Bayer AG v. Apotex: XARELTO® Rivaroxaban Patent Dismissed Without Prejudice
Bayer AG and Janssen Pharmaceuticals filed suit against generic manufacturer Apotex in Delaware over US10828310B2, covering rivaroxaban 2.5 mg tablets — the low-dose formulation of blockbuster anticoagulant XARELTO®. After 187 days, plaintiffs voluntarily dismissed all claims without prejudice, leaving the door open for future enforcement.
XARELTO® Generic Challenge Ends in Voluntary Exit — Door Left Open
In June 2025, Bayer AG and co-plaintiff Janssen Pharmaceuticals, Inc. initiated a patent infringement action in the Delaware District Court (Case No. 1:25-cv-00694) against Apotex, Inc., a major Canadian generic pharmaceutical manufacturer. The suit centred on US10828310B2, a patent covering rivaroxaban 2.5 mg tablets — the low-dose formulation of XARELTO®, an anticoagulant widely prescribed for cardiovascular risk reduction. Apotex’s ANDA filing for a 2.5 mg rivaroxaban generic was the apparent trigger for this Hatch-Waxman action before Judge Richard G. Andrews.
On 9 December 2025 — 187 days after filing — plaintiffs filed a notice of voluntary dismissal under Fed. R. Civ. P. 41(a)(1)(A)(i), terminating all claims without prejudice. A Rule 41(a)(1)(A)(i) dismissal requires no court approval and takes effect immediately upon filing. Critically, the ‘without prejudice’ designation means Bayer and Janssen have not relinquished their infringement claims; they may refile the same action in any competent court, subject to applicable statutes of limitations and any applicable 30-month stay implications under Hatch-Waxman.
The 187-day window is notable: it is long enough to suggest preliminary negotiations or discovery exchanges occurred, yet short enough to preclude a substantive merits ruling. The public record offers no indication of a settlement agreement, licence, or consent judgment, which is common in ANDA litigation where parties negotiate market entry dates confidentially. What drove the dismissal — whether a licensing deal, a reassessment of patent strength, or a strategic delay — remains undisclosed. Apotex’s generic launch position for rivaroxaban 2.5 mg therefore remains uncertain from the public docket.
Filing to Voluntary dismissal in 187 days
187-day case duration — resolved well before trial, consistent with early-stage ANDA litigation settlements or negotiated exits
Voluntarily dismissed: what the without-prejudice exit means for both parties
Rule 41(a)(1)(A)(i): a unilateral, no-court-approval exit
Under Fed. R. Civ. P. 41(a)(1)(A)(i), a plaintiff may dismiss an action without a court order by filing a notice before the defendant serves an answer or a motion for summary judgment. This is the most procedurally lightweight dismissal available — it is self-executing and requires no judicial sign-off. It signals the plaintiff chose to exit at an early stage, before substantive litigation obligations crystallised.
No merits adjudicationWithout prejudice: Bayer and Janssen preserve their enforcement rights
The dismissal was expressly filed ‘without prejudice,’ meaning the plaintiffs’ claims have not been adjudicated and no res judicata bar attaches. Bayer and Janssen may refile the same infringement claims against Apotex at a future date, subject to applicable limitations periods. This is distinct from a dismissal ‘with prejudice,’ which would permanently extinguish the asserted claims. The public record confirms the without-prejudice designation explicitly in the Rule 41 notice.
Claims survive — refiling possibleApotex faces no injunction — but litigation risk persists
Apotex secured a clean exit from this particular action with no adverse judgment, no injunction, and no damages exposure from this case. However, the without-prejudice dismissal offers no definitive clearance. If Apotex proceeds toward commercial launch of its rivaroxaban 2.5 mg generic, it remains exposed to a refiled infringement action under US10828310B2 or related patents in Bayer’s portfolio. The absence of a consent judgment or licence agreement on the public record means Apotex’s FTO position cannot be confirmed from the docket alone.
No clearance grantedXARELTO® 2.5 mg generic market entry: timeline remains unresolved
XARELTO® is one of the world’s highest-revenue anticoagulants. The 2.5 mg low-dose formulation targets cardiovascular indications, representing a distinct and commercially significant market segment. The voluntary dismissal without prejudice — and the absence of any public licence or agreed entry date — suggests the competitive dynamics around Apotex’s generic launch remain unresolved. Other ANDA filers in this space should monitor whether Bayer refiles or whether a negotiated market-entry date emerges through subsequent filings.
Generic entry date unconfirmedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Global pharmaceutical innovator — holder of US10828310B2 covering rivaroxaban 2.5 mgSearch in Eureka ↗ |
| Defendant | Apotex, Inc. | Company | Apotex, Inc. — major Canadian generic drug manufacturer seeking ANDA approval for rivaroxaban 2.5 mg tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | 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 | Cortlan S. Hitch | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Defendant counsel | Kenneth Laurence Dorsney | Attorney | Counsel for Apotex, Inc.Search in Eureka ↗ |
| Defendant law firm | Morris James LLP | Law Firm | Representing Apotex, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The voluntary dismissal notice invokes Rule 41(a)(1)(A)(i), the self-executing mechanism available to a plaintiff before responsive pleadings are served. The express ‘without prejudice’ language is legally operative: it forecloses any res judicata defence by Apotex in a subsequent action based on the same patent and product. No merits determination — on infringement, validity, or claim construction of US10828310B2 — issued from this proceeding. The filing’s precision in naming all three plaintiffs (Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals, Inc.) suggests coordinated enforcement strategy, consistent with co-ownership or co-exclusive-licence arrangements common in branded pharmaceutical portfolios.
