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SODIUM ZIRCONIUM CYCLOSILICATE

ANDA

SODIUM ZIRCONIUM CYCLOSILICATE | A217549 | LUPIN LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LOKELMA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ZS Pharma, Inc. et al v. Lupin Limited et al 1:2022cv01055 12 patentsANDA 217549sodium zirconium cyclosilicate	D. Del.	2022-08-10	Terminated 2025-06-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

SICHUAN GOWELL PHARMACEUTICAL CO LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 424702025

MACLEODS PHARMACEUTICALS LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 363632021

LUPIN MANUFACTURING SOLUTIONS LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 364132022

LAURUS LABS LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 364382021

HETERO DRUGS LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 369152022

SOLARA ACTIVE PHARMA SCIENCES LTDSODIUM ZIRCONIUM CYCLOSILICATE

DMF 382362023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 5GM/PACKET

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Aug 7, 2026

No patent or exclusivity listings for this strength.

#002 — 10GM/PACKET

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Aug 7, 2026