Bayer & Janssen v. Dr. Reddy’s: XARELTO® Patent Dismissed With Prejudice
Bayer AG and Janssen Pharmaceuticals brought a patent infringement action in Delaware against Dr. Reddy’s Laboratories over US10828310B2, protecting the 2.5 mg dose of XARELTO® (rivaroxaban). After 985 days of litigation, all claims were dismissed with prejudice by joint stipulation — with each party bearing its own costs.
XARELTO® ANDA battle ends by mutual stipulation in Delaware
On 13 April 2023, Bayer AG and Janssen Pharmaceuticals, Inc. filed a patent infringement action in the United States District Court for the District of Delaware (Case No. 1:23-cv-00410) against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. The suit asserted US10828310B2, a patent covering the 2.5 mg formulation of XARELTO® (rivaroxaban), a blockbuster Factor Xa inhibitor used in cardiovascular indications. The case was assigned to Judge Richard G. Andrews.
After 985 days of litigation, the parties filed a joint stipulation of dismissal on 23 December 2025 pursuant to Federal Rules of Civil Procedure 41(a)(1) and 41(c). All claims asserted by plaintiffs against Dr. Reddy’s and all counterclaims and defenses asserted by Dr. Reddy’s against plaintiffs were dismissed with prejudice. The parties agreed to bear their own costs, disbursements, and attorneys’ fees, with no prevailing-party fee award.
The nearly three-year duration before a stipulated dismissal with prejudice is consistent with ANDA litigation resolved after substantive engagement — potentially following settlement negotiations, licensing discussions, or agreed entry terms. The public record does not disclose any consent judgment, license agreement, or launch terms, which is typical for commercially sensitive ANDA resolutions. The with-prejudice designation means Dr. Reddy’s cannot refile on the same claims, and Bayer and Janssen have permanently waived any further infringement action under this case.
Filing to Dismissed with Prejudice in 985 days
985 days — nearly 2.7 years of active ANDA litigation before resolution
Dismissed with prejudice: what the stipulation means for both parties
Rules 41(a)(1) and 41(c) — bilateral stipulated dismissal
Under FRCP 41(a)(1), parties may dismiss an action by filing a signed stipulation. Rule 41(c) extends this to counterclaims. Here, both plaintiffs’ infringement claims and Dr. Reddy’s counterclaims and defenses were dismissed simultaneously — an unusually comprehensive bilateral wipeout suggesting a negotiated resolution rather than a unilateral concession.
Bilateral — all claims extinguishedFinality bars any re-filing on the same patent and product
A dismissal with prejudice operates as a final adjudication on the merits, meaning Bayer and Janssen cannot reassert US10828310B2 against Dr. Reddy’s for the 2.5 mg XARELTO® product in a future action. Conversely, Dr. Reddy’s loses its counterclaims — typically invalidity and non-infringement declarations — permanently. Neither party retains any live claim from this litigation.
Final — no re-filing permittedPatent survives unchallenged — no invalidity ruling on US10828310B2
Because no court ruled on validity or infringement, US10828310B2 remains presumptively valid and enforceable. Bayer and Janssen retain the right to assert it against other ANDA filers for the 2.5 mg rivaroxaban product. The dismissal also suggests the parties may have reached commercial accommodation — potentially a licensed or agreed entry date — though this is not confirmed in the public record.
Patent intact — enforceable against othersDr. Reddy’s path to market depends on undisclosed terms
Dr. Reddy’s voluntarily dismissed all its invalidity and non-infringement counterclaims, foregoing a potentially precedent-setting ruling. This is consistent with an agreed market entry date or a license. Without public disclosure, it is unclear whether Dr. Reddy’s secured a launch right or agreed to stay out of market until patent expiry. Other generic filers for rivaroxaban 2.5 mg should note this precedent carefully.
Entry terms undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Pharmaceutical innovator and XARELTO® co-rights holder — holder of US10828310B2Search in Eureka ↗ |
| Co-Plaintiff | Janssen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Dr. Reddy’s Laboratories, Ltd. | Company | Indian generic pharmaceutical manufacturer seeking ANDA approval for rivaroxaban 2.5 mgSearch in Eureka ↗ |
| Co-Defendant | Dr. Reddy’s Laboratories, 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 | Daniel Taylor | Attorney | Counsel for Dr. Reddy’s Laboratories, Ltd.Search in Eureka ↗ |
| Defendant counsel | Kiersten A. Fowler | Attorney | Counsel for Dr. Reddy’s Laboratories, Ltd.Search in Eureka ↗ |
| Defendant counsel | Neal C. Belgam | Attorney | Counsel for Dr. Reddy’s Laboratories, Ltd.Search in Eureka ↗ |
| Defendant law firm | Smith, Katzenstein & Jenkins LLP | Law Firm | Representing Dr. Reddy’s Laboratories, Ltd.Search in Eureka ↗ |
| Defendant law firm | Smith, Katzenstein, & Jenkins LLP | Law Firm | Representing Dr. Reddy’s Laboratories, 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) and Rule 41(c), confirming that the dismissal is bilateral and comprehensive — extinguishing not only the plaintiffs’ infringement claims but also all counterclaims and affirmative defenses raised by Dr. Reddy’s. The with-prejudice designation forecloses any re-litigation of these specific claims between these parties. Critically, no court issued any ruling on patent validity, claim construction, or infringement, leaving US10828310B2 judicially untested and fully presumptively valid for enforcement against third parties.
