Eli Lilly weight loss drug Zepbound is no longer available

On Thursday, the Food and Drug Administration said the active ingredient Eli Lilly This is the Zepbound weight loss drug there is no shortage anymorea decision that will ultimately bar pharmacies from making cheaper, unbranded versions of the shots.

“The FDA has determined that the shortage of tyrzepatide injectable that began in December 2022 has been resolved.” – the agency stated in the letter. “The FDA continues to monitor the supply and demand for these products.”

The agency's decision, based on a comprehensive review, ends the period during which some pharmacies could produce, distribute or dispense unapproved versions of tirzepatid, the active ingredient in Zepbound, without facing consequences for violations related to the drug's shortage status.

The agency said pharmacies must stop producing compounded versions of tirzepatid within the next 60 to 90 days, depending on the type of facility. The FDA said the transition period would give patients time to switch to the brand-name version.

That's a blow to some pharmacies, which say their copycats are helping patients who don't have Zepbound insurance and can't afford its high price of about $1,000 a month. Many insurance plans don't cover Zepbound and other weight-loss drugs, but Eli Lilly's diabetes drug Mounjaro does.

This is the latest result of a high-stakes dispute between pharmacies and the FDA over shortages of tirzepatid, the active ingredient in Zepbound and Mounjaro. Eli Lilly has invested billions to expand its production capacity for tyrzepatid as it tries to keep pace with unprecedented demand.

Industry organization associating pharmacies – Association of Outsourcing Facilities – defendant FDA on October 8 following the agency's decision to remove tirzepatid from its official drug shortage list just days earlier. The group maintains that the FDA acted without proper notice, ignoring evidence that shortages of tirzepatid persist. He also claimed that the FDA's action was a coup for Eli Lilly that came at the expense of patients.

Following the lawsuit, the FDA said it would reconsider removing tirzepatid from the deficiency list. This allowed compounding pharmacies to continue to follow suit until the agency reviewed its decision.

Compounded medications are custom-made alternatives to brand-name medications designed to meet a patient's specific needs. If a brand-name drug is unavailable, pharmacies can prepare copies of the drug if they meet certain requirements under federal law.

The Food and Drug Administration does not review the safety and effectiveness of combination products, but the agency does – consumers called taking approved, brand-name GLP-1 medications when available.

However, she says the FDA is inspecting some drug compounding outsourcing facilities website.

Patients have started using compounded versions of tirzepatid because of occasional shortages in the U.S. of the brand-name drugs, which cost $1,000 a month without insurance and other discounts. Many health plans do not cover tirzepatid for weight loss, making combination versions a cheaper alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been reported sporadically over the past two years. However, earlier this month, the FDA said all doses of these drugs were now available.

The agency has not yet announced whether it is removing semaglutide from the shortage list – a decision that will likely impact even more pharmacies because it is more widely used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients of their drugs to outside groups. Companies say so raises questions about what certain manufacturers sell and advertise to consumers.

Both Novo Nordisk and Eli Lilly have stepped in to address illegal versions of their treatments, sue at weight loss clinics, medical spas and pharmacies across the United States over the past year. Last month, the FDA also said yes reports received patients overdosed with combined semaglutide due to dosing errors, e.g. patients self-administering incorrect amounts of the drug.