So You Want to Compound a Patented Drug? A Legal Survival Guide for the Brave, the Bold, and the Bewildered
On February 9, 2025, I was watching Super Bowl LIX. On came a commercial by Him & Hers offering to deliver weight loss medications to your door.[1] And they looked a lot like Ozempic® and Wegovy®. Being a pharma patent geek watching with another pharma patent geek, we stopped talking about using MALDI-TOF in infringement analyses and started asking a question that Novo Nordisk single-handedly made vogue last week.
Why don’t compounders run afoul of patent law all the time? Or do they?
Welcome to the delightful intersection of patent law and Food and Drug Administration (FDA) compounding law—a place where legal certainty goes to die and pharma lawyers play. If you’ve ever wondered whether the FDA giving you a green light to compound a drug also means you won’t get sued into oblivion by the patent holder, buckle up. Spoiler alert: it likely does not, but more on the “likely” part later.
The Great Regulatory-Patent Paradox: Or, How, Like Schrödinger’s cat[2], to Be Legal and Liable at the Same Time
When is it legal under FDA regulations but still potentially infringing under patent law to compound a drug? The likely answer: always.
Here’s how it works. Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) establish a regulatory framework for compounders.
Section 503A governs traditional compounding by state-licensed pharmacies and physicians. A pharmacy may compound drug products for an identified individual patient based on a valid prescription from a prescribing practitioner indicating that the compounded product is necessary for the identified patient.
Section 503B governs outsourcing facilities, which are FDA-registered facilities that may compound drugs on a larger scale without patient-specific prescriptions. But they must register with FDA and adhere to Current Good Manufacturing Practices (cGMPs). In essence, 503B outsourcing facilities bridge the gap between traditional compounding pharmacies and commercial drug manufacturing.
But both face a significant restriction on compounding a product that is “essentially a copy” of a commercially available drug. “Essentially a copy” is generally defined as identical or nearly identical to an FDA approved drug.[3] FDA recognizes a major exception to the “essentially a copy” restriction: when the FDA approved drug appears on the “drug shortage list” at the time of compounding, distribution, and dispensing.[4] You see, when the FDA places a patented blockbuster drug on its shortage list, it effectively hands compounders a regulatory permission slip. “Go ahead,” FDA says, “make copies of that commercially unavailable drug. Patients need access!” What FDA doesn’t say—because it cannot—is “And don’t worry about that pesky patent still protecting the drug until 2032.”
The FDA, bless its regulatory heart, has no jurisdiction over patent law.[5] It cannot grant a “safe harbor” from infringement liability, no matter how many helpful guidance documents it publishes. So, what we have is a beautiful legal contradiction: an action that is permissible under sections 503A and 503B may simultaneously constitute patent infringement under the U.S. Patent Act.
According to the World Intellectual Property Organization (WIPO), over 85 countries and territories exclude in some way compounding from patent infringement, recognizing that patents shouldn’t stand between physicians and their patients’ health needs.[6] The United States, in its infinite wisdom, is not among WIPO’s list. The Hatch-Waxman Act provides a limited research exemption for generic drug development, but compounding? Sorry, that’s not in the statute.[7]
The Dearth of Patent Litigation: Why Big Pharma Prefers to Play Nice (Until It Doesn’t)
One might reasonably ask: if compounders have been walking this legal tightrope for years, where are all the patent infringement lawsuits? Excellent question. The answer involves a delightful cocktail of economics, optics, and strategic restraint.
Patent lawsuits are expensive—we’re talking millions on average, with cases taking one to three years to reach trial. That’s a lot of legal fees to spend going after a small-town compounding pharmacy making personalized medications for Mrs. Henderson.
There’s also the optics problem. When your patented drug is in shortage and patients can’t get it, suing the compounders trying to fill that gap doesn’t exactly scream “we care about patient access.”
But times, as they say, are changing.
Enter the Drama: Novo Nordisk vs. Hims & Hers, or How to Spend Super Bowl Weekend
Let’s recap the truly theatrical week of February 5-9, 2026, shall we?
