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AstraZeneca v. Sandoz – Olaparib (LYNPARZA) Patent Consent Judgment | PatSnap
Patent Litigation

AstraZeneca v. Sandoz: Olaparib (LYNPARZA) Patent Consent Judgment — 636 Days

AstraZeneca, Kudos Pharmaceuticals, and MSD International Business GmbH filed a patent infringement action against Sandoz Inc. in New Jersey over generic olaparib tablets (ANDA No. 217936). After 636 days, the parties resolved the dispute through a court-entered consent judgment that enjoins Sandoz from launching its generic product absent authorisation under the Settlement Agreement.

Resolution time
636days
636 days from filing to consent judgment — typical Hatch-Waxman ANDA cases often resolve within this window
Patents asserted
1
US12048695B2 and six further Licensed Patents asserted covering olaparib (LYNPARZA) formulations
Outcome
Consent Judgment
Agreed by parties, entered by court April 2026 — binding, final, with injunction and retained jurisdiction
Cost ruling
No Costs
Dismissed with prejudice; no costs, disbursements, or attorneys' fees awarded to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

AstraZeneca secures consent judgment and injunction against Sandoz over LYNPARZA generics

AstraZeneca AB, AstraZeneca UK Limited, Kudos Pharmaceuticals Limited, and MSD International Business GmbH filed this patent infringement action on 31 July 2024 in the District of New Jersey against Sandoz Inc. The case was consolidated for pretrial purposes under docket 3:23-796 and concerned Sandoz's Abbreviated New Drug Application No. 217936 — its bid to market generic olaparib tablets (100 mg and 150 mg), the active ingredient in AstraZeneca's oncology product LYNPARZA. Seven patents were designated as Licensed Patents in the resulting consent judgment.

The recorded basis of termination is Consent Judgment. The docket order, entered in April 2026, reflects a negotiated Settlement Agreement under which Sandoz and its affiliates are enjoined from making, using, selling, offering to sell, importing, or distributing the Sandoz Product unless specifically authorised under that Settlement Agreement. All claims, counterclaims, and affirmative defenses relating to the Sandoz Product were dismissed with prejudice and without costs to any party. The District Court expressly retained jurisdiction to enforce or supervise performance under the consent judgment.

The case reached resolution 636 days after filing, consistent with the typical pace of Hatch-Waxman ANDA litigation before full trial. The specific commercial terms of the underlying Settlement Agreement — including any authorised launch date or licensing provisions — are not disclosed in the available public record. Notably, the consent judgment resolves the action only as between the AstraZeneca plaintiffs and Sandoz; litigation in the 3:23-796 consolidated matter against Natco Pharma, Cipla, Zydus Pharmaceuticals, and Zydus Lifesciences remains active.

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Case at a glance
DefendantSandoz, Inc.
CourtNew Jersey District Court
JudgeN/A
FiledJuly 31, 2024
ClosedApril 28, 2026
Duration636 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case timeline

Filing to Consent Judgment in 636 days

636 days from filing to consent judgment — typical Hatch-Waxman ANDA cases often resolve within this window

Case timeline: Complaint filed JUL 31 2024 — 636 days total Horizontal timeline showing the three key events in AstraZeneca AB v Sandoz, Inc. from filing to resolution. Source: PACER, New Jersey District Court. JUL 31 2024 Complaint filed Pre-trial proceedings APR 28 2026 Consent Judgment 636 DAYS TOTAL
Patent at issue

US12048695B2 — olaparib formulation patent (LYNPARZA)

Publication No.US12048695B2
Application No.US18/312375
Patent details
ProductOlaparib tablet formulations for oncology — LYNPARZA 100 mg and 150 mg
Cited in actionJuly 31, 2024
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 1 independent)
1. An immediate-release pharmaceutical composition in the form of a tablet comprising: (a) a core composition comprising: a solid dispersion comprising: (i) 100 mg to 200 mg of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluorobenzyl]-2H-phthalazin-1-one (Compound 1); and (ii) at least one polymer chosen from copovidone, povidone, hypromellose phthalate, hypromellose acetate succinate, 2-hydroxypropyl-B-cyclodextrin, hypromellose, polymethacrylates, hydroxypropyl cellulose, and cellulose acetate phthalate; wherein the weight ratio of Compound 1 to the at least one polymer in the core composition is in t…
Technical background
This is a continuation of application Ser. No. 17/483,070, filed Sep. 23, 2021, which is a continuation of application Ser. No. 16/863,074, filed Apr. 30, 2020, which is a continuation of application Ser. No. 16/224,096013,301, filed Dec. 18, 2018, which is a continuation of application Ser. No. 15/707,376, filed Sep. 18, 2017, which is a continuation of application Ser. No. 15/449,353, filed Mar. 3, 2017, which is a continuation of application Ser. No. 14/688,326, filed Apr. 16, 2015, which is a continuation of ap…
Patent family
116 family members across 56 jurisdictions (US, CL, NZ, ME, IL, PH, RS, SG, CY, BR, EP, ZA)
PatSnap Eureka · FTO Search Agent
Should you run an FTO analysis against US12048695B2 and the LYNPARZA patent cluster?

