Lupin Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Siponimod Tablets, used in the treatment of multiple sclerosis (MS). The approval covers product strengths of 0.25 mg, 1 mg, and 2 mg.
Product and Manufacturing Details
- The approved formulation is bioequivalent to Mayzent®, the reference product developed by Novartis Pharmaceuticals.
- The product is manufactured at Lupin’s Pithampur advanced manufacturing facility.
- The approval marks an expansion of Lupin’s neurology-focused product portfolio for the U.S. market.
Usage and Therapeutic Scope
Siponimod is indicated for the treatment of adults aged 18 or older diagnosed with:
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
Market Overview
According to IQVIA MAT October 2025 data, the U.S. market for Siponimod Tablets is valued at approximately:
| Region | Product | Estimated Market Size |
| United States | Siponimod Tablets | ~US$ 195 million annually |
The tentative approval positions Lupin to participate in this market upon final regulatory clearance.
Pipeline and Portfolio Expansion
The approval contributes to Lupin’s ongoing efforts to:
- Expand its portfolio of specialty and complex generic medicines
- Strengthen its presence in the neurology therapeutic area
- Build a broader pipeline for global regulated markets
The company stated that it will continue investment in research, product development, and advanced manufacturing to support future product introductions.
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