Bayer & Janssen v. Aurobindo: Rivaroxaban Patent Action Dismissed With Prejudice
Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals brought a patent infringement action in the Delaware District Court against generic manufacturer Aurobindo Pharma over US10828310B2, a patent covering 2.5 mg rivaroxaban tablets. The case resolved in just 161 days — well before trial — with a stipulated dismissal with prejudice and each side bearing its own costs.
A Fast-Tracked Rivaroxaban ANDA Dispute Ends in Mutual Finality
On 1 December 2023, Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals, Inc. jointly filed suit in the United States District Court for the District of Delaware against Aurobindo Pharma Limited and its U.S. subsidiary Aurobindo Pharma USA, Inc. The complaint asserted infringement of US10828310B2, a patent directed to 2.5 mg rivaroxaban tablet formulations — the lowest approved dose of the blockbuster oral anticoagulant marketed as Xarelto. The action is consistent with Hatch-Waxman ANDA litigation triggered by Aurobindo’s filing of a Paragraph IV certification against the listed patent.
The case closed on 10 May 2024, just 161 days after filing, through a stipulated dismissal with prejudice entered pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure. The dismissal is bilateral — covering all claims and defenses asserted by both plaintiffs and defendants — and carries a with-prejudice designation, meaning neither side may relitigate the same claims. Each party bears its own attorneys’ fees and costs, suggesting a negotiated resolution rather than a unilateral capitulation.
A 161-day resolution is notably swift for Delaware ANDA litigation, where cases routinely proceed to a 30-month stay and beyond. The mutual with-prejudice dismissal and own-costs structure are consistent with a confidential settlement — potentially involving a licensing agreement or agreed market entry date — though the public record discloses no such terms. What remains unknown is whether Aurobindo secured any authorised generic rights or launch date concession, which would be material to the competitive dynamics around Xarelto’s 2.5 mg formulation.
Filing to Dismissed with Prejudice in 161 days
161 days — resolved well before the typical Delaware ANDA trial window of 24–30 months
Dismissed with prejudice: what the stipulated exit means for both sides
Rules 41(a)(1) and 41(c): a bilateral, final dismissal
A stipulated dismissal under Rule 41(a)(1) requires agreement of all parties and, when entered with prejudice, operates as a final adjudication on the merits. Rule 41(c) extends the same framework to counterclaims. Here, both plaintiffs’ infringement claims and Aurobindo’s defences — including any invalidity or non-infringement counterclaims — are extinguished. Neither side can re-file the same action in any federal forum.
Bilateral and final — no appeal pathPatentees exit with claims intact but no public judgment
Bayer and Janssen avoid the risk of an adverse invalidity ruling that could have weakened US10828310B2 against other generic challengers. The with-prejudice bar prevents Aurobindo from relitigating infringement or validity. However, the absence of a court-affirmed infringement finding means the patent’s enforceability against other ANDA filers was not publicly tested in this proceeding.
Patent untested — protected from invalidity riskAurobindo exits litigation but loses the right to challenge again
Aurobindo’s ANDA pathway and any invalidity arguments against US10828310B2 are foreclosed against Bayer and Janssen in future proceedings. The dismissal with prejudice prevents re-filing. If a confidential settlement underlies the stipulation — as the own-costs structure suggests — Aurobindo may have negotiated a defined market entry date or licensing arrangement, though neither is disclosed in the public record.
Cannot refile — likely negotiated exitRivaroxaban 2.5 mg remains shielded — for now
The swift, confidential-looking resolution preserves market uncertainty around the 2.5 mg Xarelto dose. Other ANDA filers targeting US10828310B2 should note that no public invalidity record was created, leaving the patent’s claims untested in litigation. Branded revenue attributable to the 2.5 mg indication remains commercially significant, and any undisclosed entry date in a settlement would be a key variable for forecasting generic competition.
No invalidity precedent createdFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer Pharma AG | Company | Pharmaceutical patentees — holders of US10828310B2 covering rivaroxaban tablet formulationsSearch in Eureka ↗ |
| Co-Plaintiff | Janssen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Aurobindo Pharma, Ltd. | Company | Indian generic manufacturer and U.S. subsidiary seeking ANDA approval for rivaroxaban tabletsSearch in Eureka ↗ |
| Co-Defendant | Aurobindo Pharma USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Derek James Fahnestock | Attorney | Counsel for Bayer Pharma AGSearch in Eureka ↗ |
| Plaintiff counsel | Jack B. Blumenfeld | Attorney | Counsel for Bayer Pharma AGSearch in Eureka ↗ |
| Plaintiff counsel | Rodger Dallery Smith , II | Attorney | Counsel for Bayer Pharma AGSearch in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Bayer Pharma AGSearch in Eureka ↗ |
| Defendant counsel | George J. Barry , III | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | Michael P. Hogan | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | R. Touhey Myer | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant counsel | Timothy H. Kratz | Attorney | Counsel for Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | Kratz & Barry LLP | Law Firm | Representing Aurobindo Pharma, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation expressly invokes both Rule 41(a)(1) and Rule 41(c), ensuring the dismissal with prejudice operates symmetrically across the plaintiffs’ infringement claims and Aurobindo’s counterclaims and defences. The ‘all parties bear their own costs’ clause is a standard marker of a negotiated exit, distinguishing this from a unilateral withdrawal. Critically, no infringement finding and no invalidity ruling was entered, leaving US10828310B2’s enforceability profile unchanged for future ANDA challengers.
