South African court grants Novo Nordisk petition to block Ozempic copies

South Africa's High Court has granted an interim order to block a local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, a key ingredient in Novo Nordisk's Ozempic and Wegovy drugs.

South Africa's High Court on Monday granted an interim order to block a local pharmacy group from manufacturing and selling weight-loss medicines containing ‌semaglutide, the key ingredient in Novo Nordisk's Ozempic and Wegovy drugs.

Following an application from Novo, the court ruled that iDexis and its director must immediately stop compounding, supplying and marketing semaglutide-based products pending the outcome of further investigations. 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.

The Danish drugmaker's blockbuster diabetes drug Ozempic and weight-loss ‌drug Wegovy both have semaglutide as an active ingredient. Novo said it would issue a statement early on Tuesday, while the legal team for iDexis did not immediately respond to a request for comment.

COURT REJECTED SIMILARITY ARGUMENT FROM IDEXIS Novo told the Gauteng Division of the High Court in Pretoria that iDexis had been producing ⁠compounded semaglutide ​medicines at scale, supplying about 84,500 units ⁠each month, more than sales of Ozempic and Wegovy combined, and marketing them for weight loss despite lacking regulatory approval.

iDexis argued it could compound semaglutide because ⁠it used a similar ingredient to that found in Ozempic and Wegovy, which are registered. Compounding involves pharmacies mixing the active ingredients of a medicine to ​address specific patient needs. Judge Petrus van Niekerk rejected that argument, ruling that a section of the Medicines Act that allows ⁠limited drug compounding applies only where the same active ingredient appears in a registered medicine, not one that is merely similar.

iDexis used a chemical synthetic version of semaglutide, whereas 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 was sourced from undisclosed suppliers.

ORDER WILL REMAIN IN FORCE UNTIL INVESTIGATIONS FINALISED Van Niekerk also ⁠said the court could not ignore that a SAHPRA inspection had found serious deficiencies in quality, safety and compliance, in support of the ⁠illegality complaints of Novo Nordisk.

He held ⁠that the interim interdict was necessary to prevent ongoing illegality and to safeguard public health. The order will remain in force until SAHPRA and the South African Pharmacy Council finalise their investigations and ‌any internal appeals, or ‌until further court proceedings determine the parties' rights.