Compounding GLP-1 medications, drugs related to immensely popular name-brand drugs such as Ozempic and Wegovy, has been going on since 2022 despite issued patents covering these name-brand drugs. This is because the FDA suspended enforcement of patents covering these name-brand drugs due to the inability of the drug owner and patent holder, Novo Nordisk, to meet the overwhelming demand for the drug. This enforcement suspension allowed state-licensed compounding pharmacies and outsourcing facilities, which make compounded drugs in bulk, to begin making their versions of these drugs. Compounding refers to the process of mixing, altering, or combining ingredients to create a medication, usually in tiny batches. Following this decision by the FDA, the industry exploded overnight with thousands of these facilities producing GLP-1 drugs.
On March 10, the FDA declared that the shortage was over and ordered the compounding pharmacies and outsourcing facilities to stop making them by April 22 and May 22, respectively. However, enforcement may be further delayed due to a requested injunction in a court case filed by the Outsourcing Facility Association against the FDA. If you’ve received a cease and desist letter, you’re not alone, as Novo Nordisk has wasted no time sending cease and desist letters to potential infringers.
Whether or not Novo Nordisk will ultimately be successful remains to be seen, as there will likely be multiple challenges to these patents and all of the ensuing enforcement actions.
Have you received a cease and desist letter from Novo Nordisk, or any other entity? Rest assured, the attorneys at Sandberg Phoenix are ready to help you understand your options and respond appropriately.
