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SA Regulator Reviews 12 Generic Semaglutide Apps
21 Jul
Summary
- South Africa's health regulator is reviewing 12 generic semaglutide applications.
- Novo Nordisk's patent for semaglutide expired this year in South Africa.
- Sun Pharma received approval to sell a generic version in South Africa.

South Africa's health regulator, SAHPRA, is actively assessing 12 applications for generic semaglutide, the key component in Novo Nordisk's widely used Ozempic and Wegovy medications. The expiration of Novo Nordisk's patent for semaglutide in South Africa this year has opened the door for generic drug manufacturers.
Recently, India's Sun Pharmaceutical Industries secured the first approval from SAHPRA to produce and distribute a generic version within South Africa. The increasing number of generic applications under review could significantly lower treatment costs for patients in the country.
This development intensifies competition in the rapidly expanding GLP-1 market, currently led by Novo Nordisk and its U.S. competitor Eli Lilly. To counter this, Novo Nordisk plans to launch an affordable, authorized copy of Ozempic in South Africa this month through a partnership with Acino, alongside price reductions for Wegovy.