United States: Eli Lilly executed legal proceedings against two medical centers that manufacture Zepbound and Mounjaro through compounding because these operations violate Food and Drug Administration medical preparation restrictions and attract patients from Lilly’s approved treatments.
Legal Action Against Pharmacies
On Tuesday, Lilly filed two court documents in Delaware and New Jersey against Strive Pharmacy and Empower Pharmacy for falsely advertising their untested compounded medicine that they portrayed as approved drugs from clinical trials.
Lilly has introduced multiple allegations demonstrating why individuals choose compounded drugs instead of taking regulatory-approved medications.
The companies Strive Pharmacy and Empower Pharmacy did not provide any response when CNBC requested comments.
Eli Lilly sues two pharmacies making copycat Zepbound, Mounjaro https://t.co/XVIscL4BCB
— CNBC (@CNBC) April 1, 2025
FDA Regulations and Compounding Practices
The FDA established last month that both compounding pharmacies and outsourcing facilities should stop creating their versions of tirzepatide because the brand-name products appeared out of shortage.
Some facilities have continued to compound medications by altering dosage levels and vitamin combinations, which enables them to work outside of the FDA ban against Lilly’s drugs.
Strive and Empower function as mass production facilities to make modified versions of tirzepatide that do not qualify as personalized medications, according to Lilly.
Large-scale compounding of branded drugs becomes possible during shortages of those specific products.
Special versions of medication exist for such unique personal needs as when patients suffer from ingredient allergies or require drugs in distinct dosage formats compared to existing commercial versions.
The companies Strive and Empower deliver tirzepatide through major telehealth providers, Lavender Sky Health and Mochi Health.
The mentioned companies failed to answer CNBC’s inquiries about their business activities.
Lilly faces its first judicial challenge against compounding pharmacies while having removed Zepbound and Mounjaro from the FDA’s shortage list.