Bayer & Janssen v. Lupin: Rivaroxaban Patent Dispute Dismissed With Prejudice
Bayer AG and Janssen Pharmaceuticals brought a patent infringement action against Lupin Limited over 2.5 mg rivaroxaban tablets in the District of Delaware. After 686 days of litigation, both sides stipulated to dismiss all claims and counterclaims with prejudice, each bearing their own attorneys’ fees — a resolution that closes the door on re-litigation.
Stipulated dismissal ends Xarelto ANDA battle in Delaware
On 2 February 2024, Bayer AG and Janssen Pharmaceuticals, Inc. filed suit in the District of Delaware against Lupin Limited and Lupin Pharmaceuticals, Inc., asserting infringement of US10828310B2 — a patent covering rivaroxaban tablet formulations. The action arose from Lupin’s ANDA filing seeking approval for 2.5 mg rivaroxaban tablets, a dosage form of the blockbuster anticoagulant marketed as Xarelto. The case was assigned to Judge Richard G. Andrews, a seasoned Delaware jurist with extensive Hatch-Waxman experience.
The litigation concluded on 19 December 2025, when both parties filed a joint stipulation of dismissal under Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure. All claims and counterclaims — including Lupin’s invalidity and non-infringement defenses — were dismissed with prejudice. Critically, each party agreed to bear its own costs and attorneys’ fees, meaning no financial judgment was entered in favour of either side.
The 686-day duration is consistent with ANDA litigation that reaches a negotiated resolution, potentially including a patent licence, an agreed entry date, or a commercial settlement — though the public record is silent on any such terms. The mutual with-prejudice dismissal forecloses re-litigation of these specific claims, which typically signals a durable commercial arrangement rather than a pure litigation capitulation. What drove the resolution remains undisclosed.
Filing to Dismissed with Prejudice in 686 days
686 days — longer than median Hatch-Waxman first-instance resolution, suggesting substantive negotiation
Dismissed with prejudice: what the stipulation means for both parties
Rule 41 dismissal with prejudice — the door is permanently closed
A dismissal with prejudice under Rule 41 of the Federal Rules of Civil Procedure operates as a final adjudication on the merits. Neither Bayer/Janssen nor Lupin may re-file these specific claims in any US federal court. Rule 41(c) extends the same effect to counterclaims, meaning Lupin’s invalidity and non-infringement defenses are also extinguished. The joint stipulation suggests both sides reached a mutually acceptable resolution.
Permanent bar on re-litigationWith prejudice vs. without prejudice: a critical commercial difference
Unlike a dismissal without prejudice — which preserves the right to refile — a with-prejudice dismissal is permanent. Here, Bayer and Janssen cannot reassert US10828310B2 against Lupin for the same accused 2.5 mg rivaroxaban tablets, and Lupin cannot revive its invalidity counterclaims. This mutual finality typically reflects an underlying commercial deal, though the public record discloses no licence terms, entry date, or settlement amount.
No refiling permittedBayer and Janssen retain patent, but Lupin’s path remains uncertain
Bayer and Janssen secured a dismissal that prevents Lupin from continuing invalidity challenges through this case. US10828310B2 remains in force. However, the with-prejudice nature also binds the plaintiffs — they cannot use this patent to re-challenge Lupin on the same product. Any commercial arrangement that shaped this outcome, such as an agreed launch date, would define the real-world IP boundary going forward.
Patent survives, terms undisclosedLupin exits litigation — generic entry timeline remains a commercial question
Lupin’s ANDA for 2.5 mg rivaroxaban tablets remains an active regulatory matter separate from this litigation. The dismissal removes the 30-month stay trigger concern from this case but does not itself grant market access. If no entry-date agreement was reached, Lupin’s commercial launch depends on FDA approval timing and whether any other patent barriers remain. The cost-neutral outcome suggests neither party viewed continued litigation as the optimal path.
ANDA status separate from dismissalFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bayer AG | Company | Pharmaceutical innovators and co-holders of US10828310B2 covering rivaroxabanSearch in Eureka ↗ |
| Co-Plaintiff | Janssen Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Lupin Limited | Individual | Indian generic pharmaceutical manufacturer and its US subsidiary seeking ANDA approval for 2.5 mg rivaroxaban tabletsSearch in Eureka ↗ |
| Co-Defendant | Lupin Pharmaceuticals, 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 | John C. Phillips , Jr. | Attorney | Counsel for Lupin LimitedSearch in Eureka ↗ |
| Defendant counsel | Megan C. Haney | Attorney | Counsel for Lupin LimitedSearch in Eureka ↗ |
| Defendant law firm | Phillips, McLaughlin & Hall PA | Law Firm | Representing Lupin LimitedSearch in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation is drafted to achieve maximum finality: by invoking both Rule 41(a)(1) and Rule 41(c), the parties ensured that not only the plaintiffs’ infringement claims but also all counterclaims — including Lupin’s invalidity and non-infringement defenses — are permanently extinguished. The ‘all parties bear their own costs’ clause is a standard hallmark of commercial settlements, and its inclusion here suggests the economic resolution lies in undisclosed deal terms rather than in the court record itself.
