US judge bars copies of Lilly weight-loss drug

Brendan Pierson - Reuters - 06/03
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and diabetes drugs Zepbound and Mounjaro in the United States.
  • Small compounding pharmacies must halt selling copies immediately, larger facilities by March 19
  • Compounders argue FDA relied on Lilly for shortage figures
  • Separate lawsuit by compounders over Novo Nordisk's Ozempic and Wegovy remains pending
March 6 (Reuters) - A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's (LLY.N), opens new tab popular weight-loss and diabetes drugs Zepbound and Mounjaro in the United States.
The decision was filed late on Wednesday in response to an October lawsuit from a compounding industry group against the U.S. Food and Drug Administration's decision last year that there was no longer a shortage of the medicines' active ingredient, tirzepatide.
Compounders had been allowed to produce hundreds of thousands of doses of copies of obesity drugs only while the FDA said there was a shortage of them.
The Outsourcing Facility Association, the lead plaintiff in this case, has said its estimates put the number of people taking compounded tirzepatide in the millions.
Without a shortage, compounders may not produce copies of commercially available drugs regularly or in large amounts, according to FDA guidance.
The FDA had said it would not take any enforcement action against compounders before the court ruled.
Smaller compounding pharmacies, which make...
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