Synthon has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval for Ozanimod capsules, indicated for the treatment of relapsing forms of multiple sclerosis. The company has already received tentative FDA approval within 30 months of filing, positioning the product for a shared 180-day exclusivity period upon launch.
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Under the agreement, Synthon will be responsible for securing final regulatory approval, as well as the manufacturing and supply of the product. Zydus will take charge of commercialisation in the US market.
What is Zeposia?
Zeposia (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is also approved for moderately to severely active ulcerative colitis (UC) in adults. Zeposia is a trademark of Receptos, LLC, a Bristol Myers Squibb company.
President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., Punit Patel, said, “This collaboration with Synthon enables us to bring this important treatment to the US market. This collaboration reinforces our strategic focus on advancing care in therapeutic areas and reflects our commitment to making essential medicines more accessible to patients.”
The total addressable market opportunity of Ozanimod capsules in the US is approximately $637 million, as per the IQVIA MAT July 2025. Shares of Zydus Lifesciences Ltd ended at ₹1,013.25, up by ₹5.05, or 0.50%, on the BSE.