Wednesday, February 5: Hims & Hers announces plans to offer a compounded version of Novo Nordisk’s brand-new Wegovy pill for the budget-friendly price of $49 per month—roughly $100 less than the FDA-approved version. Bold move! Novo promptly threatens legal action.[8]
Thursday, February 6: The Department of Health and Human Services refers Hims & Hers to the Department of Justice for potential violations of the FD&C Act.[9] FDA announces it will restrict GLP-1 ingredients used in compounded drugs, citing concerns about “drugs for which the FDA cannot verify quality, safety, or efficacy.”[10] That all sounds bad.
Saturday, February 7: It was bad! Hims & Hers announces it will stop offering the compounded semaglutide pill, citing “constructive conversations with stakeholders across the industry.”[11] One can only imagine how constructive those conversations were.
Sunday, February 9: Both companies run Super Bowl ads. Ah, capitalism.
Also Sunday, February 9: Novo Nordisk files a patent infringement lawsuit in Delaware against Hims & Hers, asserting U.S. Patent 8,129,343—which covers any oral, injectable, or other drug containing semaglutide and expires in 2032. [12]
This wasn’t just any patent lawsuit. It was Novo’s first U.S. patent infringement case against a compounder over Wegovy. After years of focusing on trademark claims and false advertising, Novo went nuclear. As Sydbank analyst Søren Løntoft Hansen delicately put it, Novo is “not only declaring war on Hims & Hers’ Wegovy pill, but GLP-1 [compounders] in general.”[13]
Hims & Hers responded with characteristic restraint, calling the lawsuit “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care” and describing it as “Big Pharma weaponizing the US judicial system to limit consumer choice.”[14] Surprisingly, they did not go on to say “and we would have gotten away with it too, if it weren’t for you meddling kids!”[15]
Novo’s position? It’s protecting public safety. Novo’s testing allegedly found impurities of up to 86% in compounded injectable semaglutide and up to 75% in compounded oral versions. In Novo’s telling, these “knock-offs” are “dangerous and deceptive to patients” and undermine “the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective.”[16]
The market reacted accordingly: Hims & Hers stock fell more than 18%, while Novo’s Copenhagen-listed shares climbed more than 3%.
The Legal Arguments: Why Everyone Thinks They’re Right
Let’s examine the competing arguments with the intellectual charity they deserve.
The Case for Compounder Immunity (Such as It Is)
The Alliance for Pharmacy Compounding and sympathetic legal scholars argue that FDA compounding guidance makes no distinction for patented drugs. If Congress had intended to exclude patented drugs from shortage compounding, the guidance would have explicitly said. An exception for patented drugs would “contradict the very reason the law allows compounding of FDA-approved drugs in shortage in the first place—to ensure patients can continue to access needed and often essential medications even when the manufacturer cannot maintain its supply chain.”[17]
Some even argue that the FD&C Act preempts patent infringement claims against compounding pharmacies and outsourcing. Because compounded drugs are exempt from ANDA requirements, no Paragraph IV patent certification is required and manufacturers can’t sue compounders the same way they’d sue generic manufacturers.
The Prevailing View: No Immunity, No How
The legal establishment’s response to those arguments is essentially: “That’s adorable, but no.”
The prevailing view seems to be that regulatory compliance does not provide patent immunity. Adherence to FDA Section 503A or 503B regulations does not shield a pharmacy from federal patent infringement liability. The FDA may create a regulatory pathway for compounding during a shortage, but the patent holder retains its private right to sue.
GlaxoSmithKline LLC v. Teva Pharms. Illustrated the principle, noting that even though “skinny labeling” was permissible under FDA regulations, GSK still established induced patent infringement.[18] The lesson? The FDA cannot protect alleged infringers from patent liability, no matter how many regulatory boxes they’ve checked.
The Innovator’s Toolbox: Beyond Patent Suits
Smart pharmaceutical companies know that patent litigation isn’t their only weapon. Sure, they can use cease-and-desist letters or trademark and unfair competition claims. And they do. Novo successfully went after wellness spas marketing compounded semaglutide as “compounded Ozempic” or “generic Wegovy.”