US10828310B2 — rivaroxaban 2.5 mg tablet formulation patent
US10828310B2 is a US utility patent protecting formulation technology related to rivaroxaban, the active ingredient in Xarelto — a Factor Xa inhibitor widely prescribed for stroke prevention and venous thromboembolism. The 2.5 mg dosage form is specifically indicated for cardiovascular risk reduction in patients with coronary artery disease or peripheral artery disease, a distinct indication from the higher-dose anticoagulation regimens. The underlying application number US16/264032 places the filing in the post-AIA era, subject to inter partes review eligibility.
For Bayer and Janssen, this patent represents a downstream formulation asset protecting a commercially significant low-dose Xarelto indication — one that faces growing generic competition pressure as the broader rivaroxaban patent estate matures. A valid and enforceable US10828310B2 creates a meaningful barrier to generic entry for the 2.5 mg market segment. Any ANDA filer targeting this product must independently assess both invalidity and design-around options before committing to a regulatory strategy.
Should your team run an FTO against US10828310B2?
Any pharmaceutical company developing or advancing an ANDA for rivaroxaban 2.5 mg tablets should treat US10828310B2 as an active enforcement risk. This case confirms that Bayer and Janssen are willing to litigate this patent aggressively — the dismissal with prejudice does not signal patent weakness, only that a resolution with Lupin specifically was reached. Other ANDA filers are fully exposed to the same infringement allegations.
PatSnap Eureka’s FTO Search Agent enables R&D and regulatory teams to map the full rivaroxaban formulation patent landscape — including continuation applications, related Bayer and Janssen filings, and expiry timelines — in a fraction of the time required for manual prosecution history analysis. Use Eureka to identify design-around opportunities and generate a defensible FTO position before your ANDA submission.
Run a freedom-to-operate analysis on US10828310B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman rivaroxaban patent cases in Delaware
Explore comparable ANDA infringement actions involving rivaroxaban formulation patents litigated in the District of Delaware before Judge Andrews and other Delaware jurists.
What this case signals for the Hatch-Waxman anticoagulant IP landscape
Stipulated with-prejudice dismissals in ANDA cases often reflect undisclosed commercial settlements — and signal broader portfolio dynamics worth monitoring.
With-prejudice ANDA dismissals often mask commercial entry agreements
When both parties in Hatch-Waxman litigation agree to dismiss with prejudice and bear their own costs, market practice suggests a negotiated resolution — frequently an agreed generic entry date or licence. Competitors and payers should monitor Lupin’s ANDA status and any future Xarelto generic launch announcements as a proxy for undisclosed deal terms.
US10828310B2 remains enforceable against other ANDA filers
This dismissal binds only Bayer/Janssen and Lupin. US10828310B2 is unaffected for purposes of enforcement against any other generic manufacturer that files an ANDA for rivaroxaban 2.5 mg tablets. Companies in the generic anticoagulant pipeline should treat this patent as live and conduct independent FTO analysis before advancing an ANDA.
Bayer v Lupin — key questions answered
A dismissal with prejudice permanently bars both parties from re-litigating the same claims. Bayer and Janssen cannot reassert US10828310B2 against Lupin for the 2.5 mg rivaroxaban tablets, and Lupin cannot revive its invalidity counterclaims. However, the patent remains enforceable against all other parties.
The plaintiffs asserted US10828310B2, a patent covering rivaroxaban tablet formulations. The case arose from Lupin’s ANDA filing for 2.5 mg rivaroxaban tablets — the low-dose form of Xarelto used for cardiovascular risk reduction. Application number US16/264032 underlies the granted patent.
The public record does not disclose the reason. In Hatch-Waxman practice, a mutual with-prejudice dismissal with each party bearing its own costs is consistent with a negotiated commercial resolution — potentially including an agreed generic entry date or licence — though no such terms are publicly confirmed.
The court dismissal and FDA approval are separate proceedings. The dismissal removes this specific patent litigation barrier, but Lupin’s commercial launch of generic rivaroxaban 2.5 mg tablets still depends on FDA approval and the absence of other unresolved patent obstacles. No launch date is confirmed in the court record.
Yes. The dismissal with prejudice does not adjudicate patent validity. Because Lupin’s invalidity counterclaims were also dismissed with prejudice by stipulation — not decided on the merits — US10828310B2 remains fully valid and enforceable against other ANDA filers and potential infringers.
PatSnap Eureka searches patents and litigation data to answer instantly.