After months of scarcity, all doses of Eli Lilly’s tirzepatide, branded as Zepbound for obesity and Mounjaro for diabetes, are now accessible in the U.S. Previously, the FDA’s database had listed certain doses of these medications as being in short supply up until last week. However, the FDA updated their status to available last Friday.
Eli Lilly is set to release its second-quarter earnings on Thursday. Given the recent supply issues and the strong demand for tirzepatide, it is anticipated that analysts will heavily scrutinize the sales and supply figures for Zepbound and Mounjaro. Earlier in the year, Eli Lilly increased its annual financial forecast by $2 billion, driven by the revenue generated from these drugs. In the first quarter alone, Zepbound and Mounjaro brought in $2.3 billion.
In an effort to meet the rising demand, Eli Lilly has been significantly expanding its production capabilities. This includes ramping up production at existing facilities, purchasing new factories, and constructing additional production sites. Despite these expansions, the demand for tirzepatide, along with Novo Nordisk’s rival drugs Ozempic and Wegovy, has remained exceptionally high, leading to ongoing supply challenges.
Nevertheless, according to the FDA’s latest update, Eli Lilly has managed to resolve the supply shortages for tirzepatide. On the other hand, several starter doses of Wegovy are still marked as having limited availability, with no clear timeline for when the shortage will end.
The improved supply situation for Zepbound and Mounjaro could have implications for telemedicine companies like Hims & Hers, which have been offering unbranded tirzepatide from compounding pharmacies at lower prices. Although Zepbound and Mounjaro are under patent protection, compounding pharmacies are allowed to produce drugs that are in short supply. Eli Lilly emphasized that compounding pharmacies cannot manufacture identical copies of FDA-approved drugs that are commercially available.
The tirzepatide shortage has also led to a rise in counterfeit or adulterated versions of the drug. Eli Lilly, along with the FDA and the World Health Organization, has warned consumers to avoid these potentially dangerous alternatives.