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Eisai v. Torrent Pharmaceuticals — Lenvatinib Patent Litigation | PatSnap
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Case ID1:24-cv-07067
FiledJun 2024
ClosedNov 2025
Patent Litigation

Eisai & MSD v. Torrent Pharmaceuticals: Lenvatinib Patent Consent Judgment

Eisai and MSD International Business GmbH brought an ANDA-triggered infringement action against Torrent Pharmaceuticals in New Jersey over lenvatinib mesylate capsules (LENVIMA), asserting three patents. After 514 days, the parties resolved the dispute via a negotiated consent judgment that enjoins Torrent from marketing its generic until the asserted patents expire.

Resolution time
514days
514 days — longer than the median ANDA Hatch-Waxman district court resolution
Patents asserted
3
US10407393B2, US11186547B2, and US7612208B2 — lenvatinib compound and formulation patents
Outcome
Consent Judgment
Resolved by consent judgment; Torrent enjoined, validity acknowledged
Cost ruling
No Costs
All claims dismissed with prejudice; no fees or disbursements awarded to either party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

ANDA battle over cancer drug lenvatinib ends in Eisai’s favour

Filed on 17 June 2024 in the District of New Jersey, this Hatch-Waxman action was brought by Eisai R&D Management Co., Ltd., Eisai Co., Ltd., Eisai Manufacturing Ltd., Eisai Inc., and MSD International Business GmbH against Torrent Pharmaceuticals Ltd. The suit targeted Torrent’s Abbreviated New Drug Application No. 219352 seeking approval to market lenvatinib mesylate capsules (equivalent to 4 mg and 10 mg base), a bioequivalent to Eisai’s oncology product LENVIMA, which is approved for thyroid cancer, hepatocellular carcinoma, and endometrial carcinoma in combination with pembrolizumab.

The case closed on 13 November 2025 through a consent judgment — a negotiated settlement converted into a binding court order. Under its terms, Torrent acknowledged the validity and enforceability of US10,407,393 and US11,186,547 with respect to its ANDA product and any generic equivalent containing lenvatinib referencing NDA No. 206947. Torrent is enjoined from manufacturing, selling, or importing its generic lenvatinib product in the United States prior to expiration of both patents. All claims and counterclaims were dismissed with prejudice, with no costs to either party.

At 514 days from filing to closure, the timeline is consistent with a case that proceeded through early litigation posture before reaching settlement — likely after claim construction signalling or early merits assessment. The public record does not disclose a licensed entry date, leaving the commercial terms of the Settlement Agreement confidential. What is confirmed is that Torrent retains the right to maintain its Paragraph IV certifications, suggesting a potential future authorised entry window exists under undisclosed terms in the private settlement agreement.

Case at a glance
Case no.1:24-cv-07067
PlaintiffEisai
CourtNew Jersey
JudgeN/A
FiledJune 17, 2024
ClosedNovember 13, 2025
Duration514 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 514 days

514 days — longer than the median ANDA Hatch-Waxman district court resolution

Case timeline: Complaint filed JUN 17 2024, MAR — 514 days total Horizontal timeline showing the three key events in Eisai v Torrent Pharmaceuticals, Ltd. from filing to resolution. Source: PACER, New Jersey District Court. JUN 17 2024 Complaint filed Pre-trial proceedings NOV 13 2025 Consent Judgment 514 DAYS TOTAL
Settlement terms

Consent judgment: what Torrent’s validity acknowledgment means for both sides

Legal mechanism

Consent judgment converts settlement into enforceable court order

A consent judgment is more than a settlement — it is a binding judicial decree that the District Court retains jurisdiction to enforce. By stipulating to its entry, Torrent accepted an injunction that carries contempt-of-court consequences for any violation, giving Eisai a stronger enforcement posture than a private settlement agreement alone would provide. The court’s retained jurisdiction clause further strengthens Eisai’s hand if Torrent’s affiliates or successors attempt to commercialise the product.

Judicially enforceable injunction
Patent holder outcome

Torrent’s validity acknowledgment fortifies Eisai’s patent estate

Crucially, Torrent expressly acknowledged that US10,407,393 and US11,186,547 are valid and enforceable and that one or more claims would be infringed by its ANDA product. This admission is on the public record and may be cited in subsequent ANDA litigations against other generic filers. For Eisai and MSD, the outcome preserves the commercial exclusivity of LENVIMA while setting a precedent that discourages straightforward validity challenges from other generic applicants referencing the same NDA.