Any company developing or commercialising olaparib tablet formulations — whether as a generic, biosimilar-adjacent product, or combination therapy — should assess freedom to operate against the seven Licensed Patents identified in this consent judgment. The injunction entered here demonstrates that AstraZeneca is actively enforcing this cluster against ANDA filers, and the parallel proceedings against Natco, Cipla, and Zydus confirm continued enforcement posture across multiple generic challengers.

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Official verdict

Official order — verbatim text

AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, AstraZeneca AB, KuDOS Pharmaceuticals Limited, The University of Sheffield, and MSD International Business GmbH (hereinafter collectively "AstraZeneca"), and Sandoz Inc. (hereinafter "Sandoz"), the parties in the above-captioned actions, which have been consolidated for pretrial purposes under docket number 3:23-796 (the "796 Matter"), have agreed to terms and conditions representing a negotiated settlement of these actions and have set forth those terms and conditions in a Settlement Agreement (the "Settlement Agreement"). Now the parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and an injunction in the actions, as follows: 1. day of April, 2026: ORDERED, ADJUDGED AND DECREED as follows: As used in this Consent Judgment, (i) the term "Sandoz Product" shall mean the drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 217936; (ii) the term "Licensed Patents" shall mean United States Patent Numbers 8,475,842, 8,859,562, 11,633,396, 11,975,001, 12,048,695, 12,144,810, and 12,178,816; and (iii) the term "Affiliate" shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Sandoz; for purposes of this definition, "control" means (a) ownership, directly or through one or more intermediaries, of (1) 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 (2) 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. 2. 3. 4. All claims, counterclaims, affirmative defenses and demands in this action Unless otherwise specifically authorized pursuant to the Settlement Agreement, Sandoz, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed Patents, on its own part or through any Affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the Sandoz Product. Compliance with this Consent Judgment may be enforced by AstraZeneca and its successors in interest, or assigns. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment. 5. with respect to the Sandoz Product are hereby dismissed with prejudice and without costs, disbursements or attorneys' fees to any party. Please note that the filing of this Consent Judgment Judgement in the 796 Matter reflects resolution of that action only between Plaintiffs and Sandoz. The matters against Natco Pharma Limited, Cipla Limited, Cipla USA, Inc., Zydus Pharmaceuticals (USA) Inc., and the 79 Matra atpstill actny .. Zydus Lifesciences Ltd, that were consolidated and maintained in the 796 Matter are still active.
Source: PACER Docket, Case 3:24-cv-08164, New Jersey District Court

The consent judgment order defines the Sandoz Product by reference to ANDA No. 217936, enumerates seven Licensed Patents by number, and imposes an injunction on Sandoz and its affiliates pending any authorisation under the Settlement Agreement. The dismissal with prejudice of all claims, counterclaims, and affirmative defenses relating to the Sandoz Product forecloses re-litigation of those issues between these specific parties. The order expressly notes it resolves only the AstraZeneca-Sandoz dispute within the consolidated 3:23-796 docket; proceedings against the remaining defendants are unaffected.

PACER case 3:24-cv-08164 · Public docket record Explore in Eureka ↗
Judgment terms

Consent judgment: what the agreed resolution means for both parties

Legal mechanism

Consent judgment: a binding, court-entered resolution

A consent judgment is not merely a settlement agreement between parties — it is a court-entered judgment that carries the full force and effect of a judicial order. Here, the New Jersey District Court entered the judgment and expressly retained jurisdiction to enforce or supervise compliance. This means AstraZeneca can return to court to enforce the injunction without filing a new action.

Court-entered and enforceable
Patent holder outcome

AstraZeneca secures injunction protecting seven olaparib patents

The consent judgment enjoins Sandoz from commercialising its ANDA product (No. 217936) without authorisation under the Settlement Agreement. All seven Licensed Patents — including US12048695B2 and six others — are effectively shielded from Sandoz's challenge. The dismissal with prejudice forecloses Sandoz from re-litigating its invalidity or non-infringement counterclaims regarding the Sandoz Product in this proceeding.

Injunction secured; patents protected
Defendant outcome

Sandoz blocked from launch absent Settlement Agreement authorisation

Sandoz Inc. and its affiliates, successors, and assigns are enjoined from making, using, selling, offering to sell, importing, or distributing the generic olaparib product absent specific authorisation under the Settlement Agreement. All of Sandoz's counterclaims and affirmative defenses regarding the Sandoz Product were dismissed with prejudice. The specific terms of any authorised entry date or licensing arrangement are not disclosed in the available public record.

Generic launch restricted
Commercial implications

Olaparib patent protection reinforced; other generic challengers remain active

The consent judgment strengthens AstraZeneca's near-term exclusivity position for LYNPARZA against Sandoz's ANDA. However, the 3:23-796 consolidated matter against Natco Pharma, Cipla, Cipla USA, Zydus Pharmaceuticals, and Zydus Lifesciences remains active — meaning olaparib's patent position continues to be litigated and the broader generic entry timeline is unresolved. Stakeholders tracking LYNPARZA market exclusivity should monitor those parallel proceedings.

