A US judge has denied a bid by compounding pharmacies to continue making copies of Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy. The decision comes after a February lawsuit from the Outsourcing Facilities Association, which claimed there was still a shortage of the medicines’ active ingredient semaglutide.
Compounders, also known as compounding pharmacies, had been allowed to produce hundreds of thousands of doses of the copies while the FDA said they were in short supply. However, US District Judge Mark Pittman has rejected their request for a preliminary injunction, meaning that large compounders must exit the market by May.
The decision follows another ruling by the judge earlier this year, which refused to allow compounding pharmacies to make copies of Eli Lilly’s weight-loss and diabetes drugs Zepbound and Mounjaro. Novo Nordisk has filed 111 lawsuits in federal courts across 32 states against entities unlawfully marketing and selling compounded semaglutide.
The FDA had given larger compounders until May 22 to continue making the medicine, but smaller pharmacies must immediately stop. Analysts expect Novo Nordisk to generate $20.1 billion from Ozempic sales and $14.79 billion from Wegovy sales this year.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/ozempic-copies-restricted-after-us-judge-denies-injunction-2025-04-24