This week it would be the end of compiling pharmacies that make copycat versions of Eli LillyThe weight loss medicine Zepbound and his diabetes medicine Mounjaro. Online it does not look that much has changed.
Popular websites such as Amble, Elliemd, Willow and Mochi Health are all still advertising versions of Tirzepatide, the active ingredient in Zepbound. Some, such as Ivim, have stopped taking new patients.
Mochi Health has no plans to stop, and the four pharmacies that use it not to provide patients, said Mochi CEO Myra Ahmad. The company uses a network of around 500 providers to write recipes for weight loss medicines, including composite versions. It is bet that offering personalized versions of the drugs will keep the company out of sight.
“It can be different dosing schedules … Some patients prefer to go much slower in dosage,” said Ahmad. “Some patients like to combine a number of other medicines in their composite formulations, depending on the side effects they have. Some patients have side effects with additives and brand names formulations. Compounding really opens the door for so much personalization.”
Amble, Elliemd and Willow did not respond to CNBC's request for comments.
Compounding is where pharmacies mix ingredients from a medicine to make a specialized version for specific patients. Suppose someone is allergic to a colorant in a brand medication or needs a liquid shape and the main manufacturer only sells capsules. In that case the patient can turn to a composite version.
When medicines are in a shortage, they can be exacerbated in larger quantities to fill the hole.
Copycat versions of Lilly's Mounjaro and Zepbound and Novo Nordisk's Wegovy and Ozempic have been available on a large scale in recent years because the American Food and Drug Administration mentioned the brand versions as scarce.
This created a thriving company for pharmacies that worsen the very popular class of weight loss and diabetes drugs called GLP-1's.
But at the end of last year, the FDA said that all doses Mounjaro and Zepbound were immediately available and took the medicine of his shortage, the end of the end of the drug spells. After months of legal challenges, the FDA gave smaller pharmacies to stop until the beginning of March and larger pharmacies until this week before it started maintaining its rules.
Tirzepatide are no longer allowed to put together the larger facilities. Smaller may not make products that are essentially copies of a commercially available medicine, a name with some leeway. The FDA sees essential copies if they with a dose within 10% of the commercially available medicine or combine two or more commercially available medicines.
Mochi insists that all his regulations are personalized, including doses that differ from the standard Zepbound -strong points. Other websites such as Elliemd advertise tirzepatide mixed with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said formulations or dosing strengths that are not available on the market, are not considered a copy. Combining two medicines in one – such as adding vitamin B6 or B12 – would be considered a copy under a strict reading of FDA guidelines.
“FDA guidelines are quite clear about what is and is not a copy,” said Brunner. “And I would say that every composite pharmacy or outsourcing facility that continues to prepare copies of Tirzepatide injection after today brings itself to a certain amount of legal risks.”
John Herr, pharmacist and owner of Town & Country Compounding Pharmacy, stopped putting together Tirzepatide earlier this month. He did not want to take the risk, although his 300 to 400 patients called non -stop to complain about losing access.
Town & Country, based in Ramsey, New Jersey, patients charged around $ 200 a monthly one fifth The catalog price for Zepbound and less than half the price that Lilly himself pays.
What happens next is an open question. Forcing the ban on mass composition of tirzepatide usually falls to the FDA. The office did not immediately respond to CNBC's request for comments.
Lilly can try to sue companies that will continue, but it has not been very lucky in the past. A judge in Florida rejected one of Lilly's affairs last year and said that the company was trying to enforce a law that can only the FDA.
Ahmad, the CEO of Mochi, said she is not worried that Lilly is taking legal steps against her providers. The way she sees it, they have entered into patients-doctor relationships with autonomy to decide how to best manage their patients.
The next two months will be informative. Massa composition of Semaglutide – the active ingredient in the Ozempic and Wegovy of Novo Nordisk – must stop at the end of May according to the FDA.
HIMS & HARE HEALTH has already said that it will stop selling commercially available doses of semaglutide when the time comes. Customers with a personalized dosing regime can continue without any change, the company added.
-Cnbc's Leanne Miller has contributed to this report
