Glucagon-like peptide-1 (GLP-1) receptor agonists are a global phenomenon. These drugs treat type 2 diabetes and obesity by mimicking gut hormones that suppress appetite and regulate blood sugar (1). Pharmaceutical giant Novo Nordisk dominates the FDA-approved GLP-1 market with its products Ozempic® and Wegovy®, earning billions annually from these blockbuster medications (2).

In 2022, the public’s insatiable appetite for appetite-suppressing drugs created a demand that far outpaced supply. Consequently, the FDA placed both of Novo Nordisk’s blockbuster GLP-1 drugs on its Drug Shortage List, temporarily opening a regulatory window for compounding pharmacies to step in and make “essentially copies” to meet patient demand (3). Advertisements for compounded GLP-1 drugs soon appeared everywhere—from physician offices to national commercials.

But here’s the catch: these drugs are still covered by active patents. So how can compounding pharmacies legally produce them? The short answer: they cannot. Compliance with FDA rules may protect against regulatory action, but it offers no shield from patent infringement lawsuits.

Two Separate Legal Systems

Compounding pharmacies operate under two independent legal regimes.

• FDA Regulation – The FDA oversees drug safety and manufacturing. Under Section 506E of the Federal Drug & Cosmetic Act, it can temporarily permit compounding of “essentially copies” of FDA-approved drugs during a documented shortage (4). Normally, the compounding of such copies is prohibited because compounded drugs have not undergone the same rigorous testing as FDA-approved products and may carry a higher risk of harm to patients (5).
• Patent Law – Patent rights are governed by the Patent Act (35 U.S.C. §§ 1 et seq.), which grants patent holders the right to exclude others from making, using, or selling the patented invention.

These systems operate separately. While the FDA can authorize compounding of copies of GLP-1s, it cannot prevent a patent holder from bringing an infringement lawsuit.

The Compounding Pharmacies Activities Do Not Fall Within The Hatch-Waxman “Safe Harbor”

The Hatch-Waxman Act’s safe harbor provision (35 U.S.C. § 271(e)(1)) does not apply to compounding because it only protects activities involving patented drugs when they are conducted solely to generate data for FDA approval (6).

Courts have consistently held that this protection does not apply to commercial compounding. Pharmacies that sell compounded GLP-1 drugs directly to patients are engaging in present-day commercial activity rather than regulatory research. Because the activity is profit-generating, it falls outside the safe harbor and remains subject to patent infringement claims.

Historically, Patent Litigation Involving Compounding Pharmacies Has Been Rare.

Before the GLP-1 wave, patent owners seldom sued compounders directly for infringement, in part because mass compounding of patented molecules was not widespread or commercially significant (7). Traditional 503A compounding pharmacies mostly produced medications for individual patients in small quantities, so their sales had minimal financial impact on patent owners. Unlike today’s GLP‑1 market, most compounded drugs were low-margin generics or niche products. As a result, patent holders rarely pursued litigation, focusing their resources on competitors whose sales could meaningfully affect revenue.

The Current Wave Of GLP-1 Lawsuits Against Compounding Pharmacies

Novo Nordisk has filed approximately 130 lawsuits related to compounded semaglutide, spanning 40 states (8). Defendants include compounding pharmacies, medical spas, weight loss clinics, and telehealth platforms. The company alleges patent infringement, consumer fraud, trademark violations and deceptive marketing claims. Courts have already granted 44 permanent injunctions, barring defendants from engaging in illegal activities, such as unlawfully compounding semaglutide and falsely marketing these products as FDA-approved, safe, or equivalent to Novo Nordisk’s branded medications like Wegovy® and Ozempic®.

Trademark Rights: Adding Teeth To Enforcement

Pharmaceutical companies increasingly rely on trademark and unfair competition claims to stop the compounding of their drugs (9). These cases often focus on marketing practices—such as labeling compounded drugs as “generic” or equivalent to brand-name GLP-1s—which can improperly leverage established brand recognition.

Lanham Act claims for trademark infringement or false advertising allow companies to secure rapid injunctions stopping misleading marketing before patent cases are resolved.

These tools have become a key early enforcement strategy, complementing patent litigation.

The Economic Incentive

The scale of the compounded GLP-1 market helps explain the intensity of these legal disputes. Industry estimates place the U.S. compounded GLP-1 market at roughly $1–2 billion annually. Individual compounding pharmacies have reportedly generated $1–5 million per month in GLP-1 sales during periods of shortage (10).

