Lupin Receives Approval from U.S. FDA for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets.
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Lupin has received approval from the U.S. FDA for its generic drug application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets. The product is a generic version of Azurity Pharmaceuticals' Sutab® Tablets, used for colon cleansing before colonoscopy in adults. Lupin was the exclusive first-to-file applicant, making it eligible for 180-day generic drug exclusivity. The product will be manufactured at Lupin's Nagpur facility in India. The U.S. market for this product had estimated annual sales of USD 132.8 million as of March 2026.
This FDA approval represents a positive development for Lupin, giving it a window of exclusivity to launch a generic drug in a significant U.S. market segment worth over USD 132 million. The 180-day exclusivity period could translate into meaningful revenue contribution before generic competition intensifies.