Novo Nordisk Drops Patent Suit as Hims & Hers Shifts to FDA-Approved Semaglutide Products

Key Takeaways

• Novo Nordisk and Hims & Hers reached an agreement expanding access to US Food and Drug Administration (FDA)-approved Ozempic (semaglutide) and Wegovy (semaglutide) via telehealth, prompting Novo to dismiss its patent infringement lawsuit related to compounded semaglutide marketing.
• Hims & Hers will discontinue advertising compounded GLP-1 products and transition patients to FDA-approved therapies at Novo’s self-pay prices, aligning with increased FDA enforcement.
• The deal reflects heightened regulatory scrutiny of compounded GLP-1 drugs and highlights growing convergence of patent enforcement, FDA oversight, and telehealth distribution in the evolving weight management market.

Novo Nordisk has reached an agreement with Hims & Hers Health that will expand patient access to FDA-approved semaglutide medicines through the telehealth platform—prompting Novo to dismiss its recently filed patent infringement lawsuit against the company.

The agreement, announced March 9, 2026, marks a significant pivot in the regulatory and commercial landscape for GLP-1 therapies. It follows heightened federal scrutiny of mass-marketed compounded semaglutide products and signals alignment between a branded manufacturer and a telehealth company previously targeted in both litigation and regulatory enforcement actions.

Hims & Hers to Transition Away From Compounded GLP-1 Offerings

Under the terms of the agreement, Hims & Hers will begin offering FDA-approved Ozempic (semaglutide) injection—0.5 mg, 1 mg, and 2 mg—and Wegovy (semaglutide) in both injectable (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg) and oral tablet (25 mg) formulations to US consumers at Novo Nordisk’s established self-pay prices.

Hims & Hers will discontinue advertising compounded GLP-1 products on its platform and in marketing materials. Existing patients using compounded semaglutide will have the opportunity to transition to FDA-approved alternatives, when clinically appropriate, in consultation with a licensed health care professional.

Novo Nordisk described the shift as a “meaningful win for patients,” emphasizing that expanded access through telehealth platforms allows more consumers to obtain medicines that have undergone FDA review for safety and efficacy.

In light of the agreement, Novo Nordisk is dismissing its patent infringement lawsuit against Hims & Hers, while reserving the right to refile in the future. The lawsuit, filed in February 2026, alleged infringement related to the marketing and sale of compounded semaglutide products.

Regulatory Backdrop: FDA Enforcement Against Compounded GLP-1 APIs

The announcement comes just weeks after the FDA stated its intent to take “decisive steps” to restrict GLP-1 active pharmaceutical ingredients (APIs) used in non-FDA-approved compounded drugs that were being mass-marketed as alternatives to approved products.

In a February 6, 2026 statement, FDA Commissioner Martin A. Makary, MD, MPH, warned that the agency cannot verify the “quality, safety, or efficacy” of these compounded products and that it would use all available compliance and enforcement tools—including seizure and injunction—against entities that fail to address violations of the Federal Food, Drug, and Cosmetic Act.

The FDA also reiterated that companies may not promote compounded drugs as generic equivalents to FDA-approved products, claim they contain the same active ingredient, or assert that they are clinically proven to produce comparable outcomes.

Against this regulatory backdrop, Hims & Hers’ decision to discontinue advertising compounded GLP-1 products and instead offer branded, FDA-approved therapies reflects a substantial shift in its GLP-1 business model.

Clinical Profile of Wegovy Pill and Injectable Semaglutide

Central to Novo Nordisk’s strategy is the expansion of the Wegovy pill (oral semaglutide 25 mg), the first and only oral GLP-1 receptor agonist approved in the US for chronic weight management.

In the phase 3 OASIS 4 trial, adults with obesity or overweight (without diabetes) who received oral semaglutide 25 mg achieved an average weight loss of 16.6% under the trial product estimand (assuming all patients remained on therapy), compared with 2.7% for placebo. When analyzed under the treatment policy estimand—regardless of treatment discontinuation—average weight loss was 13.6% vs 2.4% with placebo.

Additionally, 76% of participants receiving oral semaglutide achieved at least 5% weight loss, compared with 31% in the placebo group. The most common adverse reactions were gastrointestinal and consistent with those observed for injectable semaglutide, including nausea, diarrhea, and vomiting.

Wegovy is indicated, in conjunction with diet and exercise, for chronic weight management and to reduce the risk of major adverse cardiovascular events (MACE)—including cardiovascular death, myocardial infarction, and stroke—in adults with overweight or obesity and established cardiovascular disease. Ozempic is approved for adults with type 2 diabetes to improve glycemic control and to reduce the risk of MACE in those with established cardiovascular disease.

Implications for Telehealth and Compounding Practices

The agreement underscores the rapidly evolving enforcement environment surrounding compounded GLP-1 medications. During prior supply shortages, compounding activity expanded to meet demand for semaglutide-based therapies. However, as shortages have been resolved and FDA oversight has intensified, the legal and regulatory risks associated with mass marketing compounded GLP-1 products have grown.

By transitioning to FDA-approved branded products and discontinuing promotion of compounded alternatives, Hims & Hers appears to be recalibrating its compliance posture amid increased scrutiny from both federal regulators and branded manufacturers.

For pharmacies, telehealth platforms, and digital health companies, the episode illustrates the convergence of patent enforcement, FDA regulatory authority, and advertising compliance in the GLP-1 market. As FDA enforcement actions proceed and manufacturers actively protect intellectual property rights, the pathway for large-scale promotion of non-FDA-approved compounded GLP-1 products continues to narrow.

References

Novo Nordisk expands US patient access to FDA-approved semaglutide medicines through Hims & Hers in response to a shift in their US GLP-1 business model. Press release. Published March 9, 2026. Accessed March 11, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916512

Makary MA. FDA intends to take action against non-FDA-approved GLP-1 drugs. Press release. Published February 6, 2026. Accessed March 11, 2026. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs