bedaquiline fumarate · Janssen Therap · NDA 204384
Sirturo
Earliest generic entry, as listed · earliest of 2 marketed strengths
19 Mar 2029
Blocked by patent: US 8546428.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8546428 | drug substance, drug product, use U-1321 · sets the listed date | 19 Mar 2029 |
| US 7498343 | drug substance, drug product, use U-1321 | 1 Dec 2026 |
Exclusivities · 3 unexpired
| NPP | new patient population | 28 Jul 2028 |
| M-306 | miscellaneous (3 years) | 21 Jun 2027 |
| ODE-307 | orphan drug (7 years) | 27 May 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204384 · 001 · RLD | tablet, oral | EQ 100MG BASE | 19 Mar 2029 |
| 204384 · 002 · RLD | tablet, oral | EQ 20MG BASE | 19 Mar 2029 |
Expired or delisted (2)
- ODE-251 · 9 Aug 2026
- ODE* · 9 Aug 2026