Lupin Limited has received U.S. FDA approval for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension. This generic drug is bioequivalent to Lokelma® and is indicated for treating hyperkalemia in adults. The U.S. market for the reference drug generated an estimated annual sales of USD 568 million. This approval marks a significant market entry for Lupin in the U.S. pharmaceutical landscape.
Lupin Secures FDA Approval for Key Generic Drug
Global pharmaceutical company Lupin Limited announced today that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA). The approval is for Sodium Zirconium Cyclosilicate for Oral Suspension, available in both 5 g/packet and 10 g/packet strengths. This generic drug is positioned as bioequivalent to AstraZeneca Pharmaceuticals LP’s reference listed drug (RLD), Lokelma® for Oral Suspension.
Market Opportunity and Indication
The approved Sodium Zirconium Cyclosilicate for Oral Suspension is indicated for the treatment of hyperkalemia in adults. The market potential for this drug is substantial, as the reference drug, Lokelma® (RLD), had an estimated annual sales of USD 568 million in the U.S. market as of June 2026, according to IQVIA data. This approval represents a key strategic advancement for Lupin in the United States.
About Lupin Limited
Lupin Limited is a leading global pharmaceutical company headquartered in Mumbai, India. With a strong presence across India, the U.S., other developed markets, and emerging markets, Lupin distributes its products in over 100 countries. The company boasts a diversified portfolio including generics, complex generics, specialty medicines, and biosimilars. Lupin maintains a strong market position in core therapeutic areas such as cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. Its operations are supported by 15 state-of-the-art manufacturing facilities, 6 research centers, and a workforce of over 26,000 professionals. Lupin is committed to expanding the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives, with sustainability as a core business strategy pillar.
Contact Information
For further information or queries, please contact:
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
[email protected]
Elise Titan
Director – U.S. Communications, Lupin
[email protected]
Lokelma® is a registered trademark of ZS Pharma, Inc.
Source: BSE
