Compounded GLP-1 Drugs and Patent Law: The Novo Nordisk v. Hims & Hers Dispute

[1]

By now, many people are probably familiar with the class of medications known as glucagon-like peptide 1 (GLP-1) including widely known brand name drugs such as Ozempic or Wegovy.[2] These types of medicinal treatments burst onto the scene just a few years ago and have since become very popular within the pharmaceutical market.[3] The popularity of these products is attributed to the clinical effectiveness in promoting significant weight loss and treatment for diabetes.[4] As these drugs have gained significant attention and sales, companies in the healthcare industry have tried to take advantage of the rising need for GLP-1 treatments.[5] This fast-growing market has induced a high-profile legal battle between major pharmaceutical company Novo Nordisk and telehealth company Hims & Hers Health for patent infringement.[6] 

Major pharmaceutical companies were unprepared for the increased consumer demand for GLP-1 in 2024, leading to a major shortage of weight loss products.[7] Patients experienced substantial delays between prescription refills as well as major spikes in prices for the therapies.[8] To combat the shortage, the FDA labelled certain GLP-1 products as being “in shortage.” This designation allowed other pharmacies to create compounded versions of patent-protected, brand-name GLP-1 products until the shortage subsided.[9]

Compounded drugs are variations of the brand-name product with adjustments made to dosage size and ingredients to accommodate the needs of individual patients.[10] The provisions that allow for compounded versions of the GLP-1 products are section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. [11] However, the compounded versions of the GLP-1 products that mimic commercially available drugs have since lost the exception authorization due to no longer being in shortage and are no longer be permitted without patient specific need.[12]

Hims & Hers is a telehealth platform that connects patients with licensed providers through online consultations and prescription services.[13] The company began as a digital health startup but has quickly positioned itself as a cheaper option than traditional healthcare and prescription providers.[14] In early 2024, Hims & Hers attempted to take advantage of the opportunity to provide compounded versions of the profitable and highly sought-after GLP-1 weight loss products.[15] The Hims & Hers product was a compounded oral semaglutide pill, which was marketed as a lower-cost yet equally effective product compared to the name-brand GLP-1 injectable products offered by companies like Novo Nordisk.[16]  Despite showing efficacy comparable to brand-name GLP-1 medications and traditional oral semaglutides, Hims & Hers product did not receive FDA approval as compounded drugs generally do not undergo the FDA’s premarket approval process.[17] Unlike other FDA approved GLP-1 injectable therapies, such as Ozempic and Wegovy, oral semaglutide requires unique technology to ensure absorption, which Novo Nordisk patented after significant research.[18]

The launch of Hims & Hers compounded oral semaglutide captured the attention of lawmakers and other GLP-1 manufacturers because it circumvented the FDA approval process and directly competed with a patented product outside of a market shortage.[19] Accordingly, Novo Nordisk filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware, claiming that Hims & Hers oral semaglutide pill utilized proprietary chemical contents and patented technology.[20] Novo Nordisk alleged that its U.S. Patent No. 8,129,343 covered the semaglutide compound formulations as well as its oral delivery technology, and Hims & Hers marketed and sold products containing their patented material without authorization.[21] Novo Nordisk sought a permanent court order to stop Hims & Hers from selling unapproved compounded drugs that infringe on its patents, along with damages for lost revenue and market impact.[22]   

The Hims & Hers dispute highlights the enduring importance of intellectual property in protecting innovation, even in fast-moving markets.[23] It shows that companies seeking to replicate or bypass patented products face significant legal and financial consequences.[24] For innovators, regulators, and legal professionals alike, the case reinforces that respecting IP rights is essential to maintaining both market integrity and incentives for research and development.[25] 

References

[1] Photo by Haberdoedas, A Semaglutide Injector Pen is Shown, Unsplash (Apr. 29, 2025), https://unsplash.com/photos/a-semaglutide-injection-pen-is-shown-TzKc7FGaL7Y.

[2] See Annika Kim Constantino, Novo Nordisk Sues Hims & Hers Over Copycat Versions of Wegovy Drugs; Hims Stock falls 18%, CNBC (Feb. 9, 2026), https://www.cnbc.com/2026/02/09/novo-nordisk-sues-hims-hers-compounded-obesity-drugs.html

[3] See id.

[4] See Michael Erman, Hims & Hers GLP-1 Pill Gambit Backfires, Accelerating Crackdown on Drug Compounders, Reuters (Feb. 19, 2026), https://www.reuters.com/legal/litigation/hims-hers-glp-1-pill-gambit-backfires-accelerating-crackdown-drug-compounders-2026-02-19/

[5] See id.

[6] See The Complicated Legal Battle Between Novo Nordisk and Hims & Hers, The Fashion L. (Feb. 2026), https://www.thefashionlaw.com/the-complicated-legal-battle-between-novo-nordisk-and-hims-hers/.

[7] See Dae Y. Lee, Oral Semaglutide and the GLP-1 Compounding Reckoning: From Regulatory Ambiguity to FDA Enforcement, DOJ Referrals, and Novo Nordisk’s Case Against Hims & Hers, Buchanan Ingersoll & Rooney PC (Feb. 9, 2026), https://www.bipc.com/oral-semaglutide-and-the-glp-1-compounding-reckoning-from-regulatory-ambiguity-to-fda-enforcement,-doj-referrals,-and-novo-nordisk%E2%80%99s-case-against-hims-and-hers

[8] See Erman, supra note 4.

[9] See id.

[10] See Joseph Choi, Hims & Hers Under Fire Over Copycat Weight Loss Drugs, The Hill (Feb. 9, 2026), https://thehill.com/homenews/5744317-hims-hers-weight-loss-drugs/

[11] See id (outlining that provision 503A allows for patient-specific compounded versions of approved FDA drugs 503B allows for mass production of compounded drug therapies).

[12] See Erman, supra note 4

[13] See Understanding the Hims & Hers Telehealth Business Model, Bask Health (2026), https://bask.health/blog/hims-and-hers-telehealth

[14] See id.

[15] See Erman, supra note 4

[16] See Martha Rumore, FDA and Novo’s Uncharted Waters to Exert Pressure on Hims & Hers and GLP‑1 Compounders, Health Law Alliance (Feb. 16, 2026), https://www.healthlawalliance.com/blog/fda-and-novos-uncharted-waters-to-exert-pressure-on-hims-hers-and-glp-1-compounders

[17] See id.

[18] See The Complicated Legal Battle Between Novo Nordisk and Hims & Hers, supra note 6.

[19] See Erman, supra note 4

[20] See The Complicated Legal Battle Between Novo Nordisk and Hims & Hers, supra note 6.

[21] See Rumore, supra note 16.

[22] See Juliet Gallagher, Novo Nordisk Sues Hims & Hers as FDA Moves to Restrict Compounded GLP1 Drugs, HMP Global Learning Network (Feb. 10, 2026), https://www.hmpgloballearningnetwork.com/site/pln/news/novo-nordisk-sues-hims-hers-fda-moves-restrict-compounded-glp-1-drugs (alleging Hims & Hers pill infringed on patented compounds and posed safety risks to patients by avoiding regulatory scrutiny needed for effective oral semaglutide therapy).

[23] See GLP‑1 Gold Rush Meets Legal Reality: Novo Nordisk Challenges Compounded Alternatives, Hall Render (Mar. 5, 2026), https://hallrender.com/2026/03/05/glp-1-gold-rush-meets-legal-reality-novo-nordisk-challenges-compounded-alternatives/.

[24] See Erman, supra note 4

[25] See id.