Blockbuster weight-loss and diabetes drugs Wegovy and Ozempic are no longer in shortage, the US Food and Drug Administration said on Friday.
The update about the popular semaglutide injections from drug manufacturer Novo Nordisk follows just two months after the FDA said that shortages of tirzepatide injections Zepbound and Mounjaro from competitor Eli Lilly had also ended.
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” Dave Moore, president of Novo Nordisk Inc., said in a statement Friday.
GLP-1 drugs had been in shortage since 2022 due to increased demand, and a law allowed compounding pharmacies to step in to fill supply gaps during those years. Compounded drugs use the same active ingredients but are made by pharmacies or manufacturers other than the companies that make FDA-approved versions of the medicines. This enabled thousands, or even millions, of people to access costly GLP-1 medicines at a lower price point.
The end of the shortage would effectively bar the sale of compounded versions of the drugs, but the FDA said that they do not plan to take any action against compounding pharmacies for 60 to 90 days.
“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies,” the FDA said on Friday.
The FDA announced a similar policy for pharmacies making tirzepatide compounds when that shortage was resolved in December. In August, drug manufacturer Eli Lilly began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro, according to Reuters. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug.
On Friday, drug manufacturer Novo Nordisk warned in a news release that the “FDA’s decision means that making or selling a knockoff compounded drug that is essentially a copy of Ozempic or Wegovy is illegal.”
The company has already filed more than 100 lawsuits related to “copycat” semaglutide products, most under claims of false advertising or deceptive and unfair trade practices.
“No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients,” company president Moore said in a statement Friday.
The FDA has issued safety warnings about some compounded versions of semaglutide. The agency said that it received reports of adverse events in people who used compounded semaglutide and that patients “should not use a compounded drug if an approved drug is available.”
But the Outsourcing Facilities Association, a trade group representing companies that make certain compounded medications, has sued the FDA over its removal of tirzepatide from the shortage list claiming that it happened “without notice, without soliciting input from affected parties and the public, and without meaningful rationale.”
Olympia Pharmaceuticals says that they provide compounded GLP-1 medications – the vast majority of which are semaglutide – to tens of thousands of patients each week, and there hasn’t been sufficient reassurance for prescribers to feel confident that supply is strong enough to meet demand.
“Our biggest concern would be that patient continuity of care. If we were to no longer be able to dispense this to patients, that Novo Nordisk and these brand name suppliers are able to pick up that demand where we left off,” said Josh Fritzler, chief financial officer with Olympia.
While the “national GLP-1 supply begins to stabilize,” the FDA notes that some other products – including dulaglutide injections sold under the brand name Trulicity and some liraglutide injections – remain in shortage.
