drug

bedaquiline fumarate

Marketedupdated 2mo ago

by Janssen Therapeutics

Approved

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ClinicalTrials.gov

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Patent cliff

source: FDA Orange Book

first barrier falls

Aug 9, 2026

33 days

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

patents (4)

Mar 19, 2029compositionUS 85464282.7y
Mar 19, 2029compositionUS 85464282.7y
Dec 1, 2026compositionUS 7498343147d
Dec 1, 2026compositionUS 7498343147d

FDA exclusivities (6)

Jun 21, 2027M-306Method (3y)349d
Jun 21, 2027M-306Method (3y)349d
May 27, 2027ODE-307Orphan Drug (7y)324d
May 27, 2027ODE-307Orphan Drug (7y)324d
Aug 9, 2026ODE-251Orphan Drug (7y)33d
Aug 9, 2026ODE*ODE*33d