In September, Eli Lilly took legal action against eight entities operating within the United States, alleging that these entities were engaged in the production or sale of compounded versions of their immensely successful diabetes drug, Mounjaro. A month has now passed, and Eli Lilly has escalated its legal campaign, targeting not just domestic entities but also venturing into the realm of online pharmacies, totaling 11 in number. These pharmacies, some of which are based overseas, are being accused by the pharmaceutical giant of importing, selling, or distributing unauthorized iterations of Mounjaro.
In a formal complaint submitted to the U.S. International Trade Commission, Eli Lilly has specifically identified three companies from China, three from Europe, and five from the United States. The commonality among them is the assertion that their products contain tirzepatide, the active ingredient within Mounjaro. However, Eli Lilly contends that these companies are infringing on their intellectual property and distributing what they characterize as “low-grade” versions of their acclaimed diabetes medication.
Eli Lilly’s concerns extend to the regulatory aspect, as they emphasize that the imported or distributed products in question are not subject to review by the FDA or any other global regulatory body. This lack of oversight raises issues related to safety, quality, and efficacy. Indeed, laboratory testing has indicated that at least one of the implicated companies claiming to retail tirzepatide was, in reality, marketing a product that consisted solely of sugar alcohol.
Apart from allegations of false and deceptive advertising, Eli Lilly has leveled accusations of trademark infringement against seven of the targeted entities. Furthermore, an additional seven are accused of engaging in “false designation of source,” misleadingly implying an association with Eli Lilly that is nonexistent.
In a separate development, the FDA acted against two online pharmacies in the United States, specifically Gorilla Healing and Semaspace. These companies were issued warnings by the FDA to cease the sale of unauthorized versions of Mounjaro and rival drugs from Novo Nordisk, namely Ozempic and Wegovy. These products were being sold without the requirement of a prescription which was a major concern.
The backdrop to these legal maneuvers is a surging demand for GLP-1 diabetes and weight loss medications, leading to substantial revenue increases in the industry. Notably, in the second quarter, both Novo Nordisk and Eli Lilly experienced remarkable year-over-year revenue growth, with Novo Nordisk leading at 32% and Eli Lilly closely following with a 28% increase.
During this period, Novo Nordisk’s trio of GLP-1 medications, which includes Ozempic, Wegovy, and Saxenda, achieved sales amounting to a staggering $4.8 billion. Simultaneously, Mounjaro’s sales reached an impressive $980 million in the same quarter.
