Summary:
Zydus Lifesciences has signed an exclusive licensing and supply agreement with Netherlands-based Synthon BV to commercialize generic Ozanimod Capsules in the U.S. market. The drug, a generic version of Bristol Myers Squibb’s ZEPOSIA®, is used in the treatment of multiple sclerosis and ulcerative colitis. With tentative U.S. FDA approval and eligibility for shared 180-day exclusivity, the product represents a market opportunity of about $637 million, according to IQVIA data.
Partnership Details
Zydus Lifesciences Ltd., through its wholly owned subsidiary Zydus Lifesciences Global FZE, has entered into a licensing and supply arrangement with Synthon BV for the U.S. launch of Ozanimod Capsules, a generic equivalent of ZEPOSIA®.
Under the agreement:
- Synthon will manage regulatory approvals, manufacturing, and supply of the product.
- Zydus will handle commercialization in the United States.
As one of the first filers, Synthon has received tentative approval from the U.S. FDA within 30 months, making the drug eligible for a shared 180-day exclusivity period upon launch.
About the Drug
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator approved for:
- Relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- Moderately to severely active Ulcerative Colitis (UC) in adults.
The brand version, ZEPOSIA®, is marketed by Bristol Myers Squibb’s subsidiary Receptos, LLC.
Market Opportunity
The total U.S. market size for Ozanimod Capsules is estimated at $637 million (IQVIA MAT July 2025). Entry into this segment, coupled with exclusivity benefits, offers both companies significant potential in the high-value neurology and immunology space.
Leadership Commentary
- Punit Patel, President & CEO, Zydus Pharmaceuticals (USA) Inc., said:
“This collaboration with Synthon enables us to bring this important treatment to the U.S. market and reinforces our focus on advancing care in critical therapeutic areas.” - Anish Mehta, CEO of Synthon BV, noted:
“Our partnership with Zydus on Ozanimod underlines our expertise in complex generics and strengthens our mission of expanding access to essential medicines globally.”
About the Companies
- Zydus Lifesciences is a global healthcare group with 28,000 employees and 1,500 scientists engaged in R&D. It develops and markets a wide range of therapies across geographies.
- Synthon BV, headquartered in the Netherlands, specializes in complex generics, with a presence in eight countries, four R&D labs, and manufacturing sites in Europe and Latin America. Its portfolio includes over 70 molecules serving customers in nearly 100 countries.
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