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Eli Lilly files US lawsuits over ‘unlawful’ sales of Mounjaro counterfeits

Lilly is the only FDA-approved company to legally sell products containing tirzepatide

Eli Lilly

Eli Lilly is suing ten medical spas, wellness centres and compounding pharmacies to stop the “unlawful marketing” and sales of products fraudulently claiming to be Mounjaro (tirzepatide).

Lilly said that it cannot validate the safety and effectiveness of products claiming to contain tirzepatide that are not branded by the company.

In four lawsuits filed in Florida and Texas federal courts, Lilly is seeking an order barring Better Life Pharmacy, ReviveRX, Rx Compound Store and Wells Pharmacy Network from selling tirzepatide, as well as requesting unspecified damages for violating federal and state consumer protection and competition laws.

In a statement, Lilly said that these entities “should be stopped from providing drug products in violation of consumer protection laws” particularly by promising patients “that their drugs offer the same safety profile and clinical benefits as Mounjaro”.

Similarly, the drugmaker is also seeking injunctive orders and damages against six medical spas and wellness centres from federal courts in Arizona, Florida, Georgia, South Carolina and Utah, claiming they infringe on its trademark by advertising compounded tirzepatide as Mounjaro.

In the lawsuits, Lilly said: “Defendants use Lilly’s trademark to attract customers and generate revenues and profits, including by passing off as ‘Mounjaro’ their own unapproved compounded drugs purporting to contain tirzepatide, and doing so for a use for which Mounjaro is not approved, namely weight loss.”

Mounjaro is a once-weekly glucose-dependent insulinotrophic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist to treat adults with type 2 diabetes when metformin, the main first-line medicine for type 2 diabetes, cannot be tolerated.

Since May 2022, Lilly has been the only company granted approval from the FDA to sell drugs containing tirzepatide.

Since then, Lilly has filed for FDA approval for the injections to be used for weight management.

Earlier this month, Mounjaro was recommended by the National Institute for Health and Care Excellence as a treatment for poorly controlled type 2 diabetes in adults, alongside diet and exercise.

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