The economics are compelling. Brand-name GLP-1 medications can cost more than $1,000 per month, while compounded versions often sell for $200–$400. Yet the active pharmaceutical ingredient used in each dose may cost only a few dollars when purchased in bulk. These margins have created strong incentives for pharmacies while pharmaceutical manufacturers seek to protect drugs developed through years of research and significant clinical investment.

Novo Nordisk Settles With Hims & Hers

In early February 2026, Novo Nordisk filed a federal lawsuit against telehealth provider Hims & Hers alleging that its compounded semaglutide products infringed U.S. patents on GLP‑1 medications such as Wegovy® and Ozempic®.

Shortly after the suit began—and amid increased FDA scrutiny of compounded GLP‑1 products—Hims abandoned its plan to sell the compounded pill and modified its approach. In March 2026, the two companies reached a settlement and collaboration: Hims agreed to stop advertising compounded GLP‑1 drugs and pivot to selling FDA‑approved branded GLP‑1 medications through its platform at established self‑pay prices (11).

The agreement marked a major shift from litigation to commercial partnership, showing that even a highly compliant, high‑visibility company like Hims & Hers could not sustain a mass‑compounding strategy in the face of patent and regulatory pressure.

Conclusion

The GLP‑1 compounding trend illustrates a critical point: following FDA rules does not provide immunity from patent law. Compounding pharmacies can meet regulatory standards and operate under 503B guidelines, but if they produce patented drugs without authorization, they remain liable for infringement. In addition, they may run afoul of trademark laws.

Contributed by Anna J. Sigmon – anna@rogowskilaw.com

References:

1. Moiz A., Filion K.B., Tsoukas M.A., Yu O.H., Peters T.M., & Eisenberg M.J., Mechanisms of GLP-1 Receptor Agonist–Induced Weight Loss: A Review of Central and Peripheral Pathways in Appetite and Energy Regulation, 138 Am. J. Med. 934 (2025), https://doi.org/10.1016/j.amjmed.2025.01.021.
2. S&P Global Market Intelligence, Pharma Giants Bet on Next-Generation GLP-1 Treatments to Sustain Growth (Mar. 26, 2025), https://www.spglobal.com/market-intelligence/en/news-insights/research/2025/03/pharma-giants-bet-on-next-generation-glp-1-treatments-to-sustain-growth.
3. Letter from the FDA to Novo Nordisk (Feb. 21, 2025), https://www.fda.gov/media/185526/download.
4. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (codified as amended in scattered sections of 21 U.S.C.), https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf.
5. S. Food & Drug Admin., Guidance for Industry: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Food, Drug, and Cosmetic Act (Jan. 2018), https://www.fda.gov/media/98964/download.
6. The Industrialization of Exceptions: When Compounding Crosses the Line from Patient Care to Patent Theft, DrugPatentWatch.com (Jan. 20, 2026), https://www.drugpatentwatch.com/blog/the-industrialization-of-exceptions-when-compounding-crosses-the-line-from-patient-care-to-patent-theft.
7. Shweta Kumar, Compounding Inequities Through Drug IP and Unfair Competition, 102 Wash. U. L. Rev. 371 (2024).
8. Novo Nordisk Expands Legal Action to Protect U.S. Patients from Unsafe, Non-FDA-Approved Compounded “Semaglutide,” PR Newswire (Aug. 5, 2025), https://www.prnewswire.com/news-releases/novo-nordisk-expands-legal-action-to-protect-us-patients-from-unsafe-non-fda-approved-compounded-semaglutide-302522326.html.
9. Semaglutide’s Removal from the FDA Shortages List Sets the Stage for More Novo Nordisk Lawsuits, Med. Econ. (Aug. 18, 2025), https://www.medicaleconomics.com/view/semaglutide-s-removal-from-the-fda-shortages-list-sets-the-stage-for-more-novo-nordisk-lawsuits.
10. In Earnings Call, Hims CEO Addresses Scrutiny of GLP-1 Compounding, StatNews (Feb. 23, 2026), https://www.statnews.com/2026/02/23/him-hers-earnings-2026-outlook-compounded-semaglutide/
11. Novo Nordisk Strikes Deal for Hims to Sell Wegovy and Ozempic, Drops Lawsuit, Reuters (Mar. 9, 2026), https://www.reuters.com/legal/litigation/novo-nordisk-strikes-deal-hims-sell-wegovy-ozempic-drops-lawsuit-2026-03-09/