Eli Lilly is seeking to join a lawsuit brought by compounding pharmacies against the US Food and Drug Administration (FDA) over its decision that the company’s blockbuster weight-loss and diabetes drugs, Zepbound and Mounjaro, are no longer in short supply.
The FDA declined to comment on the motion filed by Lilly in Fort Worth, Texas federal court. The Outsourcing Facilities Association and a Texas compounding pharmacy also brought the lawsuit against the agency, seeking to allow them to sell cheaper versions of these drugs, which have the same active ingredient as approved medicines.
Lilly argued that it cannot rely on the FDA to defend its interests in the case, as it may appeal any ruling against it. The company believes that compounding pharmacies, particularly smaller facilities, may not manufacture compounded drugs even if there is a shortage, which could be at odds with the FDA’s view.
The lawsuit comes after the FDA decided there was no longer a shortage of tirzepatide drugs in October. However, the agency agreed to reconsider its decision but later reaffirmed that there is no shortage. The compounding industry still seeks a court order reversing the agency’s decision.
Lilly has been taking steps to combat the sale of compounded versions of Zepbound and Mounjaro, including sending cease-and-desist letters to telehealth companies, wellness centers, and medical spas selling these drugs. The company is seeking to join the lawsuit to defend its interests and protect its brand from unauthorized sales.
Source: https://www.cnbc.com/2025/01/02/lilly-asks-to-join-lawsuit-over-compounded-versions-of-its-weight-loss-drugs.html