Like that of other GLP-1 agonists, the prescribing information for tirzepatide contains a black box warning about thyroid C-cell tumors, based on data from rats with unclear significance to humans
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Available from: Cai Q, Jeong YY (2020) Mitophagy in Alzheimers disease and other age-related neurodegenerative diseases
Before filing an ANDA, a generic developer can review the Orange Book listing for the reference listed drug, identify every patent it must address, research the legal strength of each, model expiry dates and litigation timelines, and estimate with reasonable precision what a successful Paragraph IV challenge would cost and what the 180-day exclusivity window would yield