A Danish pharmaceutical company is the only business in the U.S. with Food and Drug Administration (FDA) approval to market semaglutide drugs, but that hasn’t stopped certain healthcare providers from allegedly selling counterfeit versions.
Novo Nordisk filed five federal lawsuits in New York, Texas, Tennessee and Florida complaining that compounding pharmacies, med spas and diet clinics illegally sold unapproved versions of their popular weight loss and Type 2 diabetes drugs to their customers.
Wegovy and Ozempic both have semaglutide as an ingredient.
“At higher amounts, it increases your sense of satiation so you feel full, and once you feel full, you’re not eating, and therefore that could lead to weight loss,” said Reuben Saba, vice president of medical and business affairs at Medicure.
Wegovy is an injectable medication for obese adults, while Ozempic is a pen injector used to control high blood sugar in Type 2 diabetes patients.
“Patients prescribed FDA-approved Semaglutide injectable products, marketed under the brand names Ozempic® and Wegovy® should be vigilant in checking their medicine to ensure they are taking an authentic Novo Nordisk produced version of the authorized drug and injection device,” said Doug Langa, executive vice president of North American operations and president of Novo Nordisk, in a statement online.
TruLife Pharmacy in Clay County, Brooksville Pharmaceuticals in Hernando County and Jacksonville’s WellHealth Rx were sued in the Middle District of Florida federal court.
On July 11, U.S. District Judge William Jung ordered the appointment of a mediator in Novo Nordisk Inc. v. Brooksville Pharmaceuticals.
“Rather than invest the time and resources necessary to research, develop, and test its products in order to ensure that they are safe and effective and to obtain regulatory approval to market them, Defendant is simply creating, marketing, selling, and distributing Unapproved New Drugs throughout Florida and other states,” wrote Samantha J. Kavanaugh, the plaintiffs’ attorney, in the July 6 complaint in Novo Nordisk Inc. v. Brooksville Pharmaceuticals.
The Florida lawsuits were filed under the state Deceptive and Unfair Trade Practices Act and Novo Nordisk seeks a permanent injunction (PI) enjoining the pharmacies from manufacturing and selling copycat versions of the prescription drugs.
“Novo Nordisk hasn’t revealed to the public how to make the drug because they do hold the patent to it, and they’re not obligated to reveal that information,” said Michael Vater, a Ticktin Law Group attorney. “What we do know from the lawsuit is that these people were basically selling these versions of the drug but we don’t really know what was inside of it.”
Multiple federal lawsuits name Champion Health and Wellness Clinics in Houston; Effinger Health’s Nuvida RX Weight Loss clinic in Tallahassee, Fla.; Ekzotika’s Cosmetic Laser Professionals Med Spa in Miami; Flawless Image Medical Aesthetics in East Syracuse, N.Y.; and Pro Health Investments in Memphis, Tenn., as defendants.
“We frequently see in the industry the knockoffs occurring of pharma products, which not only cause confusion to consumers but also harm them ultimately and businesses want to ensure they are protecting their intellectual property,” Mr. Vater told PacerMonitor News.
One way that Novo Nordisk may have discovered the alleged copycat drugs is if complaints were filed with the FDA, which has yet to approve a semaglutide generic.
“Anytime an adverse event is reported to the FDA, the pharmaceutical company has to do their due diligence to investigate,” Mr. Saba told PacerMonitor. “They’ll ask for the lot number and if it’s not traceable, then obviously they got this medication from non-legitimate avenues.”
However, defendant Champion Health and Wellness Clinics said the compounded semaglutide drug it prescribes to patients is neither unsafe, ineffective nor of low quality, and does not pose any serious health risk to patients.
“Defendant denies that any of its patients have had adverse effects from using compounded Semaglutide drugs,” wrote Attorney J. David Cabello in his July 13 answer to Novo Nordisk’s complaint. “Defendant denies that the FDA’s failure to review and approve compounded drugs necessarily means these drugs are unsafe, ineffective, or have risk to patient health.”
Novo Nordisk A/S et al v. Champion Health and Wellness Clinics was filed June 20 in the Southern District of Texas with Novo Nordisk seeking disgorgement of Champion’s profits for trademark infringement, false advertising, unfair competition and treble damages for willfulness under 15 U.S.C. § 1117.
“It seems likely that Novo Nordisk will be successful in the lawsuit especially in light of the fact that they hold the patent on these particular drugs, and they’ll be able to show harm to the consumer and confusion in the marketplace if the court allowed these knockoff drugs to continue,” Mr. Vater added.