India’s Sun Pharma gets South Africa nod for generic semaglutide after Novo Nordisk patent expiry

India’s Sun Pharmaceutical Industries has received approval from South Africa’s health regulator to manufacture and sell a generic version of semaglutide, the active ingredient used in Novo Nordisk’s blockbuster diabetes and obesity drugs Ozempic and Wegovy.

The approval by the South African Health Products Regulatory Authority (SAHPRA) makes South Africa the second market after India where Sun Pharma has secured regulatory clearance for its generic semaglutide injection, the company said in a statement.

Sun Pharma said the approval is for adults with inadequately controlled type 2 diabetes and that it plans to launch the product in South Africa in the coming days.

The drug will be sold as a pre-filled, multi-dose injectable pen in two strengths — 2 mg and 4 mg — and will be administered once a week.

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The development comes after Novo Nordisk’s patent on semaglutide expired in South Africa in March, paving the way for generic drugmakers to enter the market with more affordable alternatives.

Semaglutide belongs to a class of medicines known as GLP-1 receptor agonists, which help regulate blood sugar levels and have also gained global popularity for their weight-loss benefits.

Novo Nordisk’s Ozempic, originally developed for diabetes treatment, and Wegovy, approved for obesity management, have become some of the world’s biggest-selling medicines. The patent expiry has triggered expectations of increased competition from generic manufacturers.

"We remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals," said Sun Pharma Chief Operating Officer Aalok Shanghvi.

Sun Pharma takes on obesity drug giants

Sun Pharma’s entry into the South African market is expected to increase competition for Novo Nordisk as well as US pharmaceutical major Eli Lilly, which has launched its own diabetes and obesity drug Mounjaro in the country.

South Africa’s weight-loss drug market is currently dominated by Ozempic, Wegovy and Mounjaro, but the high demand for these treatments has also led to the rise of compounded versions of the medicines.

Regulators globally have been tightening oversight of compounded drugs due to concerns around safety, quality control and manufacturing standards as demand for lower-cost versions of GLP-1 medicines rises.

The global market for diabetes and obesity treatments has expanded rapidly in recent years, driven by rising obesity rates and growing adoption of GLP-1 therapies.

For Indian pharmaceutical companies, the entry into the semaglutide market represents an opportunity to expand beyond traditional generic medicines into high-growth therapies.

Sun Pharma, India’s largest drugmaker by market capitalisation, has been increasing its presence in specialty medicines and complex therapies, including products targeting chronic diseases.

The company’s South Africa approval follows its earlier regulatory clearance in India for generic semaglutide, strengthening its position in the global race to provide cheaper alternatives to some of the world’s most expensive medicines.