Eli Lilly & Co. is ramping up its legal campaign against companies that were temporarily allowed to make and sell copycat versions of its blockbuster drugs used for weight loss until a shortage in the United States ended last week.
The drugmaker said it's sending hundreds of cease-and-desist letters to telehealth companies, compounding pharmacies and medical spas, demanding that they stop making, selling and promoting products that mimic Lilly's Mounjaro and Zepbound.
Patients around the world have been clamoring for drugs made by Lilly and Novo Nordisk A/S that can help them shed dozens of pounds. The Food and Drug Administration had deemed Lilly's drugs in short supply since December 2022, allowing compounding pharmacies to mass-produce copies often sold through telehealth firms and weight-loss spas. When the FDA removed the shortage designation on Oct. 2, compounders lost that permission.
"Because Lilly's FDA-approved medicines are available, you must immediately cease any production, sale, dispensing and marketing" of compounded copies, Lilly said in letters that it's sending to manufacturers and marketers of the copycat drugs.
Hundreds of thousands of Americans have been taking compounded versions of drugs from Lilly and Novo, likely generating as much as $1 billion in annual sales for compounding pharmacies, according to bankers that work with the industry.
There are drawbacks to compounded drugs. They aren't reviewed by regulators for safety and effectiveness like brand-name or generic versions.
Yet they give an option to patients otherwise unable to obtain weight-loss drugs due to shortages. They're also significantly cheaper than brand-name shots that can cost more than $1,000 a month.
The FDA's decision to move Lilly's branded drugs off the shortage list doesn't mean they're always available. Patients might have difficulty filling prescriptions "over the next few months," Lilly's website said Wednesday, attributing these challenges to "supply chain dynamics" outside the company's control.
Scott Welch, co-owner of Preston's Pharmacy in Virginia, said that the day after FDA declared the shortage over, he was unable to order Mounjaro or Zepbound. "I was at a loss for words," Welch said recently at a press conference hosted by the Alliance for Pharmacy Compounding, an industry group.
The trade group has called on pharmacies to "immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound." While some have complied, others have said they will continue making customized versions of Lilly's drugs for specific patients. U.S. policy allows compounders to make bespoke versions of drugs when prescribers say it's medically necessary.
Another compounding advocacy group argues that the FDA erred in lifting the shortage designation. The Outsourcing Facilities Association, which represents bulk compounders, sued the FDA, saying its decision deprives patients of needed medicines. The agency declined to comment on the suit, which doesn't name Lilly.
Information for this article was contributed by Madison Muller of Bloomberg News.