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Lupin Gets USFDA Nod for Generic Lokelma, Enters USD 568M US Hyperkalemia Market
['Parthika Patel', 'Written', 'M. Pharm', 'Pharmaceutics']
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The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet, as bioequivalent to Lokelma® for Oral Suspension, the reference listed drug (RLD) of AstraZeneca Pharmaceuticals LP.
Sodium Zirconium Cyclosilicate for Oral Suspension, with Lokelma® as the reference listed drug, had estimated annual sales of USD 568 million in the United States, according to IQVIA MAT June 2026 data.
The company's communication also includes a Safe Harbor Statement, noting that Lokelma® is a registered trademark of ZS Pharma, Inc.
The approval represents Lupin's latest U.S. regulatory milestone for its Sodium Zirconium Cyclosilicate Oral Suspension in 5 g/packet and 10 g/packet strengths.
The product has received U.S. FDA approval as bioequivalent to the reference listed drug Lokelma®, with an indication for treating hyperkalemia in adults.