Sirturo Patent Expiration

SIRTURO's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7498343 JANSSEN THERAP Mycobacterial inhibitors
Dec, 2026

(2 years from now)

US8546428 JANSSEN THERAP Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Mar, 2029

(4 years from now)



Sirturo is a drug owned by Janssen Therapeutics Div Janssen Products Lp. It is used for treating pulmonary multi-drug resistant tuberculosis. Sirturo uses Bedaquiline Fumarate as an active ingredient. Sirturo was launched by Janssen Therap in 2012. It is is available in tablet form for oral use. Its generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 19, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 28, 2017
Orphan Drug Exclusivity(ODE-38) Dec 28, 2019
Orphan Drug Exclusivity(ODE) Dec 28, 2019
New Patient Population(NPP) Aug 09, 2022
Orphan Drug Exclusivity(ODE-251) Aug 09, 2026
Orphan Drug Exclusivity(ODE-307) May 27, 2027

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Drugs and Companies using BEDAQUILINE FUMARATE ingredient

NCE-1 date: 28 December, 2016

Market Authorisation Date: 28 December, 2012

Treatment: Treatment of pulmonary multi-drug resistant tuberculosis

Dosage: TABLET

More Information on Dosage

SIRTURO family patents

Family Patents