US judge denies injunction, restricting copies of Lilly weight-loss drug

(This Mar. 6 story has been corrected to clarify that the judge denied an injunction, not barred copies, in the headline)

By Patrick Wingrove and Brendan Pierson

(Reuters) - 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.

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 drugs to fill prescriptions for individual patients and are primarily overseen by U.S. states, must immediately cease making copies of tirzepatide. The FDA has given larger so-called outsourcing facilities, which make compounded drugs in bulk and are regulated by the agency, until March 19.

The compounders argued in their lawsuit that the FDA relied solely on statements by Lilly in determining that there was no shortage, and that patients were still often unable to access the drugs. They asked U.S. District Judge Mark Pittman for a preliminary order barring the agency from taking enforcement action against them while their lawsuit went forward.

Wednesday's order from the judge rejecting that request was sealed and not available for review by Reuters or other parties, including the Outsourcing Facility Association.

"We are stunned by the judge's decision, but without the opportunity to review the sealed order, we cannot comment on why he made this decision," Lee Rosebush, chairman for the Outsourcing Facility Association, said in a statement, adding that the association was considering its options.

The FDA declined to comment. Lilly said the decision "marks the end of the road for mass compounding" of its drugs, and that it would work with regulators and law enforcement to stop the sale of these copies.

The FDA last month removed Novo Nordisk's competing drugs Wegovy and Ozempic from the shortage list, and compounders have sued the agency over that decision as well. The case remains pending.

Insurers generally cover Lilly's and Novo's drugs for diabetes, but many do not cover the weight-loss medications. That has led many patients to pay out of pocket for compounded versions, which are typically much cheaper.

(Reporting by Patrick Wingrove and Brendan Pierson in New York, Editing by Franklin Paul and Bill Berkrot)