India Pharma Outlook Team | Saturday, 06 December 2025
Drug-maker Lupin said on December 5, 2025, that it has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Siponimod Tablets.
The approved strengths are 0.25 mg, 1 mg, and 2 mg. These tablets are manufactured in Lupin’s Pithampur facility in India.
Siponimod is bioequivalent to the branded drug Mayzent of Novartis Pharmaceuticals, and is used in treating relapsing forms of Multiple Sclerosis (MS) in adults — including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS.
Also Read: Navigating the New Era of Nitrosamine Compliance
According to latest market data from October 2025 by IQVIA MAT, Siponimod (Mayzent) recorded an estimated annual sales of USD 195 million in the U.S. That underlines the potential commercial value of a generic entrant like Lupin’s.
From an industry perspective, this approval strengthens Lupin’s U.S. portfolio of specialty generics. With a high-demand drug like Siponimod coming off patent, the move could drive greater access to MS treatment through lower-cost generics, and also open up a meaningful revenue stream for Lupin. The manufacturing at Pithampur adds to India’s growing footprint in global pharmaceutical exports.
As Lupin transitions towards marketing, the tentative nod marks a key milestone; full commercialization will likely follow once regulatory and patent-related conditions clear. This step also reflects broader trends, where Indian pharma firms increasingly win approvals for complex generics, reshaping access and pricing dynamics in global markets.
.jpg)
.jpg)
