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AbbVie v. Deva Holding — Cariprazine Patent Dispute | PatSnap
Patent Litigation

AbbVie v. Deva Holding: VRAYLAR® Cariprazine Patent Dispute — Dismissed without Prejudice

AbbVie, Inc. filed suit in the Delaware District Court against Deva Holding A.S., asserting five patents protecting VRAYLAR® (cariprazine hydrochloride capsules) against Deva's ANDA 219532. The case resolved in 228 days with a court-entered stipulation finding technical infringement and permanently enjoining Deva from commercialising its generic cariprazine product for the life of all five patents.

Resolution time
228days
228 days from filing to close — resolved before trial
Patents asserted
5
US7737142B2, US7943621B2, USRE047350E, USRE049110E & USRE049302E — cariprazine HCl capsule formulations and methods
Outcome
Dismissed without Prejudice
Recorded basis of termination; remaining claims dismissed without prejudice per stipulation
Cost ruling
No award recorded
No cost or fee ruling disclosed in the available public record
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

AbbVie locks Deva out of VRAYLAR® generic market across five patents

AbbVie, Inc. filed this Hatch-Waxman infringement action on 30 October 2025 in the District of Delaware before Judge Maryellen Noreika, asserting five patents — US7737142B2, US7943621B2, USRE047350E, USRE049110E, and USRE049302E — against Deva Holding A.S.'s ANDA 219532 for generic cariprazine hydrochloride capsules (1.5 mg, 3 mg, 4.5 mg, and 6 mg), the reference-listed drug being AbbVie's branded VRAYLAR®.

The case closed on 15 June 2026, 228 days after filing, via a court-entered stipulation and order. The recorded basis of termination is 'Dismissed without Prejudice'; the docket order simultaneously adjudges Deva's ANDA filing as a technical act of infringement of all five patents under 35 U.S.C. § 271(e)(2)(A), enjoins Deva from commercialising its generic product for the life of each patent (including extensions and pediatric exclusivities), and expressly provides that the order finally resolves the action. Both parties waived any right to appeal the stipulation.

Resolution in under eight months, before any substantive merits briefing typically expected in ANDA litigation, suggests the parties reached agreement relatively early in the litigation cycle. The stipulation carves out future disputes involving products other than the specific ANDA 219532 cariprazine capsules, preserving AbbVie's right to assert the same five patents against Deva in any future action covering a different product. The specific commercial terms, if any, underlying the agreed resolution are not disclosed in the available public record.

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Case at a glance
PlaintiffAbbVie, Inc.
CourtDelaware District Court
JudgeMaryellen Noreika
FiledOctober 30, 2025
ClosedJune 15, 2026
Duration228 days
OutcomeDismissed without Prejudice
Verdict causeInfringement Action
BasisDismissed without Prejudice
Prior Art Intelligence
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Case timeline

Filing to Dismissed without Prejudice in 228 days

228 days from filing to close — resolved before trial

Case timeline: Complaint filed OCT 30 2025 — 228 days total Horizontal timeline showing the three key events in AbbVie, Inc. v Deva Holding A.S. from filing to resolution. Source: PACER, Delaware District Court. OCT 30 2025 Complaint filed Pre-trial proceedings JUN 15 2026 Dismissed without Prejudice 228 DAYS TOTAL
Patent at issue

US7737142B2 and four further patents — cariprazine HCl capsule formulations

Publication No.US7943621B2
Application No.US12/118437
Patent details
ProductCariprazine compound and pharmaceutical compositions
Cited in actionOctober 30, 2025

Publication No.USRE047350E
Application No.US15/598971
Patent details
ProductCariprazine formulations and methods of use
Cited in actionOctober 30, 2025

Publication No.US7737142B2
Application No.US11/337275
Patent details
ProductCariprazine hydrochloride capsule formulations (reissue)
Cited in actionOctober 30, 2025

Publication No.USRE049302E
Application No.US16/384264
Patent details
ProductCariprazine therapeutic methods and dosage forms (reissue)
Cited in actionOctober 30, 2025

Publication No.USRE049110E
Application No.US16/372031
Patent details
ProductCariprazine pharmaceutical compositions and treatment methods (reissue)
Cited in actionOctober 30, 2025
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 12 independent)
1. Trans 4-{2-[4-(2,3-dichlorophenyl)-piperazine-1-yl]-ethyl}-N,N-dimethylcarbamoyl-cyclohexylamine monohydrochloride, and hydrates and solvates thereof.
Technical background
CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of Hungarian Application No. HU P0700339, filed on filed May 1, 2007. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application. TECHNICAL FIELD The present invention relates to novel salts of trans 4-{2-[4-(2,3-dichlorophenyl)-piperazine-1-yl]-ethyl}-N,N-dimethylcarbamoyl-cyclohexylamine, to processes for their preparation, to pharmaceutical compositions co…
Patent family
73 family members across 47 jurisdictions (DE, LT, SG, CA, AU, IN, GE, HU, RS, IL, AT, HR)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US7737142B2 and the VRAYLAR® patent stack?

Any company developing, manufacturing, or seeking regulatory approval for a cariprazine hydrochloride capsule product in the United States should treat this five-patent portfolio as a high-priority FTO target. The consent judgment confirms enforceability of all five patents against ANDA-based entry. Generic developers, 505(b)(2) applicants, and formulation researchers working on atypical antipsychotics in similar dosage categories face direct infringement risk if their product profiles overlap with the claims of any of these patents.

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Official verdict

Official order — verbatim text

Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Deva, IT IS HEREBY ORDERED, ADJUDGED, AND DECREED THAT: Case 1:25-cv-01332-MN Document 36 Filed 06/15/26 Page 2 of 4 PageID #: 289 3 1. The filing of ANDA 219532 was a technical act of infringement of each of the ’142 Patent, the ’621 Patent, the RE’350 Patent, the RE’110 Patent, and the RE’302 Patent under 35 U.S.C. § 271(e)(2)(A). 2. All other claims and defenses asserted by the parties against each other in Plaintiffs’ and Deva’s pleadings in the Action, including the allegations and averments contained therein, are hereby dismissed, without prejudice. 3. Deva, its officers, agents, servants, employees, and attorneys, and all other persons in active concert or participation with any of them who receive actual notice of this Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the generic cariprazine hydrochloride capsule products (1.5 mg, 3 mg, 4.5 mg, and 6 mg) described by ANDA 219532 during the life of the ’142 Patent, the ’621 Patent, the RE’350 Patent, the RE’110 Patent, and the RE’302 Patent, including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the ’142 Patent, the ’621 Patent, the RE’350 Patent, the RE’110 Patent, and the RE’302 Patent are found invalid or unenforceable by a court decision from which no appeal has been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court. 4. Plaintiffs and Deva each expressly waive any right to appeal or otherwise move for relief from this Stipulation and Order. 5. This Court retains jurisdiction over Plaintiffs and Deva for purposes of enforcing this Stipulation and Order. 6. This Stipulation and Order shall finally resolve the Action.This Stipulation and Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Deva and any of the Plaintiffs regarding the ’142 Patent, the ’621 Patent, the RE’350 Patent, the RE’110 Patent, and the RE’302 Patent and a product other than a generic cariprazine hydrochloride capsule product (1.5 mg, 3 mg, 4.5 mg, and 6 mg) described by ANDA 219532. "
Source: PACER Docket, Case 1:25-cv-01332, Delaware District Court

The court-entered stipulation and order simultaneously adjudges Deva's ANDA filing as a technical act of patent infringement under 35 U.S.C. § 271(e)(2)(A) and imposes a permanent injunction covering all five asserted patents, while dismissing remaining claims and defences without prejudice. The without-prejudice dismissal of residual claims does not affect the operative injunction, which runs for the full remaining life of each patent including extensions. Both parties waived appeal rights, making the order final and immediately binding.

PACER case 1:25-cv-01332 · Public docket record Explore in Eureka ↗
Dismissal terms

Dismissed without prejudice: what the stipulated resolution means for both parties

Legal mechanism

Court-entered stipulation finds infringement and imposes injunction

The parties jointly presented a stipulation and order that the court entered as a binding decree. It adjudges Deva's ANDA filing as a technical act of infringement of all five asserted patents under 35 U.S.C. § 271(e)(2)(A), while dismissing remaining claims without prejudice. The court retained jurisdiction to enforce the order. Both parties expressly waived any appellate rights.

Stipulated order — court-entered
Patent holder outcome

AbbVie secures market exclusivity for the life of five VRAYLAR® patents

AbbVie obtained a permanent injunction blocking Deva from manufacturing, selling, or importing its generic cariprazine capsules in the United States for the life of all five patents, including any extensions and pediatric exclusivities, absent a licence. The without-prejudice dismissal of other claims preserves AbbVie's ability to pursue future actions against Deva over different products under the same patents.

Injunction secured — full patent term
Defendant outcome

Deva enjoined from commercialising generic cariprazine for patent term

Deva is permanently enjoined from launching its ANDA 219532 cariprazine product in the United States for the remaining life of all five patents unless all claims are found invalid or unenforceable by a final, non-appealable court decision, or a licence is granted. Deva waived its right to appeal the stipulation. The without-prejudice posture does not lift the injunction — it only preserves unresolved claims between the parties.

Permanently enjoined — no launch
Commercial implications

VRAYLAR® generic entry blocked; cariprazine IP estate reinforced

The stipulation reinforces AbbVie's five-patent fortress around cariprazine HCl capsules, a branded antipsychotic. Other ANDA filers in this space face a strong precedent of early, injunction-backed resolution. The carve-out for non-ANDA 219532 products signals AbbVie intends to defend the patents across any future generic challenge. Specific commercial or licensing terms underlying the agreed resolution are not disclosed in the available record.

