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Small compounding pharmacies must halt selling copies

immediately, larger facilities by March 19

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Compounders argue FDA relied on Lilly for shortage figures

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Separate lawsuit by compounders over Novo Nordisk's

Ozempic and

Wegovy remains pending

By Patrick Wingrove and Brendan Pierson

March 6 (Reuters) - A U.S. federal judge has refused to

allow compounding pharmacies to keep making copies of Eli

Lilly's ( LLY ) 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.