Orbicular Pharma gets US FDA nod for generic Ozempic with Apotex

Orbicular Pharma and Apotex secure tentative US FDA approval for generic Ozempic, marking entry into fast-growing semaglutide market pending patent clearance

Orbicular Pharmaceutical Technologies and Apotex have received tentative approval from the US Food and Drug Administration for a generic version of Ozempic (semaglutide injection), the Hyderabad-based company said on Thursday. The product will be commercialised in the United States by Apotex, which is the abbreviated new drug application (ANDA) applicant.

 

The approval marks Orbicular’s entry into the complex peptide generic segment tied to semaglutide, a fast-growing diabetes and weight-loss drug category dominated globally by Novo Nordisk’s Ozempic.

 

Tentative approval from the FDA indicates that the generic product meets required quality, safety and efficacy standards but cannot yet be marketed in the US until patent or exclusivity barriers on the reference drug are cleared.

 

 

Orbicular said it developed the semaglutide injection in partnership with Apotex, contributing formulation development and analytical work for the product. Apotex will handle US marketing and distribution once final approval is granted.

 

“Achieving technical equivalence for complex peptide products requires deep scientific rigour, advanced analytical precision, and a highly disciplined development approach,” said M S Mohan, managing director of Orbicular Pharmaceutical Technologies.

 

Apotex said the collaboration supports its strategy of expanding access to lower-cost peptide therapies in the US market.

 

Semaglutide is among the most closely watched drug molecules globally as demand for GLP-1 therapies continues to rise.