This week was supposed to mark the end of compounding pharmacies making copycat versions of Eli Lilly‘s weight-loss drug Zepbound and its diabetes drug Mounjaro. Online, it doesn’t look like much has changed.
Popular websites like Amble, EllieMD, Willow and Mochi Health are all still advertising versions of tirzepatide, the active ingredient in Zepbound. Some, like Ivim, have stopped taking new patients.
Mochi Health has no plans to stop, and neither do the four pharmacies it uses to supply patients with the medications, said Mochi CEO Myra Ahmad. The company uses a network of about 500 providers to write prescriptions for weight-loss drugs, including compounded versions. It’s betting that offering personalized versions of the drugs will keep the company out of the crosshairs.
“It can be different dosing schedules … some patients prefer to go up in dosage much more slowly,” Ahmad said. “Some patients like to mix a number of other medications into their compounded formulations, depending on the side effects that they’re having. Some patients have side effects with any additives and brand name formulations. Compounding really opens up the door for so much personalization.”
Amble, EllieMD and Willow didn’t respond to CNBC’s request for comment.
Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients. Say someone is allergic to a dye in a branded medication or needs a liquid form and the main manufacturer only sells capsules. In that case, the patient can turn to a compounded version.
When drugs are in shortage, they can be compounded in larger quantities to help fill the gap.
Copycat versions of Lilly’s Mounjaro and Zepbound and Novo Nordisk‘s Wegovy and Ozempic have been widely available in recent years because the U.S. Food and Drug Administration listed the brand versions as being in short supply.
That created a booming business for pharmacies compounding the highly popular class of weight loss and diabetes medications called GLP-1s.
But late last year, the FDA said all doses of Mounjaro and Zepbound were readily available and took the drug off its shortage list, spelling the end for mass compounding of the drug. After months of legal challenges, the FDA gave smaller pharmacies until early March to stop and larger pharmacies until this week before it started enforcing its rules.
The larger facilities aren’t allowed to compound tirzepatide at all anymore. Smaller ones aren’t supposed to make products that are essentially copies of a commercially available drug, a moniker with some wiggle room. The FDA sees essential copies as those that have a dosage within 10% of the commercially available drug or combine two or more commercially available drugs.
Mochi insists all of its prescriptions are personalized, including doses that differ from the standard Zepbound strengths. Other websites like EllieMD are advertising tirzepatide mixed with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said formulations or dosage strengths that aren’t commercially available aren’t considered a copy. However, combining two drugs into one — like adding vitamin B6 or B12 — would be considered a copy under a strict reading of FDA guidance. But tweaking the dosage and adding in other commercially available drugs wouldn’t be considered an essential copy, he added.
“FDA guidance are pretty clear about what is and is not a copy,” Brunner said. “And I would say any compounding pharmacy or outsourcing facility that continues to prepare copies of tirzepatide injection after today are putting themselves in a certain amount of legal risks.”
John Herr, pharmacist and owner of Town & Country Compounding Pharmacy, stopped compounding tirzepatide earlier this month. He didn’t want to take the risk even though his 300 to 400 patients on it have been calling nonstop to complain about losing access.
Town & Country, based in Ramsey, New Jersey, was charging patients about $200 a month — about one-fifth the list price for Zepbound and less than half the price Lilly charges self-paying patients.
What happens next is an open question. Enforcing the ban on mass compounding of tirzepatide mostly falls to the FDA. The agency didn’t immediately respond to CNBC’s request for comment.
Lilly can try to sue companies that continue, but it hasn’t had much luck in the past. A Florida judge last year dismissed one of Lilly’s cases, saying the company was trying to enforce a law that only the FDA can.
Ahmad, the CEO of Mochi, said she isn’t worried about Lilly taking legal action against her providers. The way she sees it, they have established patient-physician relationships with the autonomy to decide how best to manage their patients.
The next two months will be informative. Mass compounding of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — needs to stop by the end of May, according to the FDA.
Hims & Hers Health has already said it will stop selling commercially available doses of semaglutide when the time comes. Customers who have a personalized dosing regimen will be able to continue without any change, the company added.
— CNBC’s Leanne Miller contributed to this report
Clarification: This story has been updated to clarify Scott Brunner’s comments.
