Eli Lilly's Legal Battle Against Fake Compounded Tirzepatide Products: Bacteria, Impurities Detected

Eli Lilly And Co LLY revealed on Thursday that it has identified bacteria and elevated impurity levels in products falsely claiming to be compounded versions of tirzepatide, the active ingredient in its widely-used diabetes medication Mounjaro and the weight loss treatment Zepbound. 

The U.S. pharmaceutical giant has taken legal action against numerous medical spas, weight-loss clinics, and compounding pharmacies to halt the sale of these fraudulent products. 

Related Content: Eli Lilly’s Commercial Moat, Competitor Landscape: BofA Emphasizes Strength in Incretin Space, Undervalued Assets.

Compounded drugs, custom-made medicines with the same ingredients as branded versions, offer a potentially cheaper alternative but are subject to less regulatory oversight.

Citing an open letter, Reuters noted that Eli Lilly highlighted that some of the contested products not only differed in chemical structure but also exhibited a distinct color from the approved versions of Mounjaro or Zepbound. 

The company discovered that in at least one case, the purported tirzepatide product was nothing more than sugar alcohol.

The Alliance for Pharmacy Compounding, representing compounding pharmacists and technicians, has yet to respond to the allegations. 

While the United States permits licensed pharmacies to produce compounded drugs legally during shortages of the branded version, Eli Lilly clarified that it does not supply tirzepatide to any compounding pharmacies.

In December, its rival Danish firm Novo Nordisk A/S (NYSE: reported discovering up to 33% impurities in some samples of compounded semaglutide, emphasizing the growing concern over the authenticity and safety of such products.

Eli Lilly is aggressively pursuing collaborations with outsourcing partners to ramp up the production of its obesity drug, Zepbound (tirzepatide), as it inks deals with key players such as National Resilience and BSP Pharmaceuticals for the filling and “finishing” of its injector pens.

Price Action: LLY shares are up 0.41% at $783.00 on the last check Thursday.

Read Next: Ozempic, Wegovy And Other Weight-Loss Drugs Won’t Solve Global Obesity Crisis Affecting 1B People, WHO Warns.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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