A 0.25 mg injection pen of Novo Nordisk’s weight reduction drug Wegovy is shown on this photo in Oslo, Norway, on Aug. 31, 2023.
Victoria Klesty | Reuters
Novo Nordisk on Thursday said it sued two compounding pharmacies in Florida for allegedly selling impure and “potentially unsafe” drugs claiming to contain semaglutide, the energetic ingredient within the drugmaker’s blockbuster weight reduction treatment Wegovy and diabetes medication Ozempic.
The actions come as Novo Nordisk grapples with shortages of Wegovy and Ozempic within the U.S. as demand skyrockets for the drugs, that are known for his or her ability to cause significant weight reduction.
That has left patients scrambling to search out alternative, but sometimes dangerous and unproven, methods for shedding unwanted kilos.
Novo Nordisk is the only patent holder of semaglutide and doesn’t sell that ingredient to outside entities, which raises questions on what compounding pharmacies, clinics and other corporations sell to patients. Compounding pharmacies prepare custom-made versions of commercially available treatments to fulfill the precise needs of a patient.
The Danish drugmaker found that every one the products tested from Wells Pharmacy Network and Brooksville Pharmaceuticals were impure, meaning that they contained unknown and unauthorized substances aside from semaglutide, based on the 2 lawsuits filed in federal court in Florida. One product’s level of unknown impurities was 33%.
The unknown impurities within the products “potentially pose safety risks” to consumers, including “possibly serious and life-threatening reactions,” Novo Nordisk said within the suits.
The Danish drugmaker will not be in search of monetary damages but is asking the court to bar the pharmacies from selling their products.
Wells Pharmacy Network and Brooksville Pharmaceuticals didn’t immediately reply to CNBC’s requests for comment.
Novo Nordisk first sued Brooksville Pharmaceuticals over copycat versions of Wegovy and Ozempic in July. A federal judge in Florida dismissed the suit in October and later gave the drugmaker time to refile its criticism against the pharmacy.
Including the latest lawsuits, Novo Nordisk has filed 12 legal actions against compounding pharmacies, medical spas and weight reduction clinics allegedly selling dupes of Wegovy and Ozempic. The corporate said it has received preliminary injunctions in six of those cases.
Rival Eli Lilly has taken similar motion against businesses selling knockoffs of its popular diabetes drug Mounjaro, including its own lawsuit against Wells Pharmacy Network.
Novo Nordisk’s latest suit against Wells Pharmacy Network claims that its products contained a substance called BPC-157, which was banned by the U.S. Food and Drug Administration in September. The FDA said it didn’t have enough data to know whether the substance was harmful to humans but noted it could cause dangerous immune system reactions.
Novo Nordisk added within the lawsuit that products from Brooksville Pharmaceuticals had lower levels of semaglutide than advertised. That puts patients “liable to taking drug products which can be less effective than expected based on their labeling,” based on Novo Nordisk.
“Compounded products would not have the identical safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” Jason Brett, Novo Nordisk’s executive director of medical affairs, said in a press release.
The FDA in May warned in regards to the safety risks of unauthorized versions of Ozempic and Wegovy after reports emerged of hostile health reactions to compounded versions of the drugs.
Several states have also threatened to take legal motion against compounding pharmacies that make or distribute unapproved variations of Novo Nordisk’s weight reduction treatments.
Don’t miss these stories from CNBC PRO: