Brooksville Pharmacy Lawsuit: Novo Nordisk’s Case Dismissed

Novo Nordisk’s lawsuit against Brooksville Pharmaceuticals ended on May 12, 2025, when U.S. District Judge William F. Jung granted summary judgment to the Florida compounding pharmacy, ruling that Novo Nordisk’s claims over compounded semaglutide were moot, preempted by federal law, and lacking in merit. The Brooksville Pharmacy lawsuit, filed in July 2023 in the Middle District of Florida as Novo Nordisk Inc. v. Brooksville Pharmaceuticals Inc. (Case No. 8:23-cv-1503), had become one of the most closely watched fights in Novo Nordisk’s nationwide campaign against pharmacies making copies of Ozempic, Wegovy, and Rybelsus.

What the Court Decided

Two findings sank Novo Nordisk’s case at summary judgment. First, Judge Jung determined that Novo Nordisk failed to demonstrate “actual consumer harm,” which the court identified as a required element of a claim under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA).¹ No customers had actually been injured by Brooksville’s products, the court found.

Second, the end of the federal semaglutide shortage rendered the dispute moot in a practical sense. With semaglutide off the shortage list, compounders were already legally barred from mass-producing the drug, so an injunction from the court was unnecessary. The court noted that Brooksville remained free to continue compounding customized dosages for individual patients under the traditional rules governing pharmacy compounding, even though mass production of semaglutide copies was no longer allowed.²

Brooksville’s counsel, Matthew J. Modafferi of Frier Levitt, said the decision “reaffirms the regulatory framework that governs pharmacy compounding and reinforces the protections in place for patient-specific formulations.”³

How the Case Got There

Novo Nordisk filed suit on July 6, 2023, alleging that Brooksville was manufacturing and distributing “Unapproved New Drugs” in violation of the Florida Drug and Cosmetic Act and FDUTPA. The complaint sought a permanent injunction to stop Brooksville from making and selling compounded semaglutide, a declaratory judgment that its practices violated Florida law, and attorney’s fees.⁴

Judge Jung dismissed that original complaint without prejudice on November 8, 2023. He found that Novo Nordisk’s state-law claims were impliedly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), reasoning that the lawsuit amounted to an attempt to “privately enforce” federal drug regulations, something only the FDA has authority to do.⁵⁶ The judge also found that Novo Nordisk had failed to plead facts showing that Brooksville’s drugs actually violated the Florida Drug and Cosmetic Act, noting that the term “Unapproved New Drugs” was “simply a label” and that selling compounded semaglutide might be lawful during a federal drug shortage.

Novo Nordisk refiled with sharper allegations. The amended complaint claimed that independent testing of Brooksville’s compounded semaglutide products showed they contained at least 19 percent less semaglutide than their labels stated.⁷⁸ It also alleged that the products contained impurities, including unknown peptide-related impurities and impurities with amino acid additions and deletions not found in FDA-approved semaglutide, capable of posing immunogenicity risks such as anaphylaxis and central nervous system complications.² The complaint further alleged the presence of BPC-157, a peptide the FDA had not sanctioned for use in compounded products.

On February 2, 2024, Judge Jung denied Brooksville’s motion to dismiss the amended complaint, letting the case move past the preemption arguments that had defeated the original filing.⁹ The case survived to discovery. It did not survive summary judgment.

Why the Ruling Matters Beyond This Pharmacy

The Brooksville case tested a legal question with wide reach: can a brand-name drug manufacturer use state unfair-competition laws to stop a compounding pharmacy from selling competing products? Judge Jung’s answer, at both the dismissal and summary judgment stages, was effectively no, at least when the state-law claims rest on alleged violations of federal drug law rather than independent state duties.

That reasoning has recurred in Novo Nordisk’s broader campaign. By April 2025, the company had filed at least 111 lawsuits in federal courts across 32 states against pharmacies, clinics, and telehealth companies selling compounded semaglutide.¹⁰¹¹¹²

Novo Nordisk has fared better where it sues under the Lanham Act, targeting pharmacies and clinics that used the Ozempic or Wegovy brand names in their advertising. Trademark claims do not depend on interpreting the FDCA and have survived preemption challenges.¹ The Brooksville complaint did not include trademark claims.

The Shortage Rules That Changed Mid-Case

The regulatory ground shifted while the case was pending. While semaglutide sat on the FDA’s drug shortage list, compounding pharmacies had legal room under federal law to produce their own versions. The FDA officially determined the semaglutide shortage was resolved on February 21, 2025.¹³

Once the shortage ended, the rules tightened. State-licensed pharmacies operating under Section 503A of the FDCA had to stop compounding semaglutide copies by April 22, 2025, and 503B outsourcing facilities by May 22, 2025.¹⁴ Narrow exceptions remain for truly individualized prescriptions, such as when a prescriber documents a patient allergy to an excipient in the FDA-approved product, but routine compounding of semaglutide in standard strengths is no longer permitted.¹³ Those deadlines are what made an injunction against Brooksville unnecessary in the court’s view.

Brooksville’s Separate Regulatory Troubles

Winning the Novo Nordisk lawsuit did not leave Brooksville with a clean regulatory record. On May 9, 2025, days before the summary judgment ruling, the Ohio Board of Pharmacy voted unanimously to summarily suspend Brooksville’s Terminal Distributor of Dangerous Drugs license, finding “clear and convincing evidence of a danger of immediate and serious harm to others.”¹⁵¹⁶

The suspension order cited three problems: distribution of 580 compounded prescriptions into Ohio between April 2024 and April 2025 without required regulatory authorization, including 153 prescriptions for compounded retatrutide, a weight-loss drug not approved by the FDA; the absence of an Ohio-licensed pharmacist serving as Responsible Person from roughly August 2021 to March 2025, a period during which the pharmacy shipped about 14,503 compounded drugs into the state; and failure to timely provide records to a Board investigator. Brooksville had 30 days to request an administrative hearing; the available records do not show whether it did so or what further action the Board has taken.¹⁶

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U.S. Food and Drug Administration. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
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Drug Topics. GLP-1 No Longer on FDA’s Drug Shortage List
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