Validity acknowledged on record
Generic challenger outcome

Torrent enjoined, but Paragraph IV rights preserved for future entry

Torrent is barred from commercialising its ANDA product prior to patent expiry of both asserted patents unless specifically authorised under the private Settlement Agreement. However, the consent judgment explicitly preserves Torrent’s right to maintain its Paragraph IV certifications — a deliberate carve-out that typically signals a negotiated future launch date tied to patent expiry or a confidential licence. The true commercial cost to Torrent depends on the undisclosed entry date in the settlement.

Paragraph IV certifications preserved
Commercial implications

On-record validity raises the bar for lenvatinib generic competition

With Torrent’s admission in the public record, other ANDA filers for lenvatinib face a higher effective burden: any generic entrant challenging US10,407,393 or US11,186,547 must now contend with a prior judicial record of acknowledged validity. This dynamic typically delays the broader generic market entry and extends the commercially valuable exclusivity window for LENVIMA across its oncology indications. Companies monitoring lenvatinib FTO should treat both patents as high-risk barriers until their expiry dates.

Elevated barrier for ANDA challengers
Legal analysis based on PACER docket records for case 1:24-cv-07067 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffEisaiIndividualGlobal oncology pharma group — holder of US10407393, US11186547, and US7612208Search in Eureka ↗
Co-PlaintiffMSD International Business, GmbHCompanySearch in Eureka ↗
Co-PlaintiffEISAI MANUFACTURING LTD.CompanySearch in Eureka ↗
Co-PlaintiffEisai, Inc.CompanySearch in Eureka ↗
Co-PlaintiffEisai Co., Ltd.CompanySearch in Eureka ↗
DefendantTorrent Pharmaceuticals, Ltd.CompanyIndia-based generic pharmaceutical manufacturer seeking ANDA approval for lenvatinibSearch in Eureka ↗
Plaintiff counselJ. BRUGH LOWERAttorneyCounsel for EisaiSearch in Eureka ↗
Plaintiff counselLucas L. KresselAttorneyCounsel for EisaiSearch in Eureka ↗
Plaintiff counselStephen R. DonatAttorneyCounsel for EisaiSearch in Eureka ↗
Plaintiff counselWilliam P. Deni , Jr.AttorneyCounsel for EisaiSearch in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting EisaiSearch in Eureka ↗
Plaintiff law firmPaul Hastings, LLPLaw FirmRepresenting EisaiSearch in Eureka ↗
Defendant counselStuart D. SenderAttorneyCounsel for Torrent Pharmaceuticals, Ltd.Search in Eureka ↗
Defendant law firmWindels Marx Lane & Mittendorf, LLPLaw FirmRepresenting Torrent Pharmaceuticals, Ltd.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiffs Eisai R&D Management Co., Ltd., Eisai Co., Ltd., Eisai Manufacturing Ltd., Eisai Inc. (collectively, “Eisai”), and MSD International Business GmbH (together with Eisai, “Plaintiffs”), and defendant Torrent Pharmaceuticals Ltd. (“Torrent”), together the parties in the above-captioned action, have agreed to terms and conditions representing a negotiated settlement of this action and have set forth those terms and conditions in a Settlement Agreement (“Settlement Agreement”). Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this ___ day of ___________, 2025: ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties. 2. As used in this Consent Judgment, (i) the term “Torrent Product” shall mean the drug products sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 219352 (and defined in greater detail in the Settlement Agreement); (ii) the term “Generic Equivalent” shall mean a drug product containing lenvatinib that is the subject of an ANDA that refers to NDA No. 206947 as the reference-listed drug (and defined in greater detail in the Settlement Agreement), and (iii) the term “Affiliate” shall mean, with respect to a Party, any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (i) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (ii) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the board of directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. 3. Torrent, for itself and its Affiliates, acknowledges and agrees that United States Patent Numbers 10,407,393 and 11,186,547 are valid and enforceable with respect to the Torrent Product and any Generic Equivalent, and one or more claims thereof would be infringed by the manufacture, use, sale, offer to sell, importation or distribution of the Torrent Product in the United States. 4. Except as specifically authorized pursuant to the Settlement Agreement, Torrent, including any of its Affiliates, successors and assigns, is enjoined from making, having made, using, selling, offering to sell, importing or distributing the Torrent Product prior to the expiration of United States Patent Numbers 10,407,393 and 11,186,547. Compliance with this Consent Judgment may be enforced by Plaintiffs and their successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. 6. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. 7. Nothing herein prohibits or is intended to prohibit Torrent from maintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to United States Patent Numbers 10,407,393 and 11,186,547. 8. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.”
Source: PACER Docket, Case 1:24-cv-07067, New Jersey District Court

The consent judgment’s language is strategically weighted toward Eisai: Torrent’s acknowledgment that the two key patents ‘are valid and enforceable’ and that claims ‘would be infringed’ goes beyond a typical no-contest settlement. In Hatch-Waxman practice, such admissions are uncommon and commercially significant — they create a public record that raises the burden for any subsequent ANDA challenger seeking to invalidate the same patents. The Paragraph IV carve-out, however, preserves optionality for Torrent under undisclosed settlement terms.

