Houston-based Empower Pharmacy is one of two compounding pharmacies sued by the pharmaceutical giant Eli Lilly earlier this month for allegedly selling "knockoff" versions of its weight loss and diabetes drugs.
Eli Lilly filed the lawsuit against Empower Pharmacy in the District Court of New Jersey on April 1. According to court documents, Eli Lilly accuses Empower Pharmacy of allegedly selling potentially dangerous versions of its drugs Mounjaro and Zepbound — two injectable medications containing Tirzepatide. Empower Pharmacy produces both an injectable and tablet form of its Tirzepatide drug.
"Empower makes and sells two tirzepatide knockoff drugs that deceive consumers into believing they are purchasing medicines that are safe and effective to treat their obesity," Eli Lilly claims in the lawsuit. "Tirzepatide is the active ingredient found in Lilly's Mounjaro and Zepbound, which are the only FDA-approved Tirzepatide medicines."
Eli Lilly claims that since Empower's "Tirzepatide ODT" has not gone through the same approval process, it is potentially unsafe.
"Tirzepatide ODT, by contrast, is an untested knockoff that exposes patients to safety risks without any clinical data showing that it even works," Eli Lilly claims in the lawsuit. "By selling Tirzepatide ODT, Empower is essentially conducting a mass testing experiment on consumers."
Empower Pharmacy did not immediately respond to a request for comment Tuesday, but claims on its website that it is an FDA-registered 503B outsourcing facility. According to the FDA, outsourcing facilities that comply under section 503B are not required to receive FDA approval of their compounded drug products.
However, the FDA also said that 503B "Registration of an outsourcing facility does not mean that FDA has determined that the outsourcing facility is in compliance with CGMP requirements or that it has met the conditions for its drug products to qualify for the exemptions under section 503B."
On April 2, the FDA sent a warning letter to Empower Pharmacy claiming that it failed to meet the conditions of section 503B following an inspection.
Eli Lilly's legal actions against Empower and other compounding pharmacies come several months after the FDA announced that a shortage of Mounjaro and Zepbound hadbeen resolved.
Mounjaro and Zepbound gained immense popularity in 2024 after the drugs' ability to promote weight loss.
This caused a nationwide shortage of the drugs. In response to the shortage, the FDA permitted compounded versions of the brand-name drugs to be produced, according to theAssociated Press.
In a statement to Houston Public Media, an Eli Lilly spokesperson said Empower Pharmacy had already been told by the FDA to stop production of its Tirzepatide ODT.
“FDA and a federal court have both made clear that compounders ‘must cease production’ of compounded tirzepatide knockoffs,” the spokesperson said in a statement. “Anyone continuing to sell mass compounded tirzepatide, including by referring to it as ‘personalized,’ ‘tailored’ or something similar, is breaking the law and deceiving patients. We will continue to take action to stop these illegal actors and urgently call on regulators and law enforcement to do the same.”
In February, several compounding pharmacies sued the FDA for removing Mounjaro, Zepbound and other similar name-brand medications from the shortage list, according to Reuters.
As of Tuesday, Empower Pharmacy had not filed a response to Eli Lilly's lawsuit. The Houston-based pharmacy has until April 24 to respond, court records show.
Eli Lilly also sued Strive Pharmacy for similar accusations.
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