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doi: 10.2174/1381612826666200424180139

When a generic company files an ANDA with a Paragraph IV certification asserting that an Orange Book-listed patent is invalid, unenforceable, or not infringed, the brand manufacturer receives formal notification of that certification

Lancet 366 , 985990 (2005)

Serious but less common adverse effects include pancreatitis, gallbladder disease, acute kidney injury (particularly in the setting of dehydration from gastrointestinal symptoms), and hypoglycemia when used in combination with insulin or sulfonylureas