Drug Approval
Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
- By IPP Bureau
| May 30, 2026
Lupin Limited has secured US FDA approval for its for generic colonoscopy prep drug with first-to-file exclusivity.
The drug -- Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g -- is bioequivalent to Sutab Tablets of Azurity Pharmaceuticals and is used for colon cleansing in adults prior to colonoscopy.
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market.
The tablets will be manufactured at Lupin’s facility in Nagpur, India.
The reference product, Sutab, has estimated annual U.S. sales of USD 132.8 million (IQVIA MAT March 2026), underscoring the commercial significance of the approval.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for bowel preparation in adults undergoing colonoscopy, a routine but critical diagnostic procedure.
