The long-standing shortage of Novo Nordisk’s weight loss medication Wegovy and diabetes treatment Ozempic in the U.S. has finally come to an end, according to the U.S. Food and Drug Administration. After more than two years of limited availability, the FDA confirmed that Novo Nordisk’s supply and manufacturing capacity for semaglutide injections can now meet the current and future demand. This development could have significant implications for compounding pharmacies that have been producing cheaper, unbranded versions of these drugs during the shortage. As the FDA works to resolve the issue, these pharmacies will face challenges in continuing to make and distribute the compounded versions. Many patients had turned to unapproved semaglutide alternatives from compounding pharmacies as the only accessible option during the shortage, but the FDA’s decision to lift the shortage status means those medications must be phased out within 60 to 90 days, depending on the type of pharmacy.
Novo Nordisk’s stock saw a rise of about 5% following the announcement, while shares of telehealth company Hims & Hers, which had been offering compounded versions of Wegovy and Ozempic, dropped over 25%. The FDA noted that although the supply of semaglutide is now sufficient, localized disruptions may still occur as products move through the supply chain. The decision comes on the heels of a similar announcement regarding the shortage of Eli Lilly’s tirzepatide, used in its weight loss drug Zepbound and diabetes medication Mounjaro.
While the FDA’s announcement marks a milestone for Novo Nordisk, it also spells the end of a period during which compounding pharmacies were able to legally produce and dispense unapproved versions of semaglutide due to the shortage. Compounding pharmacies now have a limited window to stop manufacturing the unbranded versions of these drugs, although they can still create alternative formulations tailored to specific patient needs if changes are made to the drug’s dosage or ingredients.
For some patients, compounded versions had been the only affordable option, as Novo Nordisk’s drugs can cost around $1,000 per month. While Ozempic is typically covered by insurance, weight loss medications like Wegovy are often not covered by Medicare or other insurance plans.
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