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

Novo Nordisk on Thursday mentioned it sued two compounding pharmacies in Florida for allegedly promoting impure and “probably unsafe” medicine claiming to include semaglutide, the energetic ingredient within the drugmaker’s blockbuster weight reduction remedy 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 recognized for his or her potential to trigger vital weight reduction. 

That has left sufferers scrambling to seek out various, however generally 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 outdoors entities, which raises questions on what compounding pharmacies, clinics and different corporations promote to sufferers. Compounding pharmacies put together custom-made variations of commercially out there remedies to satisfy the particular wants of a affected person. 

The Danish drugmaker discovered that each one the merchandise examined from Wells Pharmacy Community and Brooksville Prescription drugs have been impure, that means that they contained unknown and unauthorized substances aside from semaglutide, in keeping with the 2 lawsuits filed in federal courtroom in Florida. One product’s degree of unknown impurities was 33%.

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

The Danish drugmaker will not be looking for financial damages however is asking the courtroom to bar the pharmacies from promoting their merchandise.

Wells Pharmacy Community and Brooksville Prescription drugs didn’t instantly reply to CNBC’s requests for remark.

Novo Nordisk first sued Brooksville Prescription drugs 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 criticism in opposition to the pharmacy.

Together with the most recent lawsuits, Novo Nordisk has filed 12 authorized actions in opposition to compounding pharmacies, medical spas and weight reduction clinics allegedly promoting dupes of Wegovy and Ozempic. The corporate mentioned it has acquired preliminary injunctions in six of these instances.

Rival Eli Lilly has taken comparable motion in opposition to companies promoting knockoffs of its widespread diabetes drug Mounjaro, together with its personal lawsuit in opposition to Wells Pharmacy Community. 

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

Novo Nordisk added within the lawsuit that merchandise from Brooksville Prescription drugs had decrease ranges of semaglutide than marketed. That places sufferers “susceptible to taking drug merchandise which might be much less efficient than anticipated based mostly on their labeling,” in keeping with Novo Nordisk. 

“Compounded merchandise don’t have the identical security, high quality and effectiveness assurances as FDA-approved medicine, and adulterated and misbranded injectable compounded medicine might expose sufferers to vital well being dangers,” Jason Brett, Novo Nordisk’s government director of medical affairs, mentioned in a press release. 

The FDA in Could warned concerning the security dangers of unauthorized variations of Ozempic and Wegovy after reviews emerged of hostile well being reactions to compounded variations of the medicine. 

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

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