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If a manufacturer files an ANDA with a Paragraph IV certification claiming the patents are invalid, it triggers a 30-month stay and likely patent infringement litigation
In the pool of placebo-controlled type 2 diabetes trials summarized on the label, diarrhea was reported by 1.9% of patients on placebo, 8.5% of patients on Ozempic 0.5 mg, and 8.8% of patients on Ozempic 1 mg
Figure 3 shows that, while there were no or small differences in discontinuation rates between subgroups according to status of ASCVD, chronic kidney disease and heart failure among users of GLP-1 receptor agonists, discontinuation rates were higher among those with normal weight vs other weight categories
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