South Africa’s medicines regulator is weighing up a dozen applications from drugmakers seeking to sell generic versions of semaglutide, the compound behind Novo Nordisk’s blockbuster diabetes and weight-loss treatments Ozempic and Wegovy. The South African Health Products Regulatory Authority confirmed the figure this week in response to a Reuters query, though it declined to name the applicants or indicate how long approvals might take.
The review follows the expiry of Novo Nordisk’s local patent on semaglutide in March, a development that opened South Africa’s market to competition for the first time since Ozempic launched. India’s Sun Pharmaceutical Industries moved fastest, becoming the first company to win SAHPRA approval for a generic version last week, covering treatment of adults with poorly controlled type 2 diabetes. Sun Pharma has said South Africa is only the second country, after India, where it has secured such clearance, and has flagged the market as a strategic gateway into the rest of sub-Saharan Africa.
The stakes are considerable given South Africa’s underlying disease burden. The country is estimated to have around 4.6 million adults living with type 2 diabetes, though only about 2 million have been formally diagnosed, according to research cited by Wits University. Obesity rates sit at roughly 41% among women and 11% among men, with a further quarter of each group classified as overweight, conditions that have fuelled demand for GLP-1 therapies well beyond their original diabetes indication.
| Milestone | Detail |
|---|---|
| Novo Nordisk SA patent on semaglutide expired | March 2026 |
| Generic applications under SAHPRA review | 12 |
| First generic approval granted | Sun Pharma, mid-July 2026 |
| Novo Nordisk’s authorised copy (Extensior) launch | 27 July 2026 |
| Estimated South Africans with type 2 diabetes | 4.6 million (2m diagnosed) |
| Projected global weight-loss drug market by 2030 | approximately $150 billion |
Novo Nordisk is not standing still while competitors queue for approval. The company is preparing to launch its own lower-cost version, branded Extensior, through a partnership with healthcare firm Acino, with sales beginning on 27 July. Unlike a generic, an authorised copy is manufactured by Novo Nordisk itself using the same active ingredient, production process and injector pen as Ozempic, simply sold under a different name. Sara Norcross, the company’s South African general manager, has said pricing will be confirmed shortly but has already indicated Extensior will undercut the branded product for diabetes patients. The company has also trimmed prices on Wegovy locally in an effort to broaden access ahead of generic competition arriving in force.
Rivalry is not confined to registered pharmaceutical companies. Durban-based Aspen Pharmacare, Africa’s largest drugmaker, is separately developing its own semaglutide copy, targeting regulatory approval in Canada by September as part of a wider push into international GLP-1 markets, a signal that South African manufacturers see opportunity well beyond the domestic market. At the same time, authorities have been cracking down on unauthorised compounded versions of the drug. In June, South Africa’s High Court granted Novo Nordisk an interim interdict against pharmacy group iDexis, barring it from manufacturing or selling semaglutide-based weight-loss products, part of a broader pattern of litigation the company has pursued against compounders both locally and abroad.
The commercial prize is substantial. Novo Nordisk now derives close to 94% of its net sales from diabetes and obesity treatments, and analysts expect the global weight-loss drug market to approach $150 billion by the end of the decade, drawing US rival Eli Lilly and its Mounjaro brand into the same contest. For South African patients, the immediate effect of a dozen pending applications, alongside Novo Nordisk’s own cheaper offering, is likely to be a steady widening of treatment options over the coming months, even as SAHPRA has given no firm indication of when further approvals might follow Sun Pharma’s.