On April 10, Apotex announced that its Abbreviated New Drug Application (ANDA) for a generic version of Ozempic ( semaglutide injection ) received the first tentative approval from the U.S. FDA .
Apotex's semaglutide injection was developed through a strategic partnership with Orbicular Pharmaceutical Technologies . Dr. MS Mohan, Managing Director of Orbicular, stated, " Achieving technical equivalence for complex peptide products requires deep scientific rigor, advanced analytical precision, and highly standardized development methodologies. We are proud to support Apotex in advancing this important project. Their regulatory leadership, combined with Orbicular's development and execution excellence, were key elements in securing FDA provisional approval. "
Barry Fishman, Chief Corporate Development Officer at Apotex, stated, “ This is powerful proof of what a true partnership can achieve. As a health advocate, this milestone demonstrates Apotex’s leadership in leveraging complementary strengths, sharing a mission, and relentlessly pursuing excellence. ”
Once final approval is granted, Apotex's semaglutide injection is expected to help patients access this key treatment area more broadly, which is crucial for affordability and accessibility for patients in this field.
In October 2024, Novo Nordisk reached a settlement with four ANDA applicants, including Apotex, regarding the patent dispute over semaglutide. The settlement covers a specific dose of semaglutide for the treatment of type 2 diabetes. However, all settlement terms are confidential, and details such as the specific launch date and whether patent licensing fees are involved have not been disclosed.

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