Zydus Lifesciences Ltd. has entered into an exclusive licensing and supply agreement with Synthon BV of the Netherlands for Ozanimod Capsules, a generic version of ZEPOSIA®, for the U.S. market. The announcement was made on September 4, 2025.
Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules indicated for relapsing forms of multiple sclerosis. Under the terms of the agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product, and thereafter, for the manufacture and supply of the product. Zydus will be responsible for the commercialization of the product in the USA.
As one of the first filers, Synthon has received tentative approval within 30 months from the U.S. Food and Drug Administration (FDA), making the product eligible for a shared 180-day exclusivity upon market entry.
ZEPOSIA® (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of 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. ZEPOSIA® is a trademark of Receptos, LLC, a Bristol Myers Squibb company.
Punit Patel, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., stated, "This collaboration with Synthon enables us to bring this important treatment to the U.S. 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."
Anish Mehta, Chief Executive Officer, Synthon BV, commented, “This collaboration with Zydus for Ozanimod capsules continues to underscore our proven expertise in developing first-to-market, complex generic products. We are pleased to strengthen our partnership with Zydus as we continue advancing our strategic commitment to expanding access to essential medicines.”
The total addressable market opportunity of Ozanimod Capsules in the U.S. is approximately US $637 million as per the IQVIA MAT July 2025.
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