Lupin receives US FDA approval for generic colonoscopy preparation tablets
Approval grants Lupin 180-day generic drug exclusivity for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in the US market
Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
According to the company, Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g are bioequivalent to the reference listed drug (RLD), Sutab Tablets, 1.479 g/0.225 g/0.188 g, of Azurity Pharmaceuticals, Inc.
Lupin said it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity in the United States. The product will be manufactured at the company’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.
According to IQVIA MAT March 2026 data cited by the company, Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab) recorded estimated annual sales of USD 132.8 million in the US market.