01:02 PM EST, 03/06/2025 (MT Newswires) -- Eli Lilly's ( LLY ) sought-after weight-loss and diabetes drugs, Zepbound and Mounjaro, cannot be replicated by compounding pharmacies, Reuters reported Thursday, citing a ruling by a US federal judge that upheld a decision by the US Food and Drug Administration last year.

The agency removed the active ingredient of both drugs, tirzepatide, from its shortage list in October, which prompted compounding pharmacies, with the Outsourcing Facility Association as the lead plaintiff, to file a lawsuit against the decision in the same month, according to a legal document. Compounders are allowed to copy branded medicines as long as the agency rules that there is a shortage.

The lawsuit said that there is still a shortage of the ingredient and alleges that the agency's "sole consideration in deciding the shortage had ended was information provided by the manufacturer."

Smaller compounding pharmacies must immediately stop making copies of tirzepatide, while the larger facilities, which make compounded drugs in bulk and are regulated by the agency, must desist by March 19, according to the report.

Lilly said in a statement to Reuters that the decision "marks the end of the road for mass compounding" of its medicines, and that it would work with authorities to halt the sale of the copies.

The Food and Drug Administration did not immediately reply to a request for comment from MT Newswires.

(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

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