Zydus Lifesciences Ltd has announced that its wholly owned subsidiary has entered into an exclusive licensing and supply agreement with Netherlands-based Synthon BV for Ozanimod Capsules, the generic version of Zeposia®, for the US market.
Agreement details
Under the agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product and will handle manufacturing and supply. Zydus will be responsible for commercializing the product in the United States. As one of the first filers, Synthon has already received tentative approval from the US Food and Drug Administration (FDA) within 30 months, making the product eligible for shared 180-day exclusivity upon launch.
About Ozanimod
Zeposia® (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for relapsing forms of multiple sclerosis (MS), 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.
Market opportunity
The total addressable market for Ozanimod Capsules in the US is estimated at approximately USD 637 million as of July 2025.
Leadership comments
The company said the collaboration will allow Zydus to bring this important treatment to patients in the US, reinforcing its focus on advancing care in key therapeutic areas. Synthon said the deal highlights its expertise in developing complex generics and strengthens its partnership with Zydus.
