Neurocrine Biosciences v. Zydus Cadila — INGREZZA SPRINKLE: 20-Patent NJ Suit Redirected to Delaware
Neurocrine Biosciences filed a 20-patent infringement action in New Jersey against Zydus Cadila and related entities over generic valbenazine sprinkle capsules. The New Jersey case was voluntarily dismissed without prejudice after 194 days — with Neurocrine explicitly consolidating the fight into a parallel Delaware proceeding filed the same day.
A 20-patent ANDA fight opened in NJ, then consolidated into Delaware
On 25 April 2025, Neurocrine Biosciences, Inc. filed suit in the District of New Jersey (Case No. 1:25-cv-03354) against Zydus Pharmaceuticals (USA) Inc. and four related Zydus entities, asserting infringement of 20 U.S. patents covering INGREZZA SPRINKLE (valbenazine) capsules in 40, 60, and 80 mg dosage forms. The asserted portfolio spans compound, formulation, and method-of-use claims and is consistent with the layered patent estate typical of branded ANDA litigation designed to maximise the statutory 30-month stay.
The New Jersey action was terminated on 5 November 2025 pursuant to Rule 41(a)(1)(A)(i) — a plaintiff-initiated voluntary dismissal filed before any answer or summary judgment motion, requiring no court order. Critically, Neurocrine’s notice expressly directed the action toward Civil Action No. 1:25-cv-00509-MN, pending in the District of Delaware, which was filed on the same date as this New Jersey case. The dismissal was entered without prejudice, meaning the substantive patent claims are not extinguished and remain live in the Delaware forum.
The 194-day lifespan of the New Jersey case, combined with the explicit consolidation language in the dismissal notice, suggests this was a deliberate venue rationalisation rather than an abandonment of the underlying infringement claims. The public record does not disclose whether Zydus consented or whether any pre-dismissal procedural activity occurred. What remains uncertain is whether the Delaware action has been broadened, narrowed, or amended relative to the New Jersey filing — those details will emerge as the Delaware docket progresses.
Filing to Voluntary dismissal in 194 days
194 days — closed faster than the median ANDA patent case, consistent with a strategic venue consolidation rather than a contested merits fight
Voluntarily dismissed: what Rule 41 means and what happens next in Delaware
Rule 41(a)(1)(A)(i): plaintiff dismisses as of right, no court approval needed
Under Federal Rule of Civil Procedure 41(a)(1)(A)(i), a plaintiff may dismiss an action without a court order by filing a notice before the opposing party serves an answer or a motion for summary judgment. Because no such filing had occurred, Neurocrine’s notice was self-executing. The action terminated automatically upon filing, with no judicial assessment of the merits.
No merits adjudicationWithout prejudice — but the public record matters here
The dismissal notice explicitly states ‘without prejudice,’ meaning Neurocrine’s patent claims survive and cannot be used as a bar in future proceedings. Had the notice been silent on this point, Rule 41(a)(1)(B) would still typically imply ‘without prejudice’ for a first dismissal. The operative battleground shifts entirely to the District of Delaware, where the parallel case has been active since April 2025.
Claims alive in DelawareZydus faces the same 20-patent exposure — now only in Delaware
The dismissal does not resolve Zydus’s infringement exposure. With five Zydus entities named and a 20-patent portfolio asserted, the Delaware proceeding carries the full enforcement risk. Zydus may benefit from litigating in a single forum rather than two parallel proceedings, but the substantive IP challenge remains entirely unresolved.
Delaware litigation continuesParallel-filing strategy is standard practice in complex ANDA patent litigation
Filing in multiple districts simultaneously before consolidating is a recognised tactic in Hatch-Waxman litigation — particularly where patent owners seek to ensure procedural standing in at least one forum. Neurocrine’s rapid consolidation into Delaware, a preferred forum for pharma IP disputes, is consistent with practised ANDA enforcement strategy and suggests the Delaware case was always intended as the primary venue.
Hatch-Waxman venue strategyFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Neurocrine Biosciences, Inc. | Company | Specialty CNS pharma company — holder of US10851104B2 and 19 related valbenazine patentsSearch in Eureka ↗ |
| Defendant | Zydus Cadila | Individual | Zydus Cadila and affiliated generics entities seeking to market generic valbenazine sprinkle capsulesSearch in Eureka ↗ |
| Plaintiff counsel | Guillermo Carlo Aatiles | Attorney | Counsel for Neurocrine Biosciences, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Matthew Adam Sklar | Attorney | Counsel for Neurocrine Biosciences, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Mccarter & English, LLP | Law Firm | Representing Neurocrine Biosciences, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice is a unilateral procedural act, not a merits ruling — no court evaluated infringement, validity, or enforceability of any of the 20 asserted patents. The reference to ‘continued prosecution’ of the Delaware action is commercially significant: it confirms Neurocrine views the infringement claims as live and worth pursuing, and that the New Jersey filing served a procedural rather than substantive purpose. All substantive findings, if any, will originate from the District of Delaware.
