Novo Nordisk and Eli Lilly and Company (Lilly) have secured back-to-back victories in U.S. courts, cementing their dominance in the GLP-1 branded treatment market. Both companies have successfully thwarted attempts by generic drug manufacturers to produce and sell copycat versions of their obesity and diabetes medications.
Industry sources and international media reported on Tuesday that a federal court in Texas rejected a preliminary injunction request from the U.S. generic drug industry on April 25. The court upheld the U.S. Food and Drug Administration’s (FDA) decision to resolve the supply shortage of semaglutide, the active ingredient in the obesity drug Wegovy and the diabetes treatment Ozempic.
FDA officially declares end to semaglutide shortage in February
The FDA has a program that temporarily allows generic drug production during supply shortages to ensure patient access to treatments. In 2022, the FDA declared a semaglutide shortage and temporarily permitted generic manufacturers to produce it. However, in February, the FDA announced the shortage had been resolved and ordered generic production to cease.
The generic drug industry challenged the FDA’s decision, calling it arbitrary and capricious. In February, they filed a lawsuit in Texas federal court, seeking a preliminary injunction. This legal measure temporarily prohibits or mandates specific actions before a final ruling. The court dismissed the generic industry’s claim that semaglutide remains in short supply.
With this ruling, Wegovy and Ozempic generics production will officially stop. The FDA can now take action against 503A pharmacies (which compound medications for individual patients) and 503B large-scale outsourcing facilities. Enforcement will begin immediately for 503A pharmacies and from May 22 for 503B facilities.
Lilly also blocks the generic production of tirzepatide
The Texas federal court earlier rejected a preliminary injunction request from generic manufacturers in a lawsuit involving Lilly’s tirzepatide. This compound is the main ingredient in Zepbound and Mounjaro, recognized for their effectiveness in weight loss and diabetes treatment as GLP-1/GIP dual agonists. Lilly has successfully prevented the production of generics for these drugs as well.
GLP-1 treatments have gained recognition in recent years for their groundbreaking effects in obesity and diabetes management, leading to skyrocketing demand. As manufacturers struggled to meet this surge, the generic market expanded rapidly. Telehealth platforms like Hims & Hers facilitated widespread distribution of semaglutide and tirzepatide generics.
This court decision suggests that Novo Nordisk and Lilly will maintain their stronghold on the GLP-1 treatment market for the foreseeable future. Market research firm GlobalData valued the GLP-1 treatment market at 31.3 billion USD in 2023 and projects it to grow at an annual rate of 14.9%, reaching 125.3 billion USD by 2033.
