Novo Nordisk sues two pharmacies for allegedly selling tainted Wegovy, Ozempic knockoffs
Novo Nordisk sues two pharmacies for allegedly selling tainted Wegovy, Ozempic knockoffs

A 0.25 mg injection pen of Novo Nordisk’s weight reduction drug Wegovy is proven on this picture in Oslo, Norway, on Aug. 31, 2023.

Victoria Klesty | Reuters

Novo Nordisk on Thursday mentioned it sued two compounding pharmacies in Florida for allegedly selling impure and “doubtlessly unsafe” medicine claiming to include semaglutide, the lively ingredient within the drugmaker’s blockbuster weight reduction therapy Wegovy and diabetes treatment Ozempic. 

The actions come as Novo Nordisk grapples with shortages of Wegovy and Ozempic within the U.S. as demand skyrockets for the medicine, that are identified for their capacity to trigger important weight reduction. 

That has left sufferers scrambling to search out various, however typically harmful and unproven, strategies for shedding undesirable kilos.

Novo Nordisk is the only real patent holder of semaglutide and doesn’t promote that ingredient to exterior entities, which raises questions on what compounding pharmacies, clinics and different firms sell to patients. Compounding pharmacies put together custom-made variations of commercially accessible remedies to fulfill the precise wants of a affected person. 

The Danish drugmaker discovered that every one the merchandise examined from Wells Pharmacy Network and Brooksville Pharmaceuticals had been impure, which means that they contained unknown and unauthorized substances aside from semaglutide, in response to the two lawsuits filed in federal court docket in Florida. One product’s stage of unknown impurities was 33%.

The unknown impurities within the merchandise “doubtlessly pose security dangers” to customers, together with “presumably critical and life-threatening reactions,” Novo Nordisk mentioned within the fits.

The Danish drugmaker isn’t in search of financial damages however is asking the court docket to bar the pharmacies from selling their merchandise.

Wells Pharmacy Network and Brooksville Pharmaceuticals didn’t instantly reply to CNBC’s requests for remark.

Novo Nordisk first sued Brooksville Pharmaceuticals over copycat variations of Wegovy and Ozempic in July. A federal choose in Florida dismissed the go well with in October and later gave the drugmaker time to refile its grievance towards the pharmacy.

Including the most recent lawsuits, Novo Nordisk has filed 12 legal actions towards compounding pharmacies, medical spas and weight reduction clinics allegedly selling dupes of Wegovy and Ozempic. The firm mentioned it has acquired preliminary injunctions in six of these circumstances.

Rival Eli Lilly has taken comparable motion towards companies selling knockoffs of its fashionable diabetes drug Mounjaro, together with its personal lawsuit towards Wells Pharmacy Network. 

Novo Nordisk’s new go well with towards Wells Pharmacy Network claims that its merchandise contained a substance known as BPC-157, which was banned by the U.S. Food and Drug Administration in September. The FDA mentioned it didn’t have sufficient knowledge to know whether or not the substance was dangerous to people however famous it might trigger harmful immune system reactions.

Novo Nordisk added within the lawsuit that merchandise from Brooksville Pharmaceuticals had decrease ranges of semaglutide than marketed. That places sufferers “vulnerable to taking drug merchandise which can be much less efficient than anticipated primarily based on their labeling,” in response to Novo Nordisk. 

“Compounded merchandise do not need the identical security, high quality and effectiveness assurances as FDA-approved medicine, and adulterated and misbranded injectable compounded medicine might expose sufferers to important well being dangers,” Jason Brett, Novo Nordisk’s govt director of medical affairs, mentioned in an announcement. 

The FDA in May warned in regards to the security dangers of unauthorized variations of Ozempic and Wegovy after experiences emerged of antagonistic well being reactions to compounded variations of the medicine. 

Several states have additionally threatened to take authorized motion towards compounding pharmacies that make or distribute unapproved variations of Novo Nordisk’s weight reduction remedies.

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