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AstraZeneca v. Sandoz: LOKELMA Patent Settlement | PatSnap
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Case ID1:22-cv-01101
FiledAug 2022
ClosedSep 2024
Patent Litigation

AstraZeneca & ZS Pharma v. Sandoz: LOKELMA Patent Consent Judgment

ZS Pharma and AstraZeneca sued Sandoz in Delaware over 14 patents protecting LOKELMA (sodium zirconium cyclosilicate), a potassium-lowering drug for hyperkalemia. After 758 days of litigation, the parties reached a confidential settlement resulting in a consent judgment that enjoins Sandoz from commercializing its ANDA product without authorization.

Resolution time
758days
758 days — above the median for ANDA patent cases in Delaware District Court
Patents asserted
13
US8802152B2 and 13 further patents asserted covering sodium zirconium cyclosilicate compositions and formulations
Outcome
Consent Judgment
Consent judgment entered with injunction; all claims dismissed with prejudice, no costs awarded
Cost ruling
No Costs
Parties agreed no costs, disbursements, or attorneys’ fees awarded to either side
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

14-patent LOKELMA portfolio defended in Delaware ANDA consent judgment

ZS Pharma, Inc. and AstraZeneca Pharmaceuticals LP filed suit on 22 August 2022 in the District of Delaware against Sandoz, Inc., asserting infringement of 14 US patents directed to sodium zirconium cyclosilicate (SZC) compositions and methods — the active ingredient in LOKELMA, AstraZeneca’s FDA-approved treatment for hyperkalemia available as 5 g and 10 g oral suspension packets. The trigger was Sandoz’s filing of Abbreviated New Drug Application No. 217405, a standard Paragraph IV ANDA challenge.

The action closed on 18 September 2024 via a consent judgment and confidential settlement agreement. Under the consent judgment, Sandoz and its affiliates are permanently enjoined from making, using, selling, offering to sell, or importing the Sandoz ANDA product unless specifically authorized under the confidential settlement terms. All claims and counterclaims were dismissed with prejudice, with no costs or fees awarded to any party, suggesting a negotiated licensing arrangement or delayed entry date is embedded in the confidential terms.

At 758 days, the case ran longer than many ANDA settlements, suggesting substantive negotiation over entry date and licensing scope rather than an early capitulation by either side. The confidential nature of the settlement agreement means the precise authorized-launch timeline for Sandoz — if any — remains unknown from the public record. What is clear is that AstraZeneca secured an injunction preserving LOKELMA’s market position through at least the settlement’s effective date.

Case at a glance
Case no.1:22-cv-01101
DefendantSandoz, Inc.
CourtDelaware
JudgeJennifer L. Hall
FiledAugust 22, 2022
ClosedSeptember 18, 2024
Duration758 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 758 days

758 days — above the median for ANDA patent cases in Delaware District Court

Case timeline: Complaint filed AUG 22 2022, SEP–OCT — 758 days total Horizontal timeline showing the three key events in ZS Pharma, Inc. v Sandoz, Inc. from filing to resolution. Source: PACER, Delaware District Court. AUG 22 2022 Complaint filed Pre-trial proceedings SEP 18 2024 Consent Judgment 758 DAYS TOTAL
Settlement terms

Consent judgment and injunction: what the settlement means for both parties

Legal mechanism

Consent judgment locks in injunction by court order

A consent judgment differs from a pure settlement: the court formally enters an order, making the injunction enforceable as a court decree rather than merely a contractual promise. Sandoz and its affiliates are now bound by a court-ordered injunction prohibiting commercialisation of ANDA No. 217405 products except as permitted under the confidential settlement. AstraZeneca retains standing to enforce directly through contempt proceedings.

Court-ordered injunction in force
Patent holder outcome

AstraZeneca secures injunctive protection across all 14 patents

By obtaining a consent judgment rather than litigating to verdict, AstraZeneca avoids the risk of any patent being invalidated or found non-infringed. All 14 licensed patents emerge from the litigation without a single adverse merits ruling. The dismissal with prejudice bars Sandoz from re-filing the same infringement claims, and the court retains jurisdiction to supervise compliance — a meaningful enforcement lever for AstraZeneca going forward.

All 14 patents uncontested on merits
Challenger outcome

Sandoz avoids invalidity risk but accepts launch constraints

Sandoz did not obtain a court ruling invalidating or narrowing any of the 14 asserted patents, which would have benefited the broader generic industry. The confidential settlement likely contains a licensed entry date that determines when Sandoz may commercially launch — a common resolution in ANDA litigation. The dismissal with prejudice means Sandoz cannot reopen this specific challenge, though IPR or other post-grant proceedings would remain theoretically available.

