Hims & Hers launches Wegovy knockoff pill, Novo Nordisk vows to sue

Telehealth company Hims & Hers announced Thursday it will launch a lower-cost alternative to Novo Nordisk’s weight-loss pill Wegovy, intensifying competition in the rapidly expanding GLP-1 medication market.

The San Francisco-based company plans to offer a compounded version of semaglutide—the active ingredient in Wegovy—at $49 for the first month for new customers, followed by $99 per month thereafter. This pricing significantly undercuts Novo Nordisk’s recently introduced pill, which retails at approximately $149 monthly.

Novo Nordisk responded swiftly and forcefully to the announcement, threatening legal action against Hims & Hers. In a strongly worded statement, the Danish pharmaceutical giant described the competing product as “an unapproved, inauthentic, and untested knockoff” of semaglutide and vowed to “take legal and regulatory action to protect patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework.”

This confrontation marks the latest chapter in the ongoing tension between established pharmaceutical companies and telehealth providers entering the lucrative weight-loss drug market. GLP-1 medications, which mimic hormones that regulate appetite and insulin production, have transformed obesity treatment in the United States since their introduction.

Hims & Hers has been selling compounded versions of weight-loss drugs for several years, initially offering them only as injections. Novo Nordisk’s Wegovy represents the first GLP-1 medication to become available in pill form, a development that promises greater convenience for patients who prefer not to use injectable treatments.

The telehealth company’s aggressive move comes despite previous regulatory scrutiny. In September, the Food and Drug Administration (FDA) issued a warning letter to Hims & Hers concerning what regulators described as “false and misleading” marketing language that suggested its compounded products were equivalent to FDA-approved GLP-1 drugs.

In Thursday’s announcement, Hims & Hers carefully stated that its pill contains “the same active ingredient as Wegovy” while acknowledging that it is not “approved or evaluated for safety, effectiveness, or quality by the FDA”—language likely crafted to address previous regulatory concerns.

Compounded medications exist in a regulatory gray area. The FDA permits specialty pharmacies and other companies to produce compounded versions of brand-name drugs during supply shortages. The extraordinary demand for GLP-1 drugs in recent years created such shortages, opening the door for companies like Hims & Hers to enter the market.

However, earlier this year, the FDA began announcing that GLP-1 drugs were no longer considered to be in shortage—a development that was expected to curtail compounding practices. An important exception remains: compounding is still permitted when prescriptions are customized for individual patients.

Hims & Hers has positioned its offerings within this exception, emphasizing the personalized nature of its products. Dr. Craig Primack, who leads weight-loss products at Hims & Hers, highlighted this approach in Thursday’s statement: “Whether a patient needs a specific dosage adjustment or prefers a compounded semaglutide pill over an injection, our platform now supports a deeper level of personalization.”

The announcement had immediate market repercussions, with shares of Novo Nordisk A/S falling more than 8% in Thursday afternoon trading, reflecting investor concerns about potential competitive pressures on the pharmaceutical company’s flagship weight-loss products.

The dispute underscores the enormous financial stakes in the weight-loss medication market, which has grown exponentially as obesity rates continue to rise across the United States. Analysts project the GLP-1 drug market could reach $100 billion annually by the end of the decade, attracting both established pharmaceutical companies and newer telehealth providers eager to capture market share.

For consumers, the competition may bring more affordable options, though questions remain about the regulatory oversight and quality assurance of compounded alternatives compared to FDA-approved medications.