drug

dronedarone hydrochloride

Marketedupdated 2mo ago

by Sanofi-Aventis US LLC

Approved

community read0 votes

indications

investigational

Atrial Fibrillation

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

Data sources

ClinicalTrials.gov

last refreshed 1h ago

Found something off?

Patent cliff

source: FDA Orange Book

first barrier falls

Apr 16, 2029

~2.8 years out

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

patents (3)

Jun 30, 2031method-of-use (U-1473)US 86022155.0y
Apr 16, 2029method-of-use (U-1388)US 84101672.8y
Apr 16, 2029method-of-use (U-1726)US 91079002.8y

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Trials studying dronedarone hydrochloride

N/ABioequivalence Study of Dronedarone Hydrochloride Tabletscompletedn=48
N/ABioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditionscompletedn=51