FDA Approves Wegovy GLP-1 Weight Loss Daily Drug
Wegovy’s daily pill form will soon be available to consumers after the FDA approves the drug.
Novo Nordisk announced on February 9 that it filed a federal lawsuit alleging that telemedicine service provider Hims & Hers infringed Novo’s patents by selling versions of the hit weight loss drug WeGoBe.
Novo’s lawsuit, filed in U.S. District Court for the District of Delaware, comes less than a week after Hims & Hers announced plans to sell a combination version of Novo’s weight loss drug Wegoby at an introductory price of $49 a month. The Food and Drug Administration has threatened to take action against Hims & Hers, and the company announced on February 7 that it would stop selling a combination version of its Wigovy tablets.
Novo’s semaglutide, sold under the Wegovy brand, is the only glucagon-like peptide-1 (GLP-1) drug approved as a pill for weight loss. Semaglutide is also sold under the brand name Ozempic for patients with type 2 diabetes.
Novo Nordisk’s lawsuit makes a broad attack on Hims & Hers, alleging that the telemedicine provider “is mass marketing unapproved copy versions of Wigobee and Ozempic that circumvent the FDA’s gold standard review process,” said John Kuckelman, Novo’s senior vice president and group general counsel. “This is dangerous, deceives patients, and undermines the scientific innovation and regulatory rigor that is in place to ensure these treatments are safe and effective.”
The Danish drugmaker said Hims continues to “illegally mass-produce complex injectable versions” of Novo’s FDA-approved injectables and that this practice “endangers the health and welfare of patients.”
Hims & Hers said in a statement that the lawsuit is a “blatant attack” on consumers who rely on compounded drugs.
“Once again, big pharmaceutical companies are using the U.S. legal system as a weapon to limit consumer choice,” Hims & Hers said. “This lawsuit does not attack just one drug or company; it directly attacks an established and important element of American pharmacy practice that has improved patient care for everything from obesity to infertility to cancer.”
The Food and Drug Administration has authorized compounding pharmacies to sell copies of drugs in case of drug shortages. In February 2025, the FDA declared the semaglutide shortage resolved and set a deadline for enforcement actions against pharmacies and facilities that essentially copied Novo’s drug.
On February 6, the FDA announced that it plans to restrict GLP-1 ingredients used in combination products and online pharmacies sold by Hims & Hers and other companies, citing quality, safety, and efficacy concerns.
