Bayer & Janssen v. Taro: Rivaroxaban Patent Dispute Dismissed With Prejudice
Bayer AG and Janssen Pharmaceuticals filed suit in the Delaware District Court against Taro Pharmaceutical over US10828310B2, a patent covering 2.5 mg rivaroxaban tablets. After 778 days of litigation, all parties stipulated to a dismissal with prejudice, each bearing their own costs — a resolution consistent with a confidential settlement.
ANDA Patent Battle Over Rivaroxaban Ends in Stipulated Dismissal
Bayer AG and Janssen Pharmaceuticals, Inc. filed suit on October 26, 2023 in the U.S. District Court for the District of Delaware against Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. The complaint asserted infringement of US10828310B2, a patent directed to 2.5 mg rivaroxaban tablet formulations — the lower-dose form of Xarelto used in cardiovascular indications including reduction of thrombotic events in patients with coronary artery disease. This type of action is characteristically triggered by Taro’s filing of an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of the product.
After 778 days of litigation before Judge Richard G. Andrews, the parties filed a stipulated dismissal on December 12, 2025, invoking Federal Rules of Civil Procedure 41(a)(1) and 41(c). All claims and counterclaims — including any invalidity or non-infringement defenses raised by Taro — were dismissed with prejudice, meaning neither party may relitigate those specific claims. The order that each party bear its own costs and attorneys’ fees is a hallmark of negotiated resolution rather than court-imposed judgment, strongly suggesting the parties reached a private agreement governing Taro’s market entry.
At 778 days, the case ran longer than many ANDA patent actions that settle early, suggesting meaningful substantive engagement — potentially including claim construction briefing or expert discovery — before resolution. The public record does not disclose any license terms, agreed entry date, or royalty arrangement. The with-prejudice designation forecloses any future litigation on the same patents and products between these parties, providing Bayer and Janssen certainty against re-challenge by Taro on US10828310B2 for the 2.5 mg rivaroxaban tablet.
Filing to Dismissed with Prejudice in 778 days
778 days — above the median for ANDA-triggered pharma patent disputes in Delaware
Dismissed with prejudice: what the stipulation means for both parties
Rule 41 dismissal with prejudice: a permanent close
A dismissal with prejudice under Rule 41 of the Federal Rules of Civil Procedure is a final adjudication on the merits for preclusion purposes. Neither Bayer/Janssen nor Taro may file a new action asserting the same claims or defenses arising from US10828310B2 against each other in relation to the 2.5 mg rivaroxaban product. Rule 41(c) extends this finality to counterclaims, eliminating Taro’s invalidity challenge permanently.
Permanent bar on re-litigationBayer & Janssen secure permanent Taro bar
The with-prejudice dismissal is strategically valuable for Bayer and Janssen: Taro cannot re-open its invalidity or non-infringement positions at any future date. Combined with the likelihood of an undisclosed license or entry-date agreement, the plaintiffs appear to have resolved the Taro ANDA threat while preserving the patent’s enforceability against other generic filers. US10828310B2 remains intact and assertable.
Patent survives; Taro challenge extinguishedTaro’s path to market likely governed by private terms
Taro’s counterclaims — typically invalidity and non-infringement in ANDA litigation — are also dismissed with prejudice, meaning its litigation-based route to market is closed. However, the structure of the dismissal (each party bearing own costs, no court judgment) is consistent with Taro having negotiated an authorised generic licence or an agreed commercial entry date. The public record does not confirm this; the actual terms remain confidential.
Likely private market-entry termsRivaroxaban IP remains potent; other ANDA filers on notice
The resolution strengthens the commercial position of Xarelto’s IP estate for the 2.5 mg dose form. Other generic filers holding Paragraph IV certifications against US10828310B2 are unaffected by this dismissal but should note that Bayer and Janssen demonstrated willingness to litigate for over two years before resolving. The patent’s validity was never publicly adjudicated, leaving its enforceability presumptively intact for subsequent ANDA challengers.
Patent presumptively valid; active risk for other genericsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Pharmaceutical patent holders — co-owners of US10828310B2 covering rivaroxaban tabletsSearch in Eureka ↗ |
| Co-Plaintiff | Janssen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Taro Pharmaceutical Industries, Ltd. | Company | Generic pharmaceutical manufacturer seeking ANDA approval for 2.5 mg rivaroxaban tabletsSearch in Eureka ↗ |
| Co-Defendant | Taro Pharmaceuticals U.S.A., 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 | Anne Shea Gaza | Attorney | Counsel for Taro Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Robert M. Vrana | Attorney | Counsel for Taro Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Young Conaway Stargatt & Taylor, LLP | Law Firm | Representing Taro Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation invokes both Rule 41(a)(1) — governing voluntary dismissal of the plaintiff’s claims — and Rule 41(c), which extends the same finality to counterclaims. By specifically designating the dismissal ‘with prejudice’ and encompassing ‘all claims and defenses asserted by Plaintiffs against Taro and all claims and defenses asserted by Taro against Plaintiffs,’ the parties achieved complete bilateral preclusion. Neither party may resurrect any aspect of this dispute. The symmetric cost provision reinforces that no party extracted a litigation victory, consistent with a negotiated commercial resolution.
