US11896563B2 — all directed to formulations and methods of use covering Auvelity®, a combination of dextromethorphan hydrobromide and bupropion hydrochloride in extended-release tablet form indicated for major depressive disorder.
On 11 February 2025, the parties filed a stipulation pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii) dismissing all claims, counterclaims, and affirmative defenses without prejudice and without costs or attorneys’ fees to any party. Notably, the stipulation preserved the District of New Jersey’s jurisdiction to enforce any future disputes arising from the subject matter of the action, a clause that is consistent with an underlying settlement or licensing arrangement that the parties have chosen not to disclose publicly.
The 259-day resolution is relatively swift for multi-patent pharmaceutical litigation, suggesting the parties may have reached a commercial accommodation — potentially a licensing deal or agreed launch date — before substantive claim construction or expert discovery. The without-prejudice dismissal formally leaves Axsome and Antecip free to re-file, though the jurisdiction-retention clause and mutual cost waiver suggest the dispute is, in practice, resolved. The precise terms of any agreement remain undisclosed.
Filing to Dismissed without Prejudice in 259 days
259 days — resolved before trial, consistent with early ANDA litigation settlements
Dismissed without prejudice: what the stipulation means for both parties
Rule 41(a)(1)(A)(ii) dismissal — what it actually means
A stipulated dismissal under FRCP 41(a)(1)(A)(ii) requires agreement from all parties who have appeared. Crucially, ‘without prejudice’ means no judgment on the merits was entered — the patents have not been found valid, invalid, infringed, or not infringed. Axsome and Antecip technically retain the right to re-file the same claims, though the retention of court jurisdiction suggests a binding side arrangement governs the parties’ ongoing conduct.
No merits adjudicationPatents survive: enforceability fully intact
Because the dismissal carries no merits finding, all five Auvelity® patents — US11925636B2, US11844797B1, US11839612B1, US11883373B1, and US11896563B2 — retain their presumption of validity. Axsome and Antecip’s ability to assert these patents against other generic filers or licensees is unaffected. The mutual cost waiver is consistent with a negotiated exit rather than a plaintiff capitulation.
Patent validity intactTeva avoids an adverse ruling — but on undisclosed terms
Teva exits the litigation without a validity or non-infringement finding it could use offensively in other proceedings. The absence of a declaratory judgment in Teva’s favour means other generics cannot free-ride on this dismissal. Whether Teva secured a licensed launch date or other commercial concession is not publicly disclosed, but the mutual no-costs structure and jurisdiction-retention clause are consistent with a negotiated resolution rather than a unilateral withdrawal.
No defensive judgment securedAuvelity® exclusivity window likely clarified privately
For the branded CNS market, the dismissal without prejudice and court jurisdiction retention suggest that any generic entry timeline for dextromethorphan/bupropion ER tablets has been governed by a private agreement. Competitors and investors in the NMDA-receptor antagonist antidepressant space should note that the underlying patent estate remains fully intact and enforceable — the commercial terms of Teva’s potential entry, if any, are shielded from the public record.
Private entry timeline likelyFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | AXSOME THERAPEUTICS, INC. | Company | CNS-focused biopharmaceutical company — holder of US11925636B2 and four related Auvelity® patentsSearch in Eureka ↗ |
| Co-Plaintiff | Antecip Bioventures II, LLC | Company | Search in Eureka ↗ |
| Defendant | Teva Pharmaceutical Industries, Ltd. | Company | Global generic pharmaceutical manufacturer and ANDA applicant — Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff counsel | Sarah Ann Sullvian | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff counsel | William C. Baton | Attorney | Counsel for AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Plaintiff law firm | Saul Ewing LLP | Law Firm | Representing AXSOME THERAPEUTICS, INC.Search in Eureka ↗ |
| Defendant counsel | Christine Intromasso Gannon | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Liza M. Walsh | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Patrick Steven Salamea | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Walsh Pizzi O’Reilly Falanga LLP | Law Firm | Representing Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation is explicit that dismissal operates ‘without prejudice’ and ‘without costs or attorneys’ fees to any party’ — language that forecloses any inference of plaintiff weakness or defendant success on the merits. The deliberate preservation of District of New Jersey jurisdiction to resolve future disputes arising from the same subject matter is the most commercially significant clause: it functions as an enforcement hook for what is almost certainly a private settlement or licensing agreement, the terms of which neither party was obliged to disclose under FRCP 41.
US11925636B2 — Auvelity® dextromethorphan/bupropion ER combination patents
The five patents-in-suit — US11925636B2, US11844797B1, US11839612B1, US11883373B1, and US11896563B2 — protect different facets of Auvelity®, the first FDA-approved oral combination of dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) and bupropion hydrochloride (a CYP450 2D6 inhibitor and aminoketone antidepressant) in an extended-release tablet. The bupropion component functions primarily to slow dextromethorphan metabolism, enabling therapeutic plasma levels not achievable with dextromethorphan alone. The patent cluster reflects a multi-layered filing strategy targeting formulation, method-of-use, and dosing regimen angles.
