On 10 April 2026, Apotex announced that it received the first US FDA Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, a generic version of Novo Nordisk’s Ozempic®. FDA Tentative Approval signifies that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.
Apotex developed its Semaglutide Injection through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India.
The FDA Tentative Approval gives Apotex an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents. Numerous generic semaglutide products launched on the Indian market in March 2026, including by Dr Reddy’s Zydus, Alkem, Sun Pharma and Glenmark, following expiry of Novo Nordisk’s core Indian patent for semaglutide.
Apotex’s news follows Novo Nordisk’s announcement on 20 March 2026 that the FDA approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection (Wegovy® HD) for weight loss and long-term maintenance of weight loss for certain adult patients. The approval was granted under the Commissioner’s National Priority Voucher (CNPV) pilot program. Wegovy® HD was subsequently launched in the US in April 2026.