South Africa Reviews 12 Generic Semaglutide Applications After Novo Nordisk Patent Expiry

Following the March 2026 expiry of Novo Nordisk’s semaglutide patent in South Africa, the South African Health Products Regulatory Authority said it was reviewing 12 applications for generic versions of the medicine. India’s Sun Pharmaceutical Industries became the first company to receive South African approval to manufacture and sell a generic semaglutide injection and said it planned to launch the product shortly. Novo Nordisk plans to launch Extensior, a lower-cost authorized copy of Ozempic produced through a partnership with Acino, on July 27, 2026, and has also reduced Wegovy prices. Separately, South African regulators have intensified enforcement against unregistered compounded GLP-1 products, including recalling semaglutide and tirzepatide products made by iDEXIS because of serious safety concerns.

Generic semaglutide regulatory applications

• ▪The South African Health Products Regulatory Authority is reviewing 12 applications for generic versions of semaglutide.
• ▪Sun Pharmaceutical Industries said its approved generic semaglutide would be sold as a pre-filled, multi-dose injectable pen containing 2 mg or 4 mg of semaglutide for once-weekly use in adults with inadequately controlled type 2 diabetes.
• ▪India's Sun Pharmaceutical Industries became the first company to receive approval from the South African Health Products Regulatory Authority to manufacture and sell generic semaglutide in South Africa.

Semaglutide patent expiry

• ▪The expiry of Novo Nordisk's semaglutide patent has allowed generic manufacturers to seek regulatory approvals to sell competing versions of the medicine.
• ▪Novo Nordisk's patent on semaglutide expired in South Africa in March 2026.

Novo Nordisk competitive response

• ▪Extensior will be available in the same 0.25mg, 0.5mg, and 1mg doses as Ozempic and uses the identical active pharmaceutical ingredient, manufacturing process, and delivery device.
• ▪Novo Nordisk plans to launch Extensior, a lower-cost authorized copy of Ozempic, in South Africa on July 27, 2026, through a partnership with Swiss healthcare company Acino.
• ▪Novo Nordisk has reduced the price of its weight-loss drug Wegovy in South Africa to make it more accessible as competition from generic and compounded GLP-1 medicines increases.

Unregistered GLP-1 safety crackdown

• ▪The South African Health Products Regulatory Authority and the South African Pharmacy Council raided an operation in May 2026 accused of unlawfully producing GLP-1 medicines.
• ▪South African regulators issued a severe safety warning and recall for unregistered iDEXIS semaglutide and tirzepatide products due to high risks of serious harm.

African diabetes treatment access

• ▪The International Diabetes Federation estimates that 25 million adults across Africa live with diabetes, including an estimated 2.32 million adults in South Africa in 2024.
• ▪In 2025, the World Health Organisation added semaglutide and other GLP-1 medicines to its Model List of Essential Medicines for selected patients with type 2 diabetes.