This week, we had to mark the end of the complex pharmacy that created the copycat version. Ellie LilyBody weight loss drug Zepbound and its diabetes drug Mounjaro. It doesn’t seem to change much online.
Popular websites such as Amble, Elliemd, Willow and Mochi Health are still an advertising version of Tirzepatide, an active ingredient of Zepbound. Like IVIM, some have stopped taking new patients.
Mochi CEO Myra Ahmad said Mochi Health has no plans to stop and the same is true for four pharmacies used to supply drugs to patients. The company uses about 500 suppliers network to create a weight loss drug prescription, including a composite version. Providing a personalized version of the drug allows you to protect your company from cross Hair.
“This can be another medication schedule. Some patients prefer to go up much more slowly with dosage.” “Some patients like to mix several other drugs into a complex formulation depending on their side effects. Some patients have side effects as additives and brand name formulations. The complex actually opens the door for a lot of personalization.”
Amble, Elliemd and Willow did not respond to CNBC’s request.
Complex is a place where a pharmacy mixes the ingredients of the drug to create a special version for a particular patient. Someone is a brand drug that requires allergies to the dye or a liquid form, and the main manufacturer sells only capsules. In this case, the patient can switch to a composite version.
If the drug is insufficient, it can be combined in large quantities to fill the gap.
Lilly’s Mounjaro and Zepbound Copycat version Novo Nordic‘Wegovy and Ozempic have been widely available in recent years since the Food and Drug Administration has recently listed the brand version as a shortage of supply.
This created a rapid growth project for pharmacies that make GLP-1 a popular weight loss and complex diabetes drugs.
At the end of last year, however, the FDA was easily obtained with all capacity MOUNJARO and Zepbound, and took the drug from the list of insufficient drugs to spell the end of the mass complex of the drug. After months of legal issues, the FDA wrote a larger pharmacy until early March before the rules were implemented by early March.
More facilities can no longer combine the Tir discipleship. Small things should not be created in essence, a copy of the commercially available drugs. The FDA is deemed to have a combination of doses within 10% of the commercially available drugs or more than two commercially available drugs.
Mochi claims that all prescriptions are personalized, including standard Zepbound strengths and other doses. Other websites, such as Elliemd, are Tirzepatide ads mixed with vitamin B12.
Scott Brunner, CEO of the Pharmacy Synthetic Association, said that the universal formal or dosage strengths that were not commercially available were not considered a copy. However, combining two drugs, such as the addition of vitamin B6 or B12, is considered a copy after strictly reading the FDA guidelines. However, adjusting the dose and adding other commercially available drugs will not be considered an essential copy.
Brunner said, “FDA guidelines are clear about what copies are.” “And I will say that since today, a complex pharmacy or outsourcing facility that continues to prepare for a copy of Tyr Fade is in a legal danger.”
John Her, a pharmacist and owner of Town & Country Compounding Pharmacy, stopped the Tir prepared tide early this month. He did not want to take risks despite the fact that 300 to 400 patients made a non -stop call to complain about their loss of access.
Town & Country, headquartered in Ramsay, New Jersey, was charged with about $ 200 a month. This is less than half of Zepbound’s list price, and Lilly imposes a fee for their own payments.
The next thing that happens is an open question. Most of the prohibition on mass complexes of Tirzepatide falls to FDA. The agency did not immediately respond to CNBC’s request.
Lilly may try to sue the continued company, but in the past, he was not very lucky. Judge Florida last year Dismissal One of Lilly’s case is that the company tried to implement a law that could only do the FDA.
Mochi’s CEO, Ahmad, said Lilly is not worried about taking legal action against his supplier. In the way she sees it, they have established autonomy and patient-doctor relationships to determine how to manage the patient.
The next two months are beneficial. According to the FDA, according to the FDA, according to the FDA, the mass compound of Semaglutide, an active ingredient of Ozempic and WEGOVY of Novo Nordisk, must be stopped by the end of May.
HIMS & Health Already Sayed As time comes, we will stop selling semagluide with commercially available capacity. Customers with personalized medications can continue without any change, the company added.
– CNBC Leanne Miller Contributed to this report
Description: This story has been updated to clarify the opinion of Scott Brunner.
