Hims & Hers $HIMS ( ▼ 10.81% ) built its brand on shaking up healthcare, but its latest move into copycat weight-loss pills has triggered a legal storm that could reshape the company’s future. After launching a version of Novo Nordisk’s new GLP-1 pill, Hims quickly pulled the product under FDA pressure only to be hit with a patent lawsuit from Novo days later.
The fallout has weighed on shares, which are now trading around the same level as before Hims first entered the GLP-1 copycat market in 2024.
From Growth Engine to Legal Headache
GLP-1 drugs have been a massive growth driver for Hims $HIMS. The company generated roughly $420 million in GLP-1 revenue in the first half of 2025 alone, nearly double what it made from those treatments in all of 2024.
But the company’s push into a pill version may have crossed a regulatory line. Unlike injectable GLP-1 copies, an oral version requires specialized absorption technology. Novo Nordisk’s pill uses patented SNAC tech to help semaglutide survive digestion. Hims’ partner pharmacy claimed it could replicate that using liposomal technology, but there are no public human trials showing that works for semaglutide.
Former FDA commissioner Scott Gottlieb suggested that if the technology truly differs, the pill could be considered an unapproved new drug, raising serious regulatory concerns.
When the DOJ Gets Involved, Stakes Go Way Up
The situation escalated quickly when a top Health and Human Services official referred Hims $HIMS ( ▼ 10.81% ) to the Department of Justice for a potential investigation into violations of federal drug laws. That move opens the door to civil or even criminal enforcement, a step beyond the FDA’s typical warning letters or recalls.
Legal experts say this dramatically raises the risk level. Title 18 statutes include federal criminal laws covering fraud and conspiracy, and in some cases executives can be held personally liable. In short, this is no longer just a regulatory scuffle — it’s potentially a courtroom battle with serious consequences.
Novo Nordisk $NVO Draws a Line in the Sand
At the same time, Novo Nordisk $NVO ( ▼ 0.51% ) filed a lawsuit accusing Hims of infringing on key patents tied to semaglutide, the active ingredient in Ozempic and Wegovy. Novo said Hims had already been pushing the limits with copycat injectables, but the pill launch was the tipping point.
Patent fights are risky for both sides. If Novo were to lose, it could threaten the strength of patents protecting some of its most valuable drugs. Still, the company says it’s confident in its IP and is prepared to pursue royalties and recover lost profits.
For Hims $HIMS, a company that built its image on challenging the system, the strategy may now be colliding with the legal and regulatory walls that protect the pharmaceutical industry’s most valuable innovations.