US10851104B2 and 19 further patents — valbenazine VMAT2 inhibitor portfolio
The asserted portfolio of 20 U.S. patents covers the full lifecycle of valbenazine — Neurocrine’s selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved as INGREZZA for tardive dyskinesia. The patents span application dates from 2006 (US8039627B2) through 2020 (US11311532B2), encompassing composition-of-matter claims, formulation patents specific to sprinkle capsule delivery, and method-of-use claims covering tardive dyskinesia treatment. This stratified structure is characteristic of a ‘patent thicket’ designed to maintain exclusivity across multiple potential generic entry points.
For the CNS and movement disorder therapeutics sector, this portfolio represents a significant barrier to generic entry. INGREZZA SPRINKLE’s sprinkle formulation — designed for patients who cannot swallow intact capsules — has its own formulation-specific IP layer beyond the core compound patents. Any generic manufacturer must navigate not only the compound and method claims but also the specific delivery technology claims, substantially raising the litigation cost and design-around complexity for potential ANDA challengers.
Should your R&D team run an FTO against the INGREZZA SPRINKLE patent estate?
Any company developing or planning to file an ANDA for valbenazine capsules — particularly sprinkle or modified-release formulations — faces direct exposure to this 20-patent portfolio. The scope extends beyond the core VMAT2 inhibitor compound to cover specific dosage forms, excipient combinations, and clinical dosing methods. R&D teams working on VMAT2-targeted therapies for tardive dyskinesia or related movement disorders should treat this portfolio as a primary FTO priority before advancing candidate formulations.
PatSnap Eureka’s FTO Search Agent can map each of the 20 asserted patents against your product specifications, flag expired or potentially invalid claims using prosecution history analytics, and identify prior art relevant to IPR petition planning. Given the stratified filing dates across the portfolio, automated claim-by-claim risk scoring can identify which patents present the highest and lowest barriers — enabling faster, more targeted freedom-to-operate decisions.
Run a freedom-to-operate analysis on US10851104B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent infringement cases: valbenazine and CNS VMAT2 inhibitors
Cases involving multi-patent ANDA assertions over CNS formulations in the District of Delaware and District of New Jersey, including related INGREZZA patent enforcement actions.
What this case signals for the valbenazine and CNS generics IP landscape
Neurocrine’s 20-patent filing in two forums on the same day signals an aggressive, coordinated defence of INGREZZA SPRINKLE’s market exclusivity.
A 20-patent ANDA stack signals near-impenetrable exclusivity defence
Asserting 20 patents across compound, formulation, and method-of-use claims is consistent with a strategy designed to maximise 30-month stay protection and raise the litigation cost for any generic entrant. Generic challengers entering the valbenazine space should anticipate a multi-front, multi-year IP fight even if individual patents appear vulnerable.
Delaware consolidation is a structural tell — watch the Delaware docket closely
The explicit reference to Civil Action No. 1:25-cv-00509-MN in the dismissal notice confirms Delaware is the primary enforcement forum. IP teams monitoring INGREZZA’s exclusivity lifecycle should track the Delaware proceedings for claim construction orders, IPR petitions, and any Paragraph IV certifications from additional ANDA filers.
Neurocrine v Zydus — key questions answered
The case was dismissed without prejudice. Neurocrine’s Rule 41(a)(1)(A)(i) notice explicitly states the dismissal is ‘without prejudice,’ preserving all patent infringement claims for continued prosecution in the parallel District of Delaware action, Civil Action No. 1:25-cv-00509-MN.
The dismissal notice states the action was ended ‘in favour of continued prosecution’ of a parallel Delaware filing made on the same date (25 April 2025). This is consistent with a venue consolidation strategy — Delaware is the dominant forum for complex pharmaceutical ANDA patent litigation, and concentrating both proceedings in one court reduces case management complexity and potential conflicting rulings.
Neurocrine asserted 20 U.S. patents in the New Jersey action. The portfolio spans composition-of-matter, formulation, and method-of-use claims covering valbenazine capsules (40, 60, and 80 mg sprinkle dosage forms), with application dates ranging from 2006 to 2020. The same patent estate is presumed to be at issue in the parallel Delaware proceeding.
Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure allows a plaintiff to voluntarily dismiss an action without a court order by filing a notice before the opposing party serves an answer or a motion for summary judgment. The dismissal is self-executing and does not require judicial approval. In this case, because no answer had been filed, Neurocrine’s notice terminated the New Jersey action automatically.
No. The New Jersey dismissal was expressly without prejudice and directed toward the Delaware parallel action. The substantive infringement claims under the 20 asserted patents remain live in Civil Action No. 1:25-cv-00509-MN (D. Del.). The New Jersey case produced no merits rulings, claim construction orders, or validity findings that could bind or affect the Delaware proceeding.
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