Lupin Gets USFDA Nod for Generic Lokelma, Enters USD 568M US Hyperkalemia Market
Mumbai: Global pharmaceutical major Lupin Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Zirconium Cyclosilicate for Oral Suspension, available in strengths of 5 g/packet and 10 g/packet. The product is indicated for the treatment of hyperkalemia in adults.
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. The approved product is indicated for the treatment of hyperkalemia in adult patients. 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.
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Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a strong presence across India, the United States, Other Developed Markets and Emerging Markets. Its products are distributed in more than 100 markets worldwide. The company has a diversified portfolio comprising generics, complex generics, specialty medicines and biosimilars, and continues to strengthen its market position through a differentiated portfolio.
Lupin maintains strong leadership in the United States and India across several core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal and women's health. The company operates 15 state-of-the-art manufacturing facilities supporting sustainable operations and has six research centres. Its workforce comprises more than 26,000 professionals.
Beyond its pharmaceutical portfolio, Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programmes and disease-management initiatives. Sustainability remains a core pillar of the company's business strategy.
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.
