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Lily’s Legal Woes Due to Compounded Copies of Its Blockbuster Drug
(Thursday, April 18, 2024) Eli Lily has been trying to rein in compounding pharmacies from selling compounded versions of its super blockbuster anti-obesity drugs for more than a year now, unsuccessfully, and in the process establishing precedence for the rights of such unauthorized legal versions of approved drugs that would have an impact on other similar scenarios. Compounding pharmacies have been used in the past to create cheaper competing products for innovator drugs, but never has this issue been litigated so vigorously before, and the outcome of these litigations will reverberate industry-wide. Eli Lily and Novo Nordisk hit the canonical jackpot with their GLP-1 agonists that were originally developed for the treatment of Type 2 diabetes but were later found to lead to remarkable weight loss and hence becoming more popular for the treatment of obesity. The demand for their drug for weight loss treatment is so high that the companies are unable to manufacture enough to meet the market needs and the authorized versions of these drugs are in shortage. Being listed by the FDA on the Drug Shortage list opens the door for compounding pharmacies to legally sell compounded versions. Although the FDA has expressed its displeasure with compounding pharmacies for manufacturing GLP-1 agonists and has warned a few for selective violations and updated its rules for mass production by compounding pharmacies, it cannot legally stop the pharmacies from selling their drugs. To legally block these sales, both Eli Lily and Novo have sued several compounding pharmacies, so far unsuccessfully. A recent Florida court ruling against Lily’s lawsuit against a compounding pharmacy clarifies that Lily is not allowed to sue the pharmacies for compounding their drugs under the current laws. The judge dismissed Lily’s lawsuit with prejudice since the pharmacies sell the compounded drug without using the brand names owned by Lily and are otherwise operating legally. Other lawsuits by the manufacturers of the FDA-approved drugs have had similar fates. The short answer from these cases is, that as long as the drugs are officially in shortage (no pun intended), compounding pharmacies can legally create their version of the FDA-approved drug. The only way, Lily and Novo can counter this competition is by increasing their production so that the drugs are no longer in shortage. Otherwise, the courts do not agree that the financial losses by the companies are sufficient grounds for stopping the sale of legal compounded versions of their drugs. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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