Product-specific guidance is a technical document that tells generic developers what evidence the FDA expects in an abbreviated new drug application. More fundamentally, patents and exclusivity still block generic semaglutide and tirzepatide in the United States. Patents and exclusivity still block generic semaglutide and tirzepatide in the United States, and no application has been approved. No generic semaglutide or tirzepatide exists. Compounded products are not FDA-approved and are not assessed against these standards.