Lupin gets US FDA nod for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets
Lupin Limited received U.S. FDA approval for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets. The product is bioequivalent to Sutab® Tablets and Lupin is eligible for 180-day generic exclusivity. The reference drug had estimated U.S. sales of USD 132.8 million.
The approval of a product with an estimated annual sale of USD 132.8 million indicates a moderate revenue potential, thus impacting the company's financial performance.
The U.S. FDA approval for a new drug product, especially one with significant market potential, is a positive development for the company.
Lupin Limited announced on May 29, 2026, that it has received approval from the United States Food and Drug Administration (U.S. 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.
This product is bioequivalent to Sutab® Tablets, 1.479 g/0.225 g/0.188 g, manufactured by Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file applicant and is eligible for 180-day generic drug exclusivity. The manufacturing of these tablets will take place at Lupin's facility in Nagpur, India.
The tablets are indicated for colon cleansing in preparation for colonoscopy in adults. The reference listed drug, Sutab® Tablets, had an estimated annual sale of USD 132.8 million in the U.S. as of March 2026 (IQVIA MAT).
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Lupin Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Lupin Limited. Read the original for the full detail.