Lupin Limited announced that it has secured tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application covering Siponimod Tablets in 0.25 mg, 1 mg and 2 mg strengths. The medicines will be produced at the company’s Pithampur facility in India.
The approved product is the generic version of Mayzent®, developed by Novartis Pharmaceuticals Corporation. It is used in adults for treating relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease. Lupin’s formulation has been deemed bioequivalent to the reference drug.
According to IQVIA MAT October 2025 data, Siponimod Tablets (RLD Mayzent®) recorded estimated annual U.S. sales of about USD 195 million. The tentative approval positions Lupin to enter the market once final clearance is granted and any exclusivity barriers are lifted.