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We urge sleep medicine providers to educate themselves on compounded tirzepatide and discuss the associated safety risks with their patients who bring up copycat tirzepatide
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They are not identical to, nor interchangeable with, any FDA-approved GLP-1 medications in composition, dosage strength, or protocol
What changes the calculus: if a generic manufacturer successfully challenges Novo Nordisk's formulation patents as invalid or files an ANDA with a Paragraph IV certification (claiming the patents are invalid or not infringed), they could trigger a 30-month stay during which the FDA cannot approve the generic
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