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.
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.
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.
Speaking on the development, 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 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-tomarket, 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 for Ozanimod capsules in the U.S. is estimated at approximately US$637 million, according to IQVIA MAT data from July 2025.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company’s consolidated net profit rose 3.3% to Rs 1,466.80 crore on 7% rise in revenue from operations to Rs 6,467 crore in Q1 FY26 over Q1 FY25.