Compounding

Hims keeps a narrow path to compounded GLP-1s under the settlement

Hims & Hers settled its patent fight with Novo Nordisk on March 9, 2026, agreeing to stop advertising compounded semaglutide and sell it only for patients whose needs a branded drug can't meet.

By the Semaglutides news desk·

Hims & Hers Health and Novo Nordisk announced on March 9, 2026, that they had resolved a patent dispute over compounded semaglutide, with Hims & Hers agreeing to carry Novo Nordisk's FDA-approved Ozempic and Wegovy products and to stop advertising compounded GLP-1 medicines [2]. Novo Nordisk is dismissing the patent infringement lawsuit it filed in February 2026, though it has reserved the right to refile [2].

Under the deal, Hims & Hers will offer Ozempic injection in 0.5 mg, 1 mg and 2 mg doses, Wegovy injectable in five strengths from 0.25 mg to 2.4 mg, and the Wegovy oral tablet at 25 mg, all sold at Novo Nordisk's established self-pay prices [2]. Patients currently using compounded semaglutide will have the option to move to an FDA-approved version "when clinically appropriate," in consultation with a licensed health care professional [2]. Compounded semaglutide is not disappearing from Hims & Hers entirely: the company can still supply it, but only where a branded product cannot meet a specific patient's clinical need, and only when the drug is made for that individual patient [1].

The settlement did not happen in isolation. On February 6, 2026, FDA Commissioner Martin Makary said the agency would take "decisive steps" against GLP-1 active ingredients used in mass-marketed compounded products it cannot verify for quality, safety or efficacy [2]. Weeks later, on March 3, 2026, the FDA made public 30 warning letters sent to telehealth companies and online clinics, alleging misleading claims that compounded GLP-1 drugs were equivalent to branded ones [1]. The letters, signed by Matthew Lash of the FDA's compounding compliance office, cite violations of federal drug-labeling law and give recipients 15 working days to respond or face possible seizure or injunction [1]. This followed roughly 100 cease-and-desist letters the agency sent in September 2025 [1].

Not everyone agrees with how the FDA is framing the issue. Scott Brunner, head of the Alliance for Pharmacy Compounding, said he was "puzzled" that the scale of a compounder's marketing, rather than whether it was truthful, seemed to matter to the commissioner, and noted that courts have limited how far the government can restrict truthful pharmacy advertising [1].

Why it matters for patients

For people currently using compounded semaglutide through Hims & Hers, the practical effect is a narrower and more individualized path to that option going forward. Compounded semaglutide will still be available in specific cases where a branded product doesn't fit a patient's clinical situation, but it can no longer be advertised, and any compounded prescription must be prepared for that particular patient rather than mass-produced [1].

Patients who switch to FDA-approved Ozempic or Wegovy will be paying Novo Nordisk's self-pay prices rather than the often-lower prices charged for compounded versions [2]. Novo Nordisk has described the move as expanding access to medicines that have gone through FDA review, while critics of the broader enforcement push argue that patients could lose access to lower-cost options that were not necessarily unsafe, just aggressively marketed [1].

What happens next

Companies that received the March 3, 2026 warning letters had 15 working days to respond to the FDA's compliance office or risk further action, including possible seizure or injunction [1]. Novo Nordisk has reserved the right to refile its patent suit against Hims & Hers if the settlement terms are not honored [2]. Whether this arrangement becomes a template other telehealth companies follow, or whether legal challenges over advertising restrictions emerge, is not yet known from the available sources [1].

Sources

  1. https://www.frierlevitt.com/articles/fda-warning-letters-hims-novo-nordisk-compounded-glp1/
  2. https://www.hmpgloballearningnetwork.com/site/pln/news/novo-nordisk-drops-patent-suit-hims-hers-shifts-fda-approved-semaglutide-products

Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.