Parallel ANDA litigation ongoing
Legal analysis based on PACER docket records for case 3:24-cv-08164 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAstraZeneca ABIndividual/Search in Eureka ↗
Co-PlaintiffMSD International Business, GmbHCompanySearch in Eureka ↗
Co-PlaintiffKudos Pharmaceuticals LimitedCompanySearch in Eureka ↗
Co-PlaintiffAstraZeneca ABIndividualSearch in Eureka ↗
Co-PlaintiffAstraZeneca UK LimitedIndividualSearch in Eureka ↗
DefendantSandoz, Inc.Company/Search in Eureka ↗
Plaintiff counselCharles H. ChevalierAttorneyCounsel for AstraZeneca ABSearch in Eureka ↗
Plaintiff law firmFBT GIBBONS LLPLaw FirmRepresenting AstraZeneca ABSearch in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
R&D signals

R&D signals in the olaparib and PARP inhibitor patent space

Forward-looking patent intelligence on AstraZeneca's olaparib lifecycle strategy, PARP inhibitor filing trends, Sandoz's generics IP posture, and white-space opportunities near the LYNPARZA patent cluster.

Patent portfolio

AstraZeneca's olaparib lifecycle patent filing activity

AstraZeneca and Kudos Pharmaceuticals have pursued a multi-patent lifecycle strategy for olaparib, with the seven Licensed Patents in this case spanning what appear to be formulation, composition, and method claims. Tracking AstraZeneca's continuation and continuation-in-part filings in the olaparib family can reveal the remaining exclusivity runway and potential new claim landscapes that generic developers must navigate.

Olaparib lifecycle filings
Technology landscape

PARP inhibitor patent filing trends across oncology developers

The PARP inhibitor class — including olaparib, niraparib, rucaparib, and talazoparib — has generated significant patent filing activity across formulation, combination therapy, and indication-specific claims. Monitoring filing trends across this class can identify convergent claim strategies and signal where the next wave of ANDA litigation is likely to emerge.

PARP inhibitor filing trends
Competitor IP posture

Sandoz's patent portfolio in oncology generics and small-molecule APIs

Sandoz, as a leading generics developer, files patents on formulation processes, crystalline forms, and manufacturing methods that can influence ANDA strategy and freedom-to-operate for its own product pipeline. Reviewing Sandoz's IP filings in the oncology API and tablet formulation space provides context for how it may approach future ANDA challenges against branded oncology assets.

Sandoz generics IP
White space

Design-around and adjacent claim space near the LYNPARZA patent cluster

With seven patents covering the olaparib product space, white-space analysis near the Licensed Patents — particularly around novel dosage forms, combination formulations, or modified-release delivery — may reveal claim space that is not yet dominated by AstraZeneca's filings. This is especially relevant for developers working on olaparib combination therapies or next-generation PARP inhibitor formulations.

Olaparib formulation white space
Related litigation

Similar ANDA patent cases involving olaparib and PARP inhibitor patents in New Jersey

Explore Hatch-Waxman patent infringement cases in the District of New Jersey involving olaparib, PARP inhibitors, and oncology ANDA challenges with comparable outcomes.

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AstraZeneca AB patent enforcement history, New Jersey District Court case history, AstraZeneca AB's full IP portfolio, and comparable case analysis
Other LYNPARZA ANDA casesPARP inhibitor NJ litigationAstraZeneca consent judgmentsOncology ANDA injunctions
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Strategic implications

What this case signals for the olaparib and PARP inhibitor IP landscape

AstraZeneca's consent judgment with Sandoz reinforces its LYNPARZA exclusivity strategy — but live proceedings against four other generic filers keep the competitive landscape fluid.

Seven-patent Licensed Patents list signals a layered exclusivity strategy for olaparib

Designating seven patents as Licensed Patents in the consent judgment — spanning at least formulation and composition claims — reflects a multi-layer exclusivity approach typical of blockbuster oncology assets. Competitors seeking to challenge LYNPARZA's generic entry timeline must navigate this entire cluster, not just a single patent.

Retained jurisdiction clause is a meaningful enforcement tool for AstraZeneca

The District Court's express retention of jurisdiction to enforce or supervise the consent judgment gives AstraZeneca a direct procedural path to seek contempt or injunctive relief if Sandoz or its affiliates deviate from the agreed terms — without initiating fresh litigation. This is a commercially significant enforcement lever in ANDA settlement structures.

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Unlock deeper olaparib IP strategy analysis from this New Jersey District Court ANDA case — including portfolio and competitive entry signals.
Generic entry timeline signalsPARP inhibitor patent clustersRemaining ANDA defendant risk
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Frequently asked questions

AB v Sandoz — key questions answered

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PatSnap Eureka

Track olaparib patent enforcement and ANDA litigation with PatSnap Eureka

The AstraZeneca-Sandoz consent judgment is one chapter in a broader olaparib patent dispute with four defendants still active. Use PatSnap Eureka to monitor the remaining ANDA proceedings, map the seven Licensed Patents, and run FTO analysis for your oncology pipeline.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.

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