Lupin Receives U.S. FDA Approval for Generic Lokelma in Hyperkalemia

12 August 2026 | Wednesday | News

Sodium Zirconium Cyclosilicate oral suspension approved in 5 g and 10 g packets, targeting a U.S. market with $568 million in annual reference-drug sales.

Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)  announced that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet.

The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet as bioequivalent to the reference listed drug (RLD) Lokelma® for Oral Suspension of AstraZeneca Pharmaceuticals LP and is indicated for the treatment of hyperkalemia in adults.

Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma®) had estimated annual sales of USD 568 million in the U.S. (IQVIA MAT Jun 2026).

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