Orange Book product · Brand (NDA)
SIRTURO
BEDAQUILINE FUMARATE
At a glance
May 27, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2020
6 yr 2 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Aug 09, 2026
in 2 mo
Patent 7498343 expires
Listed drug substance patent expiration.
Dec 01, 2026
in 6 mo
Exclusivity ends · ODE-307
Orphan-drug exclusivity (7 years)
May 27, 2027
in 11 mo
Exclusivity ends · M-306
New use / labeling-change exclusivity (3 years)
Jun 21, 2027
in 1 yr
Patent 8546428 expires
Listed drug substance patent expiration.
Mar 19, 2029
in 2 yr 9 mo
Pharmaceutical detail
Active ingredient
BEDAQUILINE FUMARATE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 204384
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- ODE*FDA marketing exclusivity
Aug 09, 2026
in 2 mo
- ODE-307Orphan-drug exclusivity (7 years)
May 27, 2027
in 11 mo
- M-306New use / labeling-change exclusivity (3 years)
Jun 21, 2027
in 1 yr
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7498343 | Dec 01, 2026 | in 6 mo | SubstanceProductU-1321 |
| 8546428 | Mar 19, 2029 | in 2 yr 9 mo | SubstanceProductU-1321 |
