To what extent will health clinics go to keep selling in-demand weight loss drugs now that the FDA has outlawed cheaper compounded versions of the branded treatments?

According to a lawsuit filed by Eli Lilly on Monday, April 7, Premier Weight Loss, a spa based in Lilly's own backyard in Indianapolis, buys autoinjector pens filled with tirzepatide, cracks them open—breaking a sterile seal—and repackages them into lower unsterile doses.

Tirzepatide is the ingredient behind Lilly's major obesity and diabetes franchise Zepbound and Mounjaro and works as a long-acting GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagonlike peptide-1) receptor agonist. 

On its website, PWL offers deals for “brand name GLP-1 weight loss injections,” selling Lilly’s Zepbound for $350 a month and Novo Nordisk’s diabetes med Ozempic (semaglutide), which has also—against its drug label—been doubled up as a weight loss med, for $300 a month. 

In the complaint, which was filed in federal court in the Southern District of Indiana, Lilly says PWL’s advertising “explicitly contrasts the products it offers from the knock-off, untested, and unapproved products offered by other compounding pharmacies and med spas.”

The drugmaker says some sellers are trying to exploit concerns about the risks of compounded products by deceiving patients into believing they are selling FDA-approved treatments.

Lilly explained in the lawsuit that its tirzepatide products are factory-sealed, ensuring their safety and effectiveness. PWL can’t make the same claim by breaking them open and repackaging them. Lilly also claims that PWL actually is charging patients more for the repackaged 2.5-mg vials than it charges for its single-use Zepbound vials through its own LillyDirect program.

The lawsuit is another in a series of actions Lilly and Novo have taken against companies that are producing and selling knockoffs of their blockbuster drugs. Last week, Lilly sued two compounding pharmacies—Strive Pharmacy of Delaware and Empower Pharmacy of New Jersey—for making copycat versions of tirzepatide.

A month ago, a Texas court rejected a request by an association representing producers of compounded drugs to extend their ability to manufacture knockoff versions of Eli Lilly's tirzepatide while a lawsuit plays out.

The lawsuit stemmed from the FDA declaring in October that the shortage was over for tirzepatide and that compounders would have to stop manufacturing their versions of the treatment.