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Sodium Zirconium Cyclosilicate Patent Expiration

Sodium Zirconium Cyclosilicate is Used for treating hyperkalemia in adults. It was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Lokelma on May 18, 2018.


Sodium Zirconium Cyclosilicate Patents

Given below is the list of patents protecting Sodium Zirconium Cyclosilicate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lokelma US10300087 Extended use zirconium silicate compositions and methods of use thereof Oct 14, 2035 Astrazeneca
Lokelma US11738044 Extended use zirconium silicate compositions and methods of use thereof Oct 14, 2035 Astrazeneca
Lokelma US9592253 Extended use zirconium silicate compositions and methods of use thereof Oct 14, 2035 Astrazeneca
Lokelma US10695365 Microporous zirconium silicate for the treatment of hyperkalemia Oct 22, 2033 Astrazeneca
Lokelma US8877255 Microporous zirconium silicate for the treatment of hyperkalemia Oct 22, 2033 Astrazeneca
Lokelma US9913860 Microporous zirconium silicate for the treatment of hyperkalemia Oct 22, 2033 Astrazeneca
Lokelma US8802152 Microporous zirconium silicate for the treatment of hyperkalemia Apr 19, 2032 Astrazeneca
Lokelma US10335432 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US10398730 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US10413569 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US11406662 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US8808750 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US9844567 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US9861658 Microporous zirconium silicate for the treatment of hyperkalemia Feb 10, 2032 Astrazeneca
Lokelma US6332985 Process for removing toxins from bodily fluids using zirconium or titanium microporous compositions Mar 29, 2019

(Expired)

 Astrazeneca



Sodium Zirconium Cyclosilicate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Sodium Zirconium Cyclosilicate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Sodium Zirconium Cyclosilicate has 5 clinical trials that have been verified in 2024. Out of these 5, 2 trial is in PHASE4.

Title Lead Sponsor Collaborators Status Phases
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone AstraZeneca COMPLETED
(Jul, 2024)
 PHASE4
A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece AstraZeneca ACTIVE NOT RECRUITING
(Jul, 2024)
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia AstraZeneca TERMINATED
(Jun, 2024)
 PHASE3
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China AstraZeneca COMPLETED
(Jun, 2024)
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia NephroNet, Inc. AstraZeneca COMPLETED
(Jun, 2024)
 PHASE4
Lokelma for RAAS Maximisation in CKD & Heart Failure. St George's, University of London RECRUITING
(May, 2023)
 PHASE3
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. AstraZeneca COMPLETED
(Oct, 2022)
 PHASE3
ZS Ph2/3 Dose-response Study in Japan AstraZeneca COMPLETED
(Feb, 2019)
 PHASE2, PHASE3
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. ZS Pharma, Inc. COMPLETED
(Jul, 2018)
 PHASE3
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS) AstraZeneca COMPLETED
(Dec, 2017)
 PHASE1