Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom

After Novo Nordisk’s diabetes bell cow ran short amid an off-label weight-loss craze, Ozempic—also known as semaglutide—is back on the menu. Mostly.

Ozempic, which has been in short supply for some six months, is once again available in two common, lower doses, according to the U.S. Food and Drug Administration’s drug shortage database. A third higher dose will maintain limited availability through the end of the month.

Novo Nordisk confirmed the restocking in an emailed statement. A company spokesperson credited continued constraints on the higher 2 mg Ozempic dose to “the combination of incredible demand coupled with overall global supply constraints.”

Separately, all doses of Eli Lilly’s rival med to Ozempic—known as Mounjaro (tirzepatide)—are also listed as available by the FDA. Back in November, Lilly warned that its incretin-based diabetes drugs Trulicity and Mounjaro would suffer supply woes in the U.S.

Novo and Lilly's new diabetes drugs have been at the center of a social media craze over their potential to help people lose weight. Illustrating the ubiquity of Ozempic’s off-label use, the drug even became the butt of a joke at the Oscars this year.

Meanwhile, the Ozempic shortfall dovetailed with a paucity of Novo Nordisk’s approved obesity drug Wegovy last year. Wegovy—which is also girded by the semaglutide molecule, albeit at a higher dose—shook off its supply woes around the new year.

Given both drugs utilize the same molecule, social media influencers and celebrities last year started touting Ozempic for its impressive weight-loss effects.

Of course, Novo would prefer people use its drugs as intended.

“[W]hile we recognize that some healthcare providers may be prescribing Ozempic for patients whose goal is to lose weight, Novo Nordisk does not promote, suggest, or encourage off-label use of our medicines,” a company spokesperson recently told Fierce Pharma.

Given the monumental demand for Novo and Lilly’s meds, both companies have made major commitments to manufacturing and supply in recent months.

Novo executives in early February said the company was continuing to scale up Wegovy manufacturing and in March revealed a land purchase in North Carolina, where the company has facilities producing obesity and diabetes meds.

Lilly, for its part, also re-upped its production commitments in the Tar Heel State, where the company telegraphed a $450 million upgrade to its diabetes drug plant in January. That project, which will add at least 100 employees, is designed to help meet an expected surge in demand for Mounjaro this year.

As Lilly expands production capacity, the company is awaiting the FDA's decision on a Mounjaro application in obesity. That decision is expected by the end of the year.

Overall, Novo and Lilly are looking at a massive opportunity in weight loss, with a market that could range in value from $30 billion to $50 billion by 2030, according to multiple analysts.