Eli Lilly weight reduction drug Zepbound now not in shortage

The Food and Drug Administration on Thursday said the lively ingredient in Eli Lilly’s weight reduction drug Zepbound is now not in shortage, a call that can eventually bar compounding pharmacies from making cheaper, unbranded versions of the injection.

“FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved,” the agency said in a letter. “FDA continues to observe supply and demand for these products.”

The agency’s decision, based on a comprehensive evaluation, marks the top of a period where certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide – the lively ingredient in Zepbound – without facing repercussions for violations related to the treatment’s shortage status.

Compounding pharmacies must stop making compounded versions of tirzepatide in the following 60 to 90 days, depending on the sort of facility, the agency said. The FDA said that transition period will give patients time to modify to the branded version.

It is a blow to some compounding pharmacies, which say their copycat drugs help patients who haven’t got insurance coverage for Zepbound and may’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight reduction drugs will not be covered by many insurance policy, but Eli Lilly’s diabetes counterpart Mounjaro is.

It’s the newest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the lively ingredient in each Zepbound and Mounjaro. Eli Lilly has invested billions to expand its manufacturing capability for tirzepatide because it struggles to maintain pace with unprecedented demand.

A trade organization representing compounding pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists. It also contended that the FDA’s motion was a coup for Eli Lilly that got here on the expense of patients.

Following the suit, the FDA said it could reevaluate removing tirzepatide from the shortages list. That allowed compounding pharmacies to proceed making copycats while the agency reviewed its decision.

Compounded medications are custom-made alternatives to branded drugs designed to fulfill a particular patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug in the event that they meet certain requirements under federal law.

The Food and Drug Administration doesn’t review the security and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications after they can be found. 

Nevertheless, the FDA does inspect some outsourcing facilities that compound drugs, in accordance with its website.

Patients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per 30 days before insurance and other rebates. Many health plans don’t cover tirzepatide for weight reduction, making compounded versions a more cost-effective alternative.

The lively ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. However the FDA earlier this month said all doses of those drugs at the moment are available.

The agency has yet to announce whether it’s removing semaglutide from its shortage list — a call that may likely affect much more compounding pharmacies because it is more widely used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection within the U.S. and abroad, and Novo Nordisk and Eli Lilly don’t supply the lively ingredients of their drugs to outside groups. The businesses say that raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have each stepped in to deal with illicit versions of their treatments, suing weight reduction clinics, medical spas and compounding pharmacies across the U.S. over the past yr. The FDA last month also said it had received reports of patients overdosing on compounded semaglutide as a result of dosing errors resembling patients self-administering incorrect amounts of a treatment.