Prime Highlights:
- Eli Lilly sued four telehealth firms for selling unauthorized compounded versions of its weight-loss medication, Zepbound.
- The firm alleges it is against FDA regulations and compromises patient safety after a drug shortage ceased.
Key Facts:
- Companies listed in the suit include Mochi Health, Henry Meds, Fella Health, and Willow Health.
- Compounded tirzepatide sold for approximately $99/month, significantly less than the $1,086 cost of Zepbound.
- Lilly asserts that these copies violate FDA policy and mislead customers.
Key Background :
Eli Lilly, the manufacturer of blockbuster weight-loss medication Zepbound, has ramped up its court battle to halt the sale of copycat versions of its drug. The company recently filed a series of lawsuits against four telemedicine companies—Mochi Health, Henry Meds, Fella Health, and Willow Health—accusing them of selling compounded forms of tirzepatide, Zepbound’s active ingredient, once the FDA’s emergency accommodation for compounding expired.
Tirzepatide was once in shortage, so the FDA permitted compounding pharmacies to make temporary substitutions. These were commonly used during the shortage since Zepbound was unavailable or too expensive for most patients, with compounded options selling for as little as $99 per month versus the regular price of more than $1,000. The FDA later announced in December 2024 that the shortage had ended and required a stop to new compounding by March 2025.
With the official supply back in action, Lilly asserts continued sales of compounded tirzepatide are unlawful. Their grievances explain how some of the companies allegedly changed ingredients or strengths, made unauthorized references to Lilly’s clinical information, and lied about FDA endorsement. For example, Mochi Health allegedly switched patients back and forth among different reformulated versions, Fella Health sold an unapproved oral pill formulation and proclaimed it superior to Zepbound.
The suits are the latest to be brought this month by Lilly against compounding pharmacies Strive and Empower. The firms have replied in defense of their actions, with Empower noting its goal is to enable patient care where there is a need. Compounding advocates, however, point out that such pharmacies play a genuine role, particularly when doctors prescribe customized versions for specific needs.
Nevertheless, Eli Lilly maintains that permitting mass-produced, unregulated duplicates of its medication endangers patients and erodes efforts to preserve safety standards. The court fight may establish a precedent in striking a balance between drug availability and the necessity to safeguard pharmaceutical patents and compliance with FDA regulations.
Read More – Click Here
