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See the DrugPatentWatch profile for tigecycline
How does tigecycline affect liver function in adults Tigecycline can raise liver enzymes in adults. Studies show rates of elevated ALT and AST occur in 3-7% of patients treated with tigecycline. These elevations are usually mild and resolve after stopping the antibiotic. What liver tests show elevation during tigecycline use ALT and AST levels rise more often than ALP or bilirubin. The increases stay below five times the normal upper limit in most cases. Clinical hepatitis or jaundice develops rarely, under 1% of cases. Can severe liver injury occur with tigecycline Severe liver injury remains rare. FDA reports list a few cases of acute liver failure, but they occur mainly in patients who already had liver disease or took other drugs that belasten the liver. Patients with Child-Pugh class B or C liver impairment need dose adjustments. Why do companies challenge tigecycline patents Patent disputes center on crystalline forms and manufacturing methods. Companies seek invalidity rulings to launch generics sooner. Several ANDA filings target the branded version made by Pfizer. When does tigecycline patent expire The main composition-of-matter patent expired in 2015. Remaining patents on crystal forms and formulations protect the product until at least 2025 in the United States.
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