Lupin announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Siponimod Tablets in 0.25 mg, 1 mg and 2 mg.  

The product is a generic equivalent of Novartis Pharmaceuticals’ Mayzent Tablets and is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults. 

Lupin said the tablets will be manufactured at its Pithampur facility in India. According to IQVIA MAT October 2025 data, Siponimod Tablets (reference listed drug Mayzent) recorded annual U.S. sales of USD 195 million.