South Africa court blocks compounded Ozempic copies in Novo Nordisk case

A South African court has granted an interim order blocking a local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, the active ingredient in Novo Nordisk's (NOVO) Ozempic and Wegovy drugs.

The High Court in Pretoria ruled that iDexis and its director must immediately halt the compounding, supply, and marketing of semaglutide-based products pending further investigation, following an application from the Danish drugmaker.

Novo Nordisk had argued that iDexis was unlawfully selling unregistered semaglutide medicines and competing in the lucrative weight-loss market without complying with South African law. Ozempic, a diabetes treatment, and Wegovy, its weight-loss counterpart, both use semaglutide as their active ingredient.

Novo Nordisk told the Gauteng Division of the High Court that iDexis had been producing compounded semaglutide medicines at scale, supplying about 84,500 units a month — more than sales of Ozempic and Wegovy combined — and marketing them for weight loss without regulatory approval.

iDexis had argued it was entitled to compound semaglutide because it used an ingredient similar to that in the registered Novo Nordisk products. Compounding involves pharmacies combining active ingredients to meet specific patient needs.

Judge Petrus van Niekerk rejected that defense, ruling that the provision of the Medicines Act permitting limited compounding applies only where the same active ingredient appears in a registered medicine, not one that is merely similar. iDexis had used a synthetic chemical version of semaglutide, while Novo Nordisk's product is biological.

The court heard that the iDexis product had never been tested or approved by the South African Health Products Regulatory Authority (SAHPRA), and that its active ingredient had been sourced from undisclosed suppliers.

Van Niekerk said the court could not overlook findings from a SAHPRA inspection that identified serious deficiencies in quality, safety, and compliance, which supported Novo Nordisk's claims of illegality. He held that the interim interdict was necessary to prevent continued unlawful conduct and to protect public health.

The order will remain in force until SAHPRA and the South African Pharmacy Council conclude their investigations and any internal appeals, or until further court proceedings determine the parties' rights.