SIRTURO

Peak

bedaquiline fumarate

Enthera Pharmaceuticals
NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
8/100

Loss of Exclusivity

LOE Date
Mar 19, 2029
37 months away
Patent Expiry
Mar 19, 2029
Exclusivity Expiry
Jun 21, 2027

Patent Records (2)

Patent #ExpiryTypeUse Code
7498343
Dec 1, 2026
SubstanceProduct
U-1321
8546428
Mar 19, 2029
SubstanceProduct
U-1321
Company
Enthera Pharmaceuticals
Enthera Pharmaceuticals
Italy - Milan
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers