Bayer & Janssen v. Cipla: Rivaroxaban Patent Suit Dismissed Without Prejudice
Bayer AG and Janssen Pharmaceuticals filed suit in the District of Delaware against Cipla Limited and CIPLA USA over alleged infringement of US10828310B2 by Cipla’s 2.5 mg rivaroxaban tablets. After 782 days of litigation, plaintiffs voluntarily dismissed all claims without prejudice — leaving the door open for future enforcement action.
Rivaroxaban ANDA dispute ends without a merits ruling — for now
Bayer AG and Janssen Pharmaceuticals, Inc. filed this Hatch-Waxman patent infringement action on 20 October 2023 in the District of Delaware before Judge Richard G. Andrews. The plaintiffs asserted US10828310B2 against Cipla Limited and its U.S. affiliate CIPLA USA, Inc., targeting Cipla’s abbreviated new drug application for 2.5 mg rivaroxaban tablets — the lower-dose formulation of Xarelto used in cardiovascular indications including post-acute coronary syndrome and peripheral artery disease.
On 10 December 2025, plaintiffs filed a notice of voluntary dismissal pursuant to Fed. R. Civ. P. 41(a)(1)(A)(i), dismissing all claims without prejudice. Because dismissal was filed before Cipla served either an answer or a motion for summary judgment, no court order was required and no merits adjudication occurred. The without-prejudice designation means the asserted patent claims remain available for future enforcement, and Bayer and Janssen are not precluded from refiling against Cipla or other generic entrants on the same patent.
The 782-day duration before dismissal is notable: it extends well past the typical early-stage settlement window, suggesting substantive pretrial activity — potentially including claim construction briefing or discovery exchanges — occurred before the parties resolved their posture. The public record does not disclose whether a licensing agreement, market entry consent, or other commercial arrangement accompanied the dismissal, and no costs award was entered, which is consistent with a negotiated resolution rather than a unilateral withdrawal.
Filing to Voluntary dismissal in 782 days
782 days — longer than the median Hatch-Waxman first-instance resolution, suggesting active pretrial proceedings before dismissal
Voluntarily dismissed: what the without-prejudice ruling means for both parties
Rule 41(a)(1)(A)(i): dismissal as of right, no court order needed
Under Fed. R. Civ. P. 41(a)(1)(A)(i), a plaintiff may dismiss without a court order by filing a notice before the defendant serves an answer or a motion for summary judgment. This is a unilateral procedural right. The case closes automatically upon filing. No judicial findings were made, no claim was decided on the merits, and the patent’s validity and infringement were never adjudicated.
No merits rulingThe distinction between with and without prejudice matters significantly
A dismissal without prejudice does not extinguish the underlying claims. Bayer and Janssen may refile suit on US10828310B2 against Cipla or any other generic filer within applicable limitations periods. A dismissal with prejudice, by contrast, would have barred refiling on the same claims. The public record here is explicit: the notice states ‘without prejudice,’ preserving full enforcement optionality for the patent holder.
Refiling permittedCipla avoids adverse ruling but gains no formal patent clearance
Cipla and CIPLA USA secured dismissal of all current claims without facing an infringement or validity judgment. However, because the dismissal carries no with-prejudice bar and no court-ordered patent license, Cipla’s commercial pathway for its 2.5 mg rivaroxaban ANDA remains subject to the patent’s expiry, any future litigation, or a separately negotiated consent. The absence of a recorded costs award is consistent with a negotiated exit rather than a Cipla-favoured outcome.
No injunction, no clearancePatent enforcement optionality preserved in a high-value cardiovascular market
Rivaroxaban (Xarelto) is among the highest-revenue oral anticoagulants globally. A without-prejudice dismissal after 782 days suggests the parties may have reached a commercial arrangement — such as a market entry date agreement — without public disclosure. Other generic filers targeting the 2.5 mg indication should treat US10828310B2 as an active enforcement risk. The patent’s continued validity means FTO analysis remains essential for any ANDA applicant in this dose category.
Active enforcement risk remainsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Pharmaceutical IP licensor and innovator — holder of US10828310B2 covering rivaroxaban formulationsSearch in Eureka ↗ |
| Co-Plaintiff | Janssen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Cipla Limited | Individual | Cipla Limited and CIPLA USA, Inc. — generic pharmaceutical manufacturer seeking ANDA approval for 2.5 mg rivaroxaban tabletsSearch in Eureka ↗ |
| Co-Defendant | CIPLA USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Jack B. Blumenfeld | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff counsel | Rodger Dallery Smith , II | Attorney | Counsel for Bayer AGSearch in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Bayer AGSearch in Eureka ↗ |
| Defendant counsel | April M. Ferraro | Attorney | Counsel for Cipla LimitedSearch in Eureka ↗ |
| Defendant counsel | John M. Seaman | Attorney | Counsel for Cipla LimitedSearch in Eureka ↗ |
| Defendant law firm | Abrams & Bayliss, LLP | Law Firm | Representing Cipla LimitedSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice invokes Rule 41(a)(1)(A)(i) and expressly specifies ‘without prejudice,’ which is the operative language determining post-dismissal rights. No judicial findings accompany this termination: validity, infringement, and claim scope of US10828310B2 remain entirely open. For Cipla, the absence of a with-prejudice bar or a formal patent licence means continued regulatory and litigation exposure. For Bayer and Janssen, every enforcement option against this and other generic filers is preserved.
