The agreement, signed by Zydus’ wholly owned subsidiary Zydus Lifesciences Global FZE, marks a significant step in strengthening the company’s U.S. generics portfolio.
Under the terms, Synthon will be responsible for securing final regulatory approval for its abbreviated new drug application (ANDA) for Ozanimod Capsules in the U.S. Once approved, Synthon will also manage manufacturing and supply, while Zydus will oversee commercialization.
Notably, Synthon is one of the first filers for this product and has already received tentative approval from the U.S. FDA within 30 months of filing. This milestone qualifies the product for a shared 180-day exclusivity period upon launch, providing a strong competitive advantage in a high-value segment.
ZEPOSIA, a sphingosine 1-phosphate receptor modulator, is indicated for relapsing forms of multiple sclerosis as well as moderately to severely active ulcerative colitis (UC). The reference brand is marketed by Bristol Myers Squibb under the trademark of Receptos LLC.
Synthon, based in the Netherlands, is a vertically integrated global leader in complex generics, with operations across eight countries, four R&D labs, and four manufacturing sites worldwide. The company has a strong track record in launching differentiated products at scale.“This collaboration with Synthon enables us to bring this important treatment to the U.S. market. It reinforces our strategic focus on advancing care in therapeutic areas and reflects our commitment to making essential medicines more accessible to patients,” said Punit Patel, President and CEO of Zydus Pharmaceuticals (USA).Also read: You will make 12-15% CAGR but don’t invest for 5-6 month horizons: Raamdeo Agrawal
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