US10828310B2 — 2.5 mg rivaroxaban oral anticoagulant tablet formulation
US10828310B2 (application number US16/264032) covers formulations of rivaroxaban at the 2.5 mg dosage strength — the lowest approved oral dose of the Factor Xa inhibitor marketed as Xarelto. Rivaroxaban is indicated for reducing cardiovascular risk in patients with coronary artery disease or peripheral arterial disease, making the 2.5 mg dose a distinct commercial and clinical asset. The patent’s listing in the Orange Book against this specific dosage strength is what triggers Hatch-Waxman Paragraph IV exposure for generic ANDA filers targeting this product.
For the pharmaceutical IP landscape, US10828310B2 sits at the intersection of a high-revenue branded franchise and a well-established generic challenger market. Rivaroxaban has faced multiple ANDA filings globally, and the 2.5 mg formulation represents a significant revenue component tied to the cardiovascular indication. The patent’s survival without an adverse court ruling — even through a with-prejudice dismissal — preserves enforcement optionality for Bayer and Janssen against subsequent Paragraph IV filers, while leaving claim scope open to fresh challenge.
Should your team run an FTO analysis against US10828310B2?
Any company developing, manufacturing, or seeking ANDA approval for a 2.5 mg rivaroxaban tablet formulation should treat US10828310B2 as a live enforcement risk. Bayer and Janssen demonstrated in this case that they will file in Delaware within the 45-day Hatch-Waxman window. The patent’s claims were never invalidated or adjudicated in this proceeding, so it retains full legal presumption of validity. R&D and regulatory teams should assess formulation design-arounds and review the prosecution history before committing to a filing strategy.
PatSnap Eureka’s FTO Search Agent allows you to map claim scope for US10828310B2, identify related family members in the Xarelto portfolio, and benchmark against prior art uncited during prosecution. Eureka’s litigation overlay flags concurrent enforcement actions, helping your team assess whether a Paragraph IV certification is likely to trigger immediate litigation and estimate the probable enforcement timeline based on Bayer and Janssen’s litigation history in Delaware.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar rivaroxaban and oral anticoagulant ANDA patent cases in Delaware
Explore related Hatch-Waxman infringement actions involving rivaroxaban formulation patents litigated in Delaware District Court against generic ANDA filers.
What this case signals for the rivaroxaban and oral anticoagulant IP landscape
A 161-day Hatch-Waxman exit in Delaware rarely happens without a deal. Here is what IP professionals should take away.
Speed of resolution suggests a pre-trial licensing deal was likely reached
Delaware ANDA cases rarely close in five months without a settlement. The own-costs structure and bilateral with-prejudice dismissal are hallmarks of a negotiated resolution. IP teams monitoring Xarelto’s exclusivity runway should track Aurobindo’s ANDA approval status and any authorised generic filings as potential signals of agreed entry dates.
US10828310B2 survives — but without a litigated validity record
Because no court ruled on validity or infringement, the patent enters future ANDA disputes with no adverse precedent — but also no reinforcing court endorsement. Subsequent Paragraph IV filers can still challenge the patent on the merits. Patentees and generic entrants alike should assess the prosecution history and claim scope of US10828310B2 independently.
Bayer v Aurobindo — key questions answered
The case was dismissed with prejudice by stipulation of all parties on 10 May 2024, approximately 161 days after filing. All claims by plaintiffs Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals, and all counterclaims and defences by Aurobindo Pharma, were extinguished. Each party bears its own costs and attorneys’ fees.
The plaintiffs asserted US10828310B2 (application number US16/264032), a patent covering 2.5 mg rivaroxaban tablet formulations. This patent is listed in the FDA Orange Book and covers the lowest approved dose of rivaroxaban, marketed as Xarelto.
A dismissal with prejudice bars the specific parties from relitigating the same claims in federal court. In the Hatch-Waxman context, it means Aurobindo cannot reassert invalidity or non-infringement claims against Bayer and Janssen for this patent. However, it does not prevent other ANDA filers from independently challenging US10828310B2 in separate proceedings.
An own-costs provision means no fee-shifting occurred — neither the plaintiffs nor Aurobindo were ordered to pay the other side’s legal fees or disbursements. In patent cases, this is often associated with a negotiated resolution, as fee-shifting under 35 U.S.C. § 285 typically requires a court finding of an ‘exceptional case’, which is absent here.
The plaintiffs — Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals — were represented by Morris, Nichols, Arsht & Tunnell LLP, a leading Delaware IP litigation firm. The defendants, Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., were represented by Kratz & Barry LLP. The case was assigned to Judge Richard G. Andrews of the Delaware District Court.
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