The composite version of Wegovy and Ozempic of Novo Nordisk will be out of production soon. Litigation for these products is underway, but a federal court ruling in Texas means that complex pharmacies cannot continue to manufacture their products as legal proceedings continue.
U.S. District Judge Mark Pittman’s April 24 order was sealed. However, the decision consistently determined that the shortage of metabolic drugs has been resolved. The law allows for compound versions of branded drugs to be short of products.
Traditional composite pharmacies, also known as the 503A facility, are used to cover their food, medicines and cosmetics, and these drugs must be stopped immediately. These pharmacies are mainly regulated by the state pharmacy board.
Outsourcing facilities belonging to the 503B section of the code can produce more composite products and are subject to FDA supervision. When the FDA announced that it would address the shortage for Semaglutide, the agency provided the 503B facility until May 22 to stop making the composite version. The federal court’s ruling completes the expiration of this period of grace. After that, the FDA may take enforcement action against 503B regulated companies that continue to manufacture compound Semaglutide products.
The lawsuit raises doubts about the FDA ruling, brought by the Outsourcing Facilities Association, which represents 503B Facilities. Trade group chairman Lee Rosebush told Reuters that the association filed other evidence of a continued shortage following the lawsuit, but Pittman refused to consider that. Rosebush added that the association believes the data suggests the shortage remains.
Novo Nordisk said the FDA’s decision was based on a review of the company’s “stable and growing supply of FDA-approved drugs.”
“We are pleased that the court’s attempt to reject the compound’s attempt to undermine the FDA’s data-based ruling that the shortages of Wegovy® and Ozempic® have been resolved,” said Novo Novo Nordisk’s corporate vice president, U.S. law and general counsel in a prepared statement.
For much of the past two years, strong demand has surpassed Novo Nordisk’s ability to offer Ozempic and Wegovy, resulting in shortages of these products. Eli Lilly metabolic drugs Mounjaro and Zepbound are also lacking supplies. The ongoing shortage has opened the door for compounders to meet market demand through their versions of metabolized drugs.
Novo Nordisk and Lilly have been investing heavily in manufacturing capabilities to meet their product needs. While some of these capabilities have not yet been online, both pharmaceutical giants have increased production to alleviate shortages. Regarding Tirzepatide, the main pharmaceutical ingredient of Eli Lilly products, the FDA announced the shortage addressed last December. The FDA announced a shortage of Semaglutide products that was addressed in February.
Pharmaceutical manufacturers have also introduced lower cost options to better compete with compounds. Last summer, Lilly added the obesity drug Zepbound to LillyDirect, which is its direct access to the patient online platform. Novo Nordisk responded last month to Novocare, a new online pharmacy that provides Wegovy directly to qualified patients.
Photo: Mykola Velychko, Getty Images
