This week was supposed to mark the end of compound interest for pharmacies making copycat versions Eli LilyWeight loss drug Zepbound and its diabetes drug Murujaro. Online, it doesn’t seem to be much different.
Popular websites such as Amble, Elliemd, Willow, and Mochi Health are all advertising versions of Tirzepatide, the active ingredient in Zepbound. Like IVIM, some have stopped taking new patients.
Mochi Health has no plans to stop, and there are no four pharmacies to use to supply patients with medication, according to Myra Ahmad, Mochi CEO. The company uses a network of around 500 providers to create weight loss drug prescriptions that include combined versions. It’s a bet to keep the company out of the crosshairs by offering a personalized version of the drug.
“It could be a different dosing schedule… Some patients prefer to increase the dosage more slowly,” Ahmad said. “Some patients want to mix many other drugs into a combined formulation depending on the side effects. Some patients have side effects with additives and branded formulations.
Amble, Elliemd, and Willow did not respond to CNBC’s request for comment.
The formulation is where pharmacies mix the ingredients of the drug to create a specialized version for a particular patient. Let’s say someone is allergic to dyes with branded medicines or needs a liquid form, and the main manufacturer only sells capsules. In that case, patients can rely on the combined version.
If you’re short on drugs, you can add a lot of compounding interest to fill the gap.
Lily’s Maunyaro and Zepbound copycat version Novo NordiskWegovy and Ozempic have been widely available in recent years, as the US Food and Drug Administration listed brand versions as lacking.
It created a booming business for a highly popular class of weight loss and pharmacies compounding diabetes medications called GLP-1.
However, late last year, the FDA said that all doses of Mounjaro and Zepbound were readily available, removing the drug from its shortage list and spelling out the end of the drug’s mass compound. After months of legal challenges, the FDA gave them a smaller pharmacy to be suspended until early March, and this week they gave them a larger pharmacy until before the rules began to be implemented.
Large facilities are not permitted to compound tilzepatide at all. Smaller ones are not intended to produce products that are essentially copies of over-the-counter drugs. The FDA considers it to be a person with a dosage within 10% of over-the-counter drugs, or a combination of two or more over-the-counter drugs.
Mochi claims that all of its prescriptions are personalized, including doses that differ from standard Zepbound strength. Other websites like Elliemd advertise tilzepatides mixed with vitamin B12.
Scott Brunner, CEO of Alliance for Pharmacy Counting, said that the strength of unmarketed formulations or doses is not considered a copy. However, combining two drugs into one, such as adding vitamin B6 or B12, is considered a copy based on a strict reading of the FDA guidance.
“The FDA guidance is pretty clear about what it is, not copying,” Bruner said. “And I think that from today onwards any combined pharmacy or outsourcing facility that continues to prepare copies of tilzepatide injections is at some level of legal risk.”
John Herr, a pharmacist and owner of Town and Country Parainering Pharmacy, stopped concoctions with tilzepatide earlier this month. He didn’t want to take a risk, despite calling non-stop to complain about 300 to 400 patients losing access.
Town & Country, based in Ramsey, New Jersey, had charged patients about $200 a month. Zepbound’s regular price is about a fifth, and Lily charges self-paid patients.
What happens next is an open question. Enforcement of the ban on mass harmony of tilzepatide is primarily classified as the FDA. The agency did not immediately respond to CNBC’s request for comment.
Lily can try and sue the ongoing companies, but she hasn’t had much luck in the past. A Florida judge dismissed one of Lily’s cases last year, saying the company is trying to enforce laws that only the FDA can make.
Mochi CEO Ahmad said he was not worried about Lily taking legal action against the provider. The way she saw it, they established autonomy and patient-doctor relationships and decided on the best way to manage patients.
The next two months will be beneficial. According to the FDA, a mass blend of Novo Nordisk’s Ozempic and Wegovy’s active ingredients, Semaglutide (Novo Nordisk’s Ozempic and Wegovy’s active ingredients) is required.
Hims & Hers Health They have already said they will stop selling commercial semaglutide when the time comes. Customers with a personalized dosing regimen can continue without any changes, the company added.
-CNBC’s Leanne Miller contributed to this report
