Apotex Corp. has received the first US FDA tentative approval for an Abbreviated New Drug Application (ANDA) for semaglutide injection, referencing Novo Nordisk’s Ozempic (semaglutide) as the originator product. The approval, granted to the Canadian generics company in partnership with Orbicular Pharmaceutical Technologies, marks the first time the US FDA has issued a tentative ANDA decision for a generic version of the widely used GLP-1 receptor agonist injection.
Tentative approval under the Hatch-Waxman framework indicates that the FDA has determined the application meets regulatory requirements for approval, but that final marketing clearance remains contingent on the resolution of outstanding patent or exclusivity barriers. Ozempic carries US FDA approvals for glycemic control in type 2 diabetes, reduction of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and — since January 2025 — reduction of kidney disease progression and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
The regulatory history of this ANDA includes patent litigation. According to third-party legal reporting, Novo Nordisk reached settlements in October 2024 with four ANDA filers — including Apotex — over US Patent No. 10,335,462, which covers specific semaglutide dosages for type 2 diabetes. The terms of those settlements, including any agreed entry dates, have not been publicly disclosed by either party.
Semaglutide is a GLP-1 receptor agonist, a class of peptide-based medicines that stimulate insulin secretion, suppress glucagon release, slow gastric emptying, and reduce appetite through activation of the GLP-1 receptor. The molecule was discovered and developed internally by Novo Nordisk and first approved by the US FDA in December 2017 as Ozempic for type 2 diabetes. A higher-dose formulation, Wegovy (semaglutide), was subsequently approved in 2021 for chronic weight management — a separate product not referenced by the Apotex ANDA.