FDA says Wegovy and Ozempic shortage resolved; Hims & Hers stock falls

The Long-Running U.S. Shortage of Novo Nordisk’s Wegovy and Ozempic is Resolved

The U.S. Food and Drug Administration (FDA) has announced that the long-running shortage of Novo Nordisk’s blockbuster weight loss injection Wegovy and diabetes treatment Ozempic is resolved after more than two years. The shortage was caused by a surge in demand for the injectable drugs, which has led to a shortage of the active ingredient, semaglutide.

Threat to Compounded Medications

The FDA’s decision will pose a threat to the ability of compounding pharmacies to make cheaper, unbranded versions of Wegovy and Ozempic over the next few months. Many patients have relied on unapproved versions of the injections since compounding pharmacies are allowed to make versions of branded medications in short supply.

Impact on Stock Prices

Novo Nordisk’s stock closed about 5% higher on Friday, while shares of Hims & Hers, a telehealth company offering compounded Wegovy and Ozempic, fell more than 25%.

Background

The active ingredient in both Novo Nordisk’s injectable drugs, semaglutide, has been in shortage in the U.S. since 2022 after demand skyrocketed. This has forced Novo Nordisk and its rival Eli Lilly to invest heavily to expand their manufacturing footprints for their respective weight loss and diabetes drugs.

FDA’s Decision

The FDA determined that Novo Nordisk’s supply and manufacturing capacity for semaglutide injections can now meet the current and projected demand in the U.S. However, the agency noted that patients and prescribers may still see "intermittent and limited localized supply disruptions" as products move through the supply chain to pharmacies.

Conclusion

The FDA’s announcement marks the end of a period where compounding pharmacies could make, distribute, or dispense unapproved versions of semaglutide without facing repercussions for violations related to the treatment’s shortage status. Compounding pharmacies must stop making compounded versions of semaglutide in the next 60 to 90 days, depending on the type of facility, giving patients time to switch to the branded versions of the medications.

Frequently Asked Questions

Q: How will this impact patients who rely on compounded versions of Wegovy and Ozempic?
A: Patients who rely on compounded versions of Wegovy and Ozempic will need to switch to the branded versions of the medications, which may not be covered by their insurance.

Q: Will the FDA continue to allow compounding pharmacies to make unapproved versions of semaglutide?
A: No, the FDA’s decision marks the end of the period where compounding pharmacies could make, distribute, or dispense unapproved versions of semaglutide without facing repercussions for violations related to the treatment’s shortage status.

Q: What is the price of Novo Nordisk’s Wegovy and Ozempic?
A: The price of Novo Nordisk’s Wegovy and Ozempic is roughly $1,000 a month.