Lupin Wins USFDA Nod for Generic Sutab, Bags 180-Day Market Exclusivity
Mumbai: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g is bioequivalent to the reference listed drug (RLD), Sutab® Tablets, 1.479 g/0.225 g/0.188 g of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab®) had an estimated annual sale of USD 132.8 million in the U.S. (IQVIA MAT March 2026).
Lupin Limited is a global pharmaceutical firm headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
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