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Hims & Hers said it will launch a compounded, lower-priced pill version of Wegovy’s active ingredient semaglutide, drawing an immediate response from Novo Nordisk, which said it will pursue legal and regulatory action. The announcement came just weeks after Novo Nordisk launched a highly anticipated reformulation of Wegovy. The companies’ dispute is rooted in how compounded versions are treated under U.S. rules, and how much demand for GLP-1 weight-loss drugs has expanded in recent years.

Hims said the new product will be a compounded pill that uses “the same active ingredient as Wegovy,” while also saying it is not “approved or evaluated for safety, effectiveness, or quality by the FDA.” Hims has previously sold compounded GLP-1 products, but the company said Wegovy was the first of the medications to become available in a pill format, and its customers have responded to lower-cost alternatives.

The San Francisco-based company said the introductory offer would price the compounded pill at $49 for the first month, followed by $99 per month. The offer was designed to undercut Novo Nordisk’s $149 per month price for Wegovy, according to the announcement.

Novo Nordisk, the maker of Wegovy, said in a statement that it would take legal and regulatory action. The company said the product was “an unapproved, inauthentic, and untested knockoff” of semaglutide, the chemical name for Wegovy’s active ingredient, and added that it will protect “patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework.”

Hims also faced prior scrutiny from regulators. In September, the FDA issued Hims a warning letter over “false and misleading” marketing language regulators said suggested compounded products were the same as FDA-approved GLP-1 drugs. Despite those warnings, the company has continued to keep its products on the market, according to the AP report, in part because compounded drugs can be customized and are not subject to the same strict federal regulations as approved brand-name medicines.

The issue has gained urgency as the FDA began announcing in 2024 that GLP-1 drugs were no longer in shortage, a development that was expected to end compounding. But the AP report said compounding remains permitted under an exception: when a prescription is customized for a specific patient, specialty pharmacies and other companies can make compounded versions of brand-name drugs.

Hims said it has marketed a personalization rationale for its offerings. In a statement, Dr. Craig Primack, who heads weight-loss products at the company, said, “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,” and described the product as expanding how patients can choose between pill and injection formats.

The announcement also came as investors reacted to the prospect of renewed legal action. Novo Nordisk shares fell more than 8% in afternoon trading Thursday, according to the AP report.

Sources:

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