Novo Nordisk is taking steps to prevent the misuse of semaglutide.
The Danish company has filed several lawsuits in the United States against some medical spas, weight-loss or wellness clinics and compound pharmacies, some of which misuse Novo Nordisk trademarks, to prevent them from advertising and selling counterfeits of its products. semaglutide products.
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The world’s largest diabetes treatment company says illegal marketing and sales practices by third parties have created a high risk of consumer confusion and deception, as well as potential safety issues considering that composite products don’t have the same guarantees of safety, quality and efficacy that its products, approved by the Food and Drug Administration (FDA), do.
Company of interest: Novo Nordisk
Novo Nordisk sells the weight loss drug under three different brand names: Ozempic injection and Rybelsus tablets for type 2 diabetes and Wegovy injection for chronic weight management.
It is the only company in the United States with Food and Drug Administration (FDA) approval for semaglutide-containing products. All three drugs are available only with a prescription and there are no approved generic versions, the FDA said in May.
Companies like WeightWatchers have legitimate agreements signed to give customers access to these products, but other entities are stocking knockoffs.
A non-exhaustive list of companies that Novo Nordisk has sued so far
Among the companies accused of misusing the Wegovy brand name to market their drugs in the Novo Nordisks lawsuits are:
Fake Ozempics abound amid drug shortages
Novo Nordisk is struggling to meet the demand for drugs. In May, the FDA placed both Ozempic and Wegovy on its drug shortages list. Under such circumstances, it is permissible to make compounded versions of commercially available drugs, but state regulators are concerned about drugs made using the cheapest semaglutide sodium salt and modified version of the compound that is suitable for scientific research but not for human use. At least four states are already cracking down on copycats.
Alarm bells have already rung for less secure off-brand alternatives. On June 16, Novo Nordisk, together with the FDA, alerted the public that a counterfeit Ozempic pen has been found in the United States. The imitator product, sold in pharmacies, apparently contained a type of diabetes drug that works differently from Ozempic, which led to an adverse reaction.
On the other side of the world in Australia, several online scammers are selling scams. Often the drug doesn’t even arrive.
Quotable: The problem with semaglutide compounds
Patients should be aware that some products sold as semaglutide may not contain the same active ingredient as FDA-approved semaglutide products and may be salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective. United States FDA in a May 31 statement
A large number: the growing global market for weight-loss drugs
15%: Weekly weight loss, on average, after 17 months in people with a BMI of 30 or greater who took semaglutide, the active ingredient in Wegovy and Ozempic, according to a 2021 study published in the New England Journal of Medicine
$200 billion: How big Barclays estimates the global weight loss therapy market could be over the next decade. Novo Nordisk is a major contender to cash in on the wave given its edge and dominance in the segment
$364.5 billion: Market capitalization of Novo Nordisk as of June 20, the second largest in Europe
$30: Groupon for a seven-week semaglutide weight management program offered by Ekzotikas Cosmetic Laser Professionals Med Spa in Miami
Novo Nordisks Semaglutide Resource Bank
Novo Nordisk launched semaglutide.com to serve as a credible resource hub for the US public, including patients, healthcare professionals, and retailers, to…
…disseminate information on the responsible use of Novo Nordisks’ FDA-approved semaglutide products.
… highlight the differences between the company’s controlled products and other medicines labeled as semaglutide.
…to equip customers with the tools to detect a counterfeit injectable product. For example, the original Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose and have very specific dose selection windows for the three pen variants of 0.25/0.5 mg, 1 mg and 2 mg available. The variant with the smallest dose comes with six needles and the other two with four. In the case of a Wegovy pen, it doesn’t have an option to set a dose, doesn’t extend or increase in length, and is only available in five configurations 0.25mg, 0.5mg, 1mg, 1.7mg and 2 .4 mg.
One more thing – to report fake Novo Nordisk drugs
1-800-727-6500: The Novo Nordisk Customer Service Line, available Monday through Friday from 8:30 am to 6:00 pm Eastern Standard Time, to report counterfeit semaglutide products or any suspected Novo Nordisk counterfeit products.
1-800-551-3989: The FDA’s Office of Criminal Investigations (OCI) helpline for reporting websites that sell counterfeit and/or tampered with medicines.
Insurance coverage for Ozempic shows the complexity of obesity treatment
WeightWatchers opens its doors to the complicated business of slimming drugs
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