This week it was supposed to mark the end of compound pharmacies that make versions of imitation of Eli LillyThe Zepbound weight loss drug and its Mounjaro diabetes drug. Online, it does not seem that much has changed.
Popular websites such as Amble, Ellied, Willow and Mochi Health still announce Tirzepatide versions, the active ingredient in Zepbound. Some, like Ivim, have stopped taking new patients.
Mochi Health has no plans to stop, nor the four pharmacies he uses to provide patients with medications, said Mochi CEO, Myra Ahmad. The company uses a network of approximately 500 suppliers to write recipes for weight loss medications, including compound versions. It is to bet that offering personalized versions of drugs will keep the company out of the sight.
“It can be different dosing schedules … Some patients prefer to climb in a much more slow dose,” said Ahmad. “Some patients like to mix a series of other medications in their compound formulations, depending on the side effects they are having. Some patients have side effects with any additive and brand formulations. The compound really opens the door to so much customization.”
Amble, Ellied and Willow did not respond to the request for comments from CNBC.
The compound is where pharmacies mix the ingredients of a medication to create a specialized version for specific patients. Let's say someone is allergic to a dye in a brand medication or needs a liquid form and the main manufacturer only sells capsules. In that case, the patient can resort to a compound version.
When drugs are scarcity, they can be aggravated in greater quantities to help fill the void.
Imitation versions of Lilly's Mounjaro and Zepbound and Novo NordiskSogovy and Ozempic have been widely available in recent years because the United States food and medication administration listed the brands of the brand as scarce.
That created a booming business for pharmacies that aggravate the very popular class of weight loss and diabetes called GLP-1.
But at the end of last year, the FDA said that all the doses of Mounjaro and Zepbound were available and took the drug out of their shortage list, spelling the end for the massive composition of the drug. After months of legal challenges, the FDA gave smaller pharmacies until the beginning of March to stop and larger pharmacies until this week before it began to enforce its rules.
The largest facilities are no longer allowed to aggravate the Tirzepatide. They are not supposed to make products that are essentially copies of a commercially available medication, a nickname with a margin of maneuver. The FDA sees essential copies such as those with a dose within 10% of the drug commercially available or combine two or more commercially available medications.
Mochi insists that all his recipes are personalized, including the doses that differ from standard Zepbound strengths. Other websites such as Ellield are advertising Tirzepatide mixed with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compilation, said that formulations or dosing strengths that are not commercially available are not considered a copy. However, combining two medications in one, such as adding vitamin B6 or B12, a copy under a strict reading of the FDA guide would be considered.
“The FDA guide is quite clear about what it is and is not a copy,” Brunner said. “And I would say that any pharmacy or a compound outsourcing installation that continues to prepare Tirzepatide injection copies after today are putting themselves in a certain amount of legal risks.”
John Herr, a pharmacist and owner of Town & Country Componding Pharmacy, stopped aggravating Tirzepatide earlier this month. He did not want to run the risk even though his 300 to 400 patients have been calling without stopping to complain about losing access.
Town & Country, based in Ramsey, New Jersey, was charging patients around $ 200 per month, approximately a fifth at the price of the Zepbound list and less than half of the price, Lilly charges the paid auto patients.
What happens next is an open question. Making the prohibition of the massive composition of Tirzepatido mainly falls to the FDA. The agency did not respond immediately to the request for comments from CNBC.
Lilly can try to sue companies that continue, but he hasn't had much luck in the past. Last year, a Florida judge dismissed one of Lilly's cases, saying that the company was trying to enforce a law that only the FDA can.
Ahmad, Mochi's executive director, said she is not worried that Lilly takes legal actions against her suppliers. The way he sees it, have established medical relationships of patients with autonomy to decide the best way to manage their patients.
The next two months will be informative. The massive compound of the semaglutida, the active ingredient in the Ozempic and the Novo Nordisk grill, must be stopped at the end of May, according to the FDA.
Hims and his health He has already said that he will stop selling a commercially available dose of semaglutida when the time comes. Customers who have a personalized dosage regime may continue without any change, the company added.
-CNBC Leanne Miller Contributed to this report
