CliffBio
small molecule

SIRTURO

BEDAQUILINE FUMARATE

Loss of exclusivityMarch 2029latest FDA-listed patent expiry
CompanyJANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

Drug detail

Brand nameSIRTURO
Active ingredientBEDAQUILINE FUMARATE
StrengthEQ 100MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2012
Marketing statusRX

Listed patents

PatentExpiresType
8546428March 2029substance, product
7498343December 2026substance, product

Regulatory exclusivity

CodeExpires
M-306June 2027
ODE-307May 2027
ODE-251August 2026

More from JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

SIRTURO patent cliff — loss of exclusivity March 2029 | CliffBio