US10828310B2 — rivaroxaban 2.5 mg tablet formulation (XARELTO®)
US10828310B2 (application number US16/264032) covers formulations of rivaroxaban at the 2.5 mg dosage — the lowest commercially available dose of XARELTO® — indicated for reduction of cardiovascular risk in patients with coronary artery disease or peripheral artery disease. This dosage form is distinct from the higher-dose anticoagulant indications and represents a separate regulatory and commercial exclusivity segment. The patent’s grant date and application history place it in the later phase of Bayer and Janssen’s layered exclusivity strategy for rivaroxaban.
From a competitive intelligence standpoint, US10828310B2 is strategically significant because the 2.5 mg rivaroxaban segment targets a large and growing cardiovascular patient population. Generic manufacturers filing ANDAs for this dose face this patent as a potential 30-month stay trigger. Because the patent was asserted but never substantively litigated here, its validity and claim breadth remain untested in US courts — meaning it retains full presumptive validity and continues to pose enforcement risk for any ANDA filer or generic entrant into the rivaroxaban 2.5 mg market.
Should you run an FTO analysis against US10828310B2?
Any pharmaceutical manufacturer, formulation scientist, or regulatory team developing a generic or biosimilar version of rivaroxaban 2.5 mg tablets for the US market should treat US10828310B2 as an active risk. The patent was asserted by Bayer and Janssen in a recent Hatch-Waxman action, dismissed without prejudice — meaning enforcement has not been abandoned. Product teams working on low-dose anticoagulant tablet formulations should conduct a formal FTO review before committing to ANDA filing, manufacturing investment, or commercial launch planning.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to rapidly map claim scope against US10828310B2, identify related patents in Bayer’s rivaroxaban family, review prosecution history for claim narrowing opportunities, and benchmark against prior art. Eureka’s litigation monitoring layer also flags any new filings by Bayer or Janssen against other ANDA filers — giving generic manufacturers early warning of enforcement activity before it affects their own timelines.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent cases: rivaroxaban and pharmaceutical formulation disputes
Cases involving Hatch-Waxman ANDA challenges to rivaroxaban and pharmaceutical tablet formulation patents in the Delaware District Court and related US federal forums.
What this case signals for the pharmaceutical patent IP landscape
Bayer’s without-prejudice exit in ANDA litigation over XARELTO® 2.5 mg carries significant signals for generic manufacturers and branded pharma alike.
Without-prejudice ANDA dismissals are rarely definitive — monitor for refiling
A Rule 41(a)(1)(A)(i) dismissal without prejudice in Hatch-Waxman litigation typically signals ongoing negotiations rather than a clean resolution. Patent holders routinely use this mechanism to pause litigation while licence or market-entry terms are finalised. Any generic manufacturer in the rivaroxaban space should track Bayer’s docket activity for a potential refile or consent judgment disclosing agreed entry dates.
Judge Andrews’ Delaware docket: a key venue signal for ANDA patent disputes
The Delaware District Court — and Judge Richard G. Andrews specifically — is a primary forum for Hatch-Waxman pharmaceutical patent litigation. The early-stage dismissal here means no claim construction or validity ruling issued, leaving US10828310B2’s scope untested in this proceeding. Companies monitoring XARELTO® patent risk should note that the patent’s strength before this court remains an open question.
Bayer v Apotex — key questions answered
A dismissal without prejudice under Rule 41(a)(1)(A)(i) means no merits ruling was issued and Bayer and Janssen retain the right to refile their infringement claims based on US10828310B2 against Apotex at any future date, subject to applicable statutes of limitations. Apotex received no judicial clearance and faces continued patent risk if it proceeds toward a rivaroxaban 2.5 mg generic launch.
Bayer AG and Janssen Pharmaceuticals asserted US10828310B2 (application US16/264032), a patent covering rivaroxaban 2.5 mg tablet formulations — the low-dose XARELTO® product indicated for cardiovascular risk reduction. The patent was the sole asserted patent identified in the public case record for Case No. 1:25-cv-00694.
The public docket for Case No. 1:25-cv-00694 does not reflect a settlement agreement, consent judgment, or negotiated market-entry date. The case was terminated by a unilateral Rule 41(a)(1)(A)(i) voluntary dismissal notice filed by the plaintiffs. Whether a confidential licence or commercial arrangement exists between Bayer and Apotex is not determinable from the public record.
Judge Richard G. Andrews of the Delaware District Court is one of the most experienced federal judges in Hatch-Waxman pharmaceutical patent litigation. The Delaware District Court is the primary US venue for ANDA patent disputes. Because the case was dismissed before any substantive ruling, no claim construction or validity decision from Judge Andrews issued — meaning US10828310B2’s scope remains unjudicially tested in this proceeding.
The dismissal without prejudice does not grant Apotex freedom to operate. Apotex’s ability to launch a rivaroxaban 2.5 mg generic depends on FDA approval status, any applicable 30-month stay, the existence of other asserted patents in Bayer’s portfolio, and whether a confidential licence or market-entry agreement was reached. The public docket confirms no consent judgment or agreed entry date was filed.
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