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doi: 10.1177/0091270005278806 [DOI] [PubMed] [Google Scholar] 150.Blase E, Taylor K, Gao HY, Wintle M, Fineman M

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* Compounded versions of semaglutide are not FDA-approved, and neither the FDA nor any global regulatory agency has reviewed these products for safety, quality, or efficacy

The clinical outcomes data is robust and the benefit-risk profile, in appropriate patient populations, is well established

In most instances, the combination of FDA approval and patent protection affords the manufacturer a legally protected monopoly over the drug substance in the United States, sometimes for 12 years or longer until the patent expires and generics can enter the market