Generic entry blocked
Legal analysis based on PACER docket records for case 1:25-cv-01332 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAbbVie, Inc.Company/Search in Eureka ↗
DefendantDeva Holding A.S.Individual/Search in Eureka ↗
Plaintiff counselAlexander TrzeciakAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselChristine SmithAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselChristopher N. SipesAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselMichael R. MoreyAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting AbbVie, Inc.Search in Eureka ↗
Defendant counselDominick T. GattusoAttorneyCounsel for Deva Holding A.S.Search in Eureka ↗
Defendant counselShashank S. UpadhyeAttorneyCounsel for Deva Holding A.S.Search in Eureka ↗
Defendant counselYixin H. TangAttorneyCounsel for Deva Holding A.S.Search in Eureka ↗
Defendant law firmHeyman Enerio Gattuso & Hirzel, LLPLaw FirmRepresenting Deva Holding A.S.Search in Eureka ↗
Presiding judgeJudge Maryellen NoreikaJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the cariprazine and atypical antipsychotic IP space

Forward-looking patent intelligence on AbbVie's cariprazine portfolio, Deva's CNS pipeline, and filing trends around atypical antipsychotic formulations.

Patent portfolio

AbbVie's cariprazine patent estate: reissues and continuation activity

AbbVie's assertion of three reissue patents alongside two originals suggests active portfolio management around cariprazine. Monitoring AbbVie's continuation and reissue filings in the cariprazine chemical and formulation space can signal where new claim scope is being sought, which directly impacts generic entry timelines and ANDA filing risk assessments.

AbbVie cariprazine filings
Technology landscape

Filing trends in atypical antipsychotic formulation patents post-2020

The cariprazine reissue patent filings extending into 2019 application dates indicate sustained innovation or claim-broadening activity in second-generation antipsychotic formulations. Tracking global filing trends in dopamine partial agonist and serotonin-dopamine activity modulator (SDAM) chemistry can reveal emerging competitive threats and white-space opportunities adjacent to the VRAYLAR® patent perimeter.

Antipsychotic formulation trends
Competitor IP posture

Deva Holding's CNS and generic pipeline patent activity

Deva Holding A.S. operates a broad generic pharmaceutical pipeline with CNS exposure. Analysing Deva's patent filings and ANDA history beyond ANDA 219532 can reveal where the company is investing in formulation differentiation or developing non-infringing alternatives in the atypical antipsychotic space — relevant for competitive intelligence on future cariprazine or adjacent CNS challenges.

Deva Holding CNS pipeline
White space

Adjacent cariprazine delivery and indication opportunities outside the ANDA 219532 scope

The stipulation's carve-out explicitly covers only the ANDA 219532 cariprazine HCl capsule product (1.5–6 mg). Alternative delivery formats, extended-release formulations, novel indications, or fixed-dose combinations involving cariprazine may fall outside the immediate injunction scope and represent potential white-space for innovation or design-around R&D activity not yet claimed by AbbVie's current reissue portfolio.

Cariprazine formulation white space
Related litigation

Similar ANDA cariprazine and CNS pharma patent cases in Delaware

Explore related Hatch-Waxman patent infringement cases involving cariprazine, antipsychotic formulations, and ANDA challenges before the Delaware District Court.

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AbbVie, Inc. patent enforcement history, Delaware District Court case history, AbbVie, Inc.'s full IP portfolio, and comparable case analysis
VRAYLAR® parallel ANDAsAbbVie ANDA enforcement historyCNS reissue patent disputesDelaware CNS pharma injunctions
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Strategic implications

What this case signals for the cariprazine and CNS pharma IP landscape

AbbVie's swift injunction in Delaware sends a clear enforcement signal across the generic cariprazine pipeline.

Early resolution with injunction is a template for ANDA defence in CNS pharma

AbbVie secured a permanent injunction on all five cariprazine patents in under eight months without trial. This pattern — technically adjudicated infringement plus agreed injunction — limits the generic challenger's ability to refile or pivot. Other ANDA filers in antipsychotic markets should expect similarly aggressive early enforcement postures from branded incumbents.

The five-patent stack signals layered exclusivity planning by AbbVie

Asserting two original patents and three reissues against a single ANDA reflects a deliberate portfolio-layering strategy. Reissue patents, which survive into the 2030s in this case, extend the effective exclusivity window beyond any single patent expiry. Competitors and FTO analysts should map each patent's remaining term and reissue scope individually before assessing generic entry risk.

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Full strategic analysis in PatSnap Eureka
Unlock gated signals on AbbVie's cariprazine enforcement posture and generic entry risk at the Delaware District Court level.
Future-action carve-out riskPediatric exclusivity timelineReissue patent expiry mapping
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Frequently asked questions

AbbVie v Deva — key questions answered

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Track cariprazine patent enforcement and VRAYLAR® generic entry risk

Monitor AbbVie's cariprazine reissue portfolio, pending ANDA challengers, and freedom-to-operate exposure across the five-patent stack with PatSnap Eureka. Stay ahead of enforcement signals before your next formulation or regulatory filing decision.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

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