#India #Ahmedabad #Zydus Lifesciences #Synthon #Ozanimod Capsules

Zydus and Synthon Collaboration for Ozanimod Capsules in the U.S. Market

In a significant move for both companies, Zydus Lifesciences Ltd. has officially partnered with Synthon BV to jointly target the U.S. pharmaceutical market with Ozanimod Capsules, the generic version of the well-known ZEPOSIA®. This collaboration, announced on September 4, 2025, aims to develop and commercialize Ozanimod Capsules, primarily targeted at patients with relapsing forms of multiple sclerosis.

Background of the Agreement

Zydus Lifesciences, including its subsidiaries, has a strong global presence in healthcare innovation. With this surprising agreement, Zydus Lifesciences Global FZE, a wholly owned subsidiary, assumes the marketing and commercialization responsibilities for Ozanimod Capsules in the U.S. market. Importantly, Synthon, which currently has a pending abbreviated new drug application (ANDA) with the FDA, will handle the final regulatory approval and the manufacturing aspects of the product.

One of the key elements is that as a ‘first filer’, Synthon secured a tentative approval from the U.S. Food and Drug Administration (FDA) within a commendable 30-month timeline. This positions Ozanimod Capsules for an enticing shared exclusivity period of 180 days upon its market entry, significantly benefiting both companies and those in need of effective treatment options for multiple sclerosis.

What is Ozanimod?

Ozanimod, marketed under the name ZEPOSIA®, serves as a sphingosine 1-phosphate receptor modulator and is approved for treating relapsing forms of multiple sclerosis, which include conditions like clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease among adults. Moreover, its application extends to managing moderately to severely active ulcerative colitis in adults. The original ZEPOSIA® trademark is held by Receptos, LLC, a subsidiary of Bristol Myers Squibb.

Strategic Insights from Leadership

The announcement featured a statement from Punit Patel, President and CEO of Zydus Pharmaceuticals (USA) Inc., emphasizing the collaboration's role in enhancing patient access to vital treatments. He stated, “This collaboration enables us to bring this important treatment to the U.S. market,” highlighting Zydus’s commitment to advancing therapeutic capabilities in critical healthcare areas.

Echoing this sentiment, Anish Mehta, CEO of Synthon BV, expressed his enthusiasm regarding the cooperation, which reinforces Synthon's established expertise in creating complex generics. This partnership illustrates both companies’ dedication to expanding accessibility to essential medications, a core mission in today's healthcare landscape.

Market Potential

The addressable market for Ozanimod Capsules in the U.S. is estimated to be a staggering $637 million according to IQVIA data from July 2025. This statistic underscores the strategic importance of this collaboration, as both companies can capitalize on the substantial demand for effective treatments addressing multiple sclerosis.

About Zydus Lifesciences

Zydus Lifesciences is a renowned global healthcare company dedicated to empowering individuals through innovative therapies. With over 28,000 employees, including 1,500 scientists dedicated to research and development, Zydus Lifesciences relentlessly aims to transform lives through groundbreaking discoveries. More information can be found on their website at www.zyduslife.com.

About Synthon

Synthon, headquartered in the Netherlands, is globally recognized for its expertise in the development and manufacture of complex generics. With an impressive track record spanning over three decades, the company operates multiple R&D labs and manufacturing sites across various countries, producing a diverse portfolio aimed at meeting the global demand for affordable medications. To learn more, visit www.synthon.com.

In summary, the partnership between Zydus and Synthon marks a substantial step forward in addressing the healthcare needs of multiple sclerosis patients in the U.S., facilitating access to crucial treatment options while aiming for regulatory success and strategic market positioning.