By: IPP Bureau
Last updated : May 30, 2026 5:03 pm
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Global pharmaceutical major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) 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.
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals and is indicated for colon cleansing prior to colonoscopy procedures in adults.
Lupin is the exclusive first-to-file applicant for the product and will benefit from 180 days of generic drug exclusivity in the US market. The medication will be manufactured at the company’s Nagpur facility in India.
According to IQVIA MAT data for March 2026, the reference product Sutab® recorded estimated annual sales of US$132.8 million in the United States, presenting a significant market opportunity for Lupin.
The approval further strengthens Lupin’s US generics portfolio and underscores its continued focus on expanding its presence in the regulated pharmaceutical market through differentiated and first-to-file opportunities.