The end of the tirzepatid shortage was a stressful moment for many patients taking the compounded version of the drug. As WIRED recently reported, many of these patients fear they won’t be able to afford or have access to brand-name versions of their medications. Although Eli Lilly recently introduced a recent, less high-priced version of Mounjaro and Zepbound (available in a vial instead of a pen), the monthly price, which ranges from $400 to $550 depending on the dose, is still significantly higher than many others in the vial range elaborate.
Some pharmacists say even people who want – and can afford – to switch to brand-name products may have trouble getting their medications right away. During an Oct. 9 roundtable hosted by the Alliance for Pharmacy Compounding, four pharmacists said they continue to have problems filling prescriptions for brand-name tirzepatid. “When the FDA determines something is missing, I expect to be able to source it,” Scott Welch, co-owner of Virginia-based Preston’s Pharmacy, said during the roundtable, explaining that he can’t buy brand-name products. Mounjaro or Zepbound from your wholesaler once the shortage ends.
The GLP-1 producing industry has already launched its own offensive to stay in business. Shortly after the shortage ended, a trade group called the Outsourcing Facilities Association formed filed a lawsuit in federal court in Texas against the FDA, affirmatively that tirzepatid is still in miniature supply and that the decision to officially end the shortage “abruptly deprives patients of much-needed treatment and artificially raises drug prices.”
Some telehealth companies selling compounded tirzepatid have introduced versions of the drug with other ingredients, including glycine, niacinamide and other B vitamins. Because these products are not technically direct copies of Eli Lilly’s offerings, some compounders may try to argue that they can still produce versions with additional dynamic ingredients. Lilly doesn’t think this is acceptable. “Because Lilly’s FDA-approved drugs are available, there is no basis for mass production or mass marketing of combination tirzepatid, alone or mixed with other ingredients,” Forbes says. “Some entities are trying to invent a new, unregulated way to mass produce unapproved medicines and circumvent the law by creating combination products mixed with another ingredient. This is not how our system works – there is no way to mass market unapproved drugs to the American public.”
Meanwhile, while Novo Nordisk’s GLP-1 drugs remain in miniature supply, the company recently opposed the utilize of combination semaglutide via publishing a peer-reviewed article in the journal Pharmaceutical Research on clinical testing of 26 samples of combination semaglutide. The study found that the samples were of “significantly poorer quality than stated on the labels” and contained contaminants such as trace metals and solvent residues. “The strength of many of the samples tested was significantly lower than that stated on the product labels, and some of these products contained ingredients banned by the FDA,” says Novo Nordisk spokesman Jamie Bennett.
With growing evidence that GLP-1s like tirzepatide are an effective treatment for conditions beyond obesity and diabetes – including addiction and Parkinson’s disease – demand can only be expected to augment. Time will tell whether pharmaceutical companies will be able to keep up with demand, or if drugs will once again become insufficient and manufacturers will be able to re-enter the market.