Far more interesting is the Demonstrable Difficulties for Compounding (DDC) list. Both Eli Lilly and Novo Nordisk have submitted citizen petitions to the FDA requesting that their GLP-1 ingredients be added to the FDA’s DDC list.[19] If the FDA grants these petitions, semaglutide and tirzepatide would be classified as “too complex to compound,” effectively prohibiting pharmacists, physicians, and outsourcing facilities from compounding them—ever, regardless of shortage status or clinical need.
And then there’s the FDA itself. In September 2025, the FDA sent dozens of warning letters to online sellers of compounded GLP-1s, citing “Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers over the Internet.” Most of the flagged language was predictably problematic—naming brand products, using “generic” terminology, making efficacy claims, or implying FDA approval.
The Future: Crystal Balls Welcome
Where does this leave us? In a state of maximum uncertainty, which is exactly where pharmaceutical companies’ legal teams thrive.
The Novo v. Hims litigation may become the test case for whether compounding during a shortage provides any patent immunity. If Novo succeeds in obtaining a permanent injunction, it will effectively shut the door on any non-branded semaglutide in the U.S. market until 2032.
Legal scholars have proposed creating a statutory exemption from patent infringement specifically for compounders during active, FDA-declared shortages. Such an exemption would address the fundamental conflict between FDA and patent regimes while protecting patient access. But I wouldn’t hold my breath.
In the meantime, compounding pharmacies operate in a state of “calculated risk.” They can be fully FDA-compliant and still face intellectual property litigation. The law, as currently structured, offers them no safe harbor—just the cold comfort of knowing that at least they filled out all the right forms before getting sued.
If you have questions or are interested in additional details or guidance, please reach out to Greg Chopskie (greg.chopskie@pierferd.com) or your regular PierFerd contact for assistance.
This publication and/or any linked publications herein do not constitute legal, accounting, or other professional advice or opinions on specific facts or matters and, accordingly, the author(s) and PierFerd assume no liability whatsoever in connection with its use. Pursuant to applicable rules of professional conduct, this publication may constitute Attorney Advertising. © 2026 Pierson Ferdinand LLP.
[1] https://www.youtube.com/watch?v=l5l6QMNnqoc
[2] https://www.youtube.com/watch?v=XHATF1MSiyc
[3] https://www.fda.gov/media/98973/download?attachment; https://www.fda.gov/media/98964/download?attachment
[4] https://tinyurl.com/2z5c3pdv
[5] Although you’re bound to hear some argue something like this: Section 503 of the Food Drug & Cosmetic Act somehow preempts the Patent Act because it does not require, unlike Section 505, the filing of a 505(b)(2) or 505(j) Abbreviated New Drug Applications (ANDAs) which are acts of infringement under 35 U.S.C. Š 271(e)(2)(a). I’m just the messenger.
[6] https://www.wipo.int/edocs/mdocs/scp/en/scp_36/scp_36_3.pdf
[7] 35 U.S.C. § 271(e)(1)
[9] https://tinyurl.com/2744uh9c
[11] https://www.cnbc.com/2026/02/07/hims-hers-weight-loss-pill.html
[13] https://www.pharmacy.biz/novo-nordisk-sues-hims-weight-loss/
[14] https://njbiz.com/hims-hers-halts-glp-1-pill-novo-nordisk-lawsuit/?utm_source=chatgpt.com
[15] https://www.youtube.com/watch?v=hXUqwuzcGeU
[16] https://www.nnpi.com/content/dam/novomedlink/semaglutide/02-09-2026-company-statement.pdf
[17] https://join.a4pc.org/hubfs/PDFs/APC-Compounding-Semaglutide-Media-Brief-REVISED-October-10-2023.pdf
[18] GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. 7 F.4th 1320 (Fed. Cir. 2021)
[19] See, e.g., https://www.regulations.gov/document/FDA-2017-N-2562-0029
