Novo Nordisk Is Suing Everyone: The GLP-1 Legal War

August 2025 was a bad month to be a compounding pharmacy.

On a single day, Novo Nordisk—the $500+ billion pharmaceutical giant behind Ozempic and Wegovy—filed lawsuits against 12 different compounding pharmacies and telehealth companies. The accusations: trademark infringement, deceptive marketing, and selling products that "pose serious health risks."

Eli Lilly, maker of Mounjaro and Zepbound, had already been in court fighting Empower Pharmacy, one of the largest 503B compounders in the country. That case escalated with emergency motions and heated legal briefs.

Welcome to the GLP-1 legal war—where billions of dollars, patient access, and the future of compounding are all on the line.

The Novo Nordisk Blitz: 12 Lawsuits in One Day

On August 7, 2025, Novo Nordisk's legal team launched a coordinated assault. They filed nearly identical lawsuits in federal courts across the country against:

• GenRx
• J&J Online Pharmacy
• Livv Natural Health
• NuImage Medical
• Pharmacy Potions
• Physicians' Compounding Pharmacy
• Peptide Sciences
• Rejuvenation Clinic
• Serenity Wellness Clinic
• SlimRX
• Taylor Made Compounding
• Titan Medical Center

The lawsuits share common allegations:

Allegation 1: Trademark Infringement

Novo claims the defendants used its trademarks—Ozempic®, Wegovy®, and Saxenda®—to market their compounded products. In legal terms, this is "trading on the goodwill" of established brands.

Example cited: Marketing materials stating "Compounded Semaglutide - Same Active Ingredient as Ozempic" or "Wegovy Alternative."

Allegation 2: False Advertising

The lawsuits claim defendants made misleading statements suggesting their compounded products are equivalent to or "as effective as" FDA-approved drugs.

Novo's argument: Compounded drugs haven't been tested for safety or efficacy. Claiming equivalence is deceptive.

Allegation 3: Consumer Safety Risks

Novo emphasizes that compounded semaglutide lacks FDA oversight and that patients have been harmed by contaminated, mislabeled, or improperly dosed products.

The evidence they cite: FDA adverse event reports showing 346 incidents linked to compounded GLP-1s (vs. 99 for brand-name versions over the same period).

Eli Lilly vs. Empower: The Big Fight

While Novo Nordisk went wide, Eli Lilly focused its firepower on one target: Empower Pharmacy, a Houston-based 503B outsourcing facility that became one of the largest suppliers of compounded tirzepatide in the country.

This case matters more than the others because of what it could establish legally.

Lilly's Arguments:

• Empower is making "essentially a copy" of Zepbound, which is illegal post-shortage
• Adding B6 or niacinamide doesn't make it a legitimately different product
• Empower's marketing implies their product is equivalent to FDA-approved tirzepatide
• Compounded tirzepatide poses safety risks to patients

Empower's Defense:

• Their products include added ingredients (B6, etc.) making them "personalized" formulations
• Each prescription is customized for individual patient needs
• 503B compounding is legal and regulated by the FDA
• Lilly is trying to maintain monopoly pricing by eliminating competition

The case has bounced between courts, with emergency motions, temporary restraining orders, and procedural battles. As of early 2026, it remains active with no final resolution.

What the Manufacturers Really Want

Let's be clear about motivations here.

Novo Nordisk and Eli Lilly frame these lawsuits as patient safety initiatives. And there are legitimate safety concerns with some compounded products—contamination, dosing errors, and lack of oversight are real issues.

But let's also acknowledge the business reality:

• Compounded GLP-1s captured significant market share during shortages—potentially billions in diverted revenue
• Compounders undercut brand pricing by 70-80%, creating price expectations that hurt brand sales
• Even post-shortage, patients who started on compounded products often don't want to switch to more expensive brands

The goal: Eliminate compounding competition entirely, or at least create enough legal risk that most compounders exit the GLP-1 market voluntarily.

This isn't cynicism—it's how pharmaceutical companies protect billion-dollar franchises. They have shareholders. They're legally obligated to maximize returns.

