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The booming market for weight-loss drugs has drug companies frustrated by the infiltration of counterfeit and synthetic imitations into the U.S. medical supply chain.
Novo Nordisk Consumer warning Last year, counterfeit semaglutide, the active ingredient in Ozempic and Wegovy, was discovered in the United States, and the FDA The alarm was raised Eli Lilly also spoke out about counterfeit Ozempic in December, urging retailers, health care workers and patients to look for specific batch numbers that may be counterfeit. Consumer warning The company is investigating the risks associated with counterfeit and compounded versions of Tirzepatide, the raw material in its medicines Maunjaro and Zepbound.
How widespread is the problem? It’s nearly impossible to know, according to Jeffrey Potter, partner and head of the anti-counterfeiting practice and brand protection team at the law firm Patterson Belknap, who has represented pharmaceutical companies in lawsuits against hundreds of defendants who allegedly sold counterfeit or substantially different medicines and medical devices.
“The amount of counterfeit medicines is staggeringly high, but there’s no way to really measure it because there’s no one to count them,” Potter said.
Despite attempts by authorities to crack down, selling counterfeit medicines remains big business. A 2020 study by the Center for Health Economics Innovation at the Pacific Research Institute estimated that global sales of counterfeit medicines amounted to $1.2 billion. $200 billion and $431 billion Every year, the weight loss drug market is the largest $200 billion by 2030there is ample room for counterfeit products to get into the hands of patients.
A complex problem
As clear leaders in the obesity market, Novo and Lilly are tackling the problem of counterfeit products, addressing both fake medicines and synthetic versions sold on alternative medicine and wellness sites.
Lily recently Open Letter The company announced it would take legal action against medical spas, wellness centers and other retailers selling compounded tirzepatide in response to “certain practices” related to the drug’s use.
Compounding drugs are approved by the FDA under certain conditions, including: ShortageHowever, these drugs are not approved by the FDA and have not been tested for safety or effectiveness. Combined versions of semaglutide and tirzepatide are now available at prices that are much cheaper for patients compared to the list price of brand-name GLP-1s. For example, direct-to-consumer online wellness company Hims & Hers announced a weight loss program last month, offering combined semaglutide starting at $199 per month. This is Retail price over $900 One month’s supply of Ozempic.
Lilly said tirzepatide, which it does not manufacture, is dangerous. The company also opposes the use of tirzepatide for cosmetic weight loss, saying “Maunjaro and Zepbound are indicated for the treatment of serious medical conditions.” Lilly also said it has found that some combination marketers are piggybacking on its clinical success and citing Lilly’s trial results to market other combination products.
“The amount of counterfeit medicines is staggeringly high, but there’s no way to really measure it because there’s no one to count them.”
Jeffrey Potter
Chairman, Partner, Anti-Counterfeit Practice and Brand Protection, Patterson Belknap
The latest wave of lawsuits announced by the company targets combination distributors who misleadingly present Lilly’s products as if the combined versions had similar effects.
“Lilly’s lawsuit is not an anti-counterfeiting action,” Potter said. “None of the defendants are alleging that their products are in fact manufactured by Lilly. Rather, the defendants are allegedly alleging that their compounded products are the same as Lilly’s products.”
By taking on just six lawsuits, Lilly may be trying to warn other distributors that it is serious, Potter said.
“Lilly has chosen to sue a representative small number of distributors who allegedly made these false claims,” Potter said. “Lilly hopes to deter others from making false claims and to encourage other wrongdoers to change their claims before they are sued.”
Lily, last year A series of lawsuits Lilly filed lawsuits in September and October and has now settled several lawsuits, including one with Totality MediSpa for monetary payments, and other lawsuits with medical spas. Lilly alleges that the medical spas engaged in false advertising, misleading consumers into thinking they were selling Lilly’s Tirzepatide products, and infringed Lilly’s trademarks.
Resource Allocation
When it comes to counterfeiting, pharmaceutical companies have the option of filing civil lawsuits or leaving it to the authorities. Potter said civil counterfeiting has advantages, such as the ability of trademark holders to quickly seize counterfeit medicines, freeze bank accounts and quickly eliminate distribution channels. Criminal lawsuits by law enforcement or government agencies can be a longer process, he said.
“Criminal proceedings can take years and there is no guarantee that criminal prosecutions will be brought. There is no way to stop the sale going on in the meantime,” Potter said.
In some versions Wegovi The supply shortage has prompted Novo Holdings to ramp up production and, in February, spent $16.5 billion to buy contract manufacturer Catalent Corp. Then this week, Novo said it would spend another $4.1 billion to buy the company. Build a manufacturing facility The company has a manufacturing facility for injectable drugs in North Carolina.
But Novo is also taking action against counterfeits. CEO Lars Fruagaard Jorgensen said the company Cooperate with authorities The suspect supplies were inspected earlier this year.
Like Lilly, Novo has taken on combination drug distributors, filing 21 lawsuits against medical spas, weight-loss clinics and pharmacies. Novo has successfully barred the defendants from the courts for good. Five Final Judgments It prohibits companies from “engaging in deceptive, misleading or unlawful marketing practices” in selling combined semaglutide.
For Lilly, the collaborative effort is not about eliminating unfair competition, but about communicating the risks.
“Lilly is trying to educate patients about the difference between genuine Lilly products and counterfeits, whether they are potentially deadly counterfeits or riskier combination drugs,” Potter said. “Because Lilly cannot manufacture in sufficient quantities to meet demand, it would be difficult to argue that these missales are costing Lilly business. Instead, Lilly is filing these lawsuits to protect patients.”
So far, both companies face an uphill battle educating patients about counterfeit drugs and dealing with compound sellers encroaching on their trademarked territory, a battle that is likely to drag on as demand for the drugs shows no signs of ending.