US10828310B2 — Rivaroxaban 2.5 mg cardiovascular formulation (XARELTO®)
US10828310B2 (application no. US16/264032) covers the 2.5 mg dose formulation of rivaroxaban, the active compound in XARELTO® — a direct oral anticoagulant (DOAC) in the Factor Xa inhibitor class. The 2.5 mg dose is approved for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease, a distinct and commercially significant indication from the higher-dose anticoagulation uses. The patent reflects the innovator strategy of extending exclusivity to specific dose-indication combinations.
XARELTO® is one of the highest-revenue branded pharmaceuticals globally, making the 2.5 mg formulation patent a high-value enforcement asset. Generic entry into this dose strength represents a material revenue threat, explaining Bayer and Janssen’s willingness to litigate for nearly three years. Any company developing a generic rivaroxaban product — including 2.5 mg — must assess US10828310B2 as a primary clearance obstacle. The absence of any invalidity ruling means the patent’s claims remain at maximum strength for future enforcement.
Should you run an FTO analysis against US10828310B2?
Any R&D team or generic manufacturer developing a rivaroxaban 2.5 mg product, or any cardiovascular DOAC formulation in the Factor Xa inhibitor class, should treat US10828310B2 as an active FTO risk. Because no court has narrowed, invalidated, or construed the claims, the patent’s full scope remains intact. This case demonstrates that Bayer and Janssen will actively enforce this asset — and the with-prejudice resolution suggests they negotiated from a position of strength.
PatSnap Eureka’s FTO Search Agent can map the independent and dependent claims of US10828310B2 against your product specification, identify prior art that survived without judicial testing in this case, and flag related continuation and divisional filings in Bayer’s rivaroxaban portfolio. This allows your team to scope design-around options and assess ANDA paragraph IV certification risk before committing to a development programme.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent cases involving branded cardiovascular DOACs in Delaware
Explore related ANDA infringement actions over rivaroxaban and Factor Xa inhibitor patents litigated in the Delaware District Court.
What this case signals for the ANDA and branded pharma IP landscape
Bilateral with-prejudice dismissals in ANDA cases almost always signal commercial resolution. Here is what that means for patent holders and generic challengers.
With-prejudice ANDA dismissals typically signal a licensing deal or agreed entry
When both sides dismiss all claims with prejudice and bear their own costs, the litigation infrastructure has almost certainly served its commercial purpose. In the ANDA context, this pattern consistently precedes an undisclosed settlement fixing a market entry date or a royalty-bearing license. IP professionals should monitor Dr. Reddy’s NDA/ANDA docket for any subsequent launch activity.
US10828310B2 remains a live enforcement asset against other ANDA filers
No court ruled on the validity or scope of US10828310B2. Bayer and Janssen retain full enforcement rights against any other generic manufacturer filing an ANDA for rivaroxaban 2.5 mg. Companies with pending or planned ANDA filings for this product should treat this patent as fully enforceable and budget for potential litigation.
Bayer v Dr. — key questions answered
The case was dismissed with prejudice by joint stipulation on 23 December 2025, after 985 days of litigation. Both parties agreed to dismiss all claims and counterclaims under FRCP Rules 41(a)(1) and 41(c), with each side bearing its own costs and attorneys’ fees.
The plaintiffs asserted US10828310B2 (application number US16/264032), covering the 2.5 mg formulation of rivaroxaban marketed as XARELTO®, used to reduce the risk of major cardiovascular events in patients with coronary artery disease or peripheral artery disease.
Dismissal with prejudice means Dr. Reddy’s has permanently waived its invalidity and non-infringement counterclaims against US10828310B2 in this litigation. The public record does not confirm whether Dr. Reddy’s secured a licensed market entry date or agreed to stay off-market until patent expiry — those terms, if any, remain undisclosed.
No. Because the case was dismissed before any court ruled on claim construction, validity, or infringement, US10828310B2 remains presumptively valid and fully enforceable. Bayer and Janssen retain the right to assert this patent against any other ANDA filer for the 2.5 mg rivaroxaban product.
The case was filed in the United States District Court for the District of Delaware and assigned to Judge Richard G. Andrews. Delaware is a preferred forum for ANDA pharmaceutical patent litigation due to its established patent jurisprudence and experienced judiciary.
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