Indian pharmaceutical company Lupin (NSE:LUPIN, BOM:500257) has received approval from the U.S. Food and Drug Administration for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in the strengths of 1.479 grams, 0.225 grams, and 0.188 grams.
The tablets are bioequivalent to Azurity Pharmaceuticals' reference listed drug, Sutab Tablets, which are used to cleanse the colon as a preparation for colonoscopy in adults.
Lupin said it is eligible for 180-day generic drug exclusivity as it was the first to file for the product, which will be manufactured at Lupin's Nagpur facility in India.
IQVIA data estimates annual sales of $132.8 million for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in the U.S. in the 12 months ended March.