Launch timing governed by confidential terms
Commercial implications

LOKELMA exclusivity reinforced; sector watches for entry date signals

With 14 patents spanning compositions, formulations, and methods of use, AstraZeneca’s SZC portfolio presents a layered exclusivity stack that proved resilient under challenge. Other ANDA filers seeking to launch competing SZC products face the same 14-patent barrier without the benefit of any invalidity ruling from this case. The hyperkalemia treatment market, which LOKELMA leads, remains protected pending any authorised generic entry under the confidential agreement.

14-patent barrier remains intact
Legal analysis based on PACER docket records for case 1:22-cv-01101 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffZS Pharma, Inc.CompanyPharmaceutical innovator — co-holder of 14 SZC patents covering LOKELMASearch in Eureka ↗
Co-PlaintiffAstrazeneca Pharmaceuticals, LPCompanySearch in Eureka ↗
DefendantSandoz, Inc.CompanyGeneric pharmaceutical company pursuing ANDA No. 217405 for sodium zirconium cyclosilicateSearch in Eureka ↗
Plaintiff counselAlexandra M. JoyceAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselDaniel M. SilverAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselDaniel O’boyleAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselGyuhyun (joanne) BaeAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselHassen SayeedAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselJames Yi LiAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff counselMark A. HaydenAttorneyCounsel for ZS Pharma, Inc.Search in Eureka ↗
Plaintiff law firmMcCarter & English LLPLaw FirmRepresenting ZS Pharma, Inc.Search in Eureka ↗
Defendant counselAlison M. KingAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselAshley GrahamAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselChang HahnAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselCharles B. KleinAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselClaire A. FundakowskiAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselDavid A. BilsonAttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant counselJohn C. Phillips , Jr.AttorneyCounsel for Sandoz, Inc.Search in Eureka ↗
Defendant law firmPhillips, McLaughlin & Hall PALaw FirmRepresenting Sandoz, Inc.Search in Eureka ↗
Presiding judgeJudge Jennifer L. HallJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“ZS Pharma, Inc. and AstraZeneca Pharmaceuticals LP (hereinafter collectively “AstraZeneca”), and Sandoz Inc. (hereinafter “Sandoz”), parties in the above-captioned action, have agreed to terms and conditions representing a negotiated settlement of the action and have set forth those terms and conditions in a confidential 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 action, as follows: IT IS this day of __________________, 2024: ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above actions and has personal jurisdiction over the parties. 2. 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. 217405 (and defined in greater detail in the Settlement Agreement); (ii) the term “Licensed Patents” shall mean United States Patent Numbers 8,802,152; 8,808,750; 8,877,255; 9,592,253; 9,844,567; 9,861,658; 9,913,860; 10,300,087; 10,335,432; 10,398,730; 10,413,569; 10,695,365; 11,406,662; and 11,738,044; and (iii) the term “Affiliate” shall mean any entity or 18th September Case 1:22-cv-01101-JLH Document 85-1 Filed 09/18/24 Page 1 of 3 PageID #: 3216 2 ME1 50018436v.1 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. 3. 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, or importing of the Sandoz Product. 4. Compliance with this Consent Judgment may be enforced by AstraZeneca and its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. 5. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. 6. 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 1:22-cv-01101, Delaware District Court

The consent judgment is notable for its dual function: it simultaneously records the parties’ negotiated resolution and constitutes a binding court order. The injunction’s scope covers Sandoz, all affiliates, successors, and assigns — unusually broad language that forecloses indirect commercialisation routes. Critically, paragraph 6 dismisses all claims and counterclaims with prejudice, meaning Sandoz’s invalidity and non-infringement defences are extinguished. No merits adjudication occurred, so the 14 licensed patents carry no litigation-tested validity status from this proceeding.

PACER case 1:22-cv-01101 · Public docket record Explore in Eureka ↗
Patent at issue

US8802152B2 and 13 further patents — sodium zirconium cyclosilicate (LOKELMA)

Publication No.US10398730B2
Application No.US14/826011
Patent details
ProductSodium zirconium cyclosilicate compositions for potassium removal
Cited in actionAugust 22, 2022

Publication No.US11406662B2
Application No.US16/850468
Patent details
ProductSodium zirconium cyclosilicate formulations and therapeutic methods
Cited in actionAugust 22, 2022

Publication No.US9592253B1
Application No.US14/883428
Patent details
ProductZirconium silicate compositions for treating hyperkalemia
Cited in actionAugust 22, 2022

Publication No.US10335432B2
Application No.US15/254688
Patent details
ProductOral sodium zirconium cyclosilicate suspension formulations
Cited in actionAugust 22, 2022

Publication No.US9861658B2
Application No.US14/826038
Patent details
ProductSodium zirconium cyclosilicate methods of use in hyperkalemia
Cited in actionAugust 22, 2022

Publication No.US10300087B2
Application No.US15/421132
Patent details
ProductZirconium cyclosilicate pharmaceutical dosage compositions
Cited in actionAugust 22, 2022

Publication No.US10413569B2
Application No.US14/692287
Patent details
ProductSodium zirconium cyclosilicate preparation and administration methods
Cited in actionAugust 22, 2022

