U.S. Judge Upholds FDA’s Removal of Ozempic and Wegovy From Drug Shortage List

MARK TERRY, ESQ.

A federal judge upheld the FDA’s decision to remove Ozempic and Wegovy from the agency’s drug-shortage list, a ruling with significant consequences for pharmaceutical patents and market exclusivity.

During the shortage, qualifying compounding pharmacies were able to produce versions of semaglutide under shortage-related exceptions. Once the FDA determined that supply was sufficient and removed the drugs from the list, those exceptions narrowed substantially.

The court sided with the FDA and recognized the agency’s discretion to determine when a shortage has ended. The decision restores the ordinary regulatory and intellectual-property framework surrounding Novo Nordisk’s products.

For patent owners, the ruling reinforces that shortage exceptions are temporary and do not permanently displace patent rights. For compounders and generic manufacturers, it underscores the risk of continuing production after the statutory exception no longer applies.

The case also shows how manufacturing capacity and distribution can affect practical exclusivity. A renewed shortage could again alter the regulatory environment, making supply-chain planning an important part of pharmaceutical IP strategy.