Eli Lilly’s blockbuster GLP-1 drug tirzepatide is finally back on track in the US after two years of intermittent shortages driven by high demand, the FDA said Wednesday.
Tirzepatide is sold as Mounjaro for type 2 diabetes and Zepbound for weight loss. The drugmaker first faced problems with the drug’s supply back in 2022 after Mounjaro’s approval, though the shortages have shown signs of easing in recent months, with certain doses being removed from the FDA’s shortage tracker in August.
The shortages have now been “resolved,” with Lilly confirming it can meet “present and projected national demand,” according to the FDA. The agency said some patients could still experience “localized supply disruptions” as the drugs make their way from manufacturers to pharmacies.
When medications are put on the FDA’s drug shortages list, compounding pharmacies can step in and make their own versions of the drugs. Given the popularity and demand of Lilly’s therapies in addition to Novo Nordisk’s Ozempic for type 2 diabetes and Wegovy for weight loss, several telehealth companies like Hims & Hers Health have marketed compounded versions of these drugs, particularly Novo’s semaglutide, since the shortages began.
In an emailed statement to Endpoints News, Lilly criticized the use of what it called “untested, unapproved knockoffs.”
“The entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately,” Eli Lilly said.
All doses of Novo’s semaglutide products, save for the lowest dose of Wegovy, are currently listed as available by the FDA. But the drug remains on the agency’s official shortage list.
Hims’ stock $HIMS was down about 9% in premarket trading on Thursday morning.
In the second quarter, Mounjaro brought in $3.1 billion in sales while Zepbound made $1.2 billion. In May, Lilly announced it is pouring $9 billion into a manufacturing site in Indiana to help boost its production of the drugs.
Patrik Jonsson“We know many people rely on our medicines,” Patrik Jonsson, president of Lilly Cardiometabolic Health and Lilly USA, said in a statement. “So we invested significantly to expand manufacturing and bring new options to the market.”
While selling compounded drugs is not illegal if the drugs in question are on the FDA’s shortages list, certain pharmacies, medspas and wellness centers have touted compounded versions of tirzepatide while passing them off as Lilly brands. In June, the drugmaker filed a fresh round of lawsuits against six of these alleged sellers and published an open letter that included images of real Mounjaro and Zepbound to help customers spot fakes.
The lawsuits in June follow a similar round of cases filed last fall, some of which have since been settled for undisclosed payments and corrective actions.
The FDA on Wednesday reiterated that compounded drugs are not technically FDA-approved.
Meanwhile, Lilly’s other GLP-1 drug dulaglutide — which is marketed as Trulicity — remains in short supply.
Editor’s note: This story has been updated with a statement from Eli Lilly.