US10828310B2 — low-dose rivaroxaban tablet formulation patent
US10828310B2, filed from application US16/264032, protects formulations of rivaroxaban — a direct Factor Xa inhibitor — in the low-dose 2.5 mg tablet configuration used in cardiovascular indications including secondary prevention after acute coronary syndrome and treatment of peripheral artery disease. The patent sits within the broader Xarelto exclusivity portfolio jointly managed by Bayer and Janssen, covering not just the active compound but the specific formulation parameters that characterise this lower-dose commercial product.
From a competitive standpoint, the 2.5 mg dose is commercially distinct from the higher-dose atrial fibrillation and VTE indications, creating a separate ANDA battleground. Generic manufacturers seeking to enter this segment must navigate US10828310B2 as a primary barrier. The Bayer-Janssen co-ownership or licensing structure means that any clearance strategy requires engagement with both entities. Given the without-prejudice dismissal, the patent’s enforceability against Cipla and all other potential generic entrants remains intact, making this a live FTO concern for any manufacturer active in oral anticoagulant generics.
Should your team run an FTO against US10828310B2?
Any pharmaceutical manufacturer, ANDA applicant, or contract development organisation working on 2.5 mg rivaroxaban tablets — or structurally similar Factor Xa inhibitor formulations — should treat US10828310B2 as an active enforcement risk. This case confirms that Bayer and Janssen are willing to assert the patent in U.S. District Court and that a voluntary dismissal without prejudice does not signal abandonment. The patent remains in force and the co-plaintiff structure means dual-party clearance is required for any licensing resolution.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US10828310B2 against your product specifications, identify related family members and continuation risk, and surface any post-grant proceedings that could affect validity. For ANDA filers specifically, Eureka’s litigation monitoring layer tracks new case filings against the same patent, giving your IP and regulatory teams early warning of enforcement activity before the 30-month stay clock starts running.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman rivaroxaban and oral anticoagulant patent cases
Cases in the District of Delaware involving Xarelto patent assertions, Factor Xa inhibitor ANDA disputes, and voluntary dismissals in pharmaceutical patent litigation.
What this case signals for the rivaroxaban and oral anticoagulant IP landscape
A 782-day without-prejudice dismissal in a Hatch-Waxman case rarely signals a clean exit. For generic filers and innovators alike, the strategic read matters.
Without-prejudice dismissal is not a safe harbour for other ANDA filers
The voluntary dismissal removes Cipla from active litigation but does not invalidate or limit US10828310B2. Any other generic manufacturer targeting the 2.5 mg rivaroxaban dose must independently assess infringement risk. Bayer and Janssen retain full standing to enforce the patent in new actions, and the 30-month stay mechanism under Hatch-Waxman may apply to subsequent filers.
Long pre-dismissal duration suggests substantive negotiation, not early exit
At 782 days, this case ran well beyond the stage at which purely strategic ANDA suits typically resolve. The timeline is consistent with claim construction activity or advanced settlement discussions that produced a commercial arrangement. IP teams monitoring the rivaroxaban generic entry timeline should watch for FDA approval actions on Cipla’s ANDA as a leading indicator of any agreed market entry date.
Bayer v Cipla — key questions answered
A without-prejudice dismissal under Rule 41(a)(1)(A)(i) means Bayer and Janssen retain the right to refile claims against Cipla on US10828310B2. No merits ruling was made, no claim was adjudicated, and the patent’s validity and infringement scope remain open. Cipla gains no formal patent clearance from this dismissal.
The sole patent asserted is US10828310B2, filed from application number US16/264032. It covers formulations of rivaroxaban in the 2.5 mg tablet dose used in cardiovascular indications. The patent is held or co-owned by Bayer and Janssen and targets Cipla’s ANDA for generic 2.5 mg rivaroxaban tablets.
The public record does not disclose the reason for dismissal. The 782-day duration is consistent with substantive pretrial activity and suggests a commercial resolution — potentially including an agreed market entry date or licensing arrangement — may have accompanied the dismissal. However, no such agreement has been publicly filed, and the basis of termination is recorded solely as voluntary dismissal.
No. The dismissal is case-specific and without prejudice. US10828310B2 remains enforceable against any ANDA filer targeting the 2.5 mg rivaroxaban formulation. Other generic manufacturers must independently assess infringement risk and cannot rely on this dismissal as establishing non-infringement or invalidity of the asserted patent.
Plaintiffs Bayer AG and Janssen Pharmaceuticals were represented by Morris, Nichols, Arsht & Tunnell LLP, with attorneys Jack B. Blumenfeld, Derek James Fahnestock, and Rodger Dallery Smith II on record. Defendants Cipla Limited and CIPLA USA were represented by Abrams & Bayliss LLP, with April M. Ferraro and John M. Seaman listed as counsel.
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