The Legal Landscape of Semaglutide & Tirzepatide: What Pharmacy Owners Need to Know
If you’ve been watching the ongoing saga of compounded GLP-1 medications, you already know that the semaglutide and tirzepatide situations are heating up. Between Novo Nordisk’s and Eli Lilly’s patent protections, FDA rulings, and lawsuits flying around, pharmacy owners need to stay informed. So, let’s break down what’s happening, what it means for your pharmacy, and how you can navigate these legal waters while keeping your patients (and your business) happy.
A Quick Recap: How We Got Here
Semaglutide—the active ingredient in Ozempic, Wegovy, and Rybelsus—and tirzepatide—the active ingredient in Mounjaro and Zepbound—have been in high demand, leading to supply shortages and skyrocketing interest in compounded versions. Now that the FDA has determined the shortages are over, there are lawsuits, compounding deadlines, and enforcement discretion, making everything as clear as mud.
Key Legal Events in the Semaglutide and Tirzepatide Stories:
March 2022 – Wegovy (semaglutide) Declared in Shortage
The FDA officially added Wegovy to its drug shortage list, opening the door for compounding pharmacies to start offering compounded semaglutide options.
August 2022 – Ozempic (semagutide) Joins the List
With demand exploding, Ozempic was also placed on the drug shortage list, further increasing interest in compounded versions of semaglutide.
December 2022 – Tirzepatide Declared in Shortage
The FDA declared a shortage of tirzepatide, allowing compounding pharmacies to begin producing compounded versions under specific conditions.
May 2023 – Novo Nordisk and Eli Lilly Start Suing Over Semaglutide & Tirzepatide Compounding
Novo Nordisk took legal action against weight loss clinics, medical spas, and some compounding pharmacies for selling unauthorized compounded semaglutide. Some of these products were found to contain impurities or not be semaglutide at all—a big problem for patient safety and a key reason why regulatory scrutiny increased. Eli Lilly also issued warnings about unauthorized tirzepatide compounding.
Recently, Novo and Lilly have suffered legal losses at the state level. The state courts have affirmed that only the FDA has the legal authority to sue to defend its regulations.
The Semaglutide & Tirzepatide Shortages Are “Over”
October 2, 2024 – FDA Declares Tirzepatide Shortage Over
The FDA removed tirzepatide from its drug shortage list, stating that supply levels had been restored. This meant that compounding tirzepatide was no longer permitted under standard shortage exemptions.
February 21, 2025 – FDA Declares the Shortage Over for Semaglutide
The FDA officially removed Ozempic and Wegovy from the drug shortage list, meaning that compounding semaglutide is now only allowed for a limited time:
- 503A Pharmacies & Physicians: Can compound until April 22, 2025.
- 503B Outsourcing Facilities: Can compound until May 22, 2025.
For tirzepatide, the enforcement discretion deadlines are:
- 503A Pharmacies & Physicians: Can compound until February 18, 2025, or until a court ruling in OFA v. FDA, whichever is later.
- 503B Outsourcing Facilities: Can compound until March 19, 2025, or until a court ruling in OFA v. FDA, whichever is later.
- When might the above-referenced court ruling happen? Many legal experts say it could be mid to late March. You need to be prepared.
February 24, 2025 – Lawsuits Filed Against the FDA
The Outsourcing Facilities Association (OFA) and a Texas-based compounding pharmacy sued the FDA, arguing that removing both semaglutide and tirzepatide from the shortage list unfairly restricts compounders. This case is ongoing, and its outcome could impact compounding pharmacies nationwide.
What About Adding Vitamins or Different Doses To Continue Compounding?
I hate to be the bearer of bad news. Still, I don’t believe that adding a vitamin or using a different strength of injection will allow any pharmacy to continue to compound either semaglutide or tizepatide legally. Both Novo Nordisk and Eli Lilly aren’t relying on just the FDA to fight compounded semaglutide and tirzepatide—they have strong patent portfolios in place. Here’s what you need to know:
Semaglutide Patents:
✔ Composition of Matter Patents (Expire 2031) – Protects the specific molecular structure of semaglutide, preventing copies until December 2031 in the U.S.
✔ Formulation Patents (Expire 2031) – Covers how semaglutide is formulated for stability and effectiveness, including its oral version, Rybelsus.
✔ Method of Treatment Patents (Varies by Indication) – Protects the use of semaglutide in treating diabetes and obesity.
✔ Dosage Regimen Patents (Various Expiry Dates) – Prevents competitors from tweaking administration schedules.
Tirzepatide Patents:
✔ Composition of Matter Patents (Expire 2036) – Protects tirzepatide’s chemical structure.
✔ Formulation Patents (Expire 2039) – Covers tirzepatide’s stability and delivery methods.
✔ Method of Treatment Patents (Varies by Indication) – Protects tirzepatide’s medical uses.
✔ Dosage Regimen Patents (Various Expiry Dates) – Blocks variations in dosing schedules.
Can Pharmacies Find a Legal Workaround To Continue Compounding Semaglutide & Tirzepatide?
If you’re wondering whether there’s a legal way to keep offering these medications after the final stoppage (whenever that may be), I don’t think so. I will say that I am not a lawyer and don’t play one on TV. This is due to the patents that are held. Using a combination of active ingredients, or adding a vitamin, or using an oral version doesn’t negate the fact that these chemical structures are patented into the 2030s.
❌ Compounding after the FDA’s Deadline – Illegal unless a new ruling in the OFA v. FDA lawsuit allows it.
The legal landscape for semaglutide & tirzepatide is shifting rapidly, and pharmacy owners must stay ahead of these changes. With deadlines approaching for compounded versions and strong patents in place, the industry is at a turning point. Now is the time to build up your alternatives to these GLP-1s for your patients.
Pharmacy Badass University members can watch the recording of the January 2025 Mastermind, where I detail some options for members.
Keep your pharmacy legal, informed, and prepared for what’s next. Stay sharp, stay compliant, and as always—keep your pharmacy badass!
