GLP-1 Courtroom Showdown: An Update from Our Regulatory Expert
The GLP-1 landscape is shifting fast. In just the past few months, courts have dismissed high-profile lawsuits, 503A pharmacies have defended compounding and won, patents are being challenged for legitimacy, and the FDA has taken new steps to safeguard patients leaning into compounded alternatives.
As someone who spends every day in the trenches of clinical education, compliance, and pharmacy strategy, I’ve been tracking these shifts closely. What’s emerging is a clear pattern: compounding isn’t counterfeiting — it’s personalized medicine — and legal precedent is beginning to catch up with what our industry has always understood.
This update pulls together the most important rulings, regulatory actions, and patent challenges shaping the future of GLP-1 access. My goal is simple: to give prescribers and clinics the clarity they need to understand what’s happening, why it matters, and how to stay compliant as the landscape continues to evolve.
This isn’t just courtroom drama — it’s reshaping patient access, affirming prescriber autonomy, and securing the future of compounding. Legalese has never been this exciting. Let’s break down GLP-1’s greatest hits...
Wells: Only the FDA Enforces FDA Law
In the Wells case, the judge made a simple point: only the FDA enforces FDA law. Private entities can’t moonlight as regulators by using the FDCA to police their rivals. The case was dismissed with prejudice, and the Ninth Circuit’s Nexus decision continues to reinforce that precedent.
Brooksville: Compounding During Shortages Was Lawful & New Standard is Met
In Florida’s Brooksville decision, the pharmacy decisively defended against copycat claims and won on summary judgment. The court held that bulk compounding was lawful during shortages, but once shortages ended, the standard is patient-specific prescriptions with a documented, significant difference. Novo couldn’t show harm — and now Brooksville is seeking fees.
Strive + Texas AG: Venue Shopping Backfires
Strive Pharmacy remains in active litigation, accused of marketing GLP-1s with additives like B12 or glycine. But here’s the twist: Lilly already dropped one case in New Jersey before re-filing in Texas.
What they probably didn’t anticipate was that added pressure would come alongside the venue change. On August 12, 2025, the Texas Attorney General separately sued Lilly, alleging provider inducements tied to GLP-1 prescribing. Lilly disputes the claims, but it’s a spotlight they likely didn’t want while these cases are still unfolding.
Willow: The “Unicorn Rule”
The Willow case added another layer of clarity. A federal judge in Los Angeles dismissed Lilly’s complaint against a nationwide telehealth clinic heavily marketing compounded GLP-1s.
The ruling underscored what I'm now calling the Unicorn Rule: personalization isn’t a snowflake standard. As the judge explained:
“Personalization does not mean that every compounded medication must be different for every patient; it, instead, need only be tailored to the specific goals of the patient.”
Federal law reinforces this: a compounded medication isn’t considered “essentially a copy” when the provider documents a meaningful clinical difference — dose, route, formulation, tolerance, or another patient-specific factor, provided it’s not just about cost.
Because Lilly couldn’t prove lost sales or show Willow’s statements were false, the complaint collapsed. Many see this as restoring confidence in compounded GLP-1s and confirming that reasonable, truthful marketing by clinics has a defensible place.
Mochi: Still Pending
Mochi remains pending on a motion to dismiss. It’s already been reshaped once, and if the pattern holds, expect similar reasoning — and another loss for Lilly.
Compounders Go on Offense
Meanwhile, compounders aren’t just dodging punches — they’re swinging back.
Empower Pharmacy filed a patent challenge, arguing that Lilly’s tirzepatide patent isn’t novel but rooted in obvious, existing science.
BPI Labs followed with a similar challenge, citing prior research Lilly is now claiming as innovation.
These are early cases, but they test the strength of exclusivity claims.
Novo Nordisk: Cracks in the Armor
Let’s not forget Novo Nordisk. Their semaglutide patents are being chipped away, and one even lapsed in Canada — opening the door to generic competition there as early as 2026.
FDA’s Green List: Cracking Down on Black Market Imports
Then on Friday, the FDA rolled out its Green List to block illegal imports of GLP-1 ingredients from unverified foreign suppliers.
Here’s the key: legitimate compounding is already required to source from registered, FDA-compliant suppliers... safeguards that reduce safety risks and help prevent supply disruptions.
This move isn’t aimed at compliant compounding. It targets black-market imports and bad actors cutting corners on cost and quality, while quietly greenlighting compounded GLP-1s as having both a regulatory pathway and a legitimate role in patient care.
The Bottom Line: Courts Are Setting Precedent
The pattern is clear. Courts are confirming that compounding isn’t counterfeiting. These aren’t knockoffs. They’re personalized, prescriber-driven, patient-specific medications. And legal precedent is being established that reinforces industry standard.
Big Pharma can’t patent personalization. Patient choice and prescriber autonomy can’t be sued away. These aren’t just lawsuits — they’re precedent.
When practitioners follow the regulatory pathway — individualized prescriptions, documented differences, transparent advertising, and clean supply chains — compounded GLP-1s aren’t knockoffs. They’re medicine. And all signs suggest they’re here to stay.
Time to Reassess
Recent rulings and FDA actions make one thing clear: the spotlight is on how clinics prescribe, advertise, and source GLP-1 therapies. Now is the time to take a second look at your current processes, marketing practices, and pharmacy partnerships.
Are your advertising claims defensible?
Is your pharmacy sourcing aligned with FDA-compliant suppliers?
Do your clinical workflows reflect the latest guidelines and precedent?
If you’re not sure — or if you want confidence that your practice is protected — we can help. Our team provides guidance on:
Quality sourcing you can trust
Clinical guidelines you can apply immediately
Regulatory compliance that keeps you on solid ground
Contact us today to schedule a 1-1 with our regulatory expert, Dianne Morrell, and let’s make sure your practice is ready for what's coming next.
Disclaimer: This content is for informational purposes only and does not constitute legal advice. For legal interpretation, consult with qualified counsel. For practical guidance on implementing compliant practices in your clinic, book a free consultation with our team.