US10828310B2 — 2.5 mg Rivaroxaban Tablet Formulation Patent
US10828310B2 (application number US16/264032) covers formulations of rivaroxaban at the 2.5 mg dose strength — the lower-dose form of Xarelto indicated for reducing cardiovascular risk in patients with coronary artery disease or peripheral artery disease. Rivaroxaban is a direct Factor Xa inhibitor and one of the most commercially significant oral anticoagulants globally. The patent’s claims likely address specific formulation parameters, excipient compositions, or manufacturing characteristics that define the approved 2.5 mg product and distinguish it from prior-art dosage forms.
For the ANDA filer community, US10828310B2 represents a formulation-layer patent — potentially the type that survives primary compound expiry and continues to block generic entry for the 2.5 mg indication. Bayer and Janssen’s willingness to litigate for over two years before settling suggests confidence in the patent’s defensibility. Any company seeking to develop a generic 2.5 mg rivaroxaban product must conduct detailed claim mapping against this patent’s formulation and method claims, as no court has yet adjudicated its validity or scope.
Should you run an FTO against US10828310B2 for rivaroxaban 2.5 mg?
Any pharmaceutical company, generic manufacturer, or contract development organisation working on a 2.5 mg rivaroxaban oral solid dosage form should treat US10828310B2 as a primary FTO target. The patent survived 778 days of adversarial ANDA litigation without a validity ruling — meaning its claims remain presumptively valid and enforceable. This case does not establish any prior art or claim interpretation on the public record. Teams advancing ANDA filings, 505(b)(2) applications, or international equivalents for this dose strength face active infringement risk.
PatSnap Eureka’s FTO Search Agent enables R&D and regulatory teams to map the claim landscape of US10828310B2 against proposed formulation parameters, identify design-around opportunities, and benchmark against the full rivaroxaban patent family held by Bayer and Janssen. Eureka can also surface related formulation patents and pending applications in the same family that may present additional clearance requirements — critical given that ANDA litigation increasingly involves stacked patent portfolios rather than single-patent disputes.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA Patent Cases: Rivaroxaban & Oral Anticoagulant Formulations
Cases below involve ANDA-triggered patent infringement actions over oral anticoagulant formulations litigated in the District of Delaware, similar in structure to this dispute.
What this case signals for the rivaroxaban and ANDA patent landscape
A 778-day ANDA dispute ending in mutual with-prejudice dismissal carries specific signals for generic pharma IP strategy.
With-prejudice ANDA settlements permanently extinguish generic invalidity bets
When an ANDA defendant accepts a with-prejudice dismissal, it surrenders any future invalidity challenge against the asserted patent for the covered product. Generic companies should weigh this foreclosure carefully before accepting settlement terms, particularly where the patent has broader claim scope that could affect related products or formulations.
Each-party-bears-own-costs clauses are a strong settlement signal
In contested ANDA litigation, fee-shifting is rare absent exceptional-case findings. A symmetric cost-bearing clause in a with-prejudice dismissal suggests the parties resolved via negotiated agreement rather than capitulation — consistent with a confidential licence or entry-date deal. IP teams monitoring competitor ANDA activity should treat such dismissals as soft evidence of authorised generic arrangements.
Bayer v Taro — key questions answered
The plaintiffs asserted US10828310B2 (application US16/264032), a patent covering 2.5 mg rivaroxaban tablet formulations. Rivaroxaban is the active ingredient in Xarelto, a direct Factor Xa inhibitor. The case was filed in the District of Delaware on October 26, 2023 and is characteristically an ANDA-triggered Hatch-Waxman patent infringement action.
The parties filed a joint stipulation under Federal Rules of Civil Procedure 41(a)(1) and 41(c), agreeing to dismiss all claims and counterclaims with prejudice. This is a bilateral, permanent resolution — neither party may re-litigate these claims. The each-party-bears-own-costs provision is consistent with a negotiated settlement, though no licence or entry-date terms are disclosed in the public record.
A with-prejudice dismissal bars Taro from reasserting any invalidity, non-infringement, or other defences against Bayer and Janssen regarding US10828310B2 for the 2.5 mg rivaroxaban product. Taro’s litigation route to market is permanently foreclosed. Any commercial entry by Taro would need to be based on a private licence or entry agreement, the terms of which are not part of the public court record.
No. The with-prejudice dismissal binds only the named parties — Bayer AG, Janssen Pharmaceuticals, Taro Pharmaceutical Industries Ltd., and Taro Pharmaceuticals U.S.A., Inc. Other ANDA filers holding Paragraph IV certifications against US10828310B2 are not affected and remain subject to potential infringement suits. The patent’s validity was never adjudicated, so it remains presumptively valid against all other challengers.
The case lasted 778 days from filing (October 26, 2023) to dismissal (December 12, 2025). This duration is above the median for ANDA patent actions that settle before substantive milestones, suggesting the parties likely engaged in meaningful discovery or claim construction proceedings before reaching resolution. It may indicate that Bayer and Janssen maintained a credible litigation posture throughout, which could inform how other generic defendants assess the strength of the ‘310 patent.
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