Lupin gets USFDA nod for multiple sclerosis drug
- IBEF
- December 8, 2025
Lupin Ltd stated that it has received tentative approval from the USFDA for a generic version of Siponimod Tablets, which will be used to treat MS. The tentative approval encompasses tablets in 0.25mg, 1mg & 2mg tablet formats. It is another important milestone for expanding Lupin’s neurology product line in the US. The Siponimod that Lupin will market is manufactured at Lupin's advanced manufacturing facility located in Pithampur & highlighting Lupin's ability to produce high-quality & complex generic drugs for global glycobiology. The Siponimod Tablets being developed by Lupin are bioequivalent to the brand-name drug Mayzent from Novartis Pharmaceuticals. Siponimod is used to treat patients over the age of eighteen suffering from the following forms of MS: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Based on IQVIA MAT Oct Data 2025, the US market for Siponimod Tablets will amount to approximately US$ 195 million per year, creating a tremendous opportunity for Lupin upon obtaining final approval.
This approval reinforces Lupin's strategy of building a strong global generic pipeline, especially in high-value specialty drugs and therapeutics. Lupin will continue its investment in research, manufacturing, and development capabilities to treat more complex/life-threatening illnesses. For this reason, the addition of Siponimod Tablets to Lupin's United States portfolio will further expand its presence in neurology. By obtaining approval for complex generic medications, Lupin expects to create further opportunities for patients in the United States to access affordable treatments, including those used to treat multiple sclerosis, in response to the growing demand for low-cost alternatives to currently available medications.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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