Eli Lilly & Co. Files Lawsuit Against Two Generic Drug Manufacturers for Copycat Adipotide, Stirring up the Weight Loss Drug Market Again

Pharmaceutical giant Eli Lilly and Company (LLY.US) will file lawsuits against two companies on Tuesday, accusing them of illegally compounding their blockbuster drug - tirzepatide, a glucagon-like peptide-1 (GLP-1) / glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. The two pharmacies being sued by Eli Lilly are Strive Pharmacy in Gilbert, Arizona and Empower Pharmacy in East Windsor, New Jersey. These two cases will be filed in federal courts in Delaware and New Jersey respectively. Tirzepatide is the active ingredient in Zepbound for weight loss and Mounjaro for treating type 2 diabetes. In the lawsuit against Strive Pharmacy, Eli Lilly pointed out, "The information conveyed by Strive to consumers is inevitably that its products are more tailored for individual consumers compared to products from 'large pharmaceutical companies,' and that Strive's treatment plans are more suitable for patients, thus leading to better treatment outcomes. However, these claims are neither true nor substantiated." In the lawsuit against Empower Pharmacy, Eli Lilly accused the pharmacy of referencing Eli Lilly's own research on tirzepatide. Despite Empower's version of the drug being in tablet form, or being an injection with niacinamide (an additive not present in Eli Lilly's Zepbound and Mounjaro). Eli Lilly also sent cease-and-desist letters to about 50 compounding pharmacies and telemedicine companies, requesting them to confirm that they have stopped compounding tirzepatide on a large scale. During the shortage of tirzepatide, compounding pharmacies were allowed by law to compound the drug into compounded formulations. The Food and Drug Administration (FDA) announced in October 2024 that the tirzepatide shortage issue had been resolved, and in December rejected the objections of the compounding pharmacy trade organization, upholding its decision. Eli Lilly's competitor Novo Nordisk A/S Sponsored ADR Class B (NVO.US) also faced a shortage of the GLP-1 drug semaglutide, sold as Wegovy for weight loss and Ozempic for treating type 2 diabetes. Currently, this shortage issue has also been resolved. The FDA has announced that action will be taken against outsourcing facilities producing tirzepatide after March 19. For semaglutide, this date is after May 22. Empower claims on its website that, "It is still legal to produce improved compounded formulations of tirzepatide and semaglutide to meet the special needs of patients." This could involve adding vitamin B that "may provide additional metabolic benefits," or making the drugs into orally disintegrating tablets. Strive states on its website about tirzepatide, "This compounded drug should only be used when commercial products are unavailable, or when a prescribing physician determines a clinically significant difference for the patient."