Publication No.US8877255B2
Application No.US14/060279
Patent details
ProductZirconium silicate ion-exchange compositions for cation removal
Cited in actionAugust 22, 2022

Publication No.US10695365B2
Application No.US15/878120
Patent details
ProductSodium zirconium cyclosilicate stability and formulation methods
Cited in actionAugust 22, 2022

Publication No.US9844567B2
Application No.US14/321659
Patent details
ProductZirconium cyclosilicate crystalline compositions for potassium binding
Cited in actionAugust 22, 2022

Publication No.US9913860B2
Application No.US14/628017
Patent details
ProductSodium zirconium cyclosilicate manufacturing process methods
Cited in actionAugust 22, 2022

Publication No.US8802152B2
Application No.US13/371080
Patent details
ProductZirconium silicate pharmaceutical compositions and synthesis
Cited in actionAugust 22, 2022

Publication No.US8808750B2
Application No.US14/036489
Patent details
ProductSodium zirconium cyclosilicate oral suspension packaging and dosing
Cited in actionAugust 22, 2022

The 14 asserted patents collectively protect the composition, formulation, manufacturing, and therapeutic use of sodium zirconium cyclosilicate (SZC), an inorganic ion-exchange compound that selectively captures potassium ions in the gastrointestinal tract. The portfolio spans application dates across the early-to-mid 2010s, consistent with ZS Pharma’s foundational R&D programme that preceded AstraZeneca’s acquisition of ZS Pharma in 2015. The earliest priority patent (US8802152) traces to application US13/371080, establishing a priority anchor for the broader portfolio.

For the hyperkalemia treatment market — where LOKELMA competes with Vifor’s patiromer (Veltassa) — this 14-patent portfolio represents a formidable exclusivity stack. Each patent addresses a different aspect of the SZC technology, meaning a generic challenger must overcome all of them to achieve a clear path to market. The absence of any invalidity ruling from this case means the portfolio’s untested strength may deter or delay future ANDA filers, maintaining AstraZeneca’s pricing power in a chronic-disease indication with high patient persistence.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should your SZC product run an FTO against LOKELMA’s 14-patent portfolio?

Any pharmaceutical company developing a sodium zirconium cyclosilicate-based product, a competing potassium binder, or an SZC formulation for hyperkalemia should treat all 14 licensed patents as live risks. Because the Sandoz consent judgment made no merits findings, none of these patents has been judicially weakened. R&D teams working on alternative polymorphs, dosing regimens, or combination products for hyperkalemia are particularly exposed if their compositions fall within the broad SZC composition claims.

PatSnap Eureka’s FTO Search Agent can map your compound’s structural and functional characteristics against all 14 LOKELMA patents simultaneously, flagging claim overlap and identifying prosecution history that may define patent boundaries. Eureka’s portfolio visualisation also shows how the 14 patents interlock chronologically, helping you identify any temporal gaps or claim scope limitations that could inform a design-around strategy or a targeted IPR petition on the most vulnerable claims.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US10398730B2 to assess your product’s exposure

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Related litigation

Similar ANDA patent cases: sodium zirconium cyclosilicate and hyperkalemia IP

These cases involve comparable ANDA patent disputes over potassium binders and specialty oral suspension formulations litigated in Delaware District Court.

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ZS Pharma, Inc. patent enforcement history, Delaware case history, ZS Pharma, Inc.’s full IP portfolio, and comparable case analysis
LOKELMA ANDA docket historyPatiromer (Veltassa) IP disputesDelaware ANDA consent judgmentsSZC portfolio challenge outcomes
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Strategic implications

What the LOKELMA settlement signals for pharma ANDA patent strategy

A 14-patent consent judgment with injunction is a strong defensive outcome — here is what it means for stakeholders across the SZC and hyperkalemia treatment space.

Portfolio depth is the most durable ANDA defence

AstraZeneca’s ability to assert 14 patents — spanning compositions, dosage forms, and methods of use — created a litigation risk profile that made patent-by-patent invalidation an unattractive path for Sandoz. Innovators building ANDA-defence strategies should consider stacking patents across multiple claim types rather than relying on a single foundational patent.

Consent judgments preserve portfolio integrity where verdicts cannot

A litigated verdict always risks narrowing or invalidating at least one patent claim. By settling to a consent judgment, AstraZeneca exits with all 14 patents unscathed on the merits — a materially stronger position for deterring the next ANDA filer. This pattern is consistent with a calculated decision to avoid appellate uncertainty on any individual patent.

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Authorised entry date analysisNext ANDA filer risk profileSZC patent expiry timeline
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Frequently asked questions

ZS v Sandoz — key questions answered

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Monitor LOKELMA patent challenges and SZC generic entry risks

Track all 14 LOKELMA patents for new ANDA filings, IPR petitions, and post-grant challenges with PatSnap Eureka. Run an FTO for your potassium binder programme before committing to clinical development.

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