PACER case 1:24-cv-07067 · Public docket record Explore in Eureka ↗
Patent at issue

US10407393B2 & US11186547B2 — lenvatinib compound and formulation patents

Publication No.US11186547B2
Application No.US17/022675
Patent details
ProductLenvatinib formulation and crystalline form patents
Cited in actionJune 17, 2024

Publication No.US7612208B2
Application No.US10/577531
Patent details
ProductLenvatinib compound chemistry and prior art base patent
Cited in actionJune 17, 2024

Publication No.US10407393B2
Application No.US16/229805
Patent details
ProductLenvatinib mesylate salt and formulation composition patents
Cited in actionJune 17, 2024

US10,407,393B2 and US11,186,547B2 are among the key exclusivity pillars protecting LENVIMA (lenvatinib mesylate), Eisai’s multi-kinase inhibitor approved for differentiated thyroid cancer, hepatocellular carcinoma, and endometrial carcinoma. US7,612,208B2, also asserted, is understood to cover earlier compound chemistry. The patents derive from application filings spanning multiple years, reflecting a layered prosecution strategy designed to extend effective market exclusivity beyond the original compound patent.

In the competitive oncology generics landscape, lenvatinib represents a high-value target: LENVIMA generated significant global revenues for the Eisai-MSD collaboration, making ANDA challenges economically attractive for generic manufacturers. The involvement of MSD International Business GmbH as a co-plaintiff reflects the co-commercialisation arrangement for certain LENVIMA indications. The consent judgment’s validity acknowledgment for the two later-expiring patents now functions as a deterrent signal to other potential ANDA filers contemplating validity challenges.

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Freedom to operate

Should you run an FTO analysis against US10407393 and US11186547?

Any company developing or manufacturing a lenvatinib-containing product, a lenvatinib mesylate formulation, or a multi-kinase inhibitor referencing NDA No. 206947 as the reference-listed drug should treat US10,407,393B2 and US11,186,547B2 as high-priority FTO barriers. The consent judgment’s validity acknowledgment strengthens their enforceability posture. R&D teams working on next-generation tyrosine kinase inhibitors with structural similarity to lenvatinib should also assess claim scope carefully.

PatSnap Eureka’s FTO Search Agent can map the claim landscapes of US10,407,393, US11,186,547, and US7,612,208 against your compound or formulation, identify the patent family members across jurisdictions, and flag related pending applications that may extend the exclusivity window further. Use Eureka to benchmark expiry timelines against known ANDA filing windows and to monitor any new continuation or divisional applications in the lenvatinib family.

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Related litigation

Similar lenvatinib and ANDA oncology patent cases in NJ District Court

Cases involving Hatch-Waxman ANDA challenges to oncology small-molecule patents in the District of New Jersey, particularly lenvatinib and related kinase inhibitor disputes.

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Strategic implications

What this case signals for the oncology ANDA litigation landscape

Consent judgments with validity admissions are among the most powerful tools in an innovator’s ANDA enforcement arsenal.

Validity admissions in consent judgments ripple across pending ANDA disputes

Torrent’s on-record acknowledgment that US10,407,393 and US11,186,547 are valid and infringed creates a persuasive public record. Eisai can reference this consent judgment in any parallel or future ANDA litigation over lenvatinib, increasing the cost and complexity of any validity challenge another generic filer might pursue.

Retained jurisdiction clauses extend Eisai’s enforcement reach post-settlement

The District Court’s explicit retention of jurisdiction to enforce or supervise the consent judgment means Eisai does not need to file a new lawsuit to act against Torrent or its affiliates. This is a meaningful commercial safeguard for a high-revenue oncology product, particularly given the broad affiliate and successor language in the judgment.

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Confidential entry date signalsPatent expiry stack analysisPending ANDA filer exposure
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Frequently asked questions

Eisai v Torrent — key questions answered

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PatSnap Eureka tracks every ANDA filing, Orange Book listing change, and patent family development for the LENVIMA portfolio. Set alerts for US10,407,393 and US11,186,547 to stay ahead of generic entry risk across oncology markets.

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