Novo Nordisk wins case to kick knockoff Ozempic off the market, but it may not last

Novo Nordisk (NVO) won a cardinal lawsuit Thursday to halt immoderate compounding pharmacies from selling knockoff versions of its blockbuster GLP-1 drugs. But it won't extremity each compounding offerings.

The institution said successful a connection Friday that the ruling successful Texas national tribunal opens the doorway for the US Food and Drug Administration to instrumentality enactment against compounding pharmacies, which are expected to halt selling compounded semaglutide — the progressive constituent successful diabetes cause Ozempic and weight-loss cause Wegovy — adjacent month.

That was the deadline acceptable by the FDA erstwhile it declared an extremity to a shortage of the drugs past year. The justice denied the compounders' efforts to frost the FDA's determination to extremity the shortage altogether.

The Outsourcing Facilities Association, a compounding manufacture commercialized group, said successful a connection Friday it was disappointed by the ruling but intends to support warring done the ineligible process and successful discussions with the FDA.

Compounders and telehealth providers person continued their offerings for some Novo's semaglutide and Eli Lilly's (LLY) tirzepatide — the cardinal constituent successful diabetes cause Mounjaro and weight-loss cause Zepbound.

But Lilly precocious sued telehealth platforms that were selling its compounded products.

Telehealth and different online platforms similar Lemonaid, Ro, and Hims & Hers (HIMS) connection compounded semaglutide — and could beryllium legally allowed to proceed to bash truthful contempt the Texas ruling.

That's due to the fact that determination are 2 antithetic types of compounding pharmacies, 503A and 503B, based connected the FDA regulations that govern their operations. The second is impacted by the ruling, according to manufacture experts.

The 503As, however, could exploit a loophole: They tin inactive marque semaglutide copies that are not "essential copies" of the drug. That means they tin marque a mentation of semaglutide that is not identical oregon astir identical to Ozempic and Wegovy.

While the FDA allows this, it besides warns connected its website, "Although compounded drugs tin service an important need, they tin besides airs a higher hazard to patients than FDA-approved drugs."

Hims owns 503A pharmacies for compounding the GLP-1s, truthful it could proceed to connection them if the formulas are not indispensable copies.

Ro besides uses 503A pharmacies, but it is unclear if they nutrient the semaglutide that Ro offers.

In a connection Friday, Ro said, "We volition proceed to enactment to guarantee that our patients tin entree the champion treatments for their idiosyncratic needs and goals, and travel applicable FDA rules and regulations connected compounding."