drug

plecanatide

Marketedupdated 2mo ago

by Salix Pharmaceuticals Ltd

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Jan 30, 2028

~1.6 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (10)

Jun 5, 2034compositionUS 10011637
Jun 5, 2034formulationUS 11142549
Jun 5, 2034formulationUS 11834521
Jun 5, 2034formulationUS 12146003
Aug 20, 2032formulationUS 9616097
Mar 1, 2032formulationUS 11319346
Sep 15, 2031method-of-use (U-2230)US 9610321
Sep 15, 2031method-of-use (U-1999)US 9919024
Sep 15, 2031formulationUS 9925231
Jan 30, 2028compositionUS 70417861.6y

Data sources

ClinicalTrials.gov

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Trials studying plecanatide

phase2Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)completedn=218
phase3Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipationcompletedn=648