Lupin Ltd announced that it has obtained tentative approval from the USFDA for a generic form of Siponimod Tablets, intended for MS treatment. The tentative approval includes tablets in 0.25mg, 1mg, and 2mg dosages. This marks another significant achievement in broadening Lupin’s neurology product range in the US. Lupin will market Siponimod, which is produced at its state-of-the-art manufacturing plant in Pithampur, showcasing Lupin's capacity to create high-quality and complex generic medications for worldwide glycobiology. The Siponimod Tablets under development by Lupin are bioequivalent to Novartis Pharmaceuticals' brand-name medication Mayzent. Siponimod is indicated for individuals aged eighteen and older diagnosed with the following types of MS: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. According to IQVIA MAT Oct Data 2025, the US market for Siponimod Tablets is projected to reach around US$195 million annually, presenting a significant opportunity for Lupin upon receiving final approval.
This endorsement strengthens Lupin's plan to create a robust global generic pipeline, particularly in valuable speciality medications and therapies. Lupin will maintain its investments in research, production, and development capabilities to address more complicated and life-threatening diseases. Consequently, incorporating Siponimod Tablets into Lupin's portfolio in the United States will enhance its presence in the field of neurology. By securing approval for intricate generic drugs, Lupin aims to generate additional options for patients in the United States to obtain affordable therapies, including those for multiple sclerosis, in response to the increasing demand for cost-effective substitutes to existing medications.
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