Novo Nordisk sues pharmacies over impure Wegovy, Ozempic dupes

Novo Nordisk on Thursday reported it sued two compounding pharmacies in Florida for allegedly offering impure and “possibly unsafe” medication saying to comprise semaglutide, the lively component in the drugmaker’s blockbuster fat decline treatment Wegovy and diabetic issues medication Ozempic. 

The steps appear as Novo Nordisk grapples with shortages of Wegovy and Ozempic in the U.S. as desire skyrockets for the medicines, which are recognized for their potential to trigger significant pounds reduction. 

That has still left individuals scrambling to locate alternate, but at times harmful and unproven, solutions for shedding undesirable lbs ..

Novo Nordisk is the sole patent holder of semaglutide and does not offer that component to exterior entities, which raises queries about what compounding pharmacies, clinics and other businesses market to clients. Compounding pharmacies prepare custom made-produced variations of commercially accessible remedies to meet up with the unique requirements of a affected person. 

The Danish drugmaker observed that all the merchandise analyzed from Wells Pharmacy Community and Brooksville Prescribed drugs were impure, this means that they contained unidentified and unauthorized substances other than semaglutide, in accordance to the two lawsuits submitted in federal courtroom in Florida. One particular product’s stage of unfamiliar impurities was 33%.

The unidentified impurities in the products “probably pose security hazards” to customers, such as “perhaps serious and lifestyle-threatening reactions,” Novo Nordisk mentioned in the satisfies.

The Danish drugmaker is not trying to find financial damages but is inquiring the court to bar the pharmacies from selling their products and solutions.

Wells Pharmacy Network and Brooksville Prescribed drugs did not instantly answer to CNBC’s requests for comment.

Novo Nordisk first sued Brooksville Pharmaceuticals in excess of copycat versions of Wegovy and Ozempic in July. A federal decide in Florida dismissed the suit in Oct and later on gave the drugmaker time to refile its criticism against the pharmacy.

Which includes the latest lawsuits, Novo Nordisk has filed 12 lawful actions against compounding pharmacies, professional medical spas and bodyweight loss clinics allegedly advertising dupes of Wegovy and Ozempic. The business stated it has acquired preliminary injunctions in 6 of individuals cases.

Rival Eli Lilly has taken comparable action against firms providing knockoffs of its well known diabetic issues drug Mounjaro, like its very own lawsuit against Wells Pharmacy Community. 

Novo Nordisk’s new match versus Wells Pharmacy Network promises that its merchandise contained a material identified as BPC-157, which was banned by the U.S. Foodstuff and Drug Administration in September. The Fda claimed it did not have sufficient knowledge to know regardless of whether the compound was damaging to humans but mentioned it could bring about hazardous immune system reactions.

Novo Nordisk included in the lawsuit that products from Brooksville Prescribed drugs experienced lower stages of semaglutide than advertised. That places individuals “at danger of having drug products that are considerably less productive than expected dependent on their labeling,” according to Novo Nordisk. 

“Compounded products do not have the exact same basic safety, excellent and success assurances as Fda-accredited medicines, and adulterated and misbranded injectable compounded medicines may possibly expose people to major health and fitness challenges,” Jason Brett, Novo Nordisk’s government director of healthcare affairs, said in a assertion. 

The Food and drug administration in May warned about the security pitfalls of unauthorized versions of Ozempic and Wegovy following reviews emerged of adverse health and fitness reactions to compounded versions of the medicines. 

Many states have also threatened to consider lawful action from compounding pharmacies that make or distribute unapproved variants of Novo Nordisk’s fat reduction remedies.

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