The Patient Lawsuits: 2,809 and Counting

Plot twist: the manufacturers aren't just suing compounders. They're also being sued by patients.

As of late 2025, there are approximately 2,809 active lawsuits consolidated in MDL-3094 (Multi-District Litigation) against Novo Nordisk and Eli Lilly. Patients allege the companies failed to adequately warn about serious side effects.

Common Claims in Patient Lawsuits:

• Gastroparesis (severe stomach paralysis)
• Ileus (intestinal obstruction)
• Severe pancreatitis
• Gallbladder disease requiring surgery
• Other serious GI complications requiring hospitalization

The patients argue that while some side effects are mentioned in labeling, the severity and frequency were understated. They also claim direct-to-consumer marketing downplayed risks while emphasizing benefits.

Status: MDL-3094 is in discovery phase. Bellwether trials (test cases) are expected to begin in late 2026 or 2027. If plaintiffs win significant verdicts, it could trigger a wave of settlements.

The OFA v. FDA Case

Meanwhile, compounders have their own legal offensive.

The Outsourcing Facilities Association (OFA)—a trade group representing 503B compounders—sued the FDA, arguing that the agency's process for declaring shortages "resolved" was arbitrary and didn't follow proper procedures.

OFA's Arguments:

• FDA didn't adequately consider patient access in declaring shortages resolved
• Grace periods were too short to wind down operations safely
• The shortage determination process was flawed

What Happened:

Judge Mark Pittman (Northern District of Texas) issued a split decision in 2025. He declined to grant a preliminary injunction that would have kept the shortage status in place, but the underlying lawsuit continues.

Bottom line: The FDA's shortage termination stood, and grace periods expired. Compounders hoping courts would save them were disappointed. The OFA appeal continues but hasn't changed the practical reality.

What's Actually at Stake

Beyond the legal technicalities, here's what these cases will determine:

1. Is "Personalization" a Valid Defense?
If courts accept that adding B6 or offering non-standard doses makes compounded GLP-1s legitimately different products, compounding can continue. If courts reject this as a pretext, the practice is effectively illegal.

2. How Far Can Manufacturers Go to Protect Markets?
These lawsuits will establish precedents for how aggressively branded drug manufacturers can use litigation to suppress generic and compounded competition.

3. What Happens to Patient Access?
If compounding is shut down and brand prices remain high, millions of patients may lose access to treatment they've benefited from. If compounding continues, regulatory uncertainty persists.

4. Will the FDA Step Up Enforcement?
So far, FDA has issued warning letters but not taken dramatic enforcement action. The lawsuits may pressure FDA to take sides more clearly.

What You Should Do

If you're currently using compounded GLP-1s:

1. Know Your Provider's Status
Ask whether your pharmacy or telehealth provider has been sued, received warning letters, or made plans for different scenarios. Reputable providers should be transparent about legal risks.

2. Have a Backup Plan
Don't assume your supply is guaranteed. Know what brand-name alternatives are available and what they cost. Wegovy pill at $149-299 and LillyDirect at $299-449 are now realistic backups.

3. Don't Panic (Yet)
Lawsuits take time. Even if manufacturers win, appeals and enforcement delays mean immediate disruption is unlikely. But the long-term trajectory is uncertain.

4. Stay Informed
The legal landscape is changing monthly. Follow developments, as court decisions could affect your access with little warning.

The Bottom Line

The GLP-1 legal war is just beginning. Manufacturers with hundreds of billions at stake are fighting to protect their franchises. Compounders are fighting to survive. Patients are suing over side effects. And regulators are caught in the middle.

Who wins? Probably the lawyers. The manufacturers have deeper pockets and can outlast most compounders in prolonged litigation. But the "personalization" defense creates enough legal ambiguity that a total shutdown isn't guaranteed.

What's certain: The compounding market for GLP-1s will never return to its 2023-2024 peak. Between legal pressure, FDA enforcement, and brand price cuts, the golden era of $150/month compounded semaglutide is ending.

What replaces it—whether affordable brand-name options like Wegovy pill fill the gap, or patients simply lose access—remains to be determined in courtrooms across America.