As of April 2025, Novo Nordisk has filed 111+ lawsuits across 32 states against entities selling compounded "semaglutide" products. The company has secured at least one permanent injunction and multiple court victories upholding FDA's removal of semaglutide from the shortage list.
Why Is Novo Nordisk Suing?
Novo Nordisk claims that compounding pharmacies and telehealth companies are engaging in trademark infringement and false advertising by:
⚖️ Common Legal Claims
- Trademark infringement: Using "Ozempic" and "Wegovy" marks to market compounded products
- False advertising (Lanham Act): Claiming compounded drugs are FDA-approved, equivalent to, or sourced from Novo Nordisk products
- Unfair competition: Misrepresenting the nature and quality of compounded products
- Product quality issues: Selling products with dangerous impurity levels (one tested at 24%+ impurities)
- No semaglutide content: Some products labeled as containing semaglutide contained none at all
"Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate 'semaglutide' drugs are working."— Steve Benz, Corporate Vice President, Legal and US General Counsel, Novo Nordisk
Timeline of Legal Actions
Key Court Decisions
MediOak Pharmacy LLC — Permanent Injunction
Novo Nordisk WonCourt: U.S. District Court, Southern District of Texas
Outcome: Federal judge entered final judgment and permanent injunction prohibiting MediOak from marketing or selling compounded "semaglutide" knockoff drugs.
Significance: First permanent injunction secured by Novo Nordisk against a 503A pharmacy.
OFA v. FDA (Semaglutide Shortage)
FDA/Novo WonCourt: U.S. District Court, Northern District of Texas (Judge Mark Pittman)
Outcome: Court denied Outsourcing Facilities Association's motion for preliminary injunction. FDA's determination that semaglutide shortage is resolved stands.
Significance: 503A pharmacies must immediately stop compounding semaglutide. 503B facilities have until May 22, 2025.
Goglia Nutrition (G-Plans/Futurhealth)
PendingCourt: U.S. District Court, Southern District of California (3:24-cv-01385)
Claims: Trademark infringement for offering Ozempic and Wegovy alongside compounded semaglutide through intake forms.
Defense: Goglia argued nominative fair use—using trademark to identify products, not to deceive.
What Novo Nordisk Has Found
In court filings, Novo Nordisk has documented specific product quality issues:
- 24%+ impurities: One compounded product tested contained more than 24% impurities, including unknown substances
- No active ingredient: An oral sublingual product labeled as containing 1 mg/mL semaglutide contained zero semaglutide
- Semaglutide salts: Products using unauthorized salt forms (semaglutide sodium, semaglutide acetate) instead of the base form
- False FDA approval claims: Websites claiming compounded drugs are FDA-approved
- DIY instructions: Retailers advertising "how to make your own" injectable semaglutide at home
- No prescription sales: Products sold without requiring a valid prescription
The Brookings Report: Chinese API Concerns
A Brookings Institution report titled "The Wild East of semaglutide" documented issues with synthetic semaglutide API imported from China:
- Manufacturers determine their own quality specifications—no external reference standard
- Three Chinese firms responsible for 20% of US semaglutide imports (March 2023–September 2024) have never been inspected by FDA
- Another three firms (45% of imports) were cited for current good manufacturing practice violations in their latest FDA inspections
State Attorney General Actions
Novo Nordisk's legal campaign is supported by regulatory action at the state level:
- 38 State Attorneys General issued a bipartisan letter calling on FDA to take action against compounders that "cut corners in pursuit of a quick profit"
- Ohio AG sent warning letters to 14 entities about deceptive marketing claiming FDA approval
- Multiple states have issued consumer warnings about compounded GLP-1 products
What This Means for Compounders
Following the April 2025 court decisions:
503A Pharmacies (State-Regulated)
- FDA can now take immediate enforcement action
- Must cease compounding semaglutide that's "essentially a copy" of commercial products
- May still compound for individual patients with valid prescriptions if medication is meaningfully different
503B Outsourcing Facilities (Federally-Regulated)
- Grace period expired May 22, 2025
- Subject to FDA enforcement including product seizures and warning letters
Required Disclosures
As part of legal settlements, some entities must now post disclosures including:
- Compounded drugs have not been reviewed or approved by FDA
- Manufacturing processes are not FDA-reviewed
- Actual FDA-approved semaglutide medicines are available
The Eli Lilly Parallel
Eli Lilly is pursuing similar legal action for tirzepatide (Mounjaro/Zepbound). In March 2025, Judge Pittman also denied the OFA's preliminary injunction request for tirzepatide, with the same effect on compounders.
Both pharmaceutical giants argue that continued compounding:
- Exposes patients to safety risks from unverified products
- Undermines R&D investments that made the drugs possible
- Violates trademark and fair competition laws
The Bottom Line
Novo Nordisk's aggressive legal strategy—111+ lawsuits across 32 states—has achieved its primary objective: reinforcing FDA's determination that the semaglutide shortage is resolved and establishing legal precedent against compounders.
For consumers, this means:
- Compounded semaglutide is increasingly difficult to obtain legally
- Remaining providers face ongoing legal and regulatory risk
- Quality and safety concerns about compounded products are well-documented in court filings
- Brand-name Wegovy and Ozempic remain the only FDA-approved semaglutide options
This tracker will be updated as new lawsuits are filed and cases are resolved.
Sources
- Novo Nordisk. "Novo Nordisk protects US patients with legal wins against compounders." PR Newswire. April 25, 2025.
- CNBC. "Novo Nordisk scores major legal win that bars many compounded versions of Wegovy, Ozempic." CNBC. April 25, 2025.
- Fierce Pharma. "US court decision stops compounders from making knockoffs of Novo Nordisk's semaglutide." Fierce Pharma. April 25, 2025.
- Medical Economics. "Semaglutide's removal from the FDA shortages list sets the stage for more Novo Nordisk lawsuits." Medical Economics. November 2025.
- Buchanan Ingersoll & Rooney PC. "Major Update on GLP-1 Litigation involving Compounding Pharmacies." BIPC. August 5, 2025.
- BioSpace. "Novo Enters the Ring in Legal Fight Against GLP-1 Compounders as Lilly Notches Victory." BioSpace. March 6, 2025.
- Fierce Pharma. "In FDA obesity drug battle with compounders, Texas court allows Novo Nordisk to weigh in." Fierce Pharma. March 7, 2025.
- Novo Nordisk. "News details: Novo Nordisk files 9 new lawsuits." Novo Nordisk US. May 30, 2024.
- Fierce Pharma. "Novo Nordisk brings new round of lawsuits against compounded versions of Ozempic and Wegovy." Fierce Pharma. July 2023.
- Brookings Institution. "The Wild East of semaglutide." Brookings.edu. 2024.
- FDA. "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss." FDA.gov.
- PACER. Federal court filings (various district courts).
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