Auvelity® received FDA approval in August 2022 as the first new oral antidepressant mechanism in decades, making its patent estate a high-value competitive target. The five-patent cluster is strategically significant: each patent creates an independent invalidity hurdle for any generic challenger, and the overlapping but distinct claim scopes mean that designing around one patent does not automatically clear the others. For companies developing competing NMDA-modulating or sigma-1 agonist CNS therapies — or CYP2D6-inhibitor combination products more broadly — this patent family represents a meaningful freedom-to-operate consideration through at least the mid-2030s.
Should you run an FTO against US11925636B2 and the Auvelity® patent cluster?
Any company developing a dextromethorphan-based CNS product, a CYP2D6 inhibitor/NMDA antagonist combination, or an extended-release formulation in the antidepressant or neurological space should treat this five-patent cluster as a priority FTO target. The patents are actively enforced — Axsome has already initiated ANDA litigation — and the without-prejudice dismissal against Teva means no invalidity findings are available to rely on. R&D teams working on sigma-1 receptor agonist combinations or bupropion co-formulations face overlapping risk across multiple independent claim sets.
PatSnap Eureka’s FTO Search Agent can map your candidate compound or formulation against the independent claims of all five Auvelity® patents simultaneously, flagging claim language that may read on your product’s mechanism, dosing, or release profile. Eureka can also surface the prosecution history for each application number — US18/353323, US18/304246, US18/177585, US18/333944, and US18/323714 — to identify any arguments or disclaimers made during examination that could define claim boundaries relevant to your design.
Run a freedom-to-operate analysis on US11925636B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent cases: CNS combination drug litigation in D.N.J.
Cases involving multi-patent ANDA challenges to CNS combination drug formulations in the District of New Jersey, including NMDA receptor and antidepressant mechanism disputes.
What this case signals for the CNS pharmaceutical IP landscape
Five-patent ANDA defences on novel MDD mechanisms are expensive — and early resolution suggests commercial leverage matters as much as legal merit.
Jurisdiction-retention clauses signal more than a clean exit
When parties to a without-prejudice dismissal expressly preserve court jurisdiction, it almost always indicates a settlement agreement exists whose breach they want judicially enforceable. For IP teams monitoring Auvelity® generics, this clause means the dispute is practically resolved under private terms — even if no public consent order was entered.
Five-patent clusters on a single product raise the ANDA litigation cost bar
Asserting five related patents across a single branded combination product significantly increases the complexity and cost of ANDA challenges. Teva’s early exit — before claim construction — is consistent with an unfavourable cost-benefit assessment, and suggests Axsome’s layered patent strategy on Auvelity® is achieving its deterrent function.
AXSOME v Teva — key questions answered
Axsome Therapeutics and Antecip Bioventures II asserted five U.S. patents: US11925636B2, US11844797B1, US11839612B1, US11883373B1, and US11896563B2. All five patents relate to Auvelity® — a combination of dextromethorphan hydrobromide and bupropion hydrochloride in extended-release tablet form indicated for major depressive disorder.
The case was dismissed without prejudice by stipulation of all parties under FRCP 41(a)(1)(A)(ii), with no costs or attorneys’ fees awarded. The parties also agreed that the District of New Jersey retains jurisdiction to enforce future disputes, which is consistent with a private settlement or licensing arrangement. No merits ruling was entered on validity or infringement.
Auvelity® is an FDA-approved extended-release tablet combining dextromethorphan hydrobromide (an NMDA receptor antagonist and sigma-1 receptor agonist) and bupropion hydrochloride (a CYP450 2D6 inhibitor). It was the first new oral antidepressant mechanism approved in decades. Its commercial significance makes it a prime target for generic ANDA challenges, triggering Hatch-Waxman patent litigation.
No. A dismissal without prejudice under FRCP 41(a)(1)(A)(ii) carries no finding on the merits. All five Auvelity® patents — US11925636B2, US11844797B1, US11839612B1, US11883373B1, and US11896563B2 — retain their full presumption of validity and remain enforceable against other parties. Teva did not obtain any invalidity or non-infringement declaration from this proceeding.
The stipulation expressly preserved the District of New Jersey’s jurisdiction to enforce disputes relating to the subject matter of the case. This type of clause is typically inserted when a private settlement agreement exists that the parties want to be judicially enforceable. It suggests the litigation concluded on negotiated commercial terms — potentially including a licensed generic entry date — rather than through a